EXCLUSIVE! COVID-19 Drugs & Vaccines: A List Of All The Research And Developments Underway Encompassing More Than 149 Projects.

COVID-19 Drugs And Vaccines: As the total number of global confirmed COVID-19 Infections reaches 10,267, 578 and the total confirmed deaths due to the SARS-CoV-2 coronavirus reaches 504, 812 (29^th June, 2.45am California), people everywhere and healthcare professionals are getting more anxious as to date there are no real confirmed drugs or treatments protocols that can really treat COVID-19 effectively while the pandemic is actually set to escalate soon.


 
The initial frontrunners such as alpha interferon, Lopinavir / Ritonavir, Oseltamivir, Hydroxychloroquine, Favipiravir, Camostat, Ledipasvir, Neifinavir, Danoprevie, Tenofovir, Azithromycin, Tocilizumab, etc used in various protocols or combos have failed to show any true efficacy against the SARS-CoV-2 coronavirus or its accompanying conditions or symptoms. https://www.thailandmedical.news/news/breaking-covid-19-drugs-us-fda-drug-trial-concludes-that-most-drugs-being-used-including-favipiravir,-lopinavir,-ritonavir,-chloroquine-has-no-effects and https://www.thailandmedical.news/news/breaking-news-study-confirms-that-lopinavir%E2%80%93ritonavir-ineffective-in-treating-covid-19 and https://www.thailandmedical.news/news/favipiravir-studies-involving-animal-models-shows-favipiravir-has-very-weak-effect-on-sars-cov-2-and-not-viable-as-an-effective-therapeutic
 
Gilead’s Remdesivir is highly controversial as no safety studies have ever been conducted on the drug and the drug was hastily approved by the Trump administration with possible ‘negative unethical connotations and acts involved’ but even then a lot of other incompetent European countries are also following suit despite the only supporting medical fact is that the drug can only reduce hospitalization time by 5 days!
 
As more details emerge as to how the SARS-CoV-2 coronavirus affects the human body, it is now recognized that it is not just a normal respiratory disease but is one that affects the various organs and systems of the human body and it is becoming a reality that no single drug will be able to treat COVID-19 but rather a whole list of drugs starting from antivirals to anti-inflammatory drugs, anti-clotting drugs, antibiotics for secondary infections and sepsis and other drugs, all depending on the strains affecting the patients and their underlying medical conditions and how the virus decides to attack their bodies.
 
Many drug repurposing studies have seen promising candidates from cheap and common drugs like ivermectin, colchicine, prazosin, famotidine, niclosamide, disulfiram, celebrex, heparin, inhaled nitric oxide and also dexamethasone, but more research and clinical trials are needed but unfortunately in most cases these is a lack of funding as the big pharma giants do not find it viable to support the research of drugs whose patents have lapsed. (studies on all these drugs can be found in Thailand Medical News, simply use the search function)
 
Then there have been supplements and phytochemicals that have shown certain degrees of efficacy towards treating or being used as adjuvant treatments for COVID-19. Some of these include Vitamin D, Vitamin C, Vitamin B12, Magnesium, Melatonin, Omega-3 fatty acids, Glutathione, NAC (N-Acety Cysteine), Alpha-Lipoic Acid, EGCG (from Green Tea), Silymarin (from Milk Thistle), Selenium, Rutin, Quercetin, Hesperidin Licorice Root, Aswagandha, Artemisia Annua,  Occulus Hirsutus, Andrographis Panniculata , Curcumin, Honeysuckle flowers, the TCM (traditional Chinese Medicine) formulations Qingfei Paidu and Lianhua Qingwen. (Articles and studies on all these can be found on Thailand Medical News.) However once again, more detailed studies and funding are needed to further explore all of these for use in possible COVID-19 treatments.
 
These are the list of 149 drug and vaccine developments and  research being done by various pharmaceutical companies in terms of finding possible drugs, vaccines or treatment protocols for COVID-19.
 
1. BioNTech, Pfizer, and Fosun Pharma
 
Candidate: BNT162 
Type: Potential first-in-class mRNA vaccine designed to induce immunity and prevent COVID-19 infection
 
Status: BioNTech and Pfizer said April 9 they intend to launch their first clinical trials for an mRNA COVID-19 vaccine as soon as the end of April, initially in the United States and Europe across multiple sites. The companies said they will advance multiple candidates.
 
2. CanSino Biologics
 
Candidate: Vaccine for prevention of COVID-19 
Type: Recombinant Novel Coronavirus Disease Vaccine incorporating the Adenovirus Type 5 Vector (Ad5-nCoV)
 
Status: CanSino on April 9 said it and China’s Beijing Institute of Biotechnology, Academy of Military Medical Sciences, plan to initiate phase II clinical trial for Ad5-nCoV in China. The vaccine candidate is the first novel coronavirus vaccine for COVID-19 to advance to Phase I in China. The company has cited results from animal studies showing that the vaccine candidate can induce strong immune response in animal models.
 
3. CytoDyn
 
Candidate: Leronlimab (PRO 140) 
Type: Humanized IgG4 monoclonal antibody. Leronlimab is CytoDyn’s lead candidate, and is a CCR5 antagonist for patients who experience respiratory illness as a result of COVID-19 with potential for multiple therapeutic indications.
 
Status:  CytoDyn has initiated enrollment in a planned 75-patient Phase II trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND is also proceeding with its second COVID-19 clinical trial, a planned 342-patient Phase IIb/III study in critically ill COVID-19 patients, with the primary endpoint being the mortality rate at 14 days. CytoDyn and Longen China Group has said they will begin exploring leronlimab as a potential treatment for coronavirus as well as cancer.
 
4. Distributed Bio
 
Candidates: Antibodies bioengineered to fight COVID-19 
Type: Broadly neutralizing antibodies based on the company’s SuperHuman platform, which according to the company is the world’s most advanced computationally optimized human antibody library for antibody discovery.
 
Status:  The company is working to extract five SARS-CoV-2 antibodies and mutate them into 1 billion different types to see whether any of the antibodies bind to the virus that causes COVID-19.If a potential antibody is identified this month, it could be mass produced in August or September. 
 
5. ncyte and Novartis
 
Candidate: Jakafi® / Jakavi® (ruxolitinib)
Type: Janus kinase (JAK1/JAK2) inhibitor first approved by the FDA in 2011, with indications in polycythemia vera, myelofibrosis, and acute graft-versus-host disease. Marketed as Jakafi in the U.S. by Incyte, and as Jakavi outside the U.S. by Novartis.
 
Status: In the U.S., Incyte added, it intends to begin an open-label emergency Expanded Access Program (EAP) that will allow eligible patients with severe COVID-19 associated cytokine storm to receive Jakafi while it is being studied for that indication. The company added that it is increasing manufacturing efforts to respond to anticipated supply needs related to its COVID-19 studies. Outside the U.S., Novartis has established an international compassionate use program for eligible patients, and said it is working to manage the anticipated increase in COVID-19 related requests for Jakavi without interrupting access for patients using the drug for its authorized indications.
 
6. Inovio Pharmaceuticals and Beijing Advaccine Biotechnology
 
Candidate: INO-4800 
Type: DNA vaccine
 
Status:  Last month, Inovio joined biologics CDMO Ology Bioservices on March 24 to announce that Ology was awarded an $11.9 million Department of Defense (DoD) contract to work with Inovio on DNA technology transfer to rapidly manufacture INO-4800 and deliver it to DoD for upcoming clinical trials. Inovio said it received a $5 million grant from the Bill and Melinda Gates Foundation to accelerate testing and scale-up of CELLECTRA® 3PSP, a hand-held smart device for the intradermal delivery of INO-4800. Inovio is partnering with Beijing Advaccine Biotechnology on a Phase I trial in China in parallel with the company’s clinical development efforts in the U.S. to develop INO-4800 as a coronavirus treatment. Inovio will develop INO-4800 through Phase I testing in the U.S., and has launched preclinical testing for clinical product manufacturing. INO-4800 development is also supported by a $9-million grant from the Coalition for Epidemic Preparedness Innovations (CEPI).
 
7. Janssen Pharmaceutical Cos. (J&J) and BARDA
 
Candidates: Lead vaccine candidate and two backups to prevent COVID-19 
Type: Not specified, but based on vaccine constructs created and tested by J&J with Beth Israel Deaconess Medical Center (BIDMC), part of Harvard Medical School, using Janssen’s AdVac^® technology.
 
Status: Johnson & Johnson expects to start Phase I human trials by September for its lead COVID-19 vaccine candidate, and has expanded its vaccine R&D and clinical testing partnership between J&J’s Janssen Pharmaceutical Cos. and the Biomedical Advanced Research and Development Authority (BARDA) that is valued at over $1 billion.J&J said it aims to have clinical data available by year’s end on the safety and efficacy of its lead COVID-19 vaccine candidate, an accelerated development and testing timeframe it said would allow vaccine availability for emergency use in early 2021.
 
8. Moderna
 
Candidate: mRNA-1273
Type: Novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein.
 
Status: Moderna’s platform is based on injecting mRNA into cells to produce protein in human cells. Moderna dosed the first patient in a Phase I open-label, dose-ranging trial of mRNA-1273 (NCT04283461) in males and non-pregnant females, 18 to 55 years old, occurring at Kaiser Permanente Washington Health Research Institute in Seattle. The 45-patient study will assess the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults. The first batch of mRNA-1273 was shipped in February to the VRC, which partnered with Moderna in designing the vaccine.
 
9. Regeneron Pharmaceuticals and Sanofi
 
Candidate: Kevzara® (sarilumab)
Type: Interleukin-6 (IL-6) receptor antagonist approved by the FDA in 2017 to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
 
Status: Regeneron Pharmaceuticals and Sanofi said March 30 they dosed the first ex-U.S. patient in the second multi-center, double-blind, Phase II/III trial (NCT04315298) conducted as part of the Kevzara COVID-19 program assessing Kevzara® (sarilumab) in severe COVID-19 patients. The 300-patient second trial will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo.
On March 16, the companies said they had launched the first Phase II/Phase III clinical trial of Kevzara in the U.S. in severe COVID-19 patients. Up to 400 adults hospitalized with serious complications from COVID-19 will be assessed in that study, set to begin in medical centers in New York. The global clinical program has been launched in Italy, Spain, Germany, France, Canada, Russia and the U.S. Regeneron leads clinical studies in the U.S., while Sanofi does so overseas.
 
 
10 .University of Pittsburgh
 
Candidate: PittCoVacc, short for “Pittsburgh Coronavirus Vaccine” 
Type: Microneedle array (MNA)-delivered recombinant protein subunit vaccine targeting SARS-CoV-2.
 
Status: Pitt researchers on April 1 published a study in the open access journal EBioMedicine detailing their development of PittCoVacc.Louis Falo, MD, PhD, and Andrea Gambotto, MD, were co-senior authors of the study, which reported that PittCoVac generated a surge of antibodies against SARS-CoV-2 within two weeks of MNA delivery when tested in mice. The MNA is a fingertip-sized patch of 400 small needles made of sugar and protein pieces, designed to deliver the spike protein pieces into the skin, where the needles dissolve. The microneedle array can sit at room temperature until it is needed.Pitt said its researchers are applying for an IND approval from the FDA, and aim to start a Phase I human clinical trial in the next few month
 
11. Vir Biotechnology and Alnylam
 
Candidates: Small interfering RNA (siRNA) treatments for up to nine infectious disease targets including three host factors required for SARS-CoV-2 infection. 
Type: siRNA treatment(s) to be identified by Alnylam that target highly conserved regions of coronavirus RNAs. Alnylam has designed and synthesized over 350 siRNAs targeting all available SARS-CoV and SARS-CoV-2 genomes, which will be screened in in vitro potency assays, the companies said.
 
Status: Vir and Alnylam said April 2 they are again expanding their 2-1/2-year-old siRNA collaboration, agreeing to develop novel siRNAs for up to nine infectious disease targets. The companies agreed to advance up to three additional host factor-targeting candidates to treat SARS-CoV-2 and potentially other coronaviruses. The companies named two of the three targets, angiotensin converting enzyme-2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2), adding that the third may emerge from Vir’s functional genomics work.
 
12. Vir Biotechnology, Biogen, and NIAID (with WuXi Biologics and Xencor)
 
Candidates: Two versions of a human monoclonal antibody. 
Types: Monoclonal antibody versions engineered through Vir’s platform and designed to neutralize SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (SARS). That, according to VIr, indicates that the epitope is highly conserved, and thus makes it harder for escape mutants to develop.Each version has a half-life extending alteration to potentially extend the time over which the antibody provides protection.One version has been developed with a second “vaccinal” mutation designed to increase short-term potency; the other version doesn’t have that mutation. The mutation allows the antibody to function both as a therapeutic and a vaccine, Vir says. The lead candidates are among additional antibodies identified by Vir that bind to different sites, and therefore could be used in combination with the lead development candidates.
 
Status: Vir Biotechnology on March 25 said it intended to move “as soon as possible” both versions of its lead antibody candidate into human Phase I/II trials, after two separate labs confirmed that the antibody neutralized SARS-CoV-2. The trial is expected to start within 3–5 months.
 
13. Vir Biotechnology and GlaxoSmithKline (GSK)
 
Candidates: Antibodies, vaccines, and functional genomics products 
Type: Antiviral antibodies based on Vir’s proprietary monoclonal antibody platform technology; Vaccines based on GSK’s vaccine technologies; Functional genomics products based on genome-wide CRISPR screening of host targets
 
Status: GSK agreed to make a $250 million equity investment in Vir under an R&D collaboration designed to advance COVID-19 candidates into Phase II clinical trials later this year, the companies said April 6. The companies agreed to identify new anti-viral antibodies, and study existing ones, to prevent and treat COVID-19 and future coronaviruses.
 
14. Alexion Pharmaceuticals
 
Candidate: Soliris® (eculizumab)
Type: Complement inhibitor approved for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
 
Status: Alexion said March 24 it had discussed possible options to investigate Soliris in COVID-19 with global health authorities, in order to better understand the role of terminal complement inhibition in managing the severe pneumonia associated with the virus. Alexion added that it had provided Soliris as an experimental emergency treatment for a small number of patients with COVID-19 infection and severe pneumonia at the request of physicians, and in accordance with relevant national regulatory agencies.
 
15. Amgen and Adaptive Biotechnologies
 
Candidate: Antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19 
Type: Fully-human neutralizing antibodies to be discovered and developed
 
Status: Amgen and Adaptive Biotechnologies said April 2 they will partner to discover and develop antibodies through a collaboration intended to combine Adaptive Bio’s immune medicine platform for identifying virus-neutralizing antibodies with Amgen’s expertise in immunology, antibody engineering, and novel antibody therapy development. Adaptive Bio will use its high throughput platform to rapidly screen the B cell receptors from individuals who have recovered from COVID-19, enabling identification of tens of thousands of naturally occurring antibodies. Amgen will select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2. Amgen subsidiary deCODE Genetics in Iceland will provide genetic insights from patients who were previously infected with COVID-19.
 
16. APEIRON Biologics
 
Candidate: APN01
Type: Recombinant human angiotensin-converting enzyme 2 (rhACE2) developed to treat acute lung injury, acute respiratory distress syndrome, and pulmonary arterial hypertension. APN01 is designed to imitate the human enzyme ACE2 so that the virus can no longer infect the cells, as SARS-CoV-2 binds to soluble ACE2/APN01 instead of ACE2 on the cell surface. APN01 is also designed to reduce harmful inflammatory reactions in the lungs and protects against acute lung injury/acute respiratory distress syndrome (ALI/ARDS).
 
Status: APEIRON said April 2 it received regulatory approvals in Austria, Germany, and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19 (NCT04335136). The trial aims to compare APN01 to placebo in up to 200 severely infected COVID-19 patients at 10 sites. The first patients are expected to be dosed shortly, according to the company. APN01 has been shown to be safe and well-tolerated in a total of 89 healthy volunteers and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS in previously completed Phase I and Phase II clinical trials.
 
17. Athersys
 
Candidate: MultiStem® for acute respiratory distress syndrome (ARDS)
Type: Adult-derived “off-the-shelf” therapy under development for several neurological and cardiovascular diseases, as well as inflammatory, immune and related disorders. Developed from Multipotent Adult Progenitor Cells (MAPC®) obtained from the bone marrow of healthy, consenting adult donors.
 
Status:  In March, Van Bokkelen told GEN the company was planning to launch the Phase III trial “as soon as possible.” The company has won the Biomedical Advanced Research and Development Authority (BARDA)’s designation as a “Highly Relevant” program for COVID-19 based on earlier positive results for MultiStem in ARDS, plus the FDA’s Fast Track designation for the MultiStem clinical program in ARDS the only Fast Track designation for an ARDS treatment.
 
18. Celularity and Sorrento Therapeutics
 
Candidate: CYNK-001
Type: Allogeneic, off-the-shelf Natural Killer (NK) cell therapy developed from placental hematopoietic stem cells; also being developed in multiple myeloma, acute myeloid leukemia, glioblastoma multiforme and various blood and solid tumors.
 
Status: Celularity on April 2 won FDA clearance for its IND of CYNK-001 in adults with COVID-19, allowing the company to begin a Phase I/II trial of up to 86 patients.In a February presentation, Celularity stated that its anti-COVID-19 construct had been generated within weeks, and that its DAR-T and DAR-NK cells “will soon be produced for anti-COVID-19 activity testing.” The companies in January launched a clinical and manufacturing collaboration designed to expand the therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and Celularity agreed to assess CYNK-001 as a potential novel therapy for coronaviruses, specifically SARS-CoV-2.
 
19. Cobra Biologics and Karolinska Institutet
 
Candidate: DNA vaccine against COVID-19 
Type: Vaccine designed to deliver DNA to patient muscle to generate a viral antigen on which the immune system will react. The project will use Cobra’s 50L DNA suite in Sweden to support vaccine development by producing plasmid DNA in accordance with GMP.
 
Status: Cobra and Karolinska Institutet said March 30 they were awarded €3 million ($3.3 million) in emergency funding through the EU’s Horizon 2020 funding program for R&D and Phase I clinical trial testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium. In addition to Karolinska Institutet, partners in the consortium also include Karolinska University Hospital, the Public Health Agency of Sweden (FoHM), IGEA, Adlego, and Giessen University.
 
20. CureVac
 
Candidate: Vaccine
Type: mRNA-based coronavirus treatment based on company’s vaccine platform
 
Status: CureVac on March 17 told reporters in a telephone briefing that it was committed to launching animal trials of its mRNA-based COVID-19 vaccine in April, and clinical trials in humans by early summer. The update came a day after the European Commission offered up to €80 million ($88 million) toward scaling up development and productions of the vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI) awarded the company up to $8.3 million in January for accelerated vaccine development, manufacturing and clinical tests.
 
21. Eli Lilly and AbCellera
 
Candidates: Antibodies to treat and prevent COVID-19 
Type: Anti-SAR-CoV-2 Antibodies based on AbCellera’s rapid pandemic response platform
 
Status: Eli Lilly and AbCellera said March 13 that they will partner to co-develop the most promising of 500+ unique fully human antibody sequences identified in a blood sample from one of the first U.S. patients to recover from COVID-19. AbCellera will tap into the expertise of the Dale and Betty Bumpers Vaccine Research Center of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which will identify the antibodies that bind the pandemic strain of SARS-CoV-2 the best. AbCellera and Lilly committed to equally share initial development costs towards a treatment, after which Lilly has agreed to oversee all further development, manufacturing and distribution. If successful, Lilly will work with global regulators to bring a treatment to patients. Globally, Lilly has joined a cross-industry collaboration and the Bill & Melinda Gates Foundation to accelerate the development, manufacturing and delivery of vaccines, diagnostics and treatments for COVID-19.
 
22. I-Mab
 
Candidate: TJM2 (TJ003234) 
Type: Neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF)
 
Status: I-Mab said April 3 that the FDA cleared its IND to initiate clinical study of TJM2 as a treatment for cytokine release syndrome associated with severe illness caused by COVID-19. I-Mab also obtained central institutional review board (IRB) approval from the Western Institutional Review Board on the same day. The planned trial is a multi-center, randomized, double-blind, placebo-controlled, three-arm study designed to assess the safety, tolerability and efficacy of TJM2 in reducing the severity of complications as well as levels of multiple cytokines in patients with severe COVID-19.I-Mab added that it submitted an IND application to South Korea’s Ministry of Food and Drug Safety for a similar study in severe COVID-19 patients in South Korea.
 
23. Karyopharm Therapeutics
 
Candidate: XPOVIO® (selinexor)
Type: First-in-class, oral selective inhibitor of nuclear export (SINE), designed to block the cellular protein XPO1. Selinexor was granted FDA accelerated approval in July 2019 in combination with dexamethasone as a treatment for some adults with relapsed refractory multiple myeloma.
 
Status: Karyopharm said April 7 it will initiate a global randomized clinical trial evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. The company noted that SINE compounds have been shown to disrupt the replication of multiple viruses in vitro and in vivo, and to mediate anti-inflammatory and anti-viral effects, including respiratory infections, in several animal models. Karyopharm cited a preprint study published March 20 in bioRxiv identifying SINE compounds as having the potential to interfere with key host protein interactions with SARS-CoV-2. The company said it is still on track to submit a supplemental NDA to the FDA in combination with once-weekly Velcade® (bortezomib) and low-dose dexamethasone as a new second line treatment for patients with relapsed or refractory multiple myeloma, based on the BOSTON Phase III trial (NCT03110562).
 
24. Mesoblast
 
Candidate: RYONCIL™ (Remestemcel-L)
Type: Allogeneic mesenchymal stem cell (MSC) product candidate, now under FDA priority review for treating pediatric steroid-refractory acute graft versus host disease (aGVHD), with a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020.
 
Status: Mesoblast said April 6 it received FDA clearance for its IND application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with intravenous infusions of remestemcel-L, nearly a month after disclosing March 10 it was in active discussions with government and regulatory authorities, medical institutions and biopharma companies about assessing remestemcel-L in that indication. The company has cited a clinical study published in February which reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia. Mesoblast also cited post-hoc analyses of a study in 60 chronic obstructive pulmonary disease (COPD) patients submitted for presentation at a future conference, showing significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in patients with elevated inflammatory biomarkers. The same inflammatory biomarkers are also elevated in COVID-19.
 
25. Pfizer
 
Candidates: Antiviral compounds 
Types: Unspecified
 
Status: Pfizer on March 13 restated earlier plans to develop its own antivirals against COVID-19 as well as collaborate with BioNTech on an mRNA vaccine to prevent the disease. The pharma giant also articulated five principles it said would govern its drug and vaccine development activity: Sharing tools and insights; creating “a SWAT team” of experts focused solely on fighting the pandemic; applying its drug development expertise; offering any excess manufacturing capacity to support other drug and vaccine developers; and building a “cross-industry rapid response team of scientists, clinicians and technicians” to improve response to future epidemics.Earlier in March, Pfizer said it completed a preliminary assessment of antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer said it was engaging with a third party to screen these compounds under an accelerated timeline and expected to have results back by the end of March.“Toxicology studies would then need to be completed prior to any clinical development, but if successful, Pfizer hopes to be in the clinic by no later than the end of 2020,” the company added.
 
26. Regeneron Pharmaceuticals
 
Candidate: Antibody cocktail therapy 
Type: Combination of neutralizing monoclonal antibodies leveraging Regeneron’s monoclonal antibody discovery platform called VelocImmune®, part of the company’s VelociSuite™ technologies.
 
Status: Regeneron on March 17 announced making progress in developing an antibody cocktail therapy against COVID-19, saying that it isolated hundreds of virus-neutralizing, fully human antibodies from its VelocImmune mice, genetically-modified to have a human immune system—as well as antibodies from humans who have recovered from COVID-19. From these antibody candidates, Regeneron said, it will select the top two antibodies for a ‘cocktail’ treatment “based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities.” Regeneron said it is working to produce hundreds of thousands of prophylactic doses per month by the end of summer, and smaller quantities for initial clinical testing at the start of the summer. Regeneron has also said it is developing the combination of REGN3048 and REGN3051 as a COVID-19 treatment. The combination completed a 48-patient Phase I trial in MERS-CoV last year (NCT03301090.)
 
27. The University of Hong Kong (HKU)
 
Candidate: Vaccine against COVID-19 
Type: Vaccine candidate based on the established flu-based DelNS1 live attenuated influenza virus (LAIV) platform, with the deletion of the key virulent element and immune antagonist, NS1, from the viral genome, adapted to express the surface protein of SARS-CoV-2. The vaccine uses flu vector to express a specific antigen to induce immunity targeting the critical element of the Receptor Binding Domain (RBD) of SARS-CoVs.
 
Status: On March 16, HKU’s State Key Laboratory for Emerging Infectious Diseases said it received an initial $620,000 from the Coalition for Epidemic Preparedness Innovations (CEPI) toward vaccine development. HKU researchers previously completed a proof-of-concept study testing their flu-based RBD vaccine system using a MERS-CoV animal infection model, and reported that vaccination with DelNS1-MERS-RBD LAIV provided full protection from pathogenic MERS-CoV. The team is currently conducting similar proof-of-concept studies in multiple animal models.
 
28. AI Therapeutics
 
Candidate: LAM-002 (apilimod)
Type: Selective first-in-class, oral PIKfyve kinase inhibitor being developed in B-cell non-Hodgkin lymphoma and amyotrophic lateral sclerosis/frontotemporal dementia
 
Status: AI Therapeutics co-founder Jonathan Rothberg, PhD, told media the company is preparing INDs for submission to the FDA, with the goal of launching clinical trials of LAM-002 in COVID-19 in the second quarter. He citing new data that he said showed the drug was effective in cell assays in inhibiting the entry of SARS-CoV-2 through its first-in-class molecular mechanism. SAM-002 can also be combined with other antiviral drugs, which typically target other molecular mechanisms, like viral replication. AI is looking to combine SAM-002 with Gilead Sciences’ Remdesivir, said Rothberg. AI is collaborating with Yale University Medical School (clinical studies), and Zhejiang University (nonclinical). AI Therapeutics and collaborators have shown that in cell cultures, LAM-002 was effective alone and lowered the level of SARS-CoV-2 virus even more when combined with Gilead Sciences’ Remdesivir.
 
29. AIM ImmunoTech
 
Candidate: Ampligen® (rintatolimod)
Type: Immune modulator indicated for severe chronic fatigue syndrome
 
Status: AIM ImmunoTech said April 6 it entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology to research in China the efficacy of Smoore’s vaping device using Ampligen, to enable inhalation of the drug deep into the lungs at the first signs of COVID-19. In March, the company said it was in talks with regulators in the Netherlands, where Ampligen was recently used to treat pancreatic cancer patients, to explore expedited preclinical and clinical trials of Ampligen. Protocols for those trials are in final stages of development. AIM ImmunoTech also said it was actively seeking investigators and sites for clinical trials—and disclosed talks with a potential partner in Argentina, GP-Pharm, to advance Ampligen in COVID-19. The drug is approved in Argentina to treat myalgic encephalomyelitis/chronic fatigue syndrome.
 
30. AlloVir and Baylor College of Medicine
 
Candidates: T-cell immunotherapies
Type: Allogeneic, off-the-shelf, virus specific T-cell therapy designed to restore natural T-cell immunity to fight off viral infections and diseases in immunocompromised patients, including recipients of stem cell and solid organ transplants
 
Status: Allovir said March 23 it is expanding its R&D collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2. The company aims to develop a therapy for multiple coronaviruses including SARS-CoV and MERS-CoV that can be used as a standalone treatment or incorporated into its multi-respiratory virus therapy candidate, ALVR106. The allogenic, off-the-shelf multi-specific T cell (VST) is being developed as a treatment for respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (HMPV).
 
31. Altimmune and University of Alabama at Birmingham (UAB)
 
Candidate: AdCOVID 
Type: Single-dose, intranasal vaccine designed to provide systemic immunity. Altimmune based the vaccine on proprietary platform technology that was applied in developing NasoVAX™, the company’s influenza vaccine candidate that showed positive Phase IIa results.
 
Status: Altimmune said March 30 it will partner with UAB to develop AdCOVID. The company said it is preparing for immunogenicity studies and manufacture of Phase I clinical trial material. Initially, Altimmune will work with UAB investigators on preclinical animal studies and characterization of the vaccine immunogenicity with the goal of enabling a Phase I trial in the third quarter. On February 28, Altimmune said it completed the design and synthesis of the vaccine, and was “actively engaged in discussions with a number of potential partners.” Six UAB labs will work with Altimmune on the urgent collaboration, the University said.
 
 
32. Ansun Biopharma
 
Candidate: DAS181 
Type: Recombinant sialidase with broad antiviral properties for the treatment of severe COVID-19
 
Status: Ansun on April 2 reported positive preliminary data from an investigator-initiated trial of DAS181 (NCT04324489), conducted in collaboration with the Renmin Hospital of Wuhan University. The study evaluated a 10-day treatment regimen of nebulized DAS181 administered to four patients with severe bilateral viral pneumonia and hypoxemia. In the study’s first 14 days, the first two patients no longer required supplemental oxygen, and showed stabilized vital signs, increased oxygen saturation, and resolution of infiltrates on chest CT scans, according to Zuojiong Gong, MD, PhD, and Ke Hu, MD, the study’s principal investigators at Renmin Hospital. They told Thailand Medical News, “The third patient, who had been a persistent SARS-CoV-2 carrier for more than 33 days, was completely virus-free before the end of the 10-day DAS181 regimen and met all discharge criteria, and the fourth is currently undergoing treatment and showing positive trends.”
 
33. Baylor College of Medicine
 
Candidate: Vaccines against COVID-19 
Types: Recombinant protein-based vaccine consisting of the receptor binding domain (RBD) of the spike protein of the coronavirus, designed to bind to receptors found deep in the host lung tissue.
 
Status: Peter J. Hoetz, MD, PhD, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM), told China’s state news agency Xinhua on March 17 that his group at BCM’s Texas Children’s Hospital Center for Vaccine Development was working to develop a vaccine in collaboration with U.S. institutions that included the University of Texas Medical Branch, and the New York Blood Center, as well as the Virology Center at Fudan University in Shanghai. The RBD for SARS has already been manufactured for clinical use, BCM said, and additional preclinical tests are being conducted to advance it into clinical trials to determine if it is safe, sufficiently protective, or cross-reactive against COVID-19. The Baylor College of Medicine teams are also developing the RBD from COVID-19.
 
34.  Brii Biosciences, Tsinghua University, and Third People’s Hospital of Shenzhen
 
Candidates: “Multiple” monoclonal antibodies to prevent and treat COVID-19 
Type: Fully human neutralizing monoclonal antibodies from patients in China who have recovered from COVID-19
 
Status: Brii Bio joined Tsinghua University and Third People’s Hospital of Shenzhen on March 31 to announce a partnership and license agreement to discover, develop, manufacture and commercialize fully human neutralizing monoclonal antibodies against COVID-19. The collaboration aims to achieve an accelerated six-month timeline from the selection of a lead development candidate to first-in-human clinical trials, with potential for additional timeline acceleration, the partners said.The partners also cited research by Linqi Zhang at Tsinghua University and Professor Zheng Zhang at Third People’s Hospital of Shenzhen, in a preprint published March 26 in bioRxiv. The researchers characterized antibody responses in eight COVID-19 patients and isolated 206 monoclonal antibodies specific to the SARS-CoV-2 receptor-binding domain. Of the antibodies with potential therapeutic potential against SARS-CoV-2, the most potent were P2C-1F11 and P2B-2F6.
 
35. British American Tobacco (Kentucky BioProcessing)
 
Candidate: Vaccine 
Type: Vaccine based on BAT’s proprietary, fast-growing tobacco plant technology
 
Status: British American Tobacco’s Kentucky biotech subsidiary, Kentucky BioProcessing (KBP), said April 1 it has developed a potential COVID-19 vaccine that is in preclinical testing. Subject to finding partners and gaining government support, KBP said, it could manufacture between 1 and 3 million doses of the vaccine per week, starting in June. Work on the COVID-19 vaccine project will be carried out on a not-for-profit basis, according to KBP, which is a commercial entity. KBP said it recently cloned a portion of COVID-19’s genetic sequence which led to the development of a potential antigen. The antigen was inserted into tobacco plants for reproduction and, once the plants were harvested, the antigen was then purified, and is now undergoing preclinical testing.
 
 
36. CalciMedica
 
Candidate: CM4620-IE
Type: Potent and selective small molecule CRAC channel inhibitor designed to prevent CRAC channel overactivation,
 
Status: CalciMedica on April 9 said it received a “Study May Proceed” letter from the FDA allowing it to study CM4620-IE in patients with severe COVID-19 pneumonia who are at risk for progression to acute respiratory distress syndrome (ARDS).The company said it plans to enroll 60 patients with severe COVID-19 pneumonia in an open-label Phase II clinical study comparing 40 patients dosed with CM4620-IE plus standard of care to 20 patients assigned to standard of care alone. The first patients are being enrolled at Regions Hospital in St. Paul, MN, with additional patients are expected to be enrolled within the next week at Henry Ford Hospital in Detroit. Additional study sites are being evaluated.
 
37. Capricor Therapeutics
 
Candidate: CAP-1002 
Type: Cardiac cell therapy consisting of allogeneic cardiosphere-derived cells. The cells are designed to function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair.
 
Status: Capricor on April 3 said it has begun providing CAP-1002 to patients with advanced COVID-19 under the compassionate use pathway.  Two patients were treated last week at “a leading healthcare center” in Los Angeles, with additional patients planned in coming weeks. Capricor cited previously published preclinical data showing that CAP-1002 mitigated the release of anti-inflammatory cytokines as well as macrophage activation in a number of models of inflammation including sepsis and autoimmune diseases. Capricor added that it has submitted an expanded-access IND application to the FDA, seeking to investigate using CAP-1002 in certain COVID-19 patients. The application is under review.
 
38. CEL-SCI
 
Candidate: Ligand Antigen Epitope Presentation System (LEAPS) peptides
Type: Immunotherapy based on CEL-SCI’s patented LEAPS peptide platform technology, directed towards antigens within the NP protein of COVID-19 that elicit cytolytic T cell responses. Such responses attack the virus infected cellular “factories” within the infected host in order to eliminate the source of virus and help subdue the infection, CEL-SCI reasons. LEAPS peptides use conserved regions of coronavirus proteins to stimulate protective cell mediated T cell responses and reduce viral load.
 
Status: CEL-SCI on March 23 said it signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop a LEAPS COVID-19 immunotherapy designed to treat patients at highest risk of dying from COVID-19. The collaboration will commence with pre-clinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic. The proposed LEAPS peptides for the COVID-19 study are directed towards antigens within the NP protein of SARS-Cov-2 virus that elicit cytolytic T cell responses. Unlike the viral glycoprotein “spike” antigens which are important for antibody-based vaccines, these NP-antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines, according to CEL-SCI. Cytolytic T cell responses attack the virus infected cellular “factories” within the infected host in order to eliminate the source of virus and help subdue the infection. Also in March, CEL-SCI said it will develop an immunotherapy to treat COVID-19 and other diseases for which disease associated antigenic peptide(s) sequences have already been identified.
 
39. Celltrion Healthcare
 
Candidate: Antiviral treatment targeting COVID-19 
Type: Monoclonal antibody to be selected
 
Status: Celltrion Group said April 3 it had begun the second phase of development for an antiviral treatment, in which it will partner with the Korea Centers for Disease Control and Prevention (KCDC) to screen antibodies to find the ones most effective in neutralizing SARS-CoV-2. The company last month secured 300 different types of antibodies that bind to the antigen last month during the first phase, creating a library of antibodies using the blood of recovered patients in South Korea. Celltrion said it anticipates the candidate screening for the therapeutic monoclonal antibody will be complete by mid-April, sooner than originally expected. Upon candidate selection, “We will roll out mass production of the therapeutic antibody treatment, with a view to starting human trials this July,” Ki-Sung Kwon, Head of Celltrion’s R&D Unit, told Thailand Medical News.
 
40. Clover Biopharmaceuticals and Dynavax Technologies
 
Candidate: Vaccine to prevent COVID-19 
Type: Combination of Clover’s protein-based coronavirus vaccine candidate (COVID-19 S-Trimer), plus Dynavax’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant CpG 1018
 
Status: Dynavax and Clover on March 24 said they launched a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover agreed to advance the evaluation of COVID-19 S-Trimer in preclinical studies. The companies said Clover could rapidly scale-up and produce large-quantities of a new coronavirus vaccine since it has one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China. Clover said it applied its patented Trimer-Tag© technology to design the viral spike (S)-protein construct and complete its gene synthesis once the genomic DNA sequence of SARS-CoV-2 became public in late January 2021.
 
41.Cocrystal and Kansas State University Research Foundation
 
Candidates: Broad-spectrum antiviral compounds 
Type: Protease inhibitors
 
Status: Cocrystal on March 6 said it was “aggressively” pursuing the development of novel antiviral compounds to treat Coronavirus infections using its established proprietary drug discovery platform. The company is leveraging patent rights and antiviral compounds it has licensed from Kansas State University Research Foundation (“KSURF”) to treat Coronavirus as well as Norovirus, an agreement announced in February. Cocrystal said its primary goal was to advance its program into preclinical development, and pursue collaborations as the program progressed through clinical phases.
 
42. CSL Behring and SAB Biotherapeutics
 
Candidate: SAB-185
Type: High-potency immunotherapy delivering human polyclonal antibodies targeted to SARS-CoV-2, generated from SAB’s proprietary DiversitAb™ platform
 
Status: CSL Behring and SAB Biotherapeutics said April 8 they will partner to develop SAB-185, which they said is expected to be ready for clinical evaluation as early as summer 2020.CSL Behring has provided seed funding to offset some of SAB’s initial development costs, while SAB earlier this year secured approximately $7.2 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) through an interagency agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND). That funding will support SAB efforts to complete manufacturing and preclinical studies. CSL Behring has agreed to commit clinical, regulatory, manufacturing and supply chain expertise and resources to deliver the therapeutic to the market as soon as possible, on terms to be agreed with SAB.
 
43. Cynata Therapeutics
 
Candidate: Cell therapy targeting COVID-19
Type: Mesenchymal stem cell (MSC) based treatments
 
Status: Cynata and CEO Ross Macdonald have discussed the company’s therapeutic approach in a March 11 statement and recent interviews. That approach uses MSC to treat complications of COVID-19 such as sepsis, pneumonia and acute respiratory distress syndrome (ARDS). The company said it has achieved positive preclinical data for MSC therapies in sepsis and lung disease, and is collaborating with the Critical Care Research Group at Prince Charles Hospital in Brisbane, Australia, to investigate in an animal model the utility of Cymerus MSCs as a treatment for ARDS. Cynata says the potential of MSCs in treating the consequences of COVID-19 is underpinned by a study published March 13 in Aging and Disease, concluding that the intravenous transplantation of MSCs was “safe and effective for treatment” in seven enrolled patients with COVID-19 pneumonia in Beijing. Pulmonary function and symptoms of all seven patients significantly improved in two days after MSC transplantation, while two patients with common pneumonia and one severe pneumonia patient recovered and were discharged 10 days after treatment.
 
44. Emergent BioSolutions
 
Candidates: COVID-HIG and COVID-EIG 
Types: Human polyclonal hyperimmune with antibodies to SARS-CoV-2 (COVID-HIG) for severe hospitalized patients and protection for at-risk individuals; Equine-derived polyclonal hyperimmune with antibodies to SARS-CoV-2 (COVID-EIG) for severe hospitalized patients
 
Status: Emergent Biosolutions said March 11 it began development of COVID-HIG and COVID-EIG using its hyperimmune platforms. Hyperimmunes are polyclonal antibody therapeutics derived from plasma that leverage the immune response in humans or animals and can provide immediate protection from infection. Emergent said it has initiated plasma collection efforts for both human and equine platforms, with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter.
 
45. Ennaid Therapeutics
 
Candidate: ENU200 
Type: Repurposed, patent-pending, oral antiviral drug previously approved by FDA
 
Status: Ennaid said April 2 it is advancing development of ENU200 to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 viral infections. Ennaid said in-silico modeling conducted by the company has shown that ENU200 delivers specific antiviral activity against two SARS-CoV-2 proteins, S glycoprotein and Mpro. Ennaid reasons that the simultaneous blockage may result in enhanced antiviral activity that could successfully and broadly treat COVID-19 and other coronaviruses. Ennaid said it is in talks with the FDA and other regulatory agencies worldwide on its planned Phase III in-home, self-dosing clinical trial, which would assess ENU200 in patients with asymptomatic, mild to moderate coronavirus infections.
 
 
46. eTheRNA, EpiVax, Nexelis, REPROCELL, and CEV
 
Candidate: mRNA vaccine against SARS-CoV-2 
Type: Intranasal vaccine integrating eTheRNA’s Trimix technology, an mRNA-based vaccine adjuvant that stimulates dendritic cells into activating a strong CD4 and CD8 T cell response; a combination of T cell epitopes from the virus on a single mRNA construct, using an in-silico epitope prediction and design approach from EpiVax to identify the target; and an intranasal vaccine delivery platform using a nasal atomizer and a proprietary formulation that delivers the mRNA to the nasal mucosa and optimizes expression.eTheRNA said a formulation candidate is being repurposed for clinical use in collaboration with REPROCELL.
 
Status: eTheRNA said March 24 that it has started preclinical development of an mRNA vaccine against SARS-CoV-2 that is intended primarily for high-risk populations such as healthcare workers and families of confirmed cases. It is also designed to be protective against future variations of the virus by targeting conserved epitopes from the whole CoV-2 genome. eTheRNA said it has formed a consortium with EpiVax, Nexelis, REPROCELL and CEV to develop the vaccine and help accelerate progress towards clinical trials; patient enrolment is expected in early 2021. The consortium’s approach selects conserved epitopes from the whole viral genome to create a vaccine that mounts a strong T cell-based response against these epitopes, which the partners reason offers a better chance to overcome viral variability.
 
47. ExpreS2ion Biotechnologies, AdaptVac, and partners
 
Candidate: Vaccine against COVID-19 
Type: Vaccine applying ExpreS2ion’s Drosophila S2 insect cell expression system, and AdaptVac’s capsid virus-like particle (cVLP) technology.
 
Status: ExpreS2ion said March 6 it is part of a consortium of vaccine developers and institutions that have been awarded an E2.7 million ($2.9 million) grant through the European Union’s Horizon 2020 funding program to support development of a COVID-19 vaccine candidate, including conducting a Phase I/IIa clinical trial. Joining ExpreS2ion as members of the consortium are AdaptVac, Leiden University Medical Center, Institute for Tropical Medicine (ITM) at University of Tübingen, University of Copenhagen, and Wageningen University. The consortium aims to launch clinical investigations within 12 months, according to ExpreS2ion. The Danish developer of vaccines and diagnostics first announced its plan to develop a COVID-19 vaccine in February, saying it use Drosophila S2 to produce 2019-nCoV viral antigens in the company’s clinically validated cell lines, as well as in its HighMan-S2™ immunogenicity-enhancing cell line. The company said its goal was to produce the vaccine antigens and test these in mice to demonstrate immunogenicity, and through collaborations demonstrate efficacy in in vitro or animal models as they become available.
 
48. Fudan University, Shanghai JiaoTong University, and RNACure Biopharma
 
Candidate: Vaccine against COVID-19 
Type: mRNA vaccine employing two strategies: researchers have placed the most emphasis on formulating mRNAs that can instruct the host to produce virus-like particles (VLPs) with morphological and structural features similar to those of native COVID-19 viruses and activate immune responses. The other approach uses mRNA to express the receptor-binding domain of the spike protein of COVID-19 to induce neutralizing-antibodies in the human body.
 
Status: Fudan University on March 7 announced the partnership, led by Fudan’s Prof. Lin Jinzhong, PhD. Researchers have formulated an mRNA cocktail containing three genes of COVID-19, which produce VLPs when used to co-transfect human cells “the first time the world has witnessed modified mRNAs that can synthesize VLPs,” according to Fudan.
 
49. Generex Biotechnology (NuGenerex Immuno-Oncology) and EpiVax
 
Candidate: Ii-Key peptide vaccine 
Type: Vaccine based on Generex’s Ii-Key immune system modulation technology platform
 
Status: Generex on March 19 said it has been in talks with the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Departments of Veterans Affairs and Health and Human Services, as well as with authorities in Canada, Greece, Iceland, Indonesia, Italy, Philippines, Romania, Saudi Arabia, and the U.K. for licensing Ii-Key-SARS-2 peptide vaccines as well as new, patented immunotherapy technology allowing those countries co-ownership of the Intellectual Property in their territories. A week earlier, Generex said it would spin out its NuGenerex Immuno-Oncology (NGIO) subsidiary into a separate public company focused on advancing Ii-Key peptide vaccines into development to treat and prevent COVID-19 and other infectious diseases, as well as cancer, with partners in the U.S. and China. Generex filed a Form 10 Registration Statement for NGIO, to be effective in 60 days. According to the company, NGIO’s Ii-Key antigenic peptides have been shown to supercharge the immune system up to 100 times more than peptides alone.
 
50. GeoVax Labs and BravoVax
 
Candidates: Vaccine for prevention/control of COVID-19 
Type: Vaccine based on GeoVax’s GV-MVA-VLPTM vaccine platform
 
Status: GeoVax said March 18 that the companies completed three vaccine candidates after making rapid progress with design, construction and in vitro characterizations. The companies will narrow down the candidates to the one that shows the best safety, immunogenicity and protective efficacy in upcoming animal studies. GeoVax and BravoVax aim to advance a vaccine candidate to human clinical trials before year’s end, GeoVax President and CEO David Dodd stated. GeoVax said it was in talks with, and submitted applications to, the Biomedical Advanced Research and Development Authority (BARDA) and other U.S. and international funding agencies. The company noted that BARDA has $3.5 billion available toward supporting the manufacturing, production and purchase of vaccines, therapeutics, and diagnostics under the $2 trillion Coronavirus Aid, Relief, and Economic Security Act (CARES ACT), signed into law by President Donald Trump on March 27.
GeoVax disclosed its intent to collaborate with BravoVax, a vaccine developer in Wuhan, China, to develop a COVID-19 vaccine in January.
 
51. GlaxoSmithKline (GSK), CEPI, and University of Queensland
 
Candidate: Vaccine to prevent SARS-CoV-2 
Type: Vaccine based on UQ “molecular clamp” technology, using GSK’s vaccine adjuvant platform
 
Status: GSK and the Coalition for Epidemic Preparedness Innovations (CEPI) said February 3 they would partner to develop a vaccine for SARS-CoV-2. CEPI agreed to coordinate engagements between GSK and CEPI-funded entities interested in combining their vaccine platforms with GSK’s adjuvant technology against SARS-CoV-2 starting with the University of Queensland, which is partnering with CEPI to develop its “molecular clamp” vaccine platform, in which a recombinant subunit vaccine of SARS-CoV-2 S protein is locked in prefusion conformation by polypeptide moiety. Last month, GSK identified University of Queensland as one of five partner companies and research groups worldwide with which GSK is collaborating on COVID-19 vaccines using GSK’s vaccine adjuvant technology. GSK said it expected data to be reported from the collaborations over the next three months.
 
52. Greffex
 
Candidate: Vaccine to protect against COVID-19 
Type: Fully-deleted, helper virus-independent adenovirus-based vector vaccine based on the company’s GreVac™ Plug-And-Play Technology
 
Status: Greffex on March 11 said it was prepared to advance its vaccine candidate into animal testing, with a commitment to distributing its vaccine for free to other countries upon approval. Two days earlier, Greffex CEO John Price told Fox News Channel’s “America’s Newsroom” broadcast that his company aimed to get its vaccine approved and available to patients by year’s end.Greffex says it has developed the world’s first universal vaccine platform that delivers unprecedented time-to-market, cost efficiency, efficacy, and safety by using proprietary clean viral vectors. The company has a pipeline of 12 vaccines that includes candidates for influenza, MERS-CoV, anthrax, Ebola, tetravalent Dengue, and Zika.
 
53. Grifols, BARDA, and FDA
 
Candidate: Anti-SARS-CoV-2 hyperimmune globulin therapy
Type: Plasma from convalescent COVID-19 patients, processed into a hyperimmune globulin
 
Status: Grifols on March 25 said it entered into a formal collaboration with the Biomedical Advanced Research Development Authority (BARDA), the FDA and other federal public health agencies to support preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease. Grifols said it will volunteer its expertise and resources by using its network of FDA-approved plasma donor centers; testing and qualifying donors in conjunction with other health agencies; processing plasma into hyperimmune globulin at a Clayton, NC, facility; and support studies to determine whether the treatment can be a viable treatment for COVID-19 and future emerging infectious diseases.
 
54. Hoth Therapeutics and Voltron Therapeutics (HaloVax)
 
Candidate: Vaccines to prevent, intercept or treat COVID-19 
Type: Vaccines to be based upon VaxCelerate, a self-assembling vaccine platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center at Massachusetts General Hospital (MGH).
 
Status: Hoth and Voltron subsidiary HaloVax said April 2 they entered into a Sponsored Research Agreement with the Vaccine and Immunotherapy Center (VIC) of Massachusetts General Hospital to co-develop a new vaccine designed to protect patients at risk of COVID-19 infection, applying the Self-Assembling Vaccine (SAV) platform developed by the VIC and licensed exclusively to Voltron. The vaccine is expected to enter animal testing within the next 30 days, the companies said. Hoth and Voltron said they formed HaloVax, a joint venture, to begin preclinical studies for COVID-19 vaccine candidates with support from MGH. VaxCelerate which consists of a fixed immune adjuvant and a variable immune target and offers several potential advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. The vaccine focuses on both DNA and internal/external mutated proteins providing the immune system with more potential targets to attack.
 
55. iBio, TAMUS, and Beijing CC-Pharming
 
Candidate: IBIO-200, vaccine for preventing SARS-CoV-2 infection ●
Type: Plant-derived vaccine SARS-CoV-2 Virus-Like Particle (VLP)-based constructs manufactured using iBio’s FastPharming System™, designed to produce the nanoparticles in, and purify them from, plants.
 
Status: iBio said April 9 the Infectious Disease Research Institute (IDRI) will support preclinical development and provide clinical trial oversight for iBio’s IBIO-200 vaccine development program for COVID-19. iBio and IDRI also agreed to establish a separate, additional agreement within the next 60 days if the company opts to include one of IDRI’s novel adjuvants in the program.In March, iBio said it advanced iBIO-200 to immunization studies at Texas A&M University System (TAMUS) laboratories, under a Master Joint Development Agreement established between iBio and TAMUS in 2016. The partners seek to optimize a combination of VLP and adjuvant to advance to human clinical trials. iBio has developed two types of VLPs, glycosylated and non-glycosylated, as options for development.
 
56. ImmunoPrecise Antibodies (IPA) and EVQLV
 
Candidates: Coronavirus-neutralizing antibodies 
Type: PolyTope mAb Therapy™, a defined antibody combination designed to target multiple epitopes and mechanisms of viral evasion, and enabled by IPA’s discovery platforms (including B Cell Select™ and DeepDisplay™) and ImmunoPrecise subsidiary Talem Therapeutics’ access to the transgenic animal platform OmniAb® for direct generation of human antibodies.
 
Status: IPA said March 30 that its collaboration partner EVQLV submitted its first panel of candidate therapeutic antibody sequences, comprised of DNA sequences encoding for potentially therapeutic antibodies against SARS-CoV-2. The sequences were generated in less than one week using computational antibody design, which combines mathematics, statistics, and computer science to identify high-affinity antibodies. IPA said it will review the antibody candidates, then select approximately 1,200 ideal candidates characterized and screened by EVQLV’s artificial intelligence, and validate the antibody candidates in vitro at IPA’s lab facilities. The companies said they will continue to work on additional panels of computationally generated sequence candidates against SARS-CoV-2. Earlier last month, IPA announced its PolyTope mAb Therapy approach to developing a COVID-19 treatment. The company also spoke of potentially developing a vaccine for COVID-19, but has not announced any such effort since then.
 
57. Imperial College London
 
Candidate: Vaccine to protect against COVID-19 
Type: Self-amplifying RNA vaccine, designed to inject new genetic code into a muscle, and instructing that muscle it to make a protein found on the surface of coronavirus, triggering a protective immune response.
 
Status: Imperial said March 20 that Prof. Robin Shattock, PhD, and colleagues developed a vaccine candidate within 14 days of getting the sequence from China. The researchers have been testing the vaccine on animals since February 10, and plan to move to clinical trials in the summer, Imperial said. “If all goes well it could be available sometime next year,” Shattock  told Thailand Medical News.
 
58. InflaRx and Beijing Defengrei Biotechnology (BDB)
 
Candidate: IFX-1 
Type: Potentially first-in-class monoclonal anti-human complement factor C5a antibody in development for COVID-19 as well as inflammatory indications that include hidradenitis suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.
 
Status: InflaRx on March 31 said it had enrolled the first patient into a randomized clinical trial in the Netherlands that is investigating the safety and efficacy of IFX-1 in patients with severe COVID-19-induced pneumonia. The patient is being treated at Amsterdam University Medical Centers, with additional centers in Germany and potentially other European countries planned. InflaRx said it had received from its Chinese licensee BDB initial positive human data from the first two patients treated in a Chinese clinical trial with BDB-001, an anti-C5a antibody produced in China by BDB from the IFX-1 cell line. That data is part of a larger study on the role of complement activation in COVID-19, made public through a preprint and not yet independently verified by InflaRx.
 
59. Innovation Pharmaceuticals
 
Candidate: Brilacidin 
Types: Vaccine and antiviral small molecule drug formulations against COVID-19 containing Defensin mimetic. The drug is in Phase II development in oral muscositis in head and neck cancer
 
Status: Innovation on April 1 announced a study published in the International Journal of Infectious Diseases that supported small molecule Brilacidin’s direct inhibition of SARS-CoV-2, based on testing on Vero cells at an undisclosed U.S. Regional Biocontainment Laboratory (RBL). At 16 hours post-infection, researchers observed a dose-dependent reduction in the SARS-CoV-2 infectious viral titers from Brilacidin treated cells as compared to the vehicle-alone control (Dimethyl sulfoxide or DMSO). According to Innovation, the antiviral activity showed Brilacidin’s 3-in-1 therapeutic potential antiviral, anti-inflammatory, antimicrobial against COVID-19 and associated complications. In other indications, the company said, Brilacidin has shown the ability to inhibit interleukin-6 (IL-6) and other pro-inflammatory cytokines and chemokines identified as key drivers in worsening prognoses of COVID-19 patients.
 
60. Institut Pasteur, Themis, and University of Pittsburgh
 
Candidate: Vaccine to treat COVID-19 
Type: Measles vector vaccine engineered to express SARS-CoV-2 proteins on its surface 
 
Status: The Institut Pasteur leads a consortium that includes Themis and the University of Pittsburgh’s Center for Vaccine Research (CVR). The consortium has been awarded an initial $4.9 million by CEPI, the Coalition for Epidemic Preparedness Innovations. As a first step, CEPI funding will support the preclinical testing, initial manufacture of vaccine materials, and preparatory work for Phase I studies, CEPI said on March 19. Pitt said CVR researchers expect to have a vaccine candidate ready for animal testing in Paris and Pittsburgh in April, to be complemented by development of an aerosol model of COVID-19 at CVR. By the end of the year, Pitt added, a total of 60 to 80 human volunteers in two sites in Europe will have been dosed with the vaccine. At the same time, Themis plans to generate a stockpile of the vaccine candidate in anticipation of a Phase II trial set to start early next year.
 
61. Izana Bioscience
 
Candidate: Namilumab (IZN-101) 
Type: Fully human monoclonal antibody therapy targeting granulocyte-macrophage colony stimulating factor (GM-CSF), in development for rheumatoid arthritis and ankylosing spondylitis
 
Status: Izana said April 6 it initiated a two-center compassionate use study of namilumab to treat patients with rapidly worsening COVID-19 before ICU admission and prior to ventilation. The study is being conducted in cooperation with the Humanitas research group, led by Prof. Carlo Selmi, MD, PhD, head of the Rheumatology and Clinical Immunology Unit at Humanitas Research Hospital and Associate Professor of Internal Medicine at Humanitas University.
Separately, Ergomed said it is providing support for namilumab’s clinical development program. The study will take place in Bergamo and Milan, Italy. According to Izana, namilumab is a Phase III-ready treatment being studied under emergency access.
 
62. Janssen Pharmaceutical Cos. (J&J) and BARDA
 
Candidate: Antiviral treatment for COVID-19 
Type: Classified
 
Status: J&J said March 30 that the company and the Biomedical Advanced Research and Development Authority (BARDA) will both provide unspecified additional funding intended to enable expansion of ongoing work to identify potential antiviral treatments against COVID-19.
 
63. Johns Hopkins
 
Candidates: Antibodies targeting SARS-CoV-2 
Types: Antibodies from the blood plasma or serum of people who have recovered from COVID-19 infection.
 
Status: Johns Hopkins researchers Arturo Casadevall, MD, PhD, and Liise-anne Pirofski, MD, published a paper March 13 in The Journal of Clinical Investigation detailing their treatment approach to COVID-19: “Human convalescent serum is an option for prevention and treatment of COVID-19 disease that could be rapidly available when there are sufficient numbers of people who have recovered and can donate immunoglobulin-containing serum.” The Johns Hopkins Research Team has put initial funding toward Casadevall’s project, to purchase equipment and set up an operation in Baltimore. Casadevall and his team are working now with state and federal officials to try to secure more resources, according to Johns Hopkins.
 
64. Kleo Pharmaceuticals and Green Cross LabCell (GCLC)–65
 
Candidate: COVID-19-targeting allogeneic Natural Killer (NK) cell combination therapy
Type: Combination of Kleo’s first non-oncology application of its Antibody Recruiting Molecule (ARM™) and GCLC’s NK cells
 
Status: Kleo on March 31 said it had entered a research collaboration with GCLC to rapidly develop a COVID-19-targeting allogeneic NK cell combination therapy, combining Kleo’s next-gen fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics with GCLC’s allogeneic, or “off-the-shelf” NK cell therapies. Earlier this year, Kleo received approval from the FDA to proceed with an ARM/NK clinical trial assessing the combination cell therapy in newly diagnosed, multiple myeloma patients. The ARM in that trial targets the cell surface protein CD38 and uses autologous cytokine induced memory like (CIML) NK cells to kill tumor cells. In the context of COVID-19, the partners said, ARM acts as a neutralizing antibody to block direct binding on the virus to human cells, then enlists immune effector cells to eliminate viral particles and/or infected cells. The ARM can produce a long-term vaccination effect by activating and expanding immune memory cells.
 
65. La Jolla Pharmaceutical
 
Candidate: GIAPREZA™ (angiotensin II)
Type: Vasoconstrictor approved by the FDA in 2017 and indicated to increase blood pressure in adults with septic or other distributive shock. The drug was approved by the European Commission in August 2019 for refractory hypotension in adults with septic or other distributive shock, but is not yet commercially available in Europe.GIAPREZA is designed to mimic the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure.
 
Status: La Jolla has disclosed five instances where it agreed to providing GIAPREZA for emergency use in patients with septic shock due to COVID-19: University Hospital Münster in Germany (April 7), Royal Surrey County Hospital in Guildford, Surrey, UK (April 6), University Hospital Frankfurt in Germany (announced April 3), Guy’s and St Thomas’ NHS Foundation Trust in London (April 2), and Italy (March 13).
 
66. Ligandal
 
Candidate: Vaccine 
Type: Vaccine providing a fully synthetic scaffold for mimicking T-cell receptor and antibody binding epitopes, which can be rapidly custom-tailored to new mutant forms of a virus
 
Status: Ligandal presented its approach for rapid vaccine prototyping on its website, stating that its synthetic scaffold can additionally serve as a targeting ligand mimicking viral entry to target diseased cells and tissues with therapeutic agents. These “mini viral scaffolds can be synthesized in hours, and rapidly scaled to 100kg+ scale to meet global needs, Ligandal stated.“Our next steps will relate to synthesis and characterization of these scaffolds, as well as additional techniques for mapping known and predicted immune-epitopes onto variable domains of the scaffolds,” the company added. Unlike recombinant and other approaches, Ligandal said, its vaccine approach needs to use fewer than 70 amino acids out of an approximately 1,200 amino acid spike protein in order to generate a predicted trifunctional scaffold for ACE2 binding and TCR/antibody recognition.
 
67. Medicago
 
Candidates: Vaccine and antibody candidates 
Types: Virus-Like Particle (VLP) vaccine and antibodies against SARS-CoV-2 developed through the company’s plant-based technology platform in collaboration with Laval University’s Infectious Disease Research Centre headed by Gary Kobinger, PhD, whose lab developed a successful Ebola vaccine. That research is being funded in part by the Canadian Institutes for Health Research.
 
Status: The Government of Canada announced March 23 that Medicago was among companies set to receive an unspecified amount of funding from the $192 million available for new, large-scale projects under the new Strategic Innovation Fund COVID-19 funding stream—part of the government’s $1 billion COVID-19 Response Fund. Two days earlier, the Government of Quebec awarded C$7 million (about $5 million) toward the company’s vaccine development effort. Medicago said March 12 it successfully produced a coronavirus VLP 20 days after obtaining the SARS-CoV-2 gene—the first step in developing a vaccine for COVID-19. The vaccine will undergo preclinical testing for safety and efficacy, followed by human trials anticipated to start by summer (July/August) 2020.
 
68. MediciNova
 
Candidate: MN-166 (ibudilast)
Type: First-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor
 
Status: MediciNova said April 8 it will initiate a clinical trial of MN-166 for acute respiratory distress syndrome (ARDS) caused by COVID-19. The study will be conducted by Yale’s Advanced Therapies Group. The lead principal investigator for the trial is Geoffrey Chupp, MD, professor of medicine (Pulmonology), director of the Yale Center for Asthma and Airway Disease and director of the Pulmonary Function Laboratory at Yale-New Haven Hospital. Earlier human studies have shown significant reductions of serum MIF level after treatment with MN-166. It also attenuates activated glial cells, which play a major role in certain neurological conditions, MediciNova said. The company reasons that MN-166 could reduce the mortality of COVID-19 by limiting the hyperinflammation and ARDS associated with severe cases.
 
69. Monash Biomedicine Discovery Institute (BDI) and Peter Doherty Institute of Infection and Immunity
 
Candidate: Ivermectin (marketed by Merck & Co. under the names Stromectol^® and Mectizan^®, but also available as a generic drug) 
Type: Anti-parasitic drug approved by the FDA for Strongyloidiasis of the intestinal tract, and onchocerciasis (river blindness). Since 1987, Merck has committed to donating Mectizan—as much as needed, for as long as needed—with the goal of eliminating river blindness through the public-private partnership Mectizan Donation Program. The program was extended in 1998 to include lymphatic filariasis (LF).
 
Status: BDI and the Doherty Institute on April 3 published a preprint study in Antiviral Research  showing that Ivermectin essentially stopped the SARS-CoV-2 virus growing in cell culture within 48 hours, and reduced viral RNA significantly at 24 hours. The in vitro study will be followed up with human clinical trials, the institutions said.
 
70. NanoVirocides
 
Candidate: Antiviral therapy based on company’s novel nanomedicines platform. 
Type: Broad-spectrum virus-binding ligand: “It is like a ‘Venus-Fly-Trap’ for the virus,” says Anil R. Diwan, PhD, president and executive chairman.
 
Status: NanoVirocides on March 16 said it completed the synthesis of “a number of” nanoviricide drug candidates for cell culture testing a few weeks after identification of virus-binding ligands, a result of the company tapping into its inventory of novel custom chemicals, including a polymer backbone that was previously manufactured in multi-kilogram quantities. NanoVirocides confirmed in January that it was developing a COVID-19 treatment, stating that it “already found some lead candidate ligands in its chemical library” that can bind to the SARS-CoV spike protein just as it binds to cognate receptor angiotensin converting enzyme type 2 (ACE2). The company’s technology relies on copying the human cell-surface receptor to which the virus binds, and making ligands that chemically attach to a nanomicelle, to create a nanoviricide®. When a virus comes in contact with the nanoviricide, the nanomicelle polymer is designed to fuse with the virus lipid envelope. The company said it has started preparing for testing of potential candidates in cell cultures against “low-threat” coronaviruses, including ones that use the ACE2 receptor, in its own BSL-2 virology laboratory at its Shelton, CT, campus. NanoViricides added that it is working on developing collaborations to advance its COVID-19 program should an effective drug candidate be identified. If initial work suggests a potential for developing a successful antiviral,  NanoVirocides said in a Form 10-Q quarterly report filed February 24, it will pursue a license allowing use for coronaviruses from the license-holder of its technology TheraCour, whose 90% owner is NanoViroCides president and chairman Anil Diwan, PhD. NanoVirocides also said it acquired and expanded two low-threat circulating coronaviruses in its BSL-certified virology lab, and has already expanded them to enable testing of drug candidates. One coronavirus, NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2, although it does not cause a similarly severe disease in humans. If the test candidates show effectiveness in the cell culture studies against coronaviruses, the company reasons, that would provide a strong rationale for expecting they would be effective against SARS-CoV-2. NanoVirocides added that it also successfully developed antiviral drug testing assays based on cell culture infection of low-threat coronaviruses in the BSL2 lab a feat accomplished in a few weeks due to the expertise of senior virologist Brian Friedrich, PhD.
 
71. Neurimmune and Ethris
 
Candidate: Immunotherapy designed to produce inhaled mRNA-based antibodies directly in the lungs of COVID-19 patients 
Type: mRNA-encoded, neutralizing anti-SARS-CoV-2 antibodies administered by inhalation
 
Status: The companies on March 31 announced their COVID-19 collaboration, designed to combine Neurimmune’s expertise in developing human antibodies via its RTM™ Technology platform, based on high-throughput immunoglobulin sequence analyses from COVID-19 patients who have recovered from the disease with Ethris’ pulmonary SNIM®RNA therapeutics platform.The first product candidate is expected to begin clinical testing in the fourth quarter, pending regulatory approval, Neurimmune and Ethris said. The companies have agreed to jointly conduct R&D activities while sharing costs and revenues resulting from the collaboration and intend to begin manufacturing of the drug product for clinical trials this summer.
 
72. Novavax and Emergent Biosolutions
 
Candidate: NVX-CoV2373 
Type: Stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and incorporating its proprietary saponin-based Matrix-M™ adjuvant.
 
Status: Novavax on April 8 said it identified a COVID-19 vaccine candidate, and will initiate a first-in-human clinical trial in mid-May. The Phase I trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July.The company said NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor, and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were also seen after a single immunization.
 
73. Novoteris and Mallinckrodt
 
Candidate: Thiolanox^®, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with SARS-CoV-2
Type: Pharmaceutical nitric oxide gaseous formulation supplied via Mallinckrodt’s high-pressure cylinders at 5,000 ppm (0.5% v/v) nitric oxide gas for inhalation canisters.
 
Status: Novoteris and Mallinckrodt said April 1 that the Therapeutic Products Directorate of Health Canada cleared the companies’ joint pilot clinical trial to investigate Thiolanox in patients infected with SARS-CoV-2 at Vancouver Coastal Health Authority facilities.  The study is designed to assess the safety and effectiveness of Thiolanox in treating COVID-19 and its associated lung complications. The companies said they expected to begin recruiting patients “in the coming days.”
 
74. OncoSec
 
Candidate: CORVax12 
Type: Prophylactic vaccine against COVID-19, consisting of OncoSec’s TAVO™ (interleukin-12 or “IL-12” plasmid), in combination with a DNA-encodable version of the SARS-CoV-2 spike or “S” glycoprotein
 
Status: OncoSec said April 6 that Providence Cancer Institute, part of Providence St. Joseph Health, submitted to the FDA an IND application and have designed a protocol for a Phase I clinical trial evaluating CORVax12 in healthy adult volunteers, using OncoSec’s next-generation, investigational APOLLO generator technology for the first time clinically.CORVax12 combines OncoSec’s IL-12 plasmid TAVO with an immunogenic component of the SARS-CoV-2 virus recently developed by researchers at NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and licensed non-exclusively to OncoSec.
 
75. Persephone Biosciences
 
Candidate: Immune-boosting microbiome therapeutic to help prevent and fight SARS-CoV-2
Type: Treatment designed to be taken at the onset of symptoms or with a vaccine or antiviral drug to mount an effective immune response with long-lasting immunity and boost the immune system of those exposed to the virus. The treatment is being developed as a general enhancer of the immune system “may be effective against mutations, seasonal flu and future pandemics,” Persephone says.
 
Status: Persephone on April 2 announced the development of the immune-boosting microbiome therapeutic, and a stool-based diagnostic, and is seeking partners for preclinical development or clinical trials. The company’s proprietary Decode.Design.Cure^® technology platform is designed to collect and analyze gut microbiome samples from thousands of patients through its nationwide Poop For The Cure^® campaign, using artificial intelligence and next-generation genome sequencing technologies.
 
76. PharmaMar
 
Candidate: Aplidin^® (plitidepsin)
Type: Anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death).
 
Status: PharmaMar on April 2 said it it submitted its protocol for the Phase II APLICOV clinical trial of Aplidin to the Spanish Medicines and Healthcare Products Agency (AEMPS). The planned 160-patient trial would be a multicenter, randomized study in which two different doses of plitidepsin will be evaluated in hospitalized patients with COVID-19 pneumonia, to assess whether plitidepsin, administered intravenously for 5 days, reduces the proportion of patients who progress to Acute Respiratory Distress Syndrome (ARDS).In March, PharmaMar announced the results of in vitro studies of plitidepsin in human coronavirus HCoV-229E, with a mechanism of multiplication and propagation that is very similar to that of SARS-CoV-2. The studies were carried out at the National Biotechnology Centre of the Spanish National Research Council (CSIC; Centro Nacional de Biotecnología). The studies confirmed that the therapeutic target of Aplidin, EF1A, is key to the multiplication and spread of the virus.
 
77. Pluristem Therapeutics
 
Candidate: PLX Cells for COVID-19
Type: “Off the shelf,” placenta-based allogeneic mesenchymal-like cells with immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages. Pluristem reasons PLX cells may prevent or reverse dangerous overactivation of the immune system by reducing the incidence and\or severity of COVID-19 pneumonia and pneumonitis.
 
Status: Pluristem on April 7 announced positive preliminary data from its compassionate use program treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with PLX cells at three medical centers in Israel. Four of six patients who completed a one-week follow up showed improvement in respiratory parameters, of which three are in advanced stages of weaning from ventilators. One such patient showed no change, and one showed deterioration. The company plans to apply to initiate a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19.
 
78. RedHill Biopharma
 
Candidates: Opaganib (Yeliva^®, ABC294640) and RHB-107, in combination and individually
Types: Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. RHB-107 is a first-in-class, orally-administered inhibitor of S1 family of trypsin-like serine proteases with potential for use in multiple oncology, gastrointestinal and inflammatory indications.
 
Status: RedHill said April 13 the first two patients were treated with opaganib at “a leading hospital in Israel” under the company’s compassionate use program according to Israeli Ministry of Health guidelines, in addition to standard-of-care, which inc