Biopharma Update on the Novel Coronavirus: August 26

CV Update_August 26

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. 


FDA Actions

Diagnostics Update: To-date the FDA has authorized 221 individual EUAs, which include 179 molecular tests, 39 antibody tests and 3 antigen tests.



Fluidigm announced it received a EUA from the FDA for a saliva-based COVID test, Advanta™ Dx SARS-CoV-2 RT-PCR Assay.


Testing Therapies, Antivirals and Vaccines

Moderna presented more detailed data from the Phase I trial of its mRNA COVID-19 vaccine at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) today. Of particular interest was the presentation of interim safety and immunogenicity data from cohorts of older adults in the study, which was led by the National Institutes of Health (NIH).

In a regulatory filing with the U.S. Securities and Exchange Commission (SEC), Translate Bio indicated that the COVID-19 vaccine it is developing with Paris-based Sanofi induced an immune response in non-human studies. The companies expect to begin human clinical trials in November.

Capricor Therapeutics announced the FDA accepted its IND application to move forward with a Phase II clinical trial of its COVID-19 therapeutic candidate, CAP-1002.

As reported by Reuters, top experts are warning that distributing a COVID-19 vaccine under a EUA before it has been proved safe and effective would have a bad effect on the testing of other vaccines.

As reported by Reuters, AstraZeneca initiated an early-stage clinical trial of an antibody-based cocktail, AZD7442, for the prevention and treatment of COVID-10. If the study proves to be safe, the company will proceed to test as both a preventative and treatment for those who have the virus in a larger-scale clinical trial.

Following intense preclinical research, VBI Vaccines selected two vaccine candidates, with the potential to be one-dose vaccines, to take into an adaptive Phase I/II human clinical study, expected to begin around year-end 2020. The candidates are VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV, and MERS-CoV spike proteins and VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.

Celltrion Group received the go-ahead from the Korean Ministry of Food and Drug Safety to begin a Phase I trial of CT-P59 for COVID-19. The company has started enrolling patients with mild symptoms. CT-P59 is an antiviral antibody treatment candidate. The company launched a Phase I trial of the therapy in the UK in July.

Q BioMEd, with its technology partner Mannin Research, announced a GMP production contract had been initiated for MAN-19, a clinical grade therapeutic to treat complications caused by COVID-19. The Phase I trial is expected to begin enrolling patients in February 2021.


Company Actions/Announcements

AstraZeneca has said it hasn’t talked to the U.S. government about fast-tracking its COVID-19 vaccine.

Partner Therapeutics, Inc. entered into a $35 million milestone-based Firm Fixed Price agreement with the U.S. Department of Defense to fund two Phase II clinical trials of inhaled Leukine (sargramostim) in COVID-19 patients with acute hypoxemia. Leukine is FDA-approved for the treatment of acute radiation syndrome and is held in the Strategic National Stockpile. The $35 million funding will also support regulatory filings for potential Emergency Use Authorization of Leukine and expansion of production capacity to meet increased demand.

Altimmune, Inc. announced additional positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. The latest study showed potent stimulation of antigen-specific CD4+ and CD8+ T cells in the lungs of CD-1 mice as early as 10 days following a single intranasal vaccination, with responses strongly biased toward CD8+ T cells. The mucosal T cell response in the respiratory tract is believed to be dependent on the intranasal route of administration and we believe it has the potential to provide additional protection against COVID-19. 

The FDA’s EUA for convalescent plasma requires that all blood donor units be tested only with Ortho Clinical Diagnostics’ VITROS Anti-Sars-CoV-2 IgG test. The test runs on Ortho’s VITROS systems, which are in more than 1,000 hospitals and reference labs in the U.S. The instrument can process up to 150 tests per hour.


Other Industry News

Although there have been unverified reports of people getting repeat cases of COVID-19, there have been significant questions as to their reliability. Now, a case report out of Hong Kong cites a 33-year-old man treated in March at a hospital for COVID-19 who tested positive at the Hong Kong airport on August 15. He was returning from Europe. He has no symptoms this time.

On Sunday, during a White House press conference, President Trump and several health care regulators announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for convalescent plasma treatments for COVID-19. Since then, FDA Commissioner Stephen Hahn and Health and Human Services Secretary Alex Azar have taken heat for overstating the benefits of the treatment. Late yesterday, Hahn issued an apology, agreeing that he had overstated the benefits of the treatment.

As reported by Reuters, researchers in Japan at Fujita Health University announced they had proven that ozone gas in concentration levels considered harmless to humans, could kill the COVID-19 virus.

HealthSpace has struck deals with two U.S. states and multiple county governments for its HSCloud Suite and My Health Department products, a digital contact tracing program for COVID-19.

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