Biopharma Update on the Novel Coronavirus: August 5

CV Update_August 5

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

 

FDA Actions

COVID-19 Drug Shortages Response: The FDA has updated its webpage to provide information on in-use time for certain drugs during the COVID-19 pandemic.

Warning Letter: The FDA and the FTC issued a warning letter to MMSTabs.com for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19.

EUAs: The FDA issued EUAs for the following:

Diagnostics Update: To-date the FDA has authorized 203 individual EUAs, which include 166 molecular tests, 35 antibody tests and 2 antigen tests.

 

Testing Therapies, Antivirals and Vaccines

Novavax is yet another biopharma company reporting promising early-stage data for a potential COVID-19 vaccine. The company announced data from Phase I of its Phase I/II placebo-controlled trial of its vaccine with and without Matrix-M adjuvant. The trial was conducted in healthy adults 18 to 59 years of age.

In early July, Regeneron Pharmaceuticals, with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), announced they were launching Phase III trials of REGN-COV-2, the company’s two-antibody cocktail to treat and prevent COVID-19. Although those results of those trials are still pending, the company issued a scientific article, not yet peer-reviewed, that shows the cocktail was able to “almost completely block the establishment of virus infection,” in rhesus macaques and hamsters.

Revive Therapeutics Ltd. will advance a Phase III study to evaluate the safety and efficacy of rheumatoid arthritis drug Bucillamine in patients with mild-moderate COVID-19. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

BioNTech and Fosun Pharma announced the initiation of a Phase I clinical trial in China for BNT162b1, an mRNA-based COVID-19 vaccine candidate.

Veru confirmed in an in vitro study that VERU-111 has anti-inflammatory action against the key cytokines involved in the cytokine storm triggered by COVID-19. VERU-111 is an oral, first-in-class microtubule depolymerization agent that has possible antiviral and anti-inflammatory dual-action.

ANA Therapeutics’ IND application for ANA001 (niclosamide capsules) for COVID-19 received the go-ahead from the FDA. The trial will enroll at least 400 patients with COVID-19 at 10 centers in the U.S.

Biophytis received approval from the Brazilian Health Regulatory Agency (ANVISA) to begin its clinical development program COVA in Brazil. The COVA Phase II/III clinical program will evaluate the efficacy and safety of Sarconeos (BIO101) for respiratory deterioration in COVID-19 patients. Sarconeos is a small molecule, oral drug in Phase IIb trials for sarcopenia in the U.S. and Europe.

Eli Lilly initiated a Phase III trial of LY-CoV555 for the prevention of COVID-19 at long-term care facilities in partnership with NIAID. LY-CoV555 is a monoclonal antibody against SARS-CoV-2.

FDA issued a EUA for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are receiving ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed.

Johns Hopkins University researchers are initiating a trial to learn whether plasma from recovered COVID-19 patients can treat those with a virus infection or prevent those who are at higher risk. Two clinical trials will enroll 1,100 people nationally and is funded by a $35 million grant from the US Department of Defense.

 

Company Actions/Announcements

Moderna will be using a tiered pricing system for its experimental COVID-19 vaccine. Moderna’s CEO said that it will charge between $32 and $37 per dose for its coronavirus vaccine. However, this is for some “low volume” customers.

Partner Therapeutics entered into a $35 million milestone-based Firm Fixed Price agreement with the U.S. Department of Defense to fund two Phase II trials of inhaled Leukine (sargramostim) in COVID-19 patients with acute hypoxemia. The studies will begin this month at sites across the U.S. and will supplement data from more than 60 patients who have completed treatment with Leukine in the SARPAC study underway in Belgium. Leukine may aid the production of antibodies against COVID-19 and help restore lung cells damaged by the pathogen, potentially improving lung function in COVID-19 patients and reducing long-term complications. They are expected to launch in August 2020 in the U.S. under an IND application approved by the FDA in May.

Adaptive Biotechnologies which partnered with Microsoft to decode the immune response to COVID-19, launched immunoSEQ T-MAP COVID, a proprietary research product and data analysis service to accurately and reproducibly measure the T-cell immune response to vaccines in development and track the persistence of that response over time.

J&J announced Janssen Pharmaceutical Inc. has an agreement with the U.S. government for the manufacturing and delivery of 100 million doses of Ad26.COV2.S, a COVID-19 investigational vaccine, following approval or EUA by the FDA.

Pfizer Canada and BioNTech SE announced an agreement with the Canadian government to supply their BNT162 mRNA-based COVID-19 vaccine candidate. Deliveries are planned over the course of 2021. The agreement is part of their commitment in the fight against the pandemic.

 

Other Industry News

Minority groups, such as blacks and Latinos, are typically less likely to participate in clinical trials, even though they are more likely to be most severely affected by COVID-19. Polls show this is consistent in COVID-19 trials as well. They have found that Americans expressing interest in participating in the COVID-19 trials tend to be young, white and healthy. But in order for it to be proven that the vaccine is safe and effective most broadly, clinical trials need to be conducted that include a range of ethnicities, races and age groups, especially in populations most at risk of catching the disease.

According to a study published in the journal Science Advances on July 24, an international team of researchers led by neuroscientists at Harvard Medical School has uncovered which olfactory cell types are most vulnerable to infection by SARS-CoV-2, which causes COVID-19.

Reported by Kaiser Health News, there is reason to believe obesity could undermine a COVID-19 vaccine and make it less effective similar to influenza, hepatitis B, tetanus and rabies vaccines.

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