Biopharma Update on the Novel Coronavirus: May 28

News information is not all-inclusive. Please check back for updates.

 

FDA Actions

Formal Meetings and User Fee Applications: The FDA issued guidance to provide answers to frequently asked questions on the effects of the COVID-19 pandemic on formal meetings and user fee applications.

Warning Letters: The FTA and FTC issued warning letters to CBD Gaze, Alternavita, Musthavemom.com and Careful Cents, LLC for promoting and selling fraudulent COVID-19 products.

Preliminary Injection: The U.S. District Court of the Eastern District of Oklahoma entered a preliminary injection against Xephyr LLC, dba N-Ergetics requiring it to immediately stop distributing colloidal silver products to treat COVID-19.

Guidance for Shortages: The FDA issued new guidance and updated guidance to address potential shortages of face masks, surgical masks, respirators and face shields during the COVID-19 pandemic.

• Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the COVID-19 Public Health Emergency
• Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency

EUA: The FDA issued a EUA to CLEW Medical Ltd for its CLEWICU System for use by healthcare providers in the ICU to assist with early identification of adult patients who are likely to be diagnosed with respiratory complications associated with COVID-19.

Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 113 individual EUAs have been issued, which includes 100 molecular tests, 12 antibody tests and 1 antigen test.

 

Diagnostics

CVS announced it will establish a total of 1,000 COVID-19 test sites on Friday, May 29 across more than 30 states and Washington, D.C.

 

Testing Therapies, Antivirals and Vaccines

Startup ViralClear drives antiviral into phase II for COVID-19 following significant preclinical results. ViralClear Chief Executive Officer Nick Spring told BioSpace that the preclinical work is “telling a very good story.” 

Roche and Gilead Sciences have launched a Phase III clinical trial in severe COVID-19 pneumonia, testing Roche’s Actemra/RoActemra with Gilead’s remdesivir. To date, remdesivir is the only drug shown to be effective against COVID-19 and is approved by the U.S. Food and Drug Administration (FDA) under emergency use authorization.

As reported by CNBC, Novartis agreed to manufacture a COVID-19 vaccine. The vaccine is expected to enter into clinical trials the second half of the year and is being developed by Harvard, Mass Eye & Ear and Mass. General.

SAB Biotherapeutics announced in vitro data demonstrating that SAB-185, its COVID-19 therapeutic candidate, has highly-potent neutralizing antibodies to SARS-CoV-2 that are four times higher than the most potent human convalescent plasma serum sample evaluated. The company also announced it initiated the manufacturing of SAB-185 to support the next phase of clinical development for its potential COVID-19 therapeutic, still on track to begin human trials in early summer.

Orpheris, a subsidiary of Ashvattha Therapeutics, received the green light from the FDA to initiate a Phase II study of OP-101 in patients with severe COVID-19. OP-101 selectively targets reactive macrophages, reducing the pro-inflammatory cytokine storm and oxidative stress in multiple animal models of inflammation. The Phase II clinical trial will evaluate the reduction in pro-inflammatory markers (CRP, ferritin, and IL-6) after treatment with OP-101 is also included in the study.

In response to the global pandemic, I-Mab reviewed its portfolio in March and identified TJM2, an asset in development for rheumatoid arthritis, that could help severe COVID-19 patients. TJM2 is a neutralizing antibody against human granulocyte-macrophage colony-stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic tissue inflammation.

Germany-based Atriva Therapeutics GmbH will investigate its asset ATR-002, an oral small molecule, against COVID-19. ATR-002 has been proven in preclinical trials to block viral propagation of SARS-CoV-2 and to have an immunomodulatory effect leading to a decreased cytokine and chemokine release. This dual benefit makes the MEK-inhibitor ATR-002 particularly relevant for the treatment of COVID-19, the company said.

ARCA Biopharma announced a development program to evaluate AB201 in COVID-19 associated coagulopathy (CAC) and the related inflammatory response. AB201 is a potent, selective inhibitor of tissue factor (TF). The drug has already undergone clinical testing through Phase II in more than 700 patients for other indications.

CalciMedica announced positive topline data from an interim analysis of its trial of Auxora in severe COVID-19 pneumonia patients on low-flow oxygen therapy. The data showed Auxora plus standard of care reduced ventilator use and improved time to recover compared to standard of care alone. Auxora is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation, which can cause pulmonary endothelial damage and cytokine storm in COVID-19.

 

Company Actions

GlaxoSmithKline inked deals earlier this year to support the development of multiple adjuvanted COVID-19 vaccine candidates and is now pledging to manufacture 1 billion doses of that efficacy-boosting system by 2021.

Oxford BioMedica announced it has signed a one year agreement with AstraZeneca UK Ltd to manufacture the adenovirus vector based COVID-19 vaccine candidate, AZD1222.

Advent Srl, an IRBM company announced it has manufactured 13,000 doses of the COVID-19 vaccine candidate, ChAdOx1 nCoV-19 (now known as AZD1222). The first 4,000 doses have been delivered to the University of Oxford, England for use in a Phase II/III clinical trial COV002.

ProMIS Neurosciences received a Digital Technology Supercluster award from the Government of Canada for $1.8 million (CAN) for their project, “Predicting the evolution of COVID-19.” The project brings together six commercial and academic collaborators to predict possible mutations of SARS-CoV-2.

Novavax acquired Praha Vaccines a.s., part of the Cyrus Poonawalla Group, which includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant.

 

Other Industry News

A protein called ACE2 is intimately involved in how SARS-CoV-2, the virus that causes COVID-19, infects the body. The protein is found on nasal membrane cells, which is typically where the virus enters the body. The ACE2 protein is found throughout the body in various concentrations, but it is in the lungs, heart and kidneys, as well as the lining of the blood vessels. There is now research suggesting that one reason children may be less likely to be infected is because of their relatively fewer ACE2 proteins.