Biopharma Update on the Novel Coronavirus: November 24
News information is not all-inclusive and updates are published once a week on Tuesdays.
FDA Actions
EUA: The FDA issued an EUA for the drug baricitinib (Oluminant) in combination with remdesivir (Veklury) for treatment of those with COVID-19.
Warning Letters: The FDA along with the FTC issued warning letters to the following for selling unapproved products with fraudulent COVID-19 claims.
Vaccine Development – 101: The FDA has updated its webpage to provide an overview of the vaccine development process.
Diagnostics Update: To-date the FDA has authorized 288 individual EUAs, which include 223 molecular tests, 58 antibody tests and 7 antigen tests.
Diagnostics
Researchers with the Rensselaer Polytechnic Institute developed an algorithm that accurately predicts COVID-19 patient outcomes. The artificial intelligence-based tool combined chest computed tomography (CT) images evaluating the severity of a patient’s lung infection with various demographic data, vital signs and lab blood test results. The algorithm predicts patient outcomes, specifically whether or not a patient will need ICU intervention.
Testing Therapies, Antivirals and Vaccines
Maryland-based vaccine company Novavax said its COVID-19 vaccine candidate, NVX‑CoV2373, prevented SARS-CoV-2 infection in monkeys, hinting that the product could likewise prove effective in humans.
Regeneron’s COVID-19 monoclonal antibody cocktail that was used to treat President Donald Trump has finally received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%.
AstraZeneca and the University of Oxford published Phase II clinical trial results for their COVID-19 vaccine in The Lancet. The data shows the vaccine is safe and offers a similar immune response in all adults.
The U.S. Food and Drug Administration granted Emergency Use Authorization to a combination of Eli Lilly’s and Incyte’s Olumiant (baricitinib), a rheumatoid arthritis treatment, and Gilead Sciences’ remdesivir as a treatment for hospitalized patients diagnosed with COVID-19 who require supplemental oxygen or ventilation.
After last week's news that Moderna reported interim efficacy data for its COVID-19 vaccine of 94.5%, only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, the U.S. and western countries have the promise of two effective and reasonably safe vaccines. There are similarities between the two, and a few differences. Here’s a look.
Bellerophon Therapeutics announced interim analysis of the first 100 patients in its Phase III COViNOX trial of INOpulse for COVID-19. As a result, they put the trial on clinical hold. The analysis included 10 respiratory failure or death (RFD) events, which was a small size for the RF endpoint. The company plans to complete the study for the remaining patients and evaluate the full data set.
CytoDyn hit the enrollment target of 293 patients in its Phase III trial for COVID-19 patients with severe-to-critical symptoms. They are evaluating Vyrologix (leronlimab-PRO 140), a CCR5 antagonist. This hits the requested criteria for a second interim efficacy analysis.
City of Hope announced it has initiated a Phase I clinical trial for its first investigational SARS-CoV-2 vaccine in healthy volunteers.
Organizational Actions/Announcements
Merck acquired Maryland-based OncoImmune and its COVID-19 therapeutic candidate CD24Fc for $425 million in upfront cash two months after the Phase III asset demonstrated efficacy during an interim analysis.
Novartis inked an exclusive worldwide license and collaboration deal with Australia-based Mesoblast to develop, commercialize and manufacture remestemcel-L for acute respiratory distress syndrome (ARDS), including when it is linked to COVID-19.
With Pfizer and Moderna lining up their COVID-19 vaccine candidates for Emergency Use Authorization (EUA), the U.S. Food and Drug Administration (FDA) announced it will make publicly available all data and information that will be used to consider authorization of vaccines and therapeutics against the virus.
Other Industry News
COVID-19 is a cardiac condition as much as it is a pulmonary or respiratory disease. This knowledge is so recent that it often is overlooked by non-cardiologists, according to physicians speaking at Demy-Colton Virtual Salon, “COVID-19: Surprising Cardiac Findings & Concern about the Potential Impact.”
COVID-19 Brief: WHO recommends against remdesivir, Roche ramps up to produce antibodies treatment and more. Please read more here.
Researchers out of the University of Arizona led by Dr. Rajesh Khanna have published interesting experimental evidence that may help explain why some people contract COVID-19 without falling ill. Please read more here.
Researchers at Weill Cornell Medicine identified a specific and unique kind of immune cell activity in the lungs of COVID-19 patients. This activity, they found, is different from the type of immune cell activity found in other respiratory infections.
Researchers from the University of Birmingham, UK, announced that they have developed a nasal spray that can potentially provide protection against COVID-19. Additionally, it is formulated using materials that have already been cleared for use in humans.
November is American Diabetes Month. We have known since early on that diabetes is a complicating risk factor for developing severe illness from the SARS-CoV-2 virus that causes COVID-19. The hypothesis is now being floated by prominent members of the medical community that COVID-19 may cause the disease to return – or potentially a unique version of it. Please read more here.
Nevada-based Flirtey, a pioneer of the commercial drone delivery industry, and Vault Health announced a partnership to test drone delivery of an FDA authorized saliva test for COVID-19. Vault Health distributes a COVID-19 saliva test kit that can be used at home under supervision from a health professional through a video call.