Biopharma Update on the Novel Coronavirus: October 6
News information is not all-inclusive and updates are published once a week on Tuesdays.
Research contract: The FDA awarded Stanford University School of Medicine a research contract to perform in-depth analysis to learn more about how SARS-CoV-2 affects different systems in the body.
Diagnostics Update: To-date the FDA has authorized 270 individual EUAs, which include 213 molecular tests, 52 antibody tests and 5 antigen tests.
The Co-Immunity Project at the University of Louisville’s Christina Lee Brown Environmental Institute observed high levels of COVID-19 infections in Metro Louisville. These confirmed previous findings, indicating that 30,000 to 40,000 people have been exposed to the virus in Jefferson County since the beginning of the pandemic, with a higher rate of infection in West Louisville than in other neighborhoods.
QIAGEN announced plans to launch a novel straightforward approach to viral RNA epidemiology that will significantly simplify and accelerate PCR analysis and remove key testing bottlenecks for SARS-CoV-2 and other RNA viruses. QIAGEN’s innovative QIAprep& Viral RNA UM Kit integrates sample preparation and detection steps in one single kit.
Testing Therapies, Antivirals and Vaccines
Early clinical trial results had already suggested that some patients receiving the Moderna COVID-19 vaccine and the Pfizer/BioNTech vaccine showed some cases of mild side effects. A few days ago, CNBC reported five patients, three in Moderna’s and two in Pfizer’s Phase III trials, that experienced more severe, although transient side effects. Please read more here.
A COVID-19 vaccine being co-developed by Hong Kong University (HKU), Xiamen University and Wantai Biological Pharmacy Enterprise Co. Ltd, which contains a weakened flu virus with some of the coronavirus’ genes, became the first COVID-19 nasal spray vaccine candidate to enter human clinical trials on September 1. Please read more here.
Moderna’s chief executive officer, Stephane Bancel, said this week that he expects the company to submit the data to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) on November 25. “25 November is the time we will have enough safety data to be able to put into a EUA file that we would send to the FDA, assuming that the safety is good, i.e., a vaccine is deemed to be safe,” he said. In terms of more broad availability, Bancel indicated late March or early 2021.
Pfizer and BioNTech have begun a rolling submission of their vaccine candidate to the European Medicines Agency (EMA). AstraZeneca has also begun a rolling review process. The rolling submission allows regulators to evaluate data as it becomes available, which can decrease the time it takes to decide on an approval once the final submission is made. Each cycle of the EMA’s rolling review typically takes two weeks and the duration of the review of the final application will depend on how much data was evaluated during the rolling process.
Vir Biotechnology is expanding its Phase III COMET-ICE study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 is a monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
Allele Biotechnology and Pharmaceuticals filed lawsuits against Regeneron Pharmaceuticals, as well as Pfizer and Germany’s BioNTech, claiming the companies infringed on Allele’s patented mNeonGreen technology in the development of their COVID-19 treatments.
The same day President Donald Trump left Walter Reed National Military Medical Center after hospitalization due to COVID-19, White House officials said they would block new vaccine guidance that would delay hurried approvals ahead of the Nov. 3 election. Please read more here.
Karyopharm Therapeutics announced an oral presentation at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group (ISIRV-AVG) Virtual Conference on Therapeutics for COVID-19. The presentation will include data from a Phase II trial of low dose oral Selinexor in hospitalized severe COVID-19 patients. An interim analysis suggested the trial was unlikely to hit its primary endpoint, so the trial was discontinued, but the results showed encouraging anti-viral and anti-inflammatory activity in a subset of treated patients.
ChromaDex published a new Phase II trial of hydroxychloroquine and combined metabolic cofactors supplementation (CMCS) of L-serine, Nacetyl-L-cysteinie (NAC), nicotinamide riboside (NR), and L-carnitine tartrate on ambulatory COVID-19 patients. The results, which have not been peer-reviewed yet, suggest the combination significantly reduced the average complete recover time compared with hydroxychloroquine and placebo alone.
Akari Therapeutics received FDA clearance received to proceed with an investigator-led multi-center double-blind randomized clinical study in the U.S. with nomacopan following prior expanded access program.
Molecular Partners AG announced supportive preclinical data from in vivo assessments of its DARPin candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease. First-in-human studies for MP0420 are anticipated to begin in November and clinical studies for the second antiviral candidate, MP0423, are expected to initiate in 2021.
Other Industry News
On Tuesday, the World Health Organization (WHO) said it is in talks with China to have its locally-produced COVID-19 vaccines available for international use.
The CDC again updated guidance to indicate that COVID-19 can spread by airborne transmission.