Biopharma Update on the Novel Coronavirus: December 22
News information is not all-inclusive and updates are published once a week on Tuesdays.
Last week, the U.S. Food and Drug Administration (FDA) authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.
Detecting the presence of SARS-CoV-2 in asymptomatic individuals has been a challenge not even PCR – the gold standard of testing – can adequately address. Now two companies have developed novel solutions with the sensitivity and specificity needed to provide ample warning. Please read more here.
The FDA issued a new emergency use authorization for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. The BinaxNOW COVID-19 Ag Card Home Test has been authorized for self-collected samples in patients ages 15 years or older, and adult-collected swabs in patients ages four years or older. Both types of samples are to be collected within the first seven days of symptom onset.
Testing Therapies, Antivirals and Vaccines
Shares of Mesoblast Limited were down more than 30% in premarket trading following the company’s disappointing announcement late Thursday regarding its stem-cell therapy trial in ventilator-dependent patients with COVID-19 patients who have moderate to severe acute respiratory distress syndrome.
Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study assessing the monoclonal antibody VIR-7831 as a potential treatment of hospitalized adults diagnosed with COVID-19.
In August, Russia approved Sputnik-V, a vaccine against COVID-19 ahead of the completion of Phase III studies. Last week, the National Research Center for Epidemiology and Microbiology in that nation announced the vaccine’s efficacy is at 90% following the latest review of clinical data.
After four people in the Pfizer-BioNTech's and three people in Moderna’s COVID-19 vaccine trials developed temporary facial weakness or paralysis, some people became concerned that it could happen to them. But experts suggest that the condition, known as Bell’s palsy, is fairly prevalent in the population and generally transient, and these experts emphasize that the benefits of the currently authorized COVID-19 vaccines far outweigh any potential risks.
RedHill Biopharma’s Phase II/III study assessing orally-administered opaganib (Yeliva, ABC294640) in patients hospitalized with severe COVID-19 pneumonia received another green light to continue following a second independent Data Safety Monitoring Board (DSMB) safety review. With the trial set to continue, topline data is expected in the first quarter of 2021, the company said.
N.C.-based BioCryst Pharmaceuticals will discontinue to assess its broad-spectrum antiviral, galidesivir in COVID-19. Instead, the company will continue to develop the asset as a potential for biodefense threats, such as Marburg virus disease. Development of galidesivir is being supported by the National Institute of Allergy and Infectious Diseases.
Germany’s CureVac N.V. vaccinated the first patient in the Phase III study of its COVID-19 vaccine, CVnCoV. The patient is a healthcare worker at the University Medical Center Mainz. The study is focusing on those patients who are considered high risk, CureVac said.
Aldeyra Therapeutics confirmed antiviral activity in studies of its asset, ADX-1612, as well as novel anti-inflammatory activity in SARS-CoV-2-infected primary human cells in preclinical studies. The anti-inflammatory activity of ADX-1612, as assessed by cytokine transcription in SARS-CoV-2-infected primary human cells, included down-regulation of TNF-α, IFN-1β, IL-6, and a variety of other cytokines and pro-inflammatory mediators, the company said.
Ugur Sahin, chief executive officer and co-founder of BioNTech said its COVID-19 vaccine should perform against mutant strains. The company has already performed laboratory assays of the vaccine's performance against 20 mutant strains, and the same tests will be performed on the new UK version. Sahin says it should take about two weeks. Please read more here.
Royalty Pharma announced charitable contributions totaling $7,660,000 that will be used to support COVID-19 research at Rockefeller University, Mount Sinai Health System and Columbia University.
Other Industry News
With two COVID-19 vaccines now beginning to be administered across the United States, House Democrats launched an investigation into incidents of political interference that stymied the national response to the ongoing pandemic.
The U.S. Food and Drug Administration (FDA) granted Moderna’s COVID-19 vaccine Emergency Use Authorization (EUA) on Friday night. The company and Operation Warp Speed began distribution of the vaccine through McKesson, along with United Parcel Services and FedEx, over the weekend. The first vaccinations were expected yesterday.
A new and more easily transmissible strain of COVID-19, dubbed VUI-202012/01, has now been reported in at least six different countries and global territories since it first appeared in the U.K. a few weeks ago. Experts warn this new mutated strain will likely become the dominant global strain of the virus, with no conclusive word yet on how the currently authorized COVID-19 vaccines will impact this strain.
A study in Nature Neuroscience shows SARS-CoV-2, the virus responsible for COVID-19, is capable of crossing the blood-brain barrier, likely contributing to symptoms of brain fog and other cognitive effects reported by people infected with the virus.
As Pfizer-BioNTech and the U.S. government begin the historic rollout of COVID-19 vaccine distribution around the U.S. and the world, there have been a few glitches. This isn’t unexpected.