Biopharma Update on the Novel Coronavirus: November 3
News information is not all-inclusive and updates are published once a week on Tuesdays.
FDA Actions
Warning Letters: The FDA, along with the FTC issued warning letters to the following companies for selling fraudulent COVID-19 products.
Diagnostics Update: To-date the FDA has authorized 287 individual EUAs, which include 223 molecular tests, 57 antibody tests and 7 antigen tests.
Diagnostics
Hong Kong-based Prenetics, a genetics testing firm, told CNBC its new COVID-19 rapid test is comparable to the gold-standard polymerase chain reaction tests. Prenetics tests use a loop-mediated isothermal amplification technique and return results within 30 minutes.
OraSure Technologies’ DNA Genotek subsidiary received emergency use authorization (EUA) from the FDA for ORAcollect RNA (OR/ORE-100) saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA. It allows for unsupervised use of the device at-home or in a healthcare setting when used with an authorized or cleared self-collection kit.
Testing Therapies, Antivirals and Vaccines
A recent study on 100 COVID-19 patients found that T-cell responses against several SARS-CoV-2 viral proteins, including the spike protein, continued for at least six months, even in patients with no symptoms. “This is promising news,” said Fiona Watt, executive chair of the UK’s Medical Research Council. “If natural infection with the virus can elicit a robust T-cell response, then this may mean that a vaccine could do the same.”
Humanigen dosed the first COVID-19 patient with lenzilumab in the Phase III trial to help hospitalized patients recover faster. The patient was at the MedStar Washington Hospital Center in Washington, DC. Lenzilumab is a humanized monoclonal antibody that targets colony-stimulating factor 2 (CSF2)/granulocyte-macrophage colony-stimulating factor (GM-CSF).
TLC is publishing its data on how inhalable liposomal hydroxychloroquine (TLC19) can provide clinical benefit and act as a potential COVID-19 treatment in Clinical and Translational Sciences. The data is from a preclinical study.
Newly announced results of a Phase I dose-escalation study show CureVac’s COVID-19 vaccine candidate, CVnCoV, generates noticeable immune responses in healthy volunteers.
Icosovax is turning its virus-like particle (VLP) technology to fight COVID-19. The news accompanies $16.5 million in new funding from the Bill and Melinda Gates Foundation and Open Philanthropy, and the publication of preclinical data in Cell. BioSpace’s Gail Dutton caught up with Icosavax CEO Adam Simpson to discuss its new vaccine candidate, IVX-411.
Results from Regeneron Pharmaceuticals’ ongoing Phase II/III trial shared last Thursday with the U.S. Food and Drug Administration (FDA) show the company’s antibody cocktail, REGN-COV2, significantly reduced viral load and need for additional medical visits in outpatients with COVID-19. The positive findings were shared as part of the company’s Emergency Use Authorization (EUA) submission for its investigational COVID-19 therapy. Please read more here.
COVID-19 vaccine race leaders strive for a balance between safety and urgency. Please read more here.
Pfizer indicated last week that its Phase III clinical trial of 44,000 volunteers now needs fewer than 2,000 people to be fully enrolled.
Organizational Actions/Announcements
The Incidental Economist blog published an overview of how states and localities are enforcing COVID-19 mandates. It was written by Caroline La Rochelle, a policy and strategy senior associate at PolicyLab at Children’s Hospital of Philadelphia, and evaluated policies in all 50 states and in 31 major metropolitan areas and leveraged state-level policy tracking resources, reviews of relevant executive and agency orders and reviews of local media coverage.
Regeneron Pharmaceuticals decided to halt enrollment of very sick patients with COVID-19 in its trial studying antibody cocktail REGN-COV2, a treatment previously touted as a “cure” by President Donald Trump after he received the experimental therapy for his COVID-19 infection in October.
Novo Nordisk announced that it has ended its development of the anti-IL-21 antibody NN9828 in combination with Victoza. The decision was made after analyzing Phase II clinical trial data in patients with Type 1 diabetes. Novo Nordisk will now shift initiatives towards the pandemic. Please read more here.
Leading pharmaceutical giants – including Moderna, Pfizer and AstraZeneca – are racing ahead to develop and distribute a COVID-19 vaccine. How many initial COVID-19 vaccine doses do these companies plan to produce? Please read more here.
Swiss pharma giant Novartis is harnessing the power of Zurich-based Molecular Partners AG's DARPin platform to develop two therapeutic candidates that could both be used to prevent and treat COVID-19 infection.
Bahrain has granted Sinopharm’s COVID-19 vaccine candidate emergency approval for frontline workers, Reuters reported. The vaccine is in Phase III studies and previous studies have shown the medication was safe and demonstrated efficacy against the virus.
Germany is seeking 5% or about 155,000 vials of Gilead Science’s remdesivir under a six-month deal the European Union struck with the California-based company, Reuters reported. The EU is acquiring about 3 million vials of the medication, which has been approved to treat COVID-19 patients.
Other Industry News
In a new article in the Journal of Biological Chemistry, a study conducted by ChromaDex, Inc. has shown that supporting nicotinamide adenine dinucleotide (NAD+), a critical coenzyme found in all cells and a regulator of a vast number of cellular processes plays a critical role in immune function, including the response to invading pathogens, such as viruses such as COVID-19.
During a Sunday campaign event in Florida, President Donald Trump appeared to hint to the crowd that following the Nov. 3 election, he would terminate the decades-long tenure of Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).
The U.S. – and global – response to the COVID-19 pandemic has been volatile at best. This is fair, considering that SARS-CoV-2 is a novel virus with a lethality we haven’t seen in more than a century. The question of the moment is whether the end result of Tuesday’s election will bring more or less stability to both the U.S. and global game plan. Please read more here.
A seroprevalence study of 15,591 children in Bavaria, published on October 28th in Med, revealed a six-fold greater prevalence of the SARS-CoV-2 virus than reported cases. More than half of those children (aged 1 to 18 years) were asymptomatic, underscoring the value of wide-spread population screenings for pandemic monitoring. Please read more here.
COVID-19 is known to negatively impact cognitive ability in a significant number of people who have become infected. A new study suggests that some patients could see a decline in cognition that is equivalent to the brain aging approximately 10 years.