2021 Biopharma Update on the Novel Coronavirus: February 9

News information is not all-inclusive and updates are published once a week on Tuesdays.

Testing Therapies, Antivirals and Vaccines

Eiger BioPharmaceuticals announced that in a small study published in Lancet Respiratory Medicine, the drug interferon lambda may provide non-hospitalized COVID-19 patients with benefits. The single dose of lambda accelerated the clearance of SARS-CoV2 in newly diagnosed patients.

Researchers at the University of Texas Medical Branch showed Pfizer’s mRNA vaccine neutralized COVID-19 variants. The study was published in Nature Medicine.

South Africa has delayed the distribution of the AstraZeneca-University of Oxford COVID-19 vaccine after data suggested it “provides minimal protection” against mild disease from the South African variant. The data was announced by the Wits Vaccines and Infectious Diseases Analytics (VIDA) Research Unit, which is running the COVID-19 vaccine trial in South Africa. The data has yet to be peer-reviewed.

According to the Wall Street Journal, The World Health Organization (WHO) defended AstraZeneca’s COVID-19 vaccine and expressed confidence it can prevent severe cases of the virus.

Johnson & Johnson’s Janssen Biotech submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its single-dose COVID-19 vaccine. The EUA submission is based on topline data from the Phase III ENSEMBLE trial. If the FDA grants authorization, J&J indicates it has the vaccine ready to ship immediately.

The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality.”

Foster City-based Gilead Sciences says its inhaled version of remdesivir, which has been increasingly used in research and practice to combat COVID-19 in hospitalized patients, won’t be available any time soon as it needs more testing in clinical research.

Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.

The University of Oxford in the U.K., with the National Immunisation Schedule Evaluation Consortium, is planning a trial to evaluate the use of first and second doses of different COVID-19 vaccines. The first dose is viewed as the “prime” vaccination with the follow-up a “booster” shot.

GlaxoSmithKline will partner with Germany’s CureVac to manufacture 100 million doses of that company’s mRNA COVID-19 vaccine, CVnCoV, and will collaborate with the company to develop a next-generation multi-valent COVID-19 vaccine aimed at emerging variants of the novel coronavirus. The collaboration is valued at €150 million (approximately $180 million). The two companies already have a history of working together.

Although designed for two doses, primary analysis of AstraZeneca and the University of Oxford’s Phase III data for its COVID-19 vaccine found it to have 76% efficacy after the first dose. That protection was maintained to a second dose, with an interval of 12 weeks or more, the efficacy increased to 82%. This is welcome news as drug companies and governments work to manufacture and distribute more vaccine to get as many people vaccinated as possible. However, when the second dose was provided less than six weeks after the initial dose, the efficacy was 54.9%. Click here for more information.

The vast majority of COVID-19 vaccines on the market or in development are administered through an injection, but South San Francisco-based Vaxart is attempting to develop an oral vaccine. Last week, the company released preliminary data that showed its medication was well-tolerated and generated an immunogenic response.

Tonix Pharmaceuticals Holding Corp. is expected to receive guidance from the U.S. Food and Drug Administration for the development of a diagnostic skin test for COVID-19. The test, dubbed TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration), will measure T cell immunity to the virus that causes COVID-19. There currently is no standardized laboratory test available to measure T cell immune responses to the virus. Tonix said T cell immunity to the virus persists longer than antibody immunity, and is sometimes present in the absence of a measurable antibody response.

Veru announced positive results from its Phase II trial of VERU-111 compared to placebo in 40 hospitalized patients at high risk for ARDS from COVID-19. The drug showed meaningful reductions in various endpoints, including respiratory failure, days in the ICU and on mechanical ventilation and patient mortality. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha an dbeta tubulin subunits of microtubules.

Covaxx announced interim Phase I data from its Phase I trial of UB-612, a multitope protein/synthetic peptide-based COVID-19 vaccine conducted in Taiwan. The vaccine was generally well-tolerated and produced a robust antibody response. The company’s subsidiary United Biomedical announced that it had received conditional approval to begin Phase II trials of the vaccine candidate in Taiwan. It will evaluate the vaccine in three distinct cohorts: adolescents ages 12 to 18 years of age, adults 19 to 64 years of age, and seniors 65 years and older.

Fluidigm Corporation reported that an NIH-sponsored Stanford University School of Medicine study was using its mass cytometry technology and the Maxpar Direct Immune Profiling Assay as part of a longitudinal study of about 250 pediatric COVID-19 patients. The study will look at immune system activity in this patient population compared to data from those with asymptomatic infections, mild COVID-19 and multisystem inflammatory syndrome (MIS-C).

Other Industry News

When all is said and done, there will have been many forgotten victims of COVID-19. With the SARS-CoV-2 virus showing up in more and more human organs, will potential recipients be among them? And what precautions are being taken to ensure that recipients are not receiving virus-infected organs at a time when they are perilously immunocompromised? Organ donations “decreased dramatically” during the first wave of the pandemic, said Dr. Atul Humar, a physician, senior scientist, and director of the Toronto General Hospital Research Institute (TGHRI). Please read here for more information.

A new study report in Science suggests SARS-CoV-2 and its mutated new variants can evade immune responses via the selective deletion of small sections of the virus’s genetic sequence.

According to the Centers for Disease Control and Prevention (CDC), seasonal influenza cases in the U.S. remain lower than usual for this time of year, with most areas experiencing minimal reported activity. While it’s most likely our social distancing, mask wearing and extra sanitizing to thank for this, the flu vaccine still has a role to play this season. Researchers from the University of Missouri School of Medicine published their study on the flu vaccine’s impact on COVID-19 pediatric patients. The team found that children who received the seasonal flu shot were less likely to suffer symptoms from COVID-19 infection.