2021 Biopharma Update on the Novel Coronavirus: February 16

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

Testing Therapies, Antivirals and Vaccines

With billions invested in R&D over the past year to find vaccines and therapies for the novel coronavirus, a few select life sciences companies and academic institutions are working on the hypothesis that intranasal vaccines and therapies could be key to stopping COVID-19 in its tracks, and provide greater protection against transmission of COVID-19. Please click here for more information.

Early results from the University of Oxford’s RECOVERY trial showed Roche’s immunosuppressant Actemra reduced deaths and the need for mechanical ventilation in severe COVID patients. Genentech’s Actemra is approved to treat rheumatoid arthritis and cytokine release syndrome resulting from chimeric antigen receptor-T cell therapy. The data was posted online before peer-reviewed publication in the preprint archive medRxiv.

There are some big surprises among the list of major players in the vaccine space who either dropped their programs or have been significantly delayed. To read the full article, click here.

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to a combination of Eli Lilly and AbCellera’s monoclonal antibody bamlanivimab and a second Eli Lilly antibody called etesevimab for mild to moderate COVID-19.

South Africa recently announced it was halting 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. Last week it was announced that the country will give its front-line health care workers the J&J vaccine, even though it has yet to be authorized in the country, starting next week as part of a study to determine if it protects against COVID-19, especially the South African variant.

One of the vaccine candidates under development by Sanofi will not be available this year, Sanofi Chief Executive Officer Paul Hudson told French news media. According to The Hill, the candidate in question is likely a mRNA vaccine under development with Translate Bio. The candidate was expected to begin clinical trials were expected to begin this quarter. A phase IIb study for a vaccine candidate developed with GlaxoSmithKline is expected to begin later this month, according to the report.

AstraZeneca and Oxford University will assess its vaccine in pediatric patients ages six to 16. Approximately 300 volunteers are expected to participate. Read more at The Hill.

All India Institute of Medical Sciences (AIIMS) indicated that Bharat Biotech’s COVID-19 vaccine, Covaxin, may offer immunity for nine to 12 months, based on mathematical models. The vaccine was already approved before the release of Phase III data and was used to inoculate healthcare workers during the Phase I trial.

Lexaria Bioscience’s DehydraTECH, a drug delivery platform, improved the “bioavailability” of pharma ingredients. The company raised $11 million to support R&D programs that target high blood pressure and COVID-19 infection.

Bar-Ilan University researchers in Israel published a study in Eurosurveillance noting that a single dose of the Pfizer-BioNTech COVID-19 vaccine was immunogenic in 92% of recipients. There was no difference between men and women, but the response decreased among older recipients. The study evaluated 514 Israeli healthcare workers.

Clene Nanomedicine initiated a Phase II trial of CNM-ZnAg liquid solution in acutely symptomatic, non-hospitalized COVID-19 patients. The primary endpoint will evaluate the rate of decreased hospitalizations at day 28. CNM-ZnAg is a proprietary zinc-silver ionic solution that has both antiviral and antibacterial properties as well as immune-boosting properties.

Organizational Announcements

Yesterday, after just a four-week review process, the World Health Organization (WHO) issued emergency use approval (EUA) to two versions of AstraZeneca-Oxford’s COVID-19 vaccine as the next weapons in the globe’s arsenal against the SARS-CoV-2 virus.

Other Industry News

One of several unusual symptoms reported in COVID-19 patients is what is being informally dubbed “brain fog” or “COVID brain,” but in medical terminology is called encephalopathy. It appears to be loss of short-term memory, headaches and confusion. At its most severe, it is associated with psychosis and seizures. Typically, if seen at all, it occurs weeks after first showing symptoms of COVID-19. Researchers at Memorial Sloan Kettering Cancer Center published research in the journal Cancer Cell that they believe explains the underlying cause of the brain fog.

A recently published observational study in the Proceedings of the National Academy of Sciences suggests there is a strong positive association between the number of coronavirus disease 2019 (COVID-19) aerosol droplets an individual breathes out with age, infection and body weight.

Last week, a WHO team announced preliminary findings following an investigatory trip to Wuhan, China, that muddies the water about the origin of the SARS-CoV-2 virus. While the investigation upholds the year-long determination that the virus was not manufactured in a laboratory and leaked from the Wuhan National Biosafety Laboratory, it does suggest the virus could have originated outside of Wuhan, where the original outbreak occurred. That has been a theory heavily promoted by the Chinese government. During the WHO press conference in Wuhan, Chinese officials said virus investigators should look outside of China’s borders for the origins of SARS-Cov-2, the Times reported.

The U.K. coronavirus variant is not only more transmissible, but also appears to be deadlier than the original strain of the virus. A new government study found the impact of the variant is more devastating to the population than imagined and is also responsible for a higher rate of hospitalization. Read more at The Washington Post.

With the increase in the number of new variants of COVID-19, vaccine makers are looking at ways to tweak their products in order to provide more protection against these new strains. The concern about variants has increased following the discovery of seven new variants found in the United States. The Associated Press reports more here.

Why can you get a common cold while masking and social distancing? First, SARS-CoV-2, the virus that causes COVID-19 is highly contagious. But it’s also only a single virus, whereas there are hundreds of different viruses that can cause the common cold. Also, rhinoviruses, of which there are 160 that can cause the common cold, survive well on surfaces—in other words, although you can catch colds or COVID-19 through the air, but you’re much more likely to catch a cold by touching infected surfaces. And finally, probably because you’re not as careful as you think you are at social distancing and hand-washing.

Zinc and Vitamin C (ascorbic acid) do not seem to improve COVID-19 infections, according to a small study published in JAMA Network Open. The study evaluated 214 people in Ohio and Florida. Keeping in mind, that despite their popularity for this, neither has been shown to help with the common cold or other illnesses.

As they have said before, biopharma companies that have developed vaccines against COVID-19 may need to modify those vaccines to deal with increased strains of variants that are resistant to earlier vaccines. In particular, studies are suggesting that the South African strain may be more resistant to existing vaccines. However, most of the new technology used in vaccines, especially the mRNA vaccines from Pfizer-BioNTech and Moderna, is easily modifiable. At this time, the vaccines appear to prevent severe illness and death, even in the South African strains. If people who are fully immunized start showing up in hospitals with the mutated strains, then that will likely be a trigger point for companies to start modifying their vaccines. Peter Marks, the FDA’s vaccine chief, recently told the American Medical Association that simply changing the vaccine recipe to better target viral mutations won’t require repeating the large clinical trials that were conducted the first time around.