2021 Biopharma Update on the Novel Coronavirus: January 12
News information is not all-inclusive and updates are published once a week on Tuesdays.
Concern has been building about the new SARS-CoV-2 strain discovered last month in the U.K., and on Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests.
NeuTigers, an Artificial Intelligence (AI) spinout of Princeton University, launched CovidDeep. CovidDeep is a screening tool that can determine if a person is positive, negative or asymptomatic for COVID-19 using wearable devices. In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes.
Testing Therapies, Antivirals and Vaccines
By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate.
One of the open questions about the various vaccines against COVID-19 has been how long the protection offered will last. Although the jury is still out, the data is beginning to look promising. Stephane Bancel, chief executive officer of Moderna, speaking at a virtual event by Oddo BHF, a financial service group, said, “We believe there will be protection potentially for a couple of years.”
China’s Sinovac Biotech reported that its COVID-19 vaccine, CoronaVac, had a 78% efficacy rate in a Phase III clinical trial in Brazil.
Pfizer and BioNTech reported that their COVID-19 vaccine appears to be effective against a key mutation in new variants of the SARS-CoV-2 virus that causes COVID-19.
A study published by the U.S. Centers for Disease Control and Prevention (CDC) cautioned that the COVID-19 vaccine seems to cause severe allergic reactions at a much higher rate than other vaccines, such as the flu vaccine.
NeuroRx, Relief Therapeutics and Quantum Leap Healthcare Collaborative announced that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of Zyesami (RLF-100 aviptadil) in the I-SPY COVID-19 trial. I-SPY COVID-19 is assessing multiple drugs for critical COVID-19 hospitalized or ICU patients.
DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19. Dalcetrapib is a potential anti-viral treatment that binds to the catalytic site of 3CLMpro of SARS-CoV-2 in vitro. The trial will be in patients with confirmed mild to moderate symptomatic COVID-19.
The European Commission is in advanced discussions with France’s Valneva SE to secure up to 60 million doses of its inactivated virus COVID-19 vaccine, VLA2001. VLA2001 entered Phase I/II clinical studies in December and Valneva expects to report initial safety and immunogenicity data in April 2021. If clinical development is successful, an initial approval may be granted in the second half of 2021, the company said.
Germany’s DiosCURE Therapeutics published a report in Science describing the company’s core technology of multivalent single-chain antibodies with a unique molecular mode-of-action to inactivate SARS-CoV-2 virions. The company’s lead candidates, DIOS-202 and DIOS-203, are synergistic combinations of single-domain antibodies derived from camelid heavy chain-only antibodies.
LabCorp received a contract from the U.S. Centers for Disease Control and Prevention (CDC) to provide genomic sequencing of SARS-CoV-2 samples.
The FDA issued a statement saying, “Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”
Gilead Sciences’ Veklury, which is better known by its scientific name remdesivir, is the only antiviral drug currently approved to treat COVID-19. Despite some controversy over its effectiveness, it is bolstering the company’s bottom line and Gilead recently updated its 2020 guidance to reflect that.
Pfizer and BioNTech indicated they plan to produce an output of their COVID-19 vaccine this year by more than 50%. The plan is to produce 2 billion doses this year.
Other Industry News
The advancing rollout of currently approved coronavirus disease 2019 (COVID-19) vaccines provides hope to many that existing lockdowns and social restrictions will soon be lifted, but experts suggest a “return to normal” likely won’t occur until herd immunity is achieved. Speaking to the Reuters Next conference, Dale Fisher, chairman of the World Health Organization's (WHO) Outbreak Alert and Response Network, said that achievement of herd immunity in most countries is unlikely in 2021.
Evidence continues to build for long-lasting immunity to COVID-19 following disease infection, with the publication of a new study showing a durable immune response as far as eight months after the initial onset of symptoms. The latest peer-reviewed study, published last week in Science, echoes several non-peer-reviewed studies published last year.
In a recent paper published in Alzheimer’s and Dementia, a team of researchers is calling for more prospective studies that will look into the impact coronavirus disease 2019 (COVID-19) has on brain functioning, given the disease has been frequently associated with neurologic symptoms such as seizures and psychosis.
SARS-CoV-2, the virus that causes COVID-19, has mutated into several strains. Most of them are not particularly different than the primary strains, but two, B.1.1.7, which was first observed in the U.K., and now 501.V2, which originated in South Africa, have virologists watching closely.
On Monday, the San Diego Zoo announced that two gorillas tested positive for COVID-19.