2021 Biopharma Update on the Novel Coronavirus: March 16

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.

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

Here’s a look at some of the top COVID-19 news over the past week.

Although the new and emerging strains of COVID-19, specifically the South African, U.K. and Brazilian strains, all appear to be more infectious than the original Wuhan wildtype virus, the South African and Brazilian strains do not appear to be more deadly. However, data is starting to accumulate to support the theory that the U.K. strain, B117, is more lethal.

Shares of GenMark Diagnostics are soaring in premarket trading after Roche announced it was acquiring the California-based company in a $1.8 billion deal to bolster its own diagnostics pipeline. In March 2020, GenMark was one of the first companies to receive Emergency Use Authorization from the U.S. Food and Drug Administration for its ePlex SARS-CoV-2 Test. That test will complement Roche’s own COVID-19 tests, including the Elecsys IL-6 test, which measures levels of IL-6 (interleukin-6), as well as its Elecsys Anti-SARS-CoV-2 antibody test.

With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine. Kirill Dmitriev, chief executive officer of Russian Direct Investment Fund, which has spearheaded Sputnik V, said RDIF has been coordinating with the governments of Italy, Spain, France and Germany to launch production of Sputnik V.

EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.

Multiple countries across Europe and parts of Asia have suspended the use of AstraZeneca’s COVID-19 vaccine over fears the medication is leading to the development of blood clots in some patients who have received the medication.

Novavax, based in Gaithersburg, Maryland, announced that its COVID-19 vaccine had final efficacy of 96.4% against mild, moderate and severe COVID-19 caused by the original Wuhan wildtype strain in its U.K. pivotal Phase III trial. And after completing analysis of its Phase IIb trial in South Africa, it reported 55.4% efficacy among the HIV-negative trial volunteers in an area where the majority of strains were the South African B1.351 variants.

Paris-based Sanofi Pasteur and Lexington, Massachusetts-based Translate Bio initiated their Phase I/II clinical trial of MRT5500, a messenger RNA (mRNA) vaccine candidate against COVID-19. Translate Bio receives a $25 million milestone payment for this step. They expect interim data in the third quarter of 2021.

Genentech, a Roche company, announced that its Phase III REMDACTA trial of Actemra (tocilizumab) plus Gilead Sciences’ Veklury (remdesivir) compared to placebo plus Veklury, failed to meet its primary endpoint in patients with severe COVID-19 pneumonia. The endpoint was measured by improved time to hospital discharge up to day 28 in this patient group receiving standard of care.

Vir Biotechnology and GlaxoSmithKline announced that an independent Data Monitoring Committee (IDMC) recommend their Phase III COMET-ICE trial of VIR-7831 as a monotherapy for early treatment of COVID-19 in adults at high risk be stopped for enrollment “due to evidence of profound efficacy.” The recommendation was based on interim analysis of data from 583 patients in the trial showing an 85% decrease in hospitalization or death in patients receiving the drug alone compared to placebo, which was the primary endpoint of the trial. The drug was well tolerated.

Topline results from an investigator-initiated trial in Brazil show that treatment with Kintor Pharmaceutical’s proxalutamide cut mortality risk by 92% and significantly shortened the median length of hospital stay by nine days compared with standard of care in hospitalized patients with coronavirus disease 2019 (COVID-19).

Patients in a Phase II trial have begun receiving Moderna’s vaccine against the SARS-CoV-2 variant first identified in South Africa, the company announced. The modified vaccine, mRNA-1273.351, is being tested out of an abundance of caution, despite the fact that previous data has shown that the company’s marketed mRNA-1273 vaccine produces neutralizing titers against all relevant variations, the company said.

Newly-announced data from Eli Lilly’s Phase III BLAZE-1 clinical trial show a combination of two of the company’s monoclonal antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), significantly reduced the risk of hospitalization and death in high-risk patients with newly diagnosed coronavirus disease 2019 (COVID-19).

A machine learning model that screened 1,482 compounds potentially effective for treating coronavirus disease 2019 (COVID-19) has ranked Innovation Pharma’s COVID-19 candidate brilacidin in the top 3% of compounds predicted to be most effective against the novel coronavirus.

MORE ON THIS TOPIC