2021 Biopharma Update on the Novel Coronavirus: March 9

CV Update_March 9_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. 

Pennsylvania-based Melior Pharmaceuticals received clearance from the FDA for its Investigational New Drug Application for clinical development of its first-in-class lyn kinase activator, tolimidone, for the treatment of COVID-19. Preclinical studies in animal models related to COVID-19 demonstrate that its orally administered drug tolimidone is a therapeutic expected to significantly mitigate the occurrence and severity of pulmonary symptoms in COVID-19 and other diseases associated with pulmonary complications that develop as a result of “cytokine storm” including sepsis.

A study published in the New England Journal of Medicine reported that in laboratory studies, the Pfizer-BioNTech COVID-19 vaccine was effective at neutralizing the Brazilian variant. This study indicated that the Pfizer-BioNTech vaccine was approximately equivalent against the P.1 Brazilian variant as it was against the Wuhan strain. The research was conducted by the companies and the University of Texas Medical Branch.

Molecular Partners AG and Novartis announced initial data from their ongoing Phase I trial of their tri-specific COVID-19 antiviral drug, ensovibep, in healthy volunteers. In the study, healthy volunteers were randomized 3:1 to receive an infusion of ensovibep or placebo, respectively. In both cohorts of two different doses of the drug, 3m or 9mg per kilogram body weight, the drug was observed to be safe and well tolerated with no significant adverse events.

Merck and Ridgeback Biotherapeutics announced preliminary results from Ridgeback’s Phase IIa trial of molnupiravir in COVID-19. They reported on one secondary objective, demonstrating a decrease in days to negativity of infectious virus isolation in nasopharyngeal swabs, as determined by isolation in Vero cell line culture. The results were presented during Science Spotlights at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021).

Newly-announced findings from a Phase III trial conducted by late-stage biotechnology company CytoDyn indicate that the use of Vyrologix™ (leronlimab), the company’s CCR5 antagonist candidate, was safe and improved the survival rate in critically ill hospitalized patients with coronavirus disease 2019 (COVID-19).

North Carolina’s Brii Biosciences announced that two antibody programs aimed at COVID-19 generated disappointing clinical results. The company said its antibodies BRII-196 and BRII-198, which were being assessed with hospitalized patients, failed to meet pre-specified efficacy criteria that would allow them to move into the Phase III component of ACTIV-3.

Bharat Biotech, based in India, reported interim vaccine efficacy of 81% for its COVID-19 vaccine. The interim data analysis was based on 43 recorded cases of the disease in the trial of 25,800 people. 

Days after vaccine-maker Bharat Biotech released interim Phase III efficacy data for a COVID-19 vaccine already in use in India, a pulmonary expert is expressing enthusiasm for the company’s next-generation intranasal vaccine on track to enter clinical testing this quarter.

Another study is adding to a growing body of literature that suggests convalescent plasma from recovered patients with COVID-19 doesn’t prevent further COVID-19 progression in at-risk people who visit the emergency room (ER).

Last week, Novavax’s chief executive officer, Stanley Erck, said he expected the U.S. Food and Drug Administration (FDA) might grant the company’s COVID-19 vaccine emergency use authorization (EUA) by May. The company reported positive interim data from the Phase III trial in the UK in January, where the vaccine candidate demonstrated 89.3% efficacy.

San Diego-based Sorrento Therapeutics received the go-ahead from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for its Phase I study of intranasal STI-2099 (COVIDROPS) for mild COVID-19. STI-2099 is a formulation of its antibody against COVID-19 that can be taken in a nasal spray.

Apellis Pharmaceuticals terminated its investigational COVID-19 asset after study data showed the therapeutic failed to reduce the mortality rate in patients compared to standard of care.

Last week, California-based MediciNova announced it was terminating its investigational COVID-19 vaccine. In a brief statement, MediciNova said it conducted a careful review of its program and the available resources the company had. Considering the stage of development for its vaccine asset and the expected costs of entering the clinic, as well as the number of vaccines that have already received Emergency Use Authorization and are in late-stage development, the company opted to discontinue its own program. 

Germany’s CureVac NV inked a deal with Switzerland’s Novartis AG to manufacture CureVac’s COVID-19 vaccine candidate, CVnCoV. 

Vir Biotechnology and GlaxoSmithKline (GSK) recently announced that their experimental COVID-19 drug will not be administered to new patients following results of a late-stage study that showed it may not be performing as well as hoped.

Sorrento Therapeutics and Icahn School of Medicine at Mount Sinai entered into an exclusive license agreement for a collection of antibodies that have SARS-CoV-2 neutralizing properties that were developed by Mount Sinai. COVISHIELD, under development, will be a combination of two monoclonal antibodies against SARS-CoV-2. Sorrento identified candidate antibody combinations that have activity against not only the Wuhan wildtype strain of the COVID-19 virus, but the emerging variants of concern (VOCs), the UK (B.1.1.7), South Africa (B.1.351) and Japan/Brazil (B.1.128) variants.

Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF), which is based in Texas, gained Federal Drug Administration authorization for the nation’s first stem cell study of Post-COVID-19 Syndrome. The 10-patient study will evaluate the effectiveness of mesenchymal stem cell therapy on COVID-19 patients who continue to display symptoms long after they have recovered from coronavirus. These patients, who have been dubbed “long haulers,” can exhibit symptoms anywhere from three to more than twelve weeks after recovery from the virus.

In the wake of an increasingly accelerated COVID-19 vaccine rollout, the Centers for Disease Control and Prevention (CDC) has released new guidance statements that give fully vaccinated individuals more freedom to socialize and participate in pre-pandemic activities. But the guidance comes with a catch, in addition to some criticism.

The Russian government is attempting to cast a negative light on the COVID-19 vaccine developed by Pfizer and BioNTech, as well as other vaccines, in order to boost sales of its own vaccine, Sputnik V, the government charged. First reported by The Wall Street Journal, the U.S. Department of State has identified multiple publications that reportedly serve as fronts for Russian intelligence that are involved in the disinformation campaign. 

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