Biopharma Update on the Novel Coronavirus: July 10

CV Update_July 10

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. 

 

FDA Actions

Warning Letter: The FDA issued a warning to Ionogen, LLC for selling fraudulent COVID-19 products.

Four Florida Residents Charged: Federal prosecutors charged Florida residents with conspiracy to defraud the U.S., conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and criminal contempt as they marketed Miracle Mineral Solution (MMS) as a cure for COVID-19. The defendants sold the product under the Genesis II Church of Health and Healing.

Diagnostics Update: To-date the FDA has authorized 171 individual EUAs, which include 142 molecular tests, 27 antibody tests and 2 antigen tests.

 

Testing Therapies, Antivirals and Vaccines

As reported by the Wall Street Journal, BioNTech’s CEO is confident its COVID-19 vaccine will be ready to seek regulatory approval by the end of the year. BioNTech who has partnered with Pfizer, expects Phase III clinical trials to start at the end of July.

Gilead Sciences published new data that shows its drug remdesivir reduces the risk of mortality for COVID-19 patients by 62% compared to standard care.

CEBINA announced positive results with the identification of commonly used approved drugs with activity against SARS-CoV-2 in in vitro assays. One antihistamine nasal spray, Azelastine, has the potential to be a topical preventive or post-exposure anti-COVID-19 approach.

Gilead Sciences launched a Phase I clinical trial that will test the safety of an inhaled version of remdesivir which could be used to treat COVID-19 patients outside of the hospital. Currently, remdesivir is given intravenously.

Nemechek Technologies indicated that COVID-19 patients have started enrolling in an interventional clinical trial at Hospital Virgen del Carmen in Zarate, Argentina. It will test the effect of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with COVID-19-associated pneumonia. It will use Vitality Smartcable taVNS devices supplied by Nemechek.

 

Company Actions

The National Institute of Allergy and Infectious Diseases (NIAID) has founded a new clinical trials network focused on enrolling volunteers in clinical trials for COVID-19 vaccines and monoclonal antibodies. It was recently reported that sponsor companies are struggling to enroll patients in clinical trials for COVID-19 vaccines, essentially competing against each.

The Bill & Melinda Gates Foundation presented a $5 million grant to Kleo Pharmaceuticals to use its Monoclonal Antibody Therapy Enhancers technology platform to fight COVID-19.

Altimmune entered into a teaming agreement with DynPort Vaccine Company (IDVC), a General Dynamics Information Technology (GDIT) company, to coordinate U.S. government funding efforts and, if successful, to provide program management, drug development activity integration, and regulatory support for AdCOVID, Altimmune’s single-dose intranasal COVID-19 vaccine candidate.

Todos Medical Ltd. expanded its agreement with 3D Medicines Corporation for COVID-19 testing products. Todos received exclusive right to seek out FDA EUA for 3D Med’s SARS-CoV-19 and exclusive branding and distribution rights to 3D Med’s qPCR test kits in the US.

Switzerland’s Molecular Partners AG announced a collaboration with AGC Biologics to support the development of the company’s tri-specific DARPin anti-COVID-19 program. The company plans to initiate clinical studies for this program in the fourth quarter of 2020. In the case of its anti-COVID-19 program, Molecular Partners is focused on unique tri-specific modalities that can bind to three parts of the novel coronavirus simultaneously.

 

Other Industry News

On Thursday the World Health Organization (WHO) acknowledged that COVID-19 could possibly be spread by airborne transmission under certain conditions. Earlier in the week, a group of researchers published an open letter pushing the WHO to take more action.

Even before a vaccine for the novel coronavirus has been completely developed, nations across the globe are jockeying for a position to lay claim for the potential preventative medicine in something of a healthcare arms race. But, this vaccine nationalism, as it’s being called, could have a significantly negative impact on the global economy and health. 

A new website has been launched that allows people to volunteer for COVID-19 vaccine trials in the United States. Currently, the website, coronaviruspreventionnetwork.org, will register volunteers for four large studies expected to start this summer and fall. Any other trials that will begin later will be added as needed.

As reported by CNBC, as pharma companies work towards a vaccine for COVID-19, they are “being careful to not set any dangerous precedent that may weaken their future intellectual property rights.”

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