Biopharma Update on the Novel Coronavirus: September 9

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

FDA Actions

Foreign establishments that failed to identify a U.S. Agent as required by the FDA’s regulations have been deactivated. Of these deactivated establishments, 131 list devices that are essential to the COVID-19 pandemic.

Diagnostics Update: To-date the FDA has authorized 243 individual EUAs, which include 195 molecular tests, 44 antibody tests and 4 antigen tests.

Diagnostics

Qiagen, based in Hilden, Germany with offices in Germantown, Maryland, plans to launch rapid portable tests for COVID-19 infections. The test is able to identify active infections in less than 15 minutes. It also is able to process about 30 swab samples per hour.

LabCorp launched the first testing method to detect simultaneously COVID-19, influenza A and B and respiratory syncytial virus (RSV).

According to researchers at the Chinese University of Hong Kong, stool tests may help detect COVID-19 more effectively than respiratory tests in children and infants.

Testing Therapies, Antivirals and Vaccines

Preclinical data for Pfizer and BioNTech’s Phase II/III COVID-19 mRNA vaccine candidate generated BNT162b2 strong anti-viral effects against an infectious SARS-CoV-2 challenge, the two companies announced this morning. Please read more here.

AstraZeneca paused its Phase III COVID-19 vaccine trial following a report of an “unexplained illness” in a patient involved in the study. In a brief statement issued Tuesday, and first reported by STAT News, the company said it paused the trial based on its standard review processes. Please read more here.

Sinovac Biotech said its COVID-19 vaccine candidate appears to be safe for older people. According to preliminary results from an early-stage trial, an immune response was produced, but it was slightly weaker than it was for younger adults.

Redhill Biopharma announced opaganib, an orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral activity, demonstrated potent inhibition of SARS-CoV-2. In an in vitro model of the human lung bronchial tissue, the drug achieved complete blockage of viral replication.

As reported by CNN, Russian frontline workers are hesitant to take the approved COVID-19 vaccine, Sputnik-V. The vaccine was approved in Russia before Phase III clinical trials were completed. These frontline workers are leery of Russian President Putin’s claims of the efficacy of the vaccine. Phase III clinical trials will begin today.

A new study published in Nature Communications on August 27 shows that a feline antiviral drug was effective at inhibiting the replication of human coronaviruses in cell cultures infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the coronavirus responsible for coronavirus disease 2019 (COVID-19) in humans. Please read more here.

Company Actions/Announcements

Pfizer and BioNTech announced they have completed talks with the European Union to potentially supply 200 million doses and to purchase an additional 100 million doses of their COVID-19 mRNA-based vaccine. The agreement is subject to regulatory approval.

As reported by CNN, Pfizer and BioNTech said their COVID-19 vaccine candidate, BNT162 could be ready for regulatory approval by the middle of October or early November. The companies plan to provide 100 million doses of the vaccine by the end of the year and up to 1.3 billion doses in 2021.

Inovio announced that it has entered into a manufacturing agreement with Thermo Fisher to produce at least 100 million doses of INO-4800, a COVID-19 vaccine candidate. Inovio plans to begin a Phase II/III clinical trial of the candidate this month.

To quell concerns over the politicization of a potential vaccine for the novel coronavirus, nine pharmaceutical companies developing a preventative treatment signed a pledge promising to uphold the integrity of the scientific process ahead of any potential approval of a medication. Please read more here.

Enzo Biochem, Inc. has expanded reagent and supply manufacturing as well as doubled its capacity for molecular laboratory testing services at its facilities in Farmingdale, N.Y. to meet rapidly increasing demand for its PCR-based COVID-19 molecular and serological testing. Demand for testing services has expanded significantly throughout the multi-state New York metropolitan region, including support for testing programs at academic institutions, physician offices, urgent care facilities, and nursing homes.

Vaxart announced pre-publication of a manuscript on BIoRxiv of its oral COVID-19 vaccine candidate, demonstrating that it induced potent systemic and mucosal immune responses in preclinical studies. It induced IgA response in the lungs of animals, and immunization induced IgG responses in a dose-dependent matter. Antigen-specific CD4+ and CD8+ T-cells were induced at both low and high doses, only low levels of IL-4 production.

Louisiana Oil Producers and Healthcare Providers chose Sensiva Health’s COVID-19 test for 12-24 hour results. Reportedly this was after Florida’s Department of Health (DOH) ordered state health agencies to cut ties with Quest Diagnostics after the company failed to report almost 75,000 COVID-19 tests in a timely fashion.