Biopharma Update on the Novel Coronavirus: July 8

CV Update_July 8

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


FDA Actions

Alert of False Positives: The FDA issued a letter to clinical laboratory staff and health care providers letting them know there is an increased risk of positive COVID-19 results with BD SARS-CoV-2 Reagents for the BD Max System test. The FDA is working with Becton, Dickinson and Company to resolve the issue.

Updates to the Molecular Diagnostic Templates: The FDA updated the templates to provide more detailed recommendations for the validation of assays which are used for pooling patient samples.

Warning Letters: The FDA issued warning letters to, Butterfly Expressions, LLC, Lotus Herbal Supplements, and Shen Clinic, LLC for selling fraudulent COVID-19 products.

Diagnostics Update: To-date the FDA has authorized 166 individual EUAs, which include 138 molecular tests, 26 antibody tests and 2 antigen tests.



Psomagen’s COVID-19 in-vitro lab-developed test (LDT) was granted EUA from the FDA. The test can confirm the presence of COVID-19 in a minimum of two hours.


Testing Therapies, Antivirals and Vaccines

What if you could get one vaccine that protects you against a wide spectrum of viruses, even viruses we haven’t discovered yet? That might sound impossible and futuristic, but this is just what Immunovative Therapies and its sister company Mirror Biologics, Inc. are aiming to achieve. Their new ‘pan-viral’ vaccine called “AlloPrime®” is slated to begin a Phase 1/2 trial next month. Just as our body slows down with age, so does our immune system. AlloPrime® focuses on remodeling the weakened older immune system by a mechanism known as “heterologous immunity.” Heterologous immunity occurs when the immune response to one pathogen causes an enhanced response to a later unrelated pathogen. This means that the immune response against the AlloPrime® vaccine can influence the response to a virus (like the coronavirus that causes COVID-19

Corvus Pharmaceuticals announced it has initiated a Phase I clinical trial to investigate a novel immunotherapy approach, CPI-006, to treat COVID-19 patients. The study is expected to enroll up to 30 patients.

CSL Behring announced its Phase II clinical study of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) enrolled its first patient suffering from severe respiratory distress, which is a leading cause of death with COVID-19. The primary endpoint is the incidence of tracheal intubation or death. Currently, CSL Behring is evaluating five approaches across its plasma fractionation and recombinant and antibody strategic scientific platforms to preventing and treating COVID-19. 

Sinovac announced it is starting Phase III clinical trials of its COVID-19 vaccine in Brazil. The study will be done in partnership with the Instituto Butantan.

7 Hills Pharma announced that preclinical studies showed 7HP349, its oral integrin activator that promotes cell adhesion, significantly increases IgG binding antibodies with a vaccine against SARS-CoV-2. The data also suggested 7HP349 can be leveraged as an immunostimulant for any COVID-19 vaccine, and possibly also accelerate immune system response.

Researchers at Cedars Sinai and the University of Michigan in an observational study found that patients who used proton pump inhibitors (PPI), a type of stomach acid treatment, increased the likelihood of COVID-19 infection. People taking PPIs twice daily have a higher likelihood of positive tests for COVID-19 than those using PPIs up to once daily. People taking the less potent H2Ras are not at increased risk.

ChromaDex and NIAID initiated a preclinical study of Niagen (nicotinamide riboside, or NR) in mouse and hamster models of COVID-19, to determine if it can decrease viral burden and inflammation. Niagen is a nutrient that supports cellular energy production and healthy mitochondrial function through efficient restoration of NAD+ levels.

Nasus Pharma announced data from a preclinical collaboration with the University of Virginia School of Medicine that showed TaffiX, its innovative nasal powder inhaler that effectively blocks viruses from reaching nasal mucosa, was able to block more than 99% of SARS-CoV-2 viruses.

France-based Osivax received €30 million to support the development of universal vaccines against coronavirus and influenza. Osivax is deploying its oligoDOM technology against COVID-19. The company’s proprietary oligoDOM technology enables the development of vaccines that aim to protect the body from all viral influenza strains. By targeting the nucleoprotein, a highly conserved antigen with a low mutation rate found in every flu variation.

Australia-based Recce Pharmaceuticals announced its RECCE 327 and RECCE 529 compounds were selected to be studied against COVID-19. RECCE 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis. RECCE 529 is a new synthetic polymer formulation.


Company Actions

With rising numbers of COVID-19 infections and as the fight against the novel coronavirus continues, Novavax received $1.6 billion in federal funding to support the clinical development of the company’s vaccine candidate, NVX‑CoV2373.

Regeneron announced that it had received a $450 million contract to manufacture and supply the antibody cocktail as part of Operation Warp Speed from the Biomedical Advanced Research and Development Authority (BARDA).

GlaxoSmithKline is providing its pandemic adjuvant technology to another Medicago to bolster the chances of developing a vaccine against COVID-19.

As reported by Reuters, the European Commission has made deals with both Roche and Merck KGaA to secure experimental COVID-19 treatment supplies. This includes the medicines RoActemra and Rebif.


Other Industry News

As the United States has begun to formally withdraw from the World Health Organization (WHO), opponents of the plan are urging Congress to block the move, citing concerns that the move will weaken global health security.

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