Biopharma Update on the Novel Coronavirus: July 15

CV Update_July 15

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

FDA Actions

Spike Proteins on Surface of COVID-19: FDA scientists have identified on the SARS-CoV-2 spike proteins, specific areas causing the virus to trigger protective antibody responses. This finding could help inform researchers about vaccine development.

EUAs: The FDA has issued EUAS for the following:

Coronavirus Treatment Acceleration Program (CTAP): The FDA posted an updated CTAP webpage. The revised webpage includes a dashboard of critical statistics related to the development of COVID-19 therapeutics.

Warning Letters: The FDA issued warning letters to Health Beauty Love and Kegan Wellness for selling products with false or misleading claims that their products can prevent or treat COVID-19.

Temporary Compounding: The FDA added dexamethasone sodium phosphate to the list of drugs approved for temporary compounding during the COVID-19 pandemic.

Diagnostics Update: To-date the FDA has authorized 179 individual EUAs, which include 148 molecular tests, 29 antibody tests and 2 antigen tests.

Diagnostics

IDbyDNA’s Explify platform for metagenomics analysis is transforming highly sophisticated research-only laboratory tools into practical diagnostics tools for routine hospital use. Now physicians can determine not just whether a patient has COVID-19, but also – in the same test – whether that patient has other respiratory pathogens that are exacerbating illness.

Genetic Technologies provided an update on the development of its Polygenic Risk Scores (PRS) test for COVID-19. The company has submitted to the Patent Office in Australia, a provisional patent for its test. The test is intended to predict the severity of COVID-19 disease using a combination of genetic and clinical information.

VolitionRx announced results from two proof-of-concept studies of Nu.Q assays for COVID-19. The studies were conducted at University Hospital Liege, Belgium and the German Heart Center in Munich, Germany, with the goal of confirming whether circulating nucleosomes could act as a potential prognostic marker for COVID-19 disease severity. The test results did show a correlation with more severe COVID-19 cases.

AXIM Biotechnologies announced the development of NeuCovixTM . The company’s test is a rapid diagnostic test that can measure levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2.

Testing Therapies, Antivirals and Vaccines

In mid-May, Moderna released positive interim data from its Phase I trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the virus that causes COVID-19. It was in a press release and although the company shares rocketed, critics immediately took aim at what they felt was a lack of data. But now Moderna and researchers involved in the study from the National Institute of Allergy and Infectious Diseases (NIAID) and clinical trial centers published the data in The New England Journal of Medicine. The bottom line was the trial showed promising safety and immune response in all the patients involved in the trial.

Stockholm, Sweden-based biotech company Kancera AB recently received approval from the Swedish Medical Products Agency to initiate a clinical trial of KAND567, which blocks the Fractalkine receptor that plays a major role in triggering the body’s inflammatory process. Fractalkine is the only known member of the CX3C chemokine family. It is a cytokine protein implicated in numerous areas of hyper-inflammation including, potentially, COVID-19.

There is talk that positive news will soon be released on the trials of Oxford and AstraZeneca’s COVID-19 vaccine. The date is planned to be published in the Lancet.

Nanobodies derived from llamas have neutralized the SARS-CoV-2 spike in the lab, effectively neutralizing the virus, according to research from the UK’s Rosalind Franklin Institute.

NeoImmuneTech, announced the FDA cleared the company’s Investigational New Drug (IND) application. The company will study NT-17 for the treatment of adults with mild COVID-19.

Biopharmaceutical company Medicago announced today that it has begun its Phase I clinical trial for its plant-derived COVID-19 vaccine candidate. It has already administered the first doses of the candidate in healthy human subjects, and the company intends to initiate a Phase II/III trial this coming October.

Rigel Pharmaceuticals, Inc. launched a trial to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. Fostamatinib, marketed in the U.S. as Tavalisse, is a treatment for adult chronic immune thrombocytopenia. By inhibiting SYK, a key mediator of immunoreceptor signaling in a host of inflammatory cells, fostamatinib may inhibit the infiltration and activation of monocytes and neutrophils in the lungs that are prominent in COVID-19.

Israel-based Can-Fite BioPharma plans to file an Investigational New Drug Application to evaluate piclidenoson for the treatment of COVID-19 infected patients with moderate symptoms. Piclidenoson is an A3 adenosine receptor (A3AR) agonist.

Bold Therapeutics announced it has in vitro data showing that it’s lead therapeutic candidate, BOLD-100 successfully inhibits life SARS-CoV-2 within a therapeutic range.

Company Actions

In a sobering message, Ken Frazier, Merck’s chief executive officer, is reminding the world that vaccine development takes time, typically a decade, and hoping for a viable vaccine against the novel coronavirus by the end of December is premature. In an interview with the Harvard Business Review, as reported by Reuters, Frazier warned that the first vaccines against COVID-19, should they meet the 50% efficacy threshold set by the U.S. Food and Drug Administration, may not have as broad of an impact as hoped. Frazier said the vaccines may not have the qualities that are necessary to be deployed rapidly and on a large enough scale as hoped.

In hopes of a late-stage COVID-19 vaccine candidate hitting the 50% efficacy threshold set by the U.S. Food and Drug Administration, U.S. drugmakers who have partnered with the U.S. government could begin to manufacture doses of a preventative treatment by the end of summer, Reuters reported.

Other Industry News

According to several studies, the risk of contracting COVID-19 or developing a serious case of the disease may be greater depending on blood type. In general, studies have shown that people with Type O blood appear to be more protected than those with Type A, who are seemingly more vulnerable, according to NBC News.

In the first securities fraud prosecution involving COVID-19 testing, the US Department of Justice charged the president of Arrayit Corporation with one count of securities fraud and one count of conspiracy to commit healthcare fraud. They charged Mark Schena with submitting more than $69 million in claims for allegedly unnecessary medical laboratory allergy and COVID-19 tests.

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