Biopharma Update on the Novel Coronavirus: April 27

CV Update_April 27

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FDA Actions

Guidance: The FDA issued guidance, called the Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This guidance will help expand the availability of remote reviewing devices and the reporting of scanned digital images of pathology slides.

Drug Safety Communication: The FDA issued communication on the side effects of hydroxychloroquine and chloroquine, including potentially life-threatening heart rhythm problems.

Warning Letter: The FDA and FTC issued a warning letter to Prefense LLC, for selling fraudulent COVID-19 products.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 44 individual EUAs have been issued. In addition, 19 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 225 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

As an overview, there are almost 3 million confirmed cases of COVID-19 worldwide, with at least 207,270 deaths. In the U.S., the figures exceed 965,900 with 54,877 deaths cited. That said, several states are beginning to reopen, including Florida and Georgia. As this happens, public health officials are watching closely to evaluate whether the pandemic will resurge in those regions.

David Ho, scientific director of the Aaron Diamond AIDS Research Center in New York City, discussed COVID-19 and the center’s pivot to work on the disease. He and a team of approximately 15 scientists are working on two approaches: isolating potentially therapeutic antibodies from people who have recovered from the disease and developing protease inhibitors that prevent the virus from replicating. He expressed optimism about Gilead’s remdesivir, noted that the studies to date on hydroxychloroquine and chloroquine “so far are unimpressive or negative.” Overall, he expressed optimism, saying, “I’m quite confident that science will come through.”



With the number of high false-positives from some antibody tests,  the FDA is bearing the brunt of criticism for allowing so many tests onto the market without properly vetting them. At the beginning of April, the U.S. Food and Drug Administration approved the first antibody test for COVID-19. Since then, the regulatory agency has allowed more than 100 antibody tests onto the market without full review and that has proven to become a problem as some tests are not as accurate as hoped.


Testing Therapies, Antivirals and Vaccines

A New York hospital is conducting a study with famotidine, the active ingredient in the heartburn treatment Pepcid, as a potential drug against COVID-19. The study was born out of an analysis in China that showed some heartburn patients who took Pepcid fared better against the disease than those who took the more expensive Prilosec, which has a different active ingredient. 

Romark Laboratories, L.C. announced it will begin two clinical trials of its investigational new drug candidate NT-300. The nitazoxanide extended-releases tablets will be tested for the prevention of COVID-19 and other viral respiratory illnesses in those who are at high risk.

Mateon Therapeutics announced it has submitted an IND to the FDA for the study of its investigational drug, OT-1010 for the treatment of COVID-19. The Phase II study will evaluate safety and efficacy and adult patients hospitalized with COVID-19.

Tiziana Life Sciences plc announced it has filed a provisional patent application for a potential therapy for the management of COVID-19. The application is for the combination of nanoparticle-Actinomycin D (NP-ACT D) with anti-interleukin-6 receptor monoclonal antibody (anti-IL-6R).

New York researchers are testing whether or not estrogen in men will increase their immune systems against COVID-19. Men are more likely to succumb to COVID-19 and estrogen could be a key, the scientists think.

Arcturus Therapeutics reported positive preclinical data for its COVID-19 vaccine candidate. The data for LUNAR-COV19 were measured by Duke-NUS Medical School in Singapore.

Regeneron and Sanofi’s rheumatoid arthritis drug Kevzara showed some promise in treating the most severe cases of COVID-19, but did not show benefit in less-advanced disease. As a result, the companies have halted the trial for that group of patients.

Rebecca Powell, assistant professor of medicine, Division of Infectious Diseases at the Icahn School of Medicine at Mount Sinai, is studying whether antibodies in breast milk that might be protective against SARS-CoV-2. She is running a study on lactating mothers to donate breast milk.

BioAegis Therapeutics published gene expression data in animal studies showing that its recombinant human plasma gelsolin (rhu-pGSN) significantly increased survival in pneumonia due to severe influenza. They believe this support the possibility that gelsolin supplementation could prevent the morbidity and mortality seen in COVID-19.

The FDA approved two blood-filtering devices for COVID-19 patients. The FDA greenlit Baxter’s Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy. The regulatory agency also approved ALung Technologies’ Hemolung system.

IBM has launched Rapid Supplier Connect, a blockchain-based solution to help battle medical supply chain shortages due to COVID-19. The network will help government agencies and healthcare organizations identify new, non-traditional suppliers who have pivoted to address the shortage of equipment, devices and supplies needed for COVID-19 relief efforts.

A series of multicenter randomized clinical trials of Roche’s Actemra (tocilizumab) in COVID-19 showed the drug significantly improves the prognosis of patients with moderate or severe COVID pneumonia. A total of 129 patients were randomized. It was conducted in seven sites in France and overseen by Assistance Publique-Hopitaux de Paris.


Company Actions

Merck is entering a collaboration agreement with the Seattle-based Institute for Systems Biology (ISB) to investigate and define the molecular activity of SARS-CoV-2 infection and COVID-19, the resulting disease. The intention is to identify targets for drugs and vaccines.

Menarini-Silicon Biosystems announced it is exploring the possible use of its proprietary CELLSEARCH technology to study the progression of COVID-19 and help identify patients who may be at risk for developing the most severe complications.

The University of Waterloo developed a method using a machine learning-based alignment-free approach to accurately and rapidly identify and classify COVID-19 virus genome’s relationship with other viruses. They believe this could identify future COVID-19-like viruses within minutes.

Kamada and Kedrion Biopharma announced a global collaboration for the development, manufacturing and distribution of a human plasma-derived anti-SARS-CoV-2 polyclonal immunoglobulin (IgG) product as a potential treatment for COVID-19.

Zegami, a spin-out from Oxford University, began a global search for 10,000 COVID-19 X-rays to complete its new technology platform that can speed up the diagnosis of the disease. They will use them to build a more robust machine learning model to assist physicians to identify the disease. So far it has 226 X-rays of COVID-19 infected lungs but needs many more.


Other Industry News

Flagship Pioneering Chief Medical Officer Michael Rosenblatt penned an opinion piece over the weekend criticizing congressional considerations that would include provisions to strip intellectual property rights from companies that receive financial support from the government in the development of COVID-19 treatments and vaccines. Rosenblatt said the concern over keeping government-supported medications at affordable price points is valid, but stressed that stripping IP protection from companies could discourage participation in future crises.

Leaders in Europe have teamed with the World Health Organization on an $8 billion vaccine program for COVID-19. Sir Andrew Witty, the former head of GlaxoSmithKline will co-lead the effort. The governments and health agencies will begin pledging financial support for the plan next month in hopes of accelerating the development of a vaccine for widespread use across the globe.

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