Biopharma Update on the Novel Coronavirus: April 15

CV Update_April 15

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FDA Actions

Warning Letters: The FDA and the FTC issued three warning letters to three companies for selling fraudulent COVID-19 products. The companies use misleading claims that their products are safe and/or effective in the prevention or treatment of COVID-19. The companies include Herbs of Kedem, the GBS dba Alpha Arogya India Pvt Ltd and Gaia Arise Farms Apothecary.

Diagnostics Update: The FDA has worked with more than 300 test developers who plan to submit EUA requests to detect COVID-19. Also, 34 EUAs have been issued. The FDA has been notified that more than 180 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.

The FDA has not authorized any COVID-19 at-home testing. However, they are actively working with developers towards the goal of authorizing EUAs for this type of testing once appropriately validated.

 

Diagnostics

Ortho Clinical Diagnostics announced the U.S. Food and Drug Administration (FDA) has granted its total antibody assay for COVID-19 Emergency Use Authorization.

Abbott Laboratories has launched its third COVID-19 test, a lab-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus. The test is expected to provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. It expects to ship 1 million tests this month. Additionally, Abbott has already shipped 566,000 of its rapid COVID-19 test to all 50 states. The test was approved by the FDA under Emergency Use Authorization last month. The point-of-care test delivers results in about five minutes. Abbott said it is manufacturing 50,000 tests per day and plans to ramp up manufacturing capacity to 2 million tests a month by June.

 

Testing Therapies, Antivirals and Vaccines

A study out of China in 150 hospitalized patients conducted at 16 sites showed that a malaria drug did not help patients clear the virus better than standard care. It was also significantly more likely to cause serious side effects.

A drug used to treat head lice in humans and parasites in animals has demonstrated efficacy against COVID-19 in laboratory tests and the U.S. Food and Drug Administration is already warning people to not attempt to self-medicate with the drug to treat the novel coronavirus. In lab tests, the drug cleared the novel coronavirus in 24 to 48 hours. The research team hopes to move the study into the clinic.  

Many investors have jumped on the news that Gilead Sciences suspended one of its clinical trials of remdesivir for COVID-19 in China. The company is running at least five clinical trials for its experimental antiviral drug remdesivir against COVID-19. Readouts for at least one or two of them will occur this month. Meanwhile, more than 1,800 patients have been treated using the drug on an individual compassionate use basis so far. They recently published data in the New England Journal of Medicine on 53 of those patients suggesting promising results. But company shares dropped 3% this morning after the company indicated it had suspended one of the trials in China. Gilead said that the Phase III trial for mild to moderate patients had been ended because of a lack of patients to enroll.

Bold Therapeutics and the University of Ottawa are exploring the potential of the company’s BOLD-100 as a novel antiviral agent against COVID-19. BOLD-100's main mechanism of action is to inhibit stress-induced upregulation of GRP78. There is extensive literature suggesting that GRP78 plays a critical role in host recognition, viral entry and viral replication.

As more studies of hydroxychloroquine as a potential treatment for COVID-19 are ramped up across the globe, a research group in New York believes it will have clinical evidence of whether or not the drug is a safe and effective treatment for the virus in the next few weeks. According to NBC, “the New York State Department of Health, in partnership with the University of Albany, is conducting a so-called observational study that researchers hope can shed some insight into the drug’s potential effectiveness in a matter of weeks, possibly before May.” Officials are analyzing the use of the drug in various patients across the state.

Aligos Therapeutics, Inc. announced an expanded license agreement with Luxna Biotech, for exclusive rights to use Luxna’s modified nucleic acid technology to target the SARS-CoV-2 virus causing COVID-19, among other respiratory viruses. Aligos plans to use the technology to explore a class of nucleic acid molecules that may target the SARS-COV-2 virus’s genetic material.

Sinovac Biotech received a go-ahead to conduct a human clinical trial on its vaccine candidate against COVID-19. In animal studies, the vaccine candidate protected animals without antibody-dependent enhancement (ADE). It also appears to neutralize virus strains from different countries.

LFB and the Nantes biotech company Xenothera signed a deal for LFB to produce the first clinical batch of a drug candidate, XAV-19, developed by Xenothera for COVID-19. XAV-19 is a combination of protective antibodies that neutralizes the virus and prevents it from multiplying.

France’s Pasteur Institute is trying to use a modified measles vaccine to “trick” the body into producing antibodies against SARS-CoV-2. They indicate they hope it will stimulate an immune response similar to the current MMR vaccine that protects against measles, mumps, and rubella. It is partnered with the University of Pittsburgh’s Centre for Vaccine Research and believes it can begin animal testing within a few months, with Austrian biotech company Themis manufacturing the vaccine for clinical trials.

7 Hills Pharma launched a COVID-19 vaccine program for older adults. It is testing its lead compound 7HP349, a next-generation small-molecule integrin activator, as an oral adjuvant with a novel recombinant coronavirus vaccine. It hopes to enter the clinic in late 2020.

CytoDyn treated the first patient with leronlimab in its Phase IIb/III trial for severe and critical COVID-19. The company also has 15 patients enrolled in a Phase II trial for mild-to-moderate COVID-19 patients in the U.S. About 30 COVID-19 patients have been treated with leronlimab throughout the country. Leronlimab was originally being developed in combination with HAART for HIV as well as for metastatic triple-negative breast cancer. It is a humanized IgG4 monoclonal antibody that blocks CCR5. The company also announced that, although it had treated the first patient in its Phase II basket trial with leronlimab for 22 solid cancer tumors, enrollment is being delayed because of the pandemic.

A study from Georgia State University researchers found that an older rheumatoid arthritis drug Ridaura (auranofin) is effective against severe COVID-19. The study, which was undertaken as part of a project to screen FDA-approved medications for their potential use against SARS-CoV-2, found that within 48 hours of treatment with Ridaura, the amount of virus within the cells dropped by 95 percent. Ridaura, which is manufactured by Hikma Pharmaceuticals, also dramatically reduced the expression of cytokines, signaling proteins that draw immune cells to the site of infection, caused by SARS-CoV-2.

Company Actions

Moleculin Biotech announced virologist Dominique Schols of the Rega Institute had joined the company’s development team as a consultant. This came shortly after an announcement by researchers at the University of Frankfurt that 2 deoxy-D-glucose (2-DG, and the active compound in WP1122) inhibited SARS-CoV-2 replication in susceptible cell lines. Schols is professor and head of the Laboratory of Virology and Chemotherapy, Department of Microbiology and Immunology and Transplantation of the University of Leuven, Belgium. WP1220 is being developed for the topical treatment of cutaneous T-cell lymphoma.

ProMIS Neurosciences announced a collaboration with Hans Frykman, the chief executive officer and medical director of BC Neuroimmunology Lab and Neurocode Labs, to develop a high-throughput, highly specific serological assay to detect antibodies against SARS-CoV-2.

 

Other Industry News

Based on predictions of recurring outbreaks of COVID-19 in the coming years, a study published in Science suggests that intermittent social distancing may be necessary into 2022. That recommendation is based on the absence of other solutions to the disease, for which there is currently no treatment nor vaccine.

Sir Andrew Witty, the former head of GlaxoSmithKline and current president of UnitedHealth Group and chief executive officer of Optum, is stepping away from his duties to co-lead a World Health Organization effort to combat COVID-19.

Forbes has compiled the perspectives on the COVID-19 pandemic from more than two dozen scientists, doctors, virus researchers, epidemiologists and more. They provide their thoughts on multiple aspects of the fight against the disease, including testing, shelter-in-place and disease-related mortality.

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