Biopharma Update on the Novel Coronavirus: April 1

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FDA Actions

Coronavirus Treatment Acceleration Program (CTAP): The FDA announced a new public-private approach to bring coronavirus treatments to market as fast as possible, as stated by HHS Secretary Alex Azar. The CTAP program will use every means the agency has access to bring new therapies to sick patients.

Shortages of Hydroxychloroquine and Chloroquine: The FDA is working with manufacturers of this drug to ensure it can be meet market demand for those patients with malaria, lupus and rheumatoid arthritis as well as the possible use in treating COVID-19 patients or for use in clinical trials.

Warning Letters to Three Companies: The FDA and FTC issued warning letters to Halosense Inc, Bioactive C60/FullerLifeC60 LLC and JRB Enterprise Group Inc. DBA Anti Aging Bed for using misleading claims that their products are safe and/or effective in the prevention or treatment of COVID-19.

Diagnostics Update: The FDA has worked with more than 220 test developers who plan to submit EUA requests to detect COVID-19. Also, 22 EUAs have been issued.

Roche’s Actemra (tocilizumab) may be approved as early as this summer to treat COVID-19, according to the FDA. The drug is already approved in the U.S. for rheumatoid arthritis. The company began a Phase III trial of the drug plus standard-of-care in hospitalized patients with COVID-19 pneumonia about two weeks ago.

Diagnostics

Cambridge, Mass.-based nference launched a software resource that synthesizes disparate Single Cell RNA-sequencing data sets to combat the COVID-19 public health crisis. By enabling researchers to study intricate molecular patterns and investigate the heterogeneity of healthy and pathologic tissues alike, the resource will help scientists to rapidly generate and pressure-test new hypotheses, the company said. The nference Single Cell resource is free to all scientists in the academic community, including physicians and practitioners in academic medical centers.

Testing Therapies, Antivirals and Vaccines

As the COVID-19 pandemic spreads around the world, researchers and public health experts are casting about for older vaccines and antiviral drugs that might be used to treat the disease caused by the novel coronavirus SARS-CoV-2. Researchers in Australia are turning to another older treatment, a vaccine once used to prevent tuberculosis (TB) called the bacillus Calmette-Guerin (BCG), which has been used for about 100 years.

CytoDyn has been quietly making unexpected progress in treating COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. The company announced today, in what has been a series of announcements, that it had filed a second clinical trial protocol with the U.S. Food and Drug Administration (FDA) to treat severely sick COVID-19 patients with COVID-19. The company currently is running a Phase II trial in mild-to-moderate COVID-19. The trial would be conducted under the same Investigational New Drug (IND) approval.

Regeneron and Sanofi dosed the first patient outside of the United States with the rheumatoid arthritis drug Kevzara as part of a second global clinical trial assessing the medication as a treatment for COVID-19, the disease caused by the novel coronavirus pandemic.

A Cuban compound known as interferon alfa-2b is showing promise in treating COVID-19 patients, Chinese researchers say. The medication is being developed through a research partnership established by both countries. According to reports, the compound produced by the Havana-based Genetic Engineering and Biotechnology Center has become a top choice in China for COVID-19 following positive results in hospital settings. Interferon alfa-2b has been used for diseases from dengue fever to Hepatitis and HIV.

DeCODE began testing people in Iceland. Early data suggests that half of its COVID-19 spreaders may be asymptomatic. The country of 360,000 began testing in early February, testing both people suspected of having the disease and people with no symptoms.

British American Tobacco is working on a COVID-19 vaccine using proteins extracted from tobacco leaves. Its Kentucky BioProcessing (KBP) unit expects to produce between 1 million and 3 million doses per week beginning in June. The company’s KBP, a division of its U.S. unit Reynolds American, will develop the vaccine on a not-for-profit basis. The vaccine, in preclinical studies, uses a cloned portion of SARS-CoV-2’s genetic sequence to create an antigen that the researchers then insert into tobacco plants for reproduction.

CRISPR Therapeutics reported the pandemic is impacting several of its clinical trials, including two trials for CTX001 for severe hemoglobinopathies like transfusion-dependent beta thalassemia and severe sickle cell disease, because intensive care unit beds and related healthcare resources are expected to be overwhelmed, so they are not dosing patients at this time. Most staffers are also now working remotely, which is expected to slow activities.

China’s Fosun Pharma is now exporting its COVID-19 diagnostics kits to Europe and is ramping up its vaccine research. Fosun previously received emergency approval from China for its test kits, which the company said can complete an analysis of 96 samples in two hours. Two weeks ago the company entered into an agreement with Germany’s BioNTech to advance an mRNA vaccine candidate in China for the prevention of COVID-19.

Chinese researchers have reportedly discovered effective antibodies against COVID-19. A research team at Tsinghua University in Beijing identified the antibodies and has partnered with Brii Biosciences to advance the most promising into clinical trials.

Ostrich Pharma USA is also having success with antibodies. The company injected a genetically engineered pseudovirus into ostriches, and antibodies were purified from their eggs. These antibodies demonstrate a strong ability to neutralize SARS-CoV-2 viruses, the company said. The company is ramping up efforts to begin using those antibodies across the globe.

UBS published a research note to clients about the republished data from one of the first trials of malaria drug hydroxychloroquine for COVID-19, saying the results were “inconclusive.” Temperature and cough recovery times were shorter by about a day and no patients in the hydroxychloroquine arm progressed to severe disease compared to four who did in the control group, and 80% of the patients receiving the drug showed improvement in pneumonia compared to 55% in the placebo arm. That sounds promising, but UBS points out that there was an imbalance in the severity of disease between the arms—one reason of many why clinical trials of this type can give unreliable results—and the fact that early-stage patients might progress better naturally rather than from the medication.

Company Actions

European companies Neurimmune AG and Ethris GmbH announced a partnership to develop mRNA-encoded, neutralizing anti-SARS-CoV-2 antibodies administered by inhalation for the treatment of Covid-19. Both companies will work together to rapidly develop an immunotherapy designed to produce therapeutic antibodies directly in the lungs of affected patients. The production of specific, neutralizing antibodies directly in patients’ lungs provides the opportunity to significantly impact the viral lung disease that is the primary driver of morbidity and mortality. Based on current development plans, the first product candidate is expected to begin clinical testing in the fourth quarter of 2020.

Microsoft and ImmunityBio are creating a 3D model of a piece of the CARS-CoV-2 virus to help battle COVID-19. The high-resolution model is of the spike protein, which the virus uses as a kind of docking station to attach to the cells in the respiratory tract it infects.

All staff of an unnamed drug company in Mysore, India was quarantined after several staffers tested positive for COVID-19. The Karnataka Health Department is investigating the source of the infection.

Novalead Pharma claims it identified 42 existing drugs that may be helpful in treating COVID-19. They analyzed 2,100 approved drugs and 30 potential viral and human targets using their computational infrastructure and technology planning that uses artificial intelligence (AI) and machine learning (ML), along with statistical modeling and simulations.

AbbVie is donating $35 million to support COVID-19 relief efforts across the globe. In the United States, the funds will be used to support healthcare capacity for hospitals as well as protect vulnerable populations by enabling access to food and essential supplies. In Europe, the money will support the provision of equipment and supplies to healthcare workers on the front lines. To distribute the funds, AbbVie is partnering with International Medical Corps, Direct Relief and Feeding America. Through the International Medical Corps, AbbVie’s donation will support the deployment of 20 mobile field hospitals to help increase surge capacity at overburdened hospitals. These mobile field units enable hospitals to expand the available triage and treatment space at existing facilities, improve patient flow and keep COVID-19 patients separated from other patients. As part of its $35 million commitment, AbbVie is also designating up to $5 million in reserve funding for additional near-term commitments to help address the COVID-19 pandemic.

Other Industry News

The message from venture capital investors to biotech is mixed. On one hand, “Companies active in the fight against COVID-19 will have plenty of funding, and those targeting severe unmet needs will weather the storm better than others. But, for the rest, it will be rough for the next 12 months,” Otello Stampacchia, founder of Omega Funds, told attendees at Bio-Europe Spring, held virtually last week.