A summary of daily Biopharma industry news. Please check out stories that are trending on March 20, 2020.
Please stay tuned for more updates throughout the day.
FDA Actions
Facilitate Development of Treatments: The FDA continues to play a critical role in response to the COVID-19 pandemic, which includes facilitating medical countermeasures to treat and prevent the disease and monitoring for potential shortages of medical products and food supply chains. The FDA will continue to work with partners across the industry to expedite the development and availability of products to treat the novel coronavirus.
Blood Donations: The FDA fully supports President Trump’s Coronavirus Guidelines for America, which includes recommendations for social distancing. Due to the coronavirus pandemic, the number of blood donations has been significantly reduced. Blood donation centers can be safe as they are skilled in infection control practices and have proper procedures in place to prevent the spread of infections.
Diagnostics
Scanwell Health, a developer of smartphone-enabled, at-home diagnostics, secured rights to a SARS-CoV-2 rapid serology test from China-based INNOVITA for at-home use. The test takes 15 minutes to complete using the Scanwell Health app, and within hours a doctor or nurse practitioner will reach out with results and next steps. The test detects IgM and IgG antibodies against novel coronavirus SARS-CoV-2 in the blood, which indicates that a person has been exposed and developed antibodies against the virus. Following a screening process, a patient can receive a test via next-day mail. The patient can then take the test at home and share results with a physician through the app.
Daxor Corporation announced this morning that the first use of its BVA-100 test to guide volume treatment in a patient infected with the COVID-19 virus. The company also announced the release of a clinical protocol for fluid guidance when utilizing the BVA-100 diagnostic test for COVID-19 patients developed by leading medical experts. Daxor’s BVA-100 is already in place at several hospitals throughout the nation. Michael Feldschuh, CEO of Daxor Corporation said the BVA-100 test has been shown in a prospective randomized control trial to reduce ICU mortality by as much as 66% and reduce ventilator days in patient populations suffering predominantly from respiratory distress and septic shock.
A University of Florida chemistry professor of Chinese heritage who fled the United States after falling under investigation for his ties to academic institutions in China has been at the forefront of developing a diagnostic test for the novel coronavirus in China.
Testing Therapies, Antivirals and Vaccines
Athersys, Inc.: MultiStem, a cell therapy in development at Athersys, was just designated “Highly Relevant as a Potential Therapy for COVID-19” by BARDA. This is the only therapy in development that targets acute respiratory distress syndrome (ARDS), the pneumonia-like condition that leads to severe illness and death among COVID-19 patients.
Tucson, Arizona-based Aqualung Therapeutics Corporation is developing ALT-100, a preclinical therapeutic monoclonal antibody, to combat serious unchecked inflammation, such as the type experienced by patients impacted by severe cases of COVID-19. The company has begun required testing as part of the Investigational New Drug package for the Food and Drug Administration (FDA).
Genentech’s Tamiflu. The company’s Tamiflu (oseltamivir), which was developed by Gilead Sciences and is marketed by Genentech, is part of a COVID-19 clinical trial being held at Rajavithi University in Bangkok, Thailand. The trial will combine protease inhibitors, Tamiflu and favipiravir with chloroquine, a drug most commonly used to treat malaria. Quite a bit of attention is being focused on chloroquine as a treatment for COVID-19. In addition to malaria, the drug is used to treat lupus and rheumatoid arthritis. Favipiravir is an influenza drug marketed by a subsidiary of FujiFilm, which has shown encouraging results in Chinese clinical trials in 340 COVID-19 patients.
Amgen’s Mvasi, the Generic Version of Genentech’s Avastin. Avastin (bevacizumab) is a recombinant humanized monoclonal antibody, an anti-VEGF drug. It is approved to treat several forms of cancer, including colorectal, non-small cell lung cancer (NSCLC), kidney cancer, cervical cancer, ovarian cancer and recurrent glioblastoma. The generic version is being tested in at least one clinical trial in China against COVID-19 pneumonia.
Bellerophon Therapeutics received FDA emergency expanded access for its inhaled nitric oxide (iNO) delivery system, INOpulse, to be immediately used for COVID-19.
More data from China shows the benefit of FUJIFILM’s influenza treatment favipiravir on COVID-19. Preliminary results of the “Clinical Study on Favipiravir’s Safety and Effectiveness to COVID-19 Patients” led by the Third People’s Hospital of Shenzhen showed that favipiravir alleviated the pneumonia symptom of COVID-19 patients with high tolerance and few adverse reactions. Another clinical trial led by the Zhongnan Hospital showed that the effectiveness in the experimental group was significantly better than that in the control group, 71.43% and 55.86%, respectively. The same significant advantage went to the average antipyretic and cough remission time.
As the world and biopharma grapple with developing vaccines and drugs against COVID-19, the disease caused by the novel coronavirus, researchers are turning to a handful of drugs that show particular promise. Several of those drugs are by companies with offices or headquarters in the San Francisco Bay Area.
Company Actions
Biogen: A Biogen employee with symptoms of COVID-19, the novel coronavirus, has been terminated by the company after she left her home in Massachusetts and boarded a plane to China without disclosing her exposure to the virus.
Michigan-based MMS Holdings, Inc., a contract research organization, is offering a $1 million award toward the development of a vaccine for COVID-19. The award is being offered in the form of data and related services to pharmaceutical and clinical research companies focused on the development of a vaccine for approval in the United States and/or other global health authorities. Organizations interested in applying for this award can submit a notification of interest at https://www.mmsholdings.com/
Other Industry News
The already jittery stock market has ups-and-downs for COVID-19 vaccine companies: Inovio Pharmaceuticals (+11), Novavax (+5%), BioNTech (-7%), Applied DNA Sciences (-15%), Vaxart (+15%), AbbVie (+2%), GlaxoSmithKline (+3%), Tonix Pharmaceuticals (+22%).
