Biopharma Update on the Novel Coronavirus: May 1

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FDA Actions

Ventilator EUA: The FDA now included a ventilator developed by NASA under the ventilator emergency use authorization (EUA) to treat COVID-19 patients.

Drug Supply Chain Security Act (DSCSA): The FDA issued guidance on flexibility under the DSCSA. The guidance will help facilitate the distribution of drug products needed to respond to COVID-19.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 53 individual EUAs have been issued. In addition, 23 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 235 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.



U.K.-based Avacta Group plc entered into a collaboration with Adeptrix to develop a high throughput COVID-19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform. Avacta and Adeptrix will collaborate to develop and manufacture an Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for COVID-19 infection in hospitals. The diagnostic test will allow hospitals around the world to utilize their existing installed base of mass spectrometers that are not currently used for COVID-19 testing, thus contributing significantly to the increase in global testing capacity.

Medigus signed a collaboration deal with L-1 Systems for joint commercialization of various COVID-19-related products and solutions to governmental agencies and institutional healthcare organizations. They have received the first commercial order for COVID-19 serological test kits by a Mexican company that distributes medical equipment around the country.

Alveo Technologies and Janssen Pharmaceutical, a division of Johnson & Johnson, forged a research collaboration to advance Alveo’s be.well platform of analyzers, nasal swabs and cartridges for the detection of viral infectious diseases, including Respiratory Syncytial Virus and potentially SARS-CoV-2. Alveo will use a phased approach to first gain Emergency Use Authorization (EUA) for a SARS-CoV-2 assay, followed by a multiplex assay for home use.


Testing Therapies, Antivirals and Vaccines

Geneius Biotechnology is developing T cells as a quasi-personalized, off-the-shelf, therapy and preventive measure against COVID-19. The assumption is that by increasing the number of antigen-specific T cells in the body, the patient’s immune system can overwhelm the SARS-CoV-2 virus, halting the disease. The work is in its early stages, and is based on research using T cells to combat SARS-CoV-1 and other conditions.

Mallinckrodt and Massachusetts General Hospital teamed up to evaluate the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19.

Cambridge, Massachusetts-based Moderna, which has an experimental mRNA vaccine against COVID-19 in clinical trials in the U.S., partnered with Basel, Switzerland’s Lonza on a 10-year strategic collaboration for larger-scale manufacture of the company’s vaccine, mRNA-1273. Moderna hopes to start manufacturing as early as July, The deal also includes other future Moderna projects. 

Gilead Sciences told analysts they are continuing to work on subcutaneous or inhaled versions of remdesivir for COVID-19 as reported by the San Francisco Business Times. 

Canada’s Algernon Pharmaceuticals received the go-ahead from Health Canada to proceed with a NP-120 (Ifenprodil) COVID-19 Phase IIb/III multinational clinical trial. The same study protocol is being prepared for submission to the FDA and Australian regulatory authorities. NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils.


Company Actions

After reporting positive clinical trials for its COVID-19 drug remdesivir, Gilead Sciences is scaling up its manufacturing to meet expected demand while simultaneously working on an emergency authorization.


Other Industry News

BioSpace Workplace Survey, Part I: During COVID-19, Biotech Professionals Feel Isolated and Less Productive. A vaccine for COVID-19 is unlikely to be ready in 2020, according to biopharma professionals responding to the BioSpace Workplace Survey: The Impact of COVID-19 – Spring 2020. Only 25% of respondents thought a vaccine might be possible this year. To see the full report from the survey, "BioSpace Workplace Survey: The Impact of COVID-19", you can download here.

According to Forbes, several teams across the nation are working on developing low-cost ventilators. Some of those include researchers at Villanova University partnering with the Pennsylvania Department of Community and Economic Development and experts from Children’s Hospital of Philadelphia and Geisinger Health System. Georgia Tech is also working on an initiative collaborating with Emory University and Cranfield University in the U.K.

Obsidian Therapeutics announced the architecture and components of its Safe Workplace Function Tool (SWFT) Productivity Solution. The SWFT Solution was designed in response to the COVID19 pandemic to support a safe work environment while maintaining productivity in the lab. The SWFT Solution is a web-based application built and integrated into Microsoft 365 that allows scientists to view and schedule lab-based activities including by date, time and lab location.

Citron Research has issued a paper that targets Inovio Pharmaceuticals as a new Theranos, claiming to have developed a COVID-19 vaccine in just 3 hours.

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