Biopharma Update on the Novel Coronavirus: April 16

CV Update_April 16

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FDA Actions

Emergency Use Authorizations (EUAs): The FDA issued two EUAs for tests to detect coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics and Chembio Diagnostic Systems.

The FDA issued a EUA to Stryker for emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle to decontaminate N95 and N95 equivalent respirators.

New Information Resource: The FDA launched “At-a-Glance Summary” identifying the agency’s major activities in fight for COVID-19.

Warning Letter: The FDA and FTC issued a warning letter to Earth Angel Oils for selling fraudulent COVID-19 products.

Diagnostics Update: The FDA has worked with more than 315 test developers who plan to submit EUA requests to detect COVID-19. Also, 36 EUAs have been issued. The FDA has been notified that more than 190 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.

Diagnostics

As numerous clinical diagnostic companies roll out tests for SARS-CoV-2, the novel coronavirus that causes COVID-19, they all tend to use similar methods—a variation on antibodies that detect viral antigens or PCR-based tests that detect viral DNA or RNA. San Francisco-based Mammoth Biosciences just published the first peer-reviewed study validating its CRISPR-based diagnostic method for COVID-19. It appeared in the journal Nature Biotechnology.

The FDA issued two EUAs for tests to detect coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics and Chembio Diagnostic Systems.

Sanofi is increasing its odds to develop a vaccine for COVID-19 through a new partnership with Luminostics. The two companies will evaluate a smartphone-based self-testing solution for COVID-19, using Luminostics’ innovative technology and Sanofi’s clinical research abilities.

Dynavax Technologies and Sinovac Biotech partner on a COVID-19 vaccine. They will work together to develop the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate with Dynavax’s advanced adjuvant, CpG 1018. CpG 1018 is the adjuvant used in HEPLISAV-B, a hepatitis B vaccine approved by the FDA.

PHASE Scientific, a biotech company founded by UCLA Samueli School of Engineering bioengineers launched a product to improve the accuracy of COVID-19 testing. The company’s Phasify liquid technology increases the yield and concentration of RNA from trace amounts of SARS-CoV-2 that might be in a patient sample.

Boston Heart Diagnostics began antibody testing for COVID-19. It started offering it to hospitals in the acute-care setting but plans to offer it more broadly through its parent company, Luxembourg-based Eurofins. The testing is to determine if a person has developed antibodies to the virus, either through recovery or previous exposure, which is presumed to give immunity to the illness.

Hemex Health is collaborating with PAI Life Sciences to develop an affordable COVID-19 six-minute diagnostic test for use in low resourced countries. Hemex’s Gazelle Diagnostic platform combines traditional testing with cloud-based reporting and uses a reader small than a shoebox that is battery powered and chargeable with a cell phone charger. Hemex’s technology was developed in collaboration with Case Western Reserve University. PAI is developing the biochemical assay needed to detect a protein on the virus’s surface.

Testing Therapies, Antivirals and Vaccines

Ligandal isn’t the only company developing peptide-based vaccines for COVID-19, but it is the only one developing a prospective “antidote” and vaccine in a single platform. The company suggests its approach can actually help eliminate the virus from an already-infected host, while also bolstering the immune response. The catch is that the company’s research is still in silico.

Following the demonstration of antiviral activity in lab tests, Eagle Pharmaceuticals is planning a Phase II trial that will assess the efficacy and safety of Malignant Hypothermia drug Ryanodex as a treatment for COVID-19. 

Washington, DC-based Vanda Pharmaceuticals and Manhasset, New York-based The Feinstein Institutes for Medical Research, the research division of Northwell Health, enrolled the first patient in the ODYSSEY VLY-686-3501 clinical trial for COVID-19. It will test the use of tradipitant for neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.

PDS Biotechnology Corporation expanded its infectious disease pandemic development program with Farmacore Biotechnology. The expanded partnership includes novel vaccines for COVID-19 and universal influenza. Additionally, the company also announced that initiation of its multi-center Phase 2 VERSATILE-002 trial for PDS0101 in advanced/metastatic head and neck cancer has been delayed due to the severe adverse impact on clinical trial operations from the COVID-19 pandemic.

Applied DNA Sciences Inc. has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech. The candidates will support preclinical animal testing expected to begin immediately. The vaccine candidates were produced by the company’s proprietary PCR-based LinearDNA manufacturing systems.

Australia-based Starpharma Holdings Ltd. announced Wednesday that its proprietary VivaGel active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19. SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against Gilead’s remdesivir. Starpharma anticipates it should be possible to fast-track certain aspects of the development path for products targeted at COVID‑19.

ViralClear, a subsidiary of BioSig Technologies announced an update to its clinical development program for Vicromax™ and will be considered as a treatment for COVID-19. A Phase II clinical trial will be conducted at Mayo Clinic. Results from the trial will be expected within three months.

Mesoblast Limited has received clearance from the FDA for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19) with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L. Remestemcel-L is being developed for various inflammatory conditions and is believed to counteract the inflammatory processes implicated in COVID-19.

California-based Dynavax Technologies Corporation has entered the race alongside Sinovac Biotech to develop a vaccine candidate against COVID-19. The two companies will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018.

Beyond Air has the approval to initiate a clinical trial in the U.S. using its LungFit system to treat COVID-19 patients. It will treat 20 patients between the ages of 22 and 65 hospitalized with COVID-19. LungFit uses nitrous oxide generated from ambient air to deliver precise volumes of NO to the lungs for possible treatment for a range of pulmonary diseases.

CalciMedica partnered with Regions Hospital St. Paul, Minnesota and Henry Ford Hospital in Detroit to test CM4620-IE in a Phase II study for COVID-19. CM4620-IE is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation, which can lead to pulmonary endothelial damage and cytokine storm in the disease. It has shown clinical safety and potential efficacy in hypoxemia secondary to systemic inflammatory response syndrome (SIRS) from acute pancreatitis.

Company Actions

Today, Biogen, Broad Institute of MIT and Harvard, and Partners HealthCare announced that they will build and share a COVID-19 biobank. The biobank will help scientists in the search for potential vaccines and treatments.

SDL is providing global health science professionals with free access to its SDL Machine Translation. The tool is available to all organizations, researchers and professionals associated in COVID-19 medical research, discovery and development.

Sino Biological, Inc. announced an agreement with Nanommune Inc., to jointly develop coronavirus antigen array products for serological studies of COVID-19 and other infectious diseases.

The University of Louisville (Kentucky) has developed solutions to various personal protective equipment for healthcare providers. Faculty and students in UofL’s Additive Manufacturing Institute of Science & Technology (AMIST), the Schools of Dentistry, Engineering and Medicine, have developed a 3D printed swab made of a pliable resin. The university has also developed 3D printed face shields, respirators and ventilators.

Zymergen’s Emeryville, California facility was chosen by the Chan Zuckerberg Initiative and UC San Francisco to test a buffer solution used to collect and analyze swab samples for COVID-19 testing. The focus is on determining if a robotic system can more precisely and accurately speed up the tests for the disease.

Other Industry News

The FDA issued a EUA to Boston Scientific and its partner, the University of Minnesota, to manufacture a low-cost ventilator. The devices would be sold for less than $1,000.

Elizabeth Holmes, the founder and former chief executive officer of Theranos, will have to wait a few months longer before she gets her day in court. Her fraud case has been delayed from July until October due to concerns regarding COVID-19.

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