Biopharma Update on the Novel Coronavirus: May 20

CV Update_May 20

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FDA Actions

FDA Approval: The FDA approved succinylcholine chloride injection USP 200 mg/10 mL. This drug is indicated to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation. This is to help with the facilitation of medial products to help the critical needs of patients during the pandemic.

Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 104 individual EUAs have been issued, which includes 91 molecular tests, 12 antibody tests and 1 antigen test.



Weeks after Mammoth Biosciences announced its CRISPR-based diagnostics test for COVID-19 had a high degree of specificity even for asymptomatic patients, the Bay Area-based company struck a deal with GlaxoSmithKline to accelerate the development of the test in hopes of getting them in consumers' hands as soon as possible.

Enzo Biochem launched a SARS-CoV-2 IgG ELISA assay kit for serological detection if IgG antibodies against COVID-19 under the FDA’s EMU authority. It is designed to provide accurate results in a clinical laboratory setting with low- to high-throughput processing of specimens.

The Dark Report issued an intelligence briefing and is offering a free webinar titled, “Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests.” The webinar will be conducted by James O. Westgard, founder of Westgard QC and Sten Westgard, Director of Client Services and Technology for Westgard QC. The webinar is Thursday, May 21 at 1 PM Eastern Daylight Time.

Bay Area-based Color announced it received Emergency Use Authorization to use LAMP technology for COVID-19 testing. LAMP (Loop-mediated isothermal amplification) is a molecular testing technology that delivers COVID-19 test results with accuracy equivalent to the current gold standard method, RT-PCR testing. LAMP testing can happen 50% faster and requires a different set of chemical reagents, meaning that Color can avoid supply chain issues that have created backlogs for other test providers, the company said.


Testing Therapies, Antivirals and Vaccines

On Tuesday, May 18, Moderna released positive interim Phase I data from its clinical trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The company reported overall positive results for both efficacy and safety, although not a lot of details were released on the actual data.

California-based Prellis Biologics announced it generated 300 human IgG antibodies that bind to either the S1 or S2 spike protein of the SARS-CoV2-Wuhan strain of the novel coronavirus with its Prellis Externalized Human Immune System technology. The company said it produced 960 synthetic human lymph nodes that were challenged with a SARS-CoV2 vaccine-like cocktail, leading to virus-specific antibody generation. The next step for the company is to determine if the generated antibodies will prevent virus replication in live cell assays.

Avrio Health L.P., a subsidiary of Purdue Pharmaceuticalshas initiated a program to evaluate the potential safety and effectiveness of certain formulations of Betadine antiseptic products against COVID-19. An in vitro study evaluating activity against a surrogate coronavirus has begun, with additional in vitro and in vivo studies planned to evaluate certain formulations of Betadine antiseptic products. Betadine antiseptic products are used to reduce the number of microorganisms on the skin that can potentially cause infection. Some of these products have been used by healthcare professionals for more than 50 years.

Genentech launched a new COVID-19 clinical study with an eye toward increasing diversity and inclusion among patients treated. The study was launched following reports from the U.S. Centers for Disease Control and Prevention, as well as other sources, that indicate the COVID-19 pandemic may be disproportionately affecting underserved and minority populations. With these health disparities in mind, Genentech has initiated the EMPACTA (Evaluating Minority Patients with Actemra) trial. This is a phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of Actemra (tocilizumab) in patients hospitalized with COVID-19 pneumonia at hospitals that largely treat underserved and minority patient populations.

Vaxart selected its lead COVID-19 vaccine candidate. It also contracted with KindredBio to manufacture bulk vaccine under cGMP to complement the manufacturing capacity of its partner, Emergent BioSolutions. The vaccine is based on the company’s VAAST oral vaccines platform.

Airway Therapeutics and Celonic Group announced a collaboration to produce the novel human recombinant protein ATR-100 (rhSP-D) as a therapeutic candidate against COVID-19. Celonic will handle process optimization and GMP manufacturing of AT-100 for clinical study, with production expected to begin in June.

Progenabiome is launching two FDA-approved clinical trials that include hydroxychloroquine to prevent or treat COVID-19.

University of Waterloo researchers studying the 3D structure of the COVID-19 protein believe a specific class of diabetes drugs could potentially be used to treat COVID-19. The study has not yet been peer-reviewed, but they found evidence that dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors) could bind to the protein. They are continuing research and hope to scale up to clinical trials. Common DPP4 inhibitors include AstraZeneca’s Onglyza (saxagliptin), Merck’s Januvia (sitagliptin), Takeda’s Nesina (alogliptin) and Boehringer Ingelheim’s Tradjenta (linagliptin).

The FDA approved an investigational new drug (IND) application from Octapharma USA, Inc. for a Phase III clinical trial assessing the efficacy and safety of Octagam therapy for COVID-19 patients. The primary endpoint of the study is to determine if high-dose Octagam 10% therapy, an immune globulin intravenous treatment, will slow or stop respiratory deterioration in patients with severe coronavirus disease. Secondary objectives will measure the effects of a high-dose of the treatment on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors.

Boston-based Atea Pharmaceuticals closed a $215 million Series D financing. At the same time, Atea announced the FDA had given the go-ahead for its investigational new drug (IND) application for AT-527 for adults hospitalized with moderate COVID-19. AT-527 is a novel, oral, purine nucleotide prodrug, a direct acting antiviral that inhibits the RNA polymerase enzyme. The Phase II trial is scheduled to begin soon.


Company Actions

Bharat Biotech and Thomas Jefferson University of Philadelphia announced they have signed an exclusive deal to develop a COVID-19 vaccine candidate. The candidate as invented at Jefferson, using an existing deactivated rabies vaccine as a vehicle for coronavirus patients.

BriaCell announced it has filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) for a novel vaccine platform to selectively deliver antigens of interest to immune cells, inducing immune responses toward pathogens including SARS-CoV-2 virus.


Other Industry News

As reported by ABC News, scientists in the U.S. and Britain are looking to dogs to help in the detection of COVID-19 in humans. An organization, Medical Detection Dogs, said they are using six dogs to train to identify the disease which they say carries a distinct scent.

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