Biopharma Update on the Novel Coronavirus: April 9
News information is not all-inclusive. Please check back for updates.
FDA Actions
Warning Letters: The FDA and the FTC issued a warning letter to Genesis II Church of Health and Healing for using fraudulent claims that their chlorine dioxide products known as “Miracle Mineral Solution” are safe and/or effective in the prevention or treatment of COVID-19. The FDA continues to warn consumers not to purchase or drink chlorine dioxide products sold online as medical treatments.
The FDA and FTC also issued two additional warning letters to Savvy Holistic Health dba Holistic Healthy Pet and CBD Online Store with misleading claims that their products are safe and/or effective in the prevention or treatment of COVID-19.
Administration and Study of Convalescent Plasma: The FDA issued guidance on recommendations for the administration and study of convalescent plasma to patients who are seriously ill with COVID-19.
Diagnostics Update: The FDA has worked with more than 270 test developers who plan to submit EUA requests to detect COVID-19. Also, 31 EUAs have been issued. The FDA has been notified that more than 150 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
Biomerica Inc. signed two separate license agreements with Mount Sinai’s Icahn School of Medicine in New York to license technologies pertaining to a laboratory version serological test for SARS-CoV-2 virus infection which has been developed at Mount Sinai. This test uses the ELISA microplate format that can run on existing open system equipment found in most hospitals and clinical laboratories in the United States. This ELISA microplate format is a serology test that detects antibodies (proteins produced by the immune system in response to infections) in the blood of patients who have been infected with the COVID-19 virus causing the current pandemic.
Testing Therapies, Antivirals and Vaccines
Pluristem Therapeutics: The world continues to wait with bated breath for a treatment for COVID-19 and Pluristem Therapeutics appears to be on the cusp of providing some hope. Preliminary data from Israel is showing promise for the company’s experimental treatment. Pluristem's PLX Cell program is showing some promise in COVID-19 patients with Acute Respiratory Distress Syndrome. 66% of the patients showed respiratory improvement and half are being weaned from ventilators. Pluristem plans to initiate a clinical trial in COVID-19 for its PLX Cell program.
Gilead Sciences is expected to report data from a clinical trial of its antiviral drug remdesivir against COVID-19 soon. Although the data hasn’t been released yet, analysts are making predictions based on what little they do know.
Pfizer: The WSJ reported that Pfizer has identified a lead candidate for COVID-19. The laboratory research indicates the drug candidate blocks the new coronavirus from replicating and aims to begin testing patients this summer.
Pfizer/BioNTech: Pfizer and BioNTech disclosed additional information on their joint effort to develop an emerging gene-based COVID-19 vaccine. The companies plan to move four different vaccines into clinical trials as early as the end of this month. The best one will move forward.
The Boston Business Journal reported that a generic vaccine showing promise for diabetes type I may potentially help people from getting COVID-19. The trials are being conducted at Massachusetts General Hospital (MGH).
Arcturus Therapeutics announced plans to initiate a human clinical trial this summer for its COVID-19 vaccine, LUNAR-COV19. LUNAR-COV19 is a very low dose, potential single-shot, self-replicating mRNA vaccine devoid of any viral material or co-adjuvants. Preclinical in vitro data shows that administration of LUNAR-COV19 generates the effective expression of the COVID-19 virus spike protein, the antigen to which protective antibodies will be formed.
Theravance Biopharma announced it is advancing TD-0903, a lung-selective nebulized Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with Acute Lung Injury (ALI) in patients hospitalized due to COVID-19, with the ultimate goal of preventing progression to Acute Respiratory Distress Syndrome (ARDS). By its mechanism, TD-0903 has the potential to block the release of cytokines and chemokines that may be associated with acute lung injury and the initiation of a cytokine storm syndrome, the company said.
BioSig Technologies published data showing that its Vicromax broad-spectrum anti-viral candidate showed strong activity against COVID-19 in cell cultures. It hopes to continue development against COVID-19 in clinical trials in the second quarter.
Todos Medical indicated its distribution partner Gibraltar Brothers had signed deals to diversity its manufacturing supplies of Ab POC Test Kits for the U.S. and select internal markets to include two additional POC Test Kits whose manufactures have already notified the FDA of an Emergency Use Authorization application, and full Chinese National Medical Products Administration (NMPA) approval. These test kits can be used to test for people previously exposed to COVID-19.
CalciMedica received the go-ahead from the FDA to investigate the use of CM4620-IE in patients with severe COVID-19 pneumonia at risk for ARDS. The drug is a potent and selective small-molecule CRAC channel inhibitor that prevents CRAC channel overactivation, which can cause pulmonary endothelial damage and cytokine storm in COVID-19.
Biohaven Pharmaceutical submitted Pre-IND/IND material to the FDA to initiate a Phase II trial of vazegepant for COVID-19 infection associated with pulmonary complications. The drug is an intranasal, high-affinity calcitonin gene-related peptide (CGRP) receptor antagonist. The drug is currently advancing to Phase III for acute migraine.
CytoDyn reported immunological metrics from blood samples of seven severely ill COVID-19 patients after seven days of treatment with leronlimab. The results demonstrate dramatic immune restoration, especially in the CD8 T-lymphocyte population. It also reported a patient with severe COVID-19 in Southern California exhibited clinical improvement after leronlimab treatment.
Mesoblast Limited announced its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be evaluated in a placebo-controlled trial in 240 patients with ARDS caused by COVID-19. The Phase II/III trial will be conducted in a partnership in collaboration with the Cardiothoracic Surgical Trials Network (CTSN).
iBio signed two Master Services Agreements and Memorandum of Understanding with the Infectious Disease Research Institute in support of its SARS-CoV-2 Virus-Like Particle vaccine development. IDRI will support preclinical development and clinical trial oversight. iBio will provide process development and manufacturing services.
Intermountain Healthcare and the University of Utah Health launched two COVID-19 clinical trials to test the effectiveness and safety of hydroxychloroquine and azithromycin. As everyone probably knows by now, hydroxychloroquine is a treatment for malaria, as well as lupus and rheumatoid arthritis. Azithromycin (Z-Pak) is an antibiotic.
Laurent Pharmaceuticals, a spin-off from McGill University, plans to test its lead compound LAU-7b in COVID-19 patients as part of a Phase II trial. The drug is a novel, once-a-day oral form of fenretinide, being developed to control inflammation in the lungs. A recent drug-library screening by researchers from the Institut Pasteur Korea suggested the drug also had anti-viral therapeutic properties against COVID-19.
Fujifilm Holdings will begin a Phase II trial of its anti-flu drug Avigan for COVID-19 in the U.S. It will enroll about 50 COVID-19 patients. The drug inhibits RNA polymerase, which, like with the influenza virus, is needed by the novel coronavirus to replicate.
Cigna is providing drugs to Washington University School of Medicine in St. Louis to launch a clinical trial to evaluate hydroxychloroquine and chloroquine and azithromycin in COVID-19.
AXON Neuroscience is developing a peptide-based vaccine candidate against COVID-19. Axon's vaccine contains only selected epitopes capable of inducing desirable T cell and B cell mediated immune responses to prevent interaction of the virus Spike (S) glycoprotein with its target human cells, thus preventing the virus from entering the cells and spreading. The vaccine is intended to treat infected patients and protect healthy individuals from infection.
PHASE Scientific launched the PHASIFY VIRAL RNA Extraction Kit as part of its global effort to help detect and control the COVID-19 disease. The kit purifies and concentrates viral RNA in patient viral transport media samples.
Company Actions
Kezar Life Sciences, Inc. said it anticipates delays for its KZR-616 clinical development program due to the impact of COVID-19 on testing centers. Preclinical work with KZR-261 remains on track for an Investigational New Drug application in the first quarter of 2021, the company said.
Quantum Genomics indicated that its QGC001/1QG4 trial in end-stage renal failure was ongoing and all patients had been enrolled, with half of the healthy volunteers already completing the trial and all renal failure patients enrolled and treated. Enrollment for the remaining healthy volunteers has been temporarily halted. For patients in the QGC001/2QG4 (QUORUM) trial, some of the patients have already completed follow-up visits. Patients currently enrolled are having follow-up visits reorganized and, when possible, conducted remotely. The FRESH trial in resistant hypertension largely continues unchanged, with patient enrollment beginning as soon as possible.
MemComputing, Inc. announced that its Xtreme Performance Computing (XPC) Software as a Service will be made free for evaluation to all researchers and developers working in response to the COVID-19 crisis.
Neoleukin Therapeutics does not expect a delay in its plan to submit an Investigational New Drug Application by the end of 2020 for its lead therapeutic, NL-201. The company is working with key vendors to assess any potential impacts to these efforts. While no delays are expected, Neoleukin acknowledges the potential exists for this timing to be impacted. Further, Neoleukin is evaluating the potential for geographic diversity of clinical trial sites to minimize any regional and/or seasonal effects of COVID-19 recurrences.
Other Industry News
CNBC reports that 87-year-old, Dr. Stanley Plotkin is consulting with pharmaceutical companies on COVID-19 vaccine development. Dr. Plotkin invented the rubella vaccine and has worked on vaccines for other diseases such as anthrax, polio, rabies and rotavirus.
Merck commits $3 million to help health systems better meet the needs of pregnant women before, during and after delivery while battling COVID-19. The funds are through Merck for Mothers, the company’s global initiative to help end preventable maternal deaths.
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