FDA Actions
FDA-ARGO SARS-CoV-2 Reference Grade Sequencing Data: The FDA has partnered with Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI). Together they have developed reference sequence data for the SARS-CoV-2 reference strain for the U.S.
Warning Letter: The FDA and FTC issued a warning letter to Neuro XPF with providing misleading claims that its products can prevent, treat, diagnose or cure COVID-19.
Diagnostics Update: The FDA has worked with more than 220 test developers who plan to submit EUA requests to detect COVID-19. Also, 23 EUAs have been issued. The FDA has been notified that more than 110 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
MicroGenDX Laboratories’ rRT-PCR assay for SARS-COV-2 received EUA from the FDA. It is the first test validated using saliva and sputum samples.
Regeneron is making $1 million worth of a liquid that preserves swab samples taken during COVID-19 testing. Workers in Regeneron’s East Greenbush manufacturing facility have been volunteering hours to help make this key component for COVID-19 test kits.
LifeSignals Group Inc. announced that a single-use, wireless biosensor patch for the early detection and monitoring of coronavirus symptoms is being fast-tracked for introduction within weeks. The patch, which is affixed to the the chest, will record temperature, respiration rate, ECG trace, heart rate and movement in real-time.
Testing Therapies, Antivirals and Vaccines
Pinpoint Therapeutics: Pinpoint Therapeutics believes that its approach to treat therapy-resistant cancers also may be effective against COVID-19. The molecule Pinpoint is developing, dimeric chloroquine, targets PPT1, an enzyme in the autophagy pathway that tumors use to block therapeutics. CEO Christian Peters, M.D., Ph.D., believes targeting this pathway and, specifically, the PPT1 enzyme, could prevent the COVID-19 virus from entering cells to cause infections.
Noxopharm: Australian-based Noxopharm, announced it has identified a clinical trial opportunity to help reduce the mortality rate of COVID-19. In preclinical research, idronoxil inhibits a range of inflammatory mediators known as cytokines, including interleukin-6 (IL-6) that are involved in a process known as a cytokine storm.
APEIRON Biologics AG: APEIRON announced it has received regulatory approvals to initiate a Phase II clinical trial of APN01 to treat COVID-19. Approvals were in Austria, Germany and Denmark. APN01 has the potential to block infection of cells by COVID-19 and reduce lung injury.
BioAegis Therapeutics Inc. believes its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), should be considered as a viable therapeutic option for patients suffering from severe lung injury due to COVID-19. The company is submitting requests to the FDA and other international regulatory authorities to accelerate their clinical trial. The company’s asset, rhu-pGSN, disrupts the course of inflammatory and infectious diseases which very often can lead to long term morbidity or death.
Altimmune, Inc. and the University of Alabama at Birmingham will collaborate on the development of a single-dose, intranasal COVID-19 vaccine, called AdCOVID. It is expected that AdCOVID has the potential to activate multiple arms of the immune system as shown in a recent Phase II clinical study with NasoVAX, an influenza vaccine candidate based on the same platform technology, the company said.
Swiss pharma company Neurimmune and Germany’s Ethris GmbH forged a partnership to develop mRNA-encoded, neutralizing anti-SARS-CoV-2 antibodies administered by inhalation for the treatment of COVID-19. The collaboration brings together Neurimmune’s expertise in developing human antibodies based on high-throughput immunoglobulin sequence analyses from COVID-19 patients who have recovered from the disease with Ethris’ proprietary and unique pulmonary SNIM RNA therapeutics platform.
CytoDyn’s leronlimab continues to show positive response in COVID-19 patients, with a “significant trend toward immunological restoration.”
CAS, a division of the American Chemical Society specializing in scientific information solutions, released an open-access dataset of chemical compounds with known or potential antiviral activity to support research, data mining and analytics applications. The new CAS COVID-19 Antiviral Candidate Compounds Dataset contains nearly 50,000 chemical substances extracted from the CAS REGISTRY that have antiviral activity reported in published literature or are structurally similar to known antivirals.
Ennaid Therapeutics: Ennaid announced that it is advancing the development of ENU200, as a therapeutic to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 infections.
Celularity: Celularity announced the FDA has cleared the company’s Investigational New Drug (IND) application for use of its CYNK-001 product in adults with COVID-19. The company will commence a Phase I/II clinical trial including up to 86 patients with COVID-19.
Company Actions
OSE Immunotherapeutics: A late-stage lung cancer drug under development by OSE Immunotherapeutics met its 12-month primary endpoint for survival rates following a Step-1 analysis. But, the ongoing COVID-19 pandemic is causing the company to rethink its ongoing clinical plans for the drug.
Vir Biotechnology and Alnylam Pharmaceuticals expanded their multi-target existing collaboration for RNAi therapies for infectious diseases to include COVID-19. It will include up to three additional targets for host factors for SARS-CoV-2, including ACE2 and TMPRSS2.
Momenta Pharmaceuticals’ trial updates: Phase II VIVACITY-MG study of nipocalimab in generalized myasthenia gravis is fully enrolled and continuing; its Phase II UNITY trial of nipocalimab in hemolytic disease of the fetus and newborn (HDFN) continues to enroll patients at sites where it can be done and doesn’t intend to pause enrollment because of the life-threatening nature of HDFN, but does expect a slower pace of enrollment; its Phase II/III Energy Study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA) is activating sites, but has temporarily suspended patient enrollment; and its M254 for intravenous immunoglobulin Phase I/II study in idiopathic thrombocytopenic purpura continues to enroll lower dose cohorts, but most of the sites have suspended enrollment.
Fulcrum Therapeutics noted its ReDUX4 trial for Facioscapulohumeral Muscular Dystrophy is fully enrolled, but because some of the clinical sites are closed, the company is assessing its timeline for topline data.
Applied Therapeutics announced its COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor in Phase III development for diabetic cardiomyopathy. It is being evaluated for acute lung inflammation and cardiomyopathy in critical COVID-19 patients.
Amgen and Adaptive Biotechnologies team to develop an antibody therapy against COVID-19.
Fluidigm Corporation’s Fluidigm CyTOF technology was used in a clinical trialthat provided preliminary data that mesenchymal stem cell (MSCL) therapy improved outcomes in COVID-19 pneumonia. Data was published by Chinese researchers in Aging and Disease.
Geron Corporation indicates that its IMerge Phase III trial is ongoing, but there have been delays because of the pandemic. On a positive note, because of the slower completion and enrollment, it expects its 2020 operating expense burn to be lower than previously indicated.
Spring Bank Pharmaceuticals reports that its Phase Ia/Ib trial of SB 11285 in solid tumors is continuing, although some institutions involved have suspended patient enrollment. The company indicates sit is reviewing its portfolio of RIG-I agonists from its STING platform for COVID-19. These compounds have shown activity against viral respiratory diseases such as RSV, influenza and parainfluenza.
Pfizer, Merck & Company and Eli Lilly and Company will allow employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay from the companies. The three companies employ thousands of doctors, nurses, pharmacists, medical laboratory technicians and other medical professionals whose services are in high demand during the COVID-19 pandemic.
Other Industry News
Elizabeth Holmes’ legal team is seeking special exemptions from the court for COVID-19-related stay-at-home orders in California in order to meet a July trial deadline. But, the judge denied that request due to safety concerns and, for now, refused to delay the start of the trial for wire fraud.
Compare: 1918 Spanish Influenza Pandemic Versus COVID-19. With all the similarities, it should be emphasized that there are several significant differences between the two pandemics.
