Biopharma Update on the Novel Coronavirus: June 2
News information is not all-inclusive. Please check back for updates.
FDA Voices: On May 29, the FDA issued a new FDA Voices, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic. It explains how the agency plays a pivotal role helping to both move new medical products to patients as soon as possible and evaluate the potential benefits and risks of these new products.
Consumer Update: The FDA issued an update, Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19, that explains some of the regulatory terminology regarding drug development programs for the pandemic.
Guidance Update: The FDA updated its guidance to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer.
Testing Therapies, Antivirals and Vaccines
Relief Therapeutics Holding AG and NeuroRx, Inc. have treated the first patients with the investigational medicine RLF-100 in a Phase IIb/III study in COVID-19 patients on mechanical ventilation who have experienced Acute Respiratory Distress Syndrome. RLF-100 is a patented formulation of Aviptadil, a synthetic human vasoactive intestinal polypeptide (VIP) that targets alveolar type 2 cells in the lungs that could be the major target of the SARS-CoV-2 virus. VIP is known from numerous animal models of lung injury and lung disease to inhibit inflammatory cytokines and to protect pulmonary epithelial cells that line the air sacs (alveolae) of the lungs. The primary endpoints will be mortality and index of respiratory distress.
Favipiravir, an influenza dug developed by FUJIFILM, is being studied in clinical trials conducted by Indian pharma companies Glenmark and Strides Pharma Science in COVID-19 patients.
Norway-based BerGenBio ASA dosed its first patients in the Phase II clinical trial assessing bemcentinib in hospitalized COVID-19 patients. The Phase II study will recruit 120 subjects in total, assessing the safety and efficacy of bemcentinib as an add-on therapy to standard of care (SoC) in 60 hospitalized COVID-19 patients with a further 60 control group patients receiving SoC.
Trevena, Inc. entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.
Netherlands-based Intravacc and Rhode Island’s EpiVax entered into a collaboration agreement to progress a novel vaccine against COVID-19, based on Intravacc's proprietary Outer Membrane Vesicles (OMV) technology platform. Using genetic engineering, the OMVs can be decorated with immunogenic peptides that combine T- cell epitopes that will drive effective adaptive immunity.
AgeX Therapeutics, Inc. and Imstem Biotechnology signed a non-binding letter of intent for ImStem to obtain AgeX’s embryonic stem cell line ESI 053 to derive ImStem’s investigational MSC product IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes.
Caladrius Biosciences has been selected to present at the BioNJ COVID-19 Rapid Fire Research Showcase on Friday. The company will present an overview of CLBS119, Caladrius’ CD34+ cell therapy product candidate targeting repair of COVID-19 induced lung damage.
Operation Warp Speed: CDMO Emergent BioSolutions, Inc. signed a public-private partnership under Operation Warp Speed worth about $628 million. The goal is for the rapid domestic production of leading COVID-19 vaccine candidates through 2021. Also, two companies owned by billionaire physician and businessman Patrick Soon-Shiong made it to the shortlist of 14 vaccine candidates evaluated by Operation Warp Speed. HHS has only announced financial support for five other vaccine candidates, which includes Moderna, Johnson & Johnson, and AstraZeneca. The announcement was made by Soon-Shiong during a May 27 investor call and press release, but HHS has not yet made an announcement.
Other Industry News
An analysis conducted by GlobalData shows that South Korea was able to gain greater control over the COVID-19 outbreak in that country due to the significant number of diagnostic tests provided to the citizenry. The study shows South Korea initiated mass testing before the disease hit its epidemiological peak in that country. Broad testing measures, combined with speedy isolation of cases and contact tracing, were performed quickly after diagnosing their first case, GlobalData said.
Related Links: Biopharma Update on the Novel Coronavirus: June 1