COVID-19 Top News – March 24, 2020

March 24, 2020

remdesivir (GS-5734) / Gilead
Gilead’s potential coronavirus treatment gets FDA’s Orphan Drug label (cnbc) – Mar 24, 2020 – “Gilead Sciences’ experimental drug remdesivir…received the orphan drug designation from the U.S. Food and Drug Administration….The announcement comes days after U.S. President Donald Trump called on the FDA to streamline its approval process for treatments such as remdesivir….It was temporarily putting new emergency access to remdesivir on hold due to an exponential increase in so-called compassionate-use requests for the drug.”


CpG 1018 / Dynavax, University of Queensland
Dynavax and Clover Biopharmaceuticals announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with CpG 1018 adjuvant (GlobeNewswire) – Mar 24, 2020 – “Dynavax Technologies Corporation…and Clover Biopharmaceuticals…announced that they have entered into a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) in preclinical studies. Dynavax is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative…Utilizing its patented Trimer-Tag© technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system….Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.”


eTheRNA launches an international consortium and starts development of cross-strain protective CoV-2 mRNA vaccine for high risk populations (PRNewswire) – Mar 24, 2020 – “eTheRNA Immunotherapies nv…announced that a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course…eTheRNA and its partners EpiVax, Nexelis, REPROCELL and CEV* have extensive experience in the mRNA vaccine field and this will help accelerate progress towards clinical trials with patient enrolment expected in early 2021.”


Actemra IV (tocilizumab) / Roche, JW Pharma
Roche response to Covid-19 pandemic (GlobeNewswire, F. Hoffmann-La Roche Ltd) – Mar 24, 2020 – “The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care….This is the first global study of Actemra/RoActemra in this setting.”


hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
New York to start clinical trials for Covid-19 treatment after a go signal from the FDA (Tech Times) – Mar 24, 2020 – “…Food and Drug Administration has already approved one of the drugs that are involved in the clinical trials for the state of New York….New York Gov. Andrew Cuomo has stated…they have now acquired 10,000 doses of Zithromax, 70,000 doses of hydroxychloroquine and 750,000 doses of chloroquine….The main drug that was approved by the FDA for clinical trials was Chloroquine…brand-name antibiotic called Zithromax was included, and another one named hydroxychloroquine….These drugs are all considered as potential treatments for coronavirus.”


COVID-19 immunotherapy / CEL-SCI
Embattled Cel-Sci to tackle Covid-19 with immunotherapy platform tech LEAPS (FierceBiotech) – Mar 24, 2020 – “Cel-Sci announced…it has formed a research partnership with the University of Georgia’s Center for Vaccines and Immunology to develop a drug candidate for patients at high risk of dying from COVID-19.”


Sorrento collaborates with Mabpharm on development and commercialization of ACE-MAB to potentially treat COVID-19 (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 24, 2020 – “Sorrento Therapeutics, Inc…today announced it has entered into an exclusive license agreement with China-based antibody biopharmaceutical company, Mabpharm Limited…for the clinical development and commercialization of the ACE-MAB fusion protein (Sorrento’s product code name STI-4920 and Mabpharm’s product code name CMAB020) for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Mabpharm has generated a fusion protein (CMAB020) that binds to the spike protein of the SARS-CoV-2 virus.”



Ampio is preparing an expanded access FDA protocol to study nebulized Ampion as a treatment for moderate to severe acute respiratory distress syndrome associated with Covid-19 (PRNewswire) – Mar 24, 2020 – “Ampio Pharmaceuticals…announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2….The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19 for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.”


Cell>Point plans to expedite research program on 99mTc-EC-Amifostine and 177Lu-EC-Amifostine as a potentially effective theranostic technology for Covid-19 (PRNewswire) – Mar 24, 2020 – “Cell>Point announced today its plans to move forward with its research program to clinically develop 99mTc-EC-Amifostine and 177Lu-EC-Amifostine to assess, treat and follow-up with confirmatory imaging for people who contract COVID-19.”


VERO Biotech announces first patient with Covid-19 infection complicating pulmonary hypertension treated with GENOSYL DS, the first and only FDA-approved tankless system for the delivery of Inhaled Nitric Oxide (PRNewswire) – Mar 24, 2020 – “VERO Biotech…today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home….The patient was treated under an emergency IND filed by a qualified Investigator and approved by the US FDA.”


Soligenix’s Covid-19 vaccine (Pharmaceutical-technology.com) – Mar 24, 2020 – “Soligenix has collaborated with the University of Hawaiʻi at Mānoa (UH Mānoa) to study Covid-19 vaccine candidates….The company will assess the use of its heat-stable technology platform against coronaviruses, including SARS-CoV-2.”


INO-4800 / Inovio
Ology Bioservices, Inovio Partner to manufacture COVID-19 DNA vaccine with $11.9 million department of defense grant (PRNewswire) – Mar 24, 2020 – “Ology Bioservices Inc…and Inovio Pharmaceuticals Inc…announced today that the Department of Defense (DOD) has awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines….Under this program, Ology Bioservices will work with Inovio Pharmaceuticals to manufacture Inovio’s DNA vaccine (INO-4800) for prevention of infection with the COVID-19 virus.”

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