Palm Beach, FL – April 14, 2020 – Many According to the World Health Organization (WHO) there are 70 coronavirus vaccines in development globally, with three candidates already being tested in human trials, as drugmakers race to find a cure for the deadly pathogen. Time magazine reported that the furthest along in the clinical process is an experimental vaccine developed by Hong Kong-listed CanSino Biologics and the Beijing Institute of Biotechnology, which is in phase 2. The other two being tested in humans are treatments developed separately by U.S. drugmakers – and Inovio Pharmaceuticals, according to a WHO document. The article added: “Progress is occurring at unprecedented speed in developing vaccines as the infectious pathogen looks unlikely to be stamped out through containment measures alone. The drug industry is hoping to compress the time it takes to get a vaccine to market — usually about 10 to 15 years — to within the next year. Drugmakers big and small have jumped in to try to develop a vaccine, which would be the most effective way to contain the virus. Pharmaceutical giants like Pfizer Inc. and Sanofi have vaccine candidates in the preclinical stages, according to the WHO document. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ:BSGM), Gilead Sciences, Inc. (NASDAQ: GILD), Moderna, Inc. (NASDAQ: MRNA), Incyte Corporation (NASDAQ: INCY), CytoDyn Inc. (OTCQB: CYDY).
CanSino said last month it received Chinese regulatory approval to start human trials of its vaccine. Cambridge, Massachusetts-based Moderna — which has never put out a product — received regulatory approval to move quickly to human trials in March, skipping the years of animal trials that are the norm in developing vaccines. Inovio began its human trials last week.” The World Economic Forum recently reported that: “As several companies race to develop a coronavirus vaccine, the public is repeatedly reminded that the finish line is at least 12 to 18 months away. This timeline feels excruciatingly long as the coronavirus pandemic continues to ravage the world around us. But it deserves some context. New technologies combined with international cooperation to fight infectious diseases are enabling faster responses to new disease outbreaks, shaving several years from traditional vaccine development timelines.
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – Positive Data Generated by Biosig Subsidiary ViralClear on Covid-19 Coronavirus Published in bioRxiv – BioSig Technologies, a medical technology company commercializing a proprietary biomedical signal processing platform, announced that an article titled “The IMPDH inhibitor merimepodib suppresses SARS-COV-2 replications” to bioRxiv, an online archive and distribution service for reprints in the life sciences. This manuscript is authored by Natalya Bukeryeva, Emily Mantlo, Rachel Sattler, Chen Huang, Slododan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear.
The article is the first public disclosure of pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The work was started with Trek Therapeutics and after Vicromax was acquired by ViralClear, the work continues under contract with ViralClear.
“Oftentimes if an antiviral agent such as Vicromax decreases viral production by over 90% as is presented in this article, it will have meaningful activity in the clinic,” said Dr. Zeldis, ViralClear’s Executive Chair and founder. “More data will be submitted to peer review journals over the coming weeks and we are looking forward to submission of our IND to the FDA and advancing to human trails with this potential therapeutic .”
Vicromax(tm), a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The pharmaceutical is currently undergoing extensive pre-clinical testing. The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials in Q2 2020. To view the the article in its entirety, please use this link: https://www.biorxiv.org/content/10.1101/2020.04.07.028589v1
In other healthcare news of note:
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. Compassionate use data have limitations and multiple Phase 3 studies are ongoing to determine the safety and efficacy of remdesivir for the treatment of COVID-19. The detailed results of this analysis were published today in The New England Journal of Medicine. Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19.
Moderna, Inc. (NASDAQ: MRNA) recently announced that the first participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Incyte Corporation (NASDAQ: INCY) recently announced that it is working with the FDA to initiate a phase III study, RUXCOVID, to evaluate the efficacy and safety of Jakafi plus standard-of-care (SoC) compared to SoC therapy alone in patients with COVID-19-associated cytokine storm.
The Jakafi study will be sponsored by Incyte in the United States and Novartis outside of the country. Moreover, Incyte plans to initiate a separate open-label emergency Expanded Access Program (EAP) in the United States. Under this protocol, eligible patients with severe COVID-19 associated cytokine storm are allowed to receive Jakafi while it is being evaluated for this indication. The RUXCOVID and EAP studies are awaiting potential FDA approvals.
CytoDyn Inc. (OTCQB: CYDY) a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, recently announced a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Company’s trials.
Patient enrollment in the Company’s two clinical trials and Emergency Investigational New Drug (EIND) is as follows: 1) More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA); 2) Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen; 3) As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available; and 4) First site cleared to enroll patients in Phase 2b/3 beginning today.
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