U.S. Support for Drugmakers Fuels Effort to Secure Shortest Timeline for COVID-19 Vaccine

PALM BEACH, Florida, June 5, 2020 /PRNewswire/ -- Vaccines to prevent Covid-19 infection are hurtling through development at speeds never before seen. But mounting promises that some vaccine may be available for emergency use as early as the autumn are fueling expectations that may be unrealistic, some experts warn.  Even if the stages of vaccine development could be compressed and supplies could be rapidly manufactured and deployed, it could take many more months or longer before most Americans would be able to roll up their sleeves. And in many countries around the world, the wait could be far longer still — perpetuating the worldwide risk the new coronavirus poses for several years to come… but most projections continue to optimistically support faster timelines than have been seen historically.  That reality is that some of the earliest vaccine candidates may within months have enough evidence behind them to be administered on an emergency use basis, industry reports say.    Active healthcare stocks in news today include:  BioSig Technologies, Inc. (NASDAQ: BSGM), Gilead Sciences, Inc. (NASDAQ: GILD), Eli Lilly and Company (NYSE: LLY), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ:NVAX).

"Michael Osterholm, director of the University of Minnesota's Center for Infectious Diseases Research and Policy, is worried people aren't preparing for the possibility of a fall wave of infections — which some experts fear will be bigger than what we've seen so far — because they expect a vaccine will be at hand. I don't think we're communicating very well at all with the public, because I keep having to tell these people, you know, even if we had a vaccine that showed some evidence of protection by September, we are so far from having a vaccine in people's arms," Osterholm said.  Assuming a vaccine can be developed quickly, the issue of manufacturing is not a small one. Production of some vaccine candidates could be more easily ramped up than others, noted Emilio Emini, who is leading work at the Bill and Melinda Gates Foundation on the issue.

BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS - ViralClear adds St. David's HealthCare in Austin, Texas, to its Planned Phase II trial for its Broad-Spectrum Oral Anti-Viral Candidate for COVID-19  - BioSig Technologies and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has expanded its patient enrollment centers to include St. David's South Austin Medical Center in Austin. The hospital is part of St. David's HealthCare, one of the largest healthcare systems in Texas. The Company intends to commence its Phase II clinical trial for merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients in the coming weeks.

The clinical trial team consists of Brian Metzger, M.D., MPH, Medical Director of Infectious Diseases at St. David's Medical Center, who is is the principal investigator,  as well as Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., Cardiac Electrophysiologist and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, and Matthew Robinson, M.D., Medical Director of Infectious Diseases at St. David's South Austin Medical Center, who are co-investigators for the study.

"The safety and quality of treatment for our patients is our top priority, and we take numerous measures to ensure the highest level of care. As such, we remain steadfast in the pursuit against the coronavirus, and we look forward to working with ViralClear on the Phase II trial of its antiviral candidate as a potential solution against this virus," commented Dr. Metzger.

"Adding St. David's South Austin Medical Center as an investigating center in the ViralClear clinical trial with merimepodib has the potential to allow the Company to accelerate clinical development and generate results from a more diverse population of patients," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. and Director at ViralClear Pharmaceuticals, Inc. "We have been innovating with Dr. Andrea Natale since we started BioSig over eleven years ago. His guidance has been vital to us through all stages of product development and in the early commercialization of our PURE EP(tm) System. We are thankful for Dr. Natale's leadership during these unprecedented times and look forward to collaborating with the whole St. David's team on this important mission."

The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced Coronavirus Disease 2019 (COVID-19). A description of this clinical trial can be accessed via www.clinicaltrials.gov.

Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in SARS-CoV-2 replication to undetectable levels. Peer reviewed publication of these findings can be found at F1000 Research: https://f1000research.com/articles/9-361

Read more news for BSGM by visiting:  https://ir.biosig.com/press-releases      

In other healthcare news of note:

Moderna, Inc. (NASDAQ: MRNA) recently announced new research to be highlighted at the Company's third annual Science Day, held virtually this year. The program is designed to provide insight into the continued diverse efforts underway at Moderna and with collaborators to better understand how to use mRNA as a medicine, and underscores the Company's continued commitment to basic science and innovation.

"Science Day is an opportunity for us to provide insights into the advancements in our platform science and our further understanding of how to use mRNA as a medicine. Our substantial investments in basic science to date have resulted in major steps forward in our platform's capabilities, and these have allowed us to open new therapeutic areas and new scientific directions," said Stephen Hoge, M.D., President of Moderna. "Today, we're excited to highlight novel approaches to our lipid nanoparticle technology, which will be used with mRNA-3745, our GSD1a candidate in preclinical development. We are also pleased to provide an update on our collaboration with IAVI, NIAID and Bill & Melinda Gates Foundation toward the development of an HIV vaccine using Moderna's mRNA platform. We remain firmly committed to further advancing our mRNA science to create a new generation of transformative medicines for patients."

Novavax, Inc. (NASDAQ: NVAX) - AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), recently announced that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax' coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the  adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax' capacity to deliver doses in 2020 and 2021.

We are quickly ramping up to successfully deliver this vital vaccine component to Novavax," says AGC Biologics' CEO Patricio Massera. "The urgency to help produce a vaccine to combat COVID-19 could not be higher."

Eli Lilly and Company (NYSE: LLY) recently announced patients have been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19.  This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19.

The first patients in the study were dosed at major medical centers in the U.S., including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.  "We are committed to working with our industry partners to generate scientific evidence to meet the urgent need for treatments that reduce the severity of COVID-19 disease," said Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center at NYU Langone Health. "Antibody treatments like the one being studied here hold promise to be effective medical countermeasures against this deadly infection," said Dr. Mulligan, also the Thomas S. Murphy, Sr. Professor in the Department of Medicine at NYU Langone.

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

"Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve," said Francisco Marty, MD, an infectious diseases physician at Brigham and Women's Hospital, and associate professor of medicine at Harvard Medical School. "These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients."

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