Race For Vaccine Intensifies As COVID-19 Second Wave of Outbreaks Threatens

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Jun 17, 2020, 08:45 ET

PALM BEACH, Florida, June 17, 2020 /PRNewswire/ -- The race for a vaccine to end the current global healthcare crisis has ramped-up even more with a second wave of outbreaks starting to appear. The White House's Office of Science and Technology Policy said in a statement that it is seeking a "whole of America response" that requires the current approach of tapping federal agencies, private industry, academia and the nonprofit sector. On the federal level, the U.S. national laboratory system has roughly 1,000 scientists and doctors at its disposal, and it operates the world's largest network of supercomputers. A recent article in the LA Times reported that: "Researchers racing to develop a vaccine for COVID-19 face an even more urgent task in light of recent reports that the coronavirus has rebounded in Asia despite efforts to tamp it down. New cases of the disease have emerged in Wuhan, China, Singapore and Hong Kong in the past week, after governments lifted some of their social distancing controls. "That raises the stakes for scientists participating in an unparalleled global effort to develop a vaccine, including hundreds in the United States. More than 125 organizations — including major drug companies, government laboratories and top universities — are working on a vaccine or other treatments, according to leading researchers." Active biotech companies with recent developments include: Nascent Biotech, Inc. (OTCQB: NBIO), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Eli Lilly and Company (NYSE: LLY).

The LA Time article continued: "No response has ever gone this fast before," said Phyllis Arthur, vice president for infectious diseases and diagnostic policy at BIO, a trade association that represents drugmakers, biotech firms and others in the health industry. "We have gone from genetic sequencing to treatment possibilities within weeks. "Don't expect this to go away soon," said David Rakestraw, a chemical physicist who is helping lead the COVID-19 work underway at Lawrence Livermore National Laboratory. "The virus is in the population now, and it will evolve." In laboratories across the nation, researchers have mobilized like never before to tap new tools in the race for medicines that could treat and prevent the disease. The 125 organizations run the gamut from the world's largest pharmaceutical firms to obscure biotech start-ups, said Amy Finan, chief executive of the nonprofit Sabin Vaccine Institute. "Researchers are working across country lines," Finan said. "People are working morning, noon and night to come up with solutions."

Nascent Biotech, Inc. (OTCQB: NBIO) BREAKING NEWS: Nascent Biotech to Begin Animal Model Studies for Pritumumab Against Coronaviruses and COVID-19 - Nascent Biotech (the "Company" or "Nascent") today announced after receiving early In-Vitro study results Pritumumab, (PTB), will be advanced to laboratory-based animal studies. Nascent founder and Advisory Board Chairman Dr. Mark Glassy commented, "the laboratory results were consistent with our Brain Cancer invitro studies and this is the next step in investigational development of PTB as potential use with COVID-19 and related Viral Infections."

An article in The Journal of Biological Medicine (Yu et al. Journal of Biomedical Science (2016) 23:14 DOI 10.1186/s12929-016-0234-7) specifically mentioned cell surface vimentin as a potential target in the treatment of conditions related to the Coronavirus which was instrumental in Nascent's investigation into Viral Infections.

Nascent's Management is continuing development in Viral Infections along with opening the Phase I Brain Cancer Clinical Trial at Hoag Family Cancer Institute and Pickup Family Neurosciences Institute Presbyterian. Read this entire press release and more news for NBIO at: https://www.financialnewsmedia.com/news-nbio

Other industry developments from around the markets include:

Moderna, Inc. (NASDAQ: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that Stéphane Bancel, Chief Executive Officer, will participate virtually in the BMO 2020 Prescriptions for Success Healthcare Conference on June 23^rd at 3:00 p.m. ET.

A live webcast will be available under "Events and Presentations" in the Investors section of the Moderna website. A replay of the webcast will be archived on Moderna's website for 30 days following the presentation.

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

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."

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) the International Vaccine Institute (IVI), and Seoul National University Hospital recently announced a partnership to start a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine INO-4800 in South Korea at a signing ceremony today. In attendance at the ceremony at SNU Hospital were IVI's Director General Dr. Jerome Kim and Deputy Director General of Science Dr. Manki Song, Dr. Anh Wartel (Associate Director General of EPIC and Head of Clinical Development and Regulatory) and Dr. Daniel Chul Woo Rhee (Project Lead), and SNU Hospital's President Yon Su Kim and Prof. Myung Don Oh.

The 2-stage trial of INO-4800, the first clinical study of COVID-19 vaccine in Korea, will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.

Eli Lilly and Company (NYSE: LLY) recently announced that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo–controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Baricitinib, marketed as OLUMIANT®, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.

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