FDA Accelerates Development of Novel Therapies for COVID-19

PALM BEACH, Florida, April 7, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration has taken an all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic. The new program is designed to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump's all-of-America approach is making progress and providing new hope in our fight against the coronavirus."   Mentioned in today's commentary include:  NanoViricides, Inc. (NYSE: NNVC), Moderna, Inc. (NASDAQ: MRNA), Gilead Sciences, Inc. (NASDAQ: GILD), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Dynavax Technologies Corporation (NASDAQ: DVAX).

Other recent industry reports show that drugs that impede the virus or treat COVID-19 complications, however, could make a difference, if they can reach patients quickly enough. "The problem is that the standard drug approval process is cautious by nature, designed to rule out major safety risks first before experimental drugs are used in trials large enough to prove a clinical benefit. With CTAP, the FDA is trying to streamline as many aspects of that process as it can.   Gilead Sciences' experimental antiviral remdesivir was one of the first to be sped into coronavirus patients, while the anti-inflammatory drugs Actemra from Roche and Kevzara from Sanofi have been authorized for experimental use in some coronavirus patients with respiratory distress.

NanoViricides, Inc. (NYSE American: NNVC) Breaking News:  U.S. Senator Richard Blumenthal Visited NanoViricides Inc. for Update on Coronavirus (COVID-19) Drug Development Efforts - NanoViricides (the "Company"), a leader in the development of highly effective antiviral drugs based on a novel, patented, nanomedicines platform, reports that U.S. Senator Richard Blumenthal visited the Company's facility in Shelton, Connecticut, on Tuesday, March 31, 2020.

The Honorable Senator Blumenthal visited the Company to receive an update regarding the coronavirus (COVID-19) drug development program and to tour the cGMP-capable manufacturing facility. The Senator, his staff, and members of the Press participated in a tour of the Company's lab and manufacturing facility.  Following the tour, the Senator held a press conference in front of the building.

"NanoViricides, Inc. must be given full and fair consideration for CARES funding because every approach that has strong potential for developing a treatment for COVID-19 must be supported immediately - it will save American lives. I am going to ask my staff in Washington, DC to do whatever we can to enable the Company to access such funding and I will do everything in my power to help NanoViricides get the attention and review they merit from BARDA, the FDA and other federal agencies," assured Senator Blumenthal.

Anil R. Diwan, PhD, President and Executive Chairman of the Company, welcomed the Senator and gave a brief overview of the Company's approach to coronavirus drug development to the Press. "We are developing what is effectively a 'Venus-Fly-Trap' for the virus particle. Just as a fly is attracted to a Venus-Fly-Trap flower, and then the flower closes onto it, our material attracts the virus particle, and then wraps around the virus particle thereby rendering the virus particle incapable of infecting cells," said Dr. Diwan, adding, "Our material, i.e., a nanoviricide, mimics the human cell surface receptors to attract the virus."

"The beauty of this technology is that, a virus would not be able to escape a nanoviricide by mutations or genomic changes, because no matter how much it changes, the mutated virus still lands on the same cellular receptor in the same fashion as its earlier version," elaborated Ms. Meeta R. Vyas, SB, MBA, the Chief Financial Officer of the Company.

"I co-authored the $8.3 Billion CARES act to support the development of drugs, diagnostics, vaccines, and other measures to combat COVID-19," said Senator Blumenthal, adding, "The drug development by NanoViricides deserves to be supported."  Read the full press release by going to:  http://www.nanoviricides.com/companynews.html 

In other biotech news in the markets this week: 

Moderna, Inc. (NASDAQ: MRNA) recently provided an update on the impact of the rapidly evolving COVID-19 pandemic on its business operations and clinical program development.  Moderna's paramount obligation is to ensure the safety of all participants in its clinical programs and the integrity of the studies in which they participate. Moderna is actively monitoring the situation and making adjustments where necessary, and is responding to regulatory, institutional, and government guidance and policies related to COVID-19. The Company is using a risk-based framework to evaluate new participant enrollment and new site initiation on a case-by-case basis. Moderna remains committed to its clinical development plans and is working closely with all stakeholders to try to mitigate the impact of the pandemic on the Company's ongoing clinical trials.

"The COVID-19 pandemic has created unprecedented challenges and we are committed to ensuring the health and safety of all participants in our and our partners' clinical trials, our clinical trial site teams, vendors and our employees. Moderna's primary focus is on the safety of all involved and the continued conduct of our clinical programs as we navigate the pandemic together," said Stéphane Bancel, Moderna's Chief Executive Officer. "We are also focused on responding to the pandemic through our work on our vaccine candidate against COVID-19, mRNA-1273. We are grateful to everyone both inside and outside Moderna who is working to address this public health crisis. We will get through this together."

Gilead Sciences, Inc. (NASDAQ: GILD) and Second Genome recently announced that the companies have entered into a four-year strategic collaboration to identify biomarkers associated with clinical response in up to five of Gilead's pipeline compounds in inflammation, fibrosis and other diseases, and to identify potential new targets and drug candidates for the treatment of inflammatory bowel disease (IBD).  Under the terms of the agreement, Second Genome will utilize its proprietary Microbiome Analytics Platform™ to identify novel biomarkers associated with clinical response to Gilead's investigational medicines. This work will harness the latest insights in microbiome science to help inform patient stratification and optimize potential treatments for patients in the future. The platform, in combination with additional discovery and development tools, will also seek to identify new targets and drug candidates relevant to IBD. This will include the identification of up to five novel IBD targets or drug candidates over the next four years, with an option to extend the collaboration for an additional two years.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced that the U.S. Food and Drug Administration has accepted the company's Investigational New Drug (IND) application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today.  Dr. J. Joseph Kim, INOVIO's President and CEO, said, "This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing. Our dedicated team of staff, partners and funders have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials."

Dynavax Technologies Corporation (NASDAQ: DVAX) recently provided a business update in relation to the impact of COVID-19 on the Company's operations.  "During the uncertainty caused by the COVID-19 pandemic, we have acted quickly to focus on four key areas," commented Ryan Spencer, Chief Executive Officer of Dynavax. "These include safeguarding the health and safety of our employees and customers; continuing effective operations to ensure patient access to HEPLISAV-B; maintaining our financial strength and stability; and supporting efforts to develop a COVID-19 vaccine. The Company's long-term value proposition remains unchanged, despite these short-term disruptions."

Mr. Spencer commented further: "This global health crisis reinforces the organization's commitment to our mission of developing vaccines to prevent infectious diseases.  We are hopeful that societal learnings from this pandemic will increase support for adult immunization and highlight the importance of providing rapid protection to our healthcare workers and others who may be exposed to deadly viral diseases that are preventable. The potential for all stakeholders - governments, policy makers, healthcare systems, and consumers - to understand the benefits of vaccines and prevention will have a significant long-term positive impact on public health and the cost of healthcare for everyone."

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