PALM BEACH, Florida, April 22, 2020 /PRNewswire/ -- Scientists around the world are trying to go where no man has gone before… to develop a vaccine in less than 12-18 months… much less. The pressure is great but the collaborations unprecedented. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said in a Live Science article, that a COVID-19 vaccine could take 12 to 18 months to develop, test and approve for public use. But new vaccines typically take years to earn approval — can we really expect a coronavirus vaccine to be ready by summer 2021? In the article, experts told Live Science that: "… for any other vaccine, the timeline would be unrealistic. But given the current pressure to stave off the pandemic, a COVID-19 vaccine could be ready sooner, as long as scientists and regulatory agencies prove willing to take a few shortcuts. More than 60 candidate vaccines are now in development, worldwide, and several have entered early clinical trials in human volunteers, according to the WHO… Despite the many challenges ahead, certain shortcuts could allow scientists to bring a COVID-19 vaccine faster than anticipated." Active biotech companies with recent developments include: Nascent Biotech, Inc. (OTCQB: NBIO), NanoViricides, Inc. (NYSE: NNVC), Aytu BioScience, Inc. (NASDAQ: AYTU), Vaxart, Inc. (NASDAQ: VXRT), Moderna, Inc. (NASDAQ: MRNA).
The article continued: "First, partnering with the U.S. Food and Drug Administration and other regulatory bodies can help scientists leap the logistical hurdles associated with clinical trials, such as recruiting healthy volunteers, Andino-Pavlovsky, a professor in the Department of Microbiology and Immunology at the University of California, San Francisco, said. "It can save six months, doing that". "If you get neutralizing antibodies," which latch onto specific structures on the virus and neutralize it, "I think you can keep moving forward on it," said Bert Jacobs a professor of virology at Arizona State University and member of the ASU Biodesign Institute's Center for Immunotherapy, Vaccines and Virotherapy, Normally, a vaccine would then enter Phase 3 clinical trials, which include hundreds to thousands of people."
Nascent Biotech, Inc. (OTCQB: NBIO) BREAKING NEWS: Nascent Biotech Provides Shareholder Update on COVID-19 Therapy and Brain Cancer Trials - Nascent Biotech (the "Company" or "Nascent"), a leading biotechnology company developing proprietary human Monoclonal Antibodies (mAbs) and immunotherapy for treatment of cancer, is pleased to present its corporate update and a dynamic strategic plan, which the company has begun executing in 2020.
The Company has initiated tests to assess the possibility that its lead asset, the monoclonal antibody Pritumumab (PTB) could be used as a potential therapy against the novel coronavirus, or SARS-CoV-2, which has caused a global pandemic (COVID-19). As specifically mentioned in a 2016 article in The Journal of Biological Medicine (Yu et al. Journal of Biomedical Science (2016) 23:14 DOI 10.1186/s12929-016-0234-7), cell-surface vimentin (recognized by PTB), is implicated in the entry of SARS-CoV-2, into the cells it infects. The Company has engaged independent third party consultants to conduct the tests and initial results are forthcoming.
The Company's strategic plans reveal that Nascent is also moving rapidly to human brain cancer trials with its PTB antibody. Nascent is currently finalizing the human brain cancer trial's timeline, which includes the selection of a Contract Research Organization (CRO) to manage the clinical trials. The search for a CRO, while considered and methodical, should be completed in the coming weeks. Completion of this task is indicative of the assertive approach Nascent is taking as it implements its plans and it is a significant step forward for the Company as its management team is excited about the momentum of opening the human trials.
As Nascent broadens operations, it is expanding its outreach to marketing and industry experts which will include expanding the Company's corporate assets. Nascent is currently exploring opportunities for strategic acquisition and tactical partnerships through an array of business relationships.
Sean Carrick, CEO of Nascent Biotech states, "Our strategic plan is based on the robust science of our antibody, PTB, and the strength, skill and talent of our seasoned clinical team. We look forward to Nascent meeting many key milestones in 2020 and with additional corporate outreach and development, we aspire to generate the best potential return for our shareholders."
Other industry developments from around the markets include:
NanoViricides, Inc. (NYSE: NNVC) a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that it will provide an update of its drug development programs for the treatment of Shingles and for COVID-19 when it presents an overview of the Company at the Planet MicroCap Showcase 2020 tomorrow, Wednesday, April 22 at 6:40 PM EST. Anil R. Diwan, PhD, President and Executive Chairman of the Company, will be presenting and answering questions from investors. To access the live presentation, please use the following information found here: https://finance.yahoo.com/news/nanoviricides-present-covid-19-shingles-180000644.html
Aytu BioScience, Inc. (NASDAQ: AYTU) recently announced the acceptance and publication of the Natesto® Spermatogenesis Study results into the Journal of Urology earlier this week.
The Phase IV single institution, prospective, clinical trial was conducted between November 2017 and September 2019 at the University of Miami's Department of Urology by lead author and the study's principal investigator Dr. Ranjith Ramasamy, MD, the Director of Reproductive Urology. The study concluded that Natesto was effective in returning hypogonadal men to back to normal testosterone levels, significantly improve erectile function and quality of life, preserve gonadotropin hormones, and most importantly preserve semen parameters through 6 months of treatment.
Vaxart, Inc. (NASDAQ: VXRT) recently announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose.
"These early pre-clinical results are in line with those for our oral influenza vaccine which was protective in a clinical Phase 2 efficacy study," said Sean Tucker, Ph.D., chief scientific officer of Vaxart. "Additional data will inform us on which candidate we will move forward into clinical trials. We are particularly interested in vaccine candidates that can generate mucosal immune responses in addition to serum antibody responses. That is a key feature of our oral vaccines and potentially significant for protection against SARS CoV-2, the virus that causes COVID-19."
Moderna, Inc. (NASDAQ: MRNA) recently announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate development of the Company's mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
"We are thankful for BARDA's support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2," said Stéphane Bancel, Moderna's Chief Executive Officer. "Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic."
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