Coronavirus / Biotechnology Stock News Bites: Moderna (NASDAQ: $MRNA) Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
CAMBRIDGE - March 16, 2020 (Investorideas.com Newswire) Coronavirus / Biotechnology (COVID-19) Stock News Bites - MassModerna, 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, today 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).
The Phase 1 study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
“This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus. On January 13, 2020 the VRC and Moderna's infectious disease research team finalized the sequence for the SARS-CoV-2 vaccine and Moderna mobilized toward clinical manufacture. The first clinical batch was completed on February 7, 2020 and underwent analytical testing; it was shipped on February 24, 2020 from Moderna and delivered to NIH from the Company's manufacturing facility in 42 days from sequence selection.
Next Steps for mRNA-1273
The Company is actively preparing for a potential Phase 2 study under its own IND to build on data from the ongoing Phase 1 study being conducted by the NIH. In order to continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organizations to be ready for a Phase 2 and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data. Manufacture of the mRNA-1273 material for the potential Phase 2 trial, which could begin in a few months, is underway. Moderna continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.
Read the company's full news and disclaimer here:
Visit Investorideas.com biotech and coronavirus stocks directory https://www.investorideas.com/BIS/stock_list.asp
About Investorideas.com - News that Inspires Big Investing Ideas Investorideas.com is a recognized news source publishing third party news, research and original financial content. Learn about investing in stocks and sector trends with our news alerts, articles, podcasts and videos, looking at cannabis, crypto, AI and IoT, mining, sports biotech, water, renewable energy and more. Investor Idea's original branded content includes the following podcasts and columns : Crypto Corner , Play by Play sports and stock news column, Investor Ideas Potcasts Cannabis News and Stocks on the Move podcast and column, Cleantech and Climate Change , Exploring Mining the AI Eye .
Stock Bites is a branded product of Investorideas.com Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. This stock bites news release publication is available as a paid for service on Investorideas.com https://www.investorideas.com/News-Upload/
More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com
Follow us on Twitter https://twitter.com/Investorideas
Follow us on Facebook https://www.facebook.com/Investorideas
Follow us on YouTube https://www.youtube.com/c/Investorideas
Download our Mobile App for iPhone and Android
Get free investor news alerts
Join our Investor Club https://www.investorideas.com/membership/
800 665 0411