Shares of Moderna Inc. traded higher, setting a new 52-week high price, after the firm reported positive interim results in its Phase 1 study of mRNA Vaccine (mRNA-1273) against SARS-CoV-2.
By The Life Science Report – Source: Streetwise Reports 05/18/2020
Clinical-stage biotechnology company Moderna Inc. (MRNA:NASDAQ), which focuses on developing therapeutics and vaccines utilizing messenger RNA (mRNA), today announced “positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).”
The company stated that “mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies.”
The firm advised that “based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies.” The company mentioned that it believes that it will establish a dosage of between 25 µg and 100 µg in its Phases 3 study, which it anticipates will commence in July, subject to finalization of the clinical trial protocol.
The company’s Chief Medical Officer Tal Zaks, M.D., Ph.D., commented, “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg…When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Free Reports:
Moderna’s CEO Stéphane Bancel remarked, “With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA…We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
The company explained that “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 Vaccine Research Center (VRC) at the NIAID, a part of the NIH.”
The firm noted that to date, greater than 1,400 individuals have participated in its infectious disease vaccine clinical studies in the Australia, Europe and the U.S. The company added that it now has nine development candidates in its prophylactic vaccines modality including vaccines against respiratory infections, vaccines against infections transmitted from mother to baby and vaccines against highly prevalent viral infections. The firm indicated that so far it has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines and highlighted that its CMV vaccine is currently in a Phase 2 dose-confirmation study and that its investigational Zika vaccine (mRNA-1893), which is currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Moderna Inc. is a clinical stage biotechnology company headquartered in Cambridge, Mass., engaged in transformative medicines based on messenger ribonucleic acid (mRNA). The firm is pursuing mRNA science to minimize the undesirable activation of the immune system by mRNA and to maximize the potency of mRNA once in the target cells. The company has a diverse development pipeline of 24 programs with multiple clinical studies underway. Its therapeutics and vaccine development programs span infectious diseases, oncology, cardiovascular diseases and rare genetic diseases.
Moderna began the day with a market capitalization of around $24.8 billion with approximately 371.2 million shares outstanding and a short interest of about 6.00%. MRNA shares opened 29% higher today at $86.14 (+$19.45, +29.16%) over Friday’s $66.69 closing price and reached a new 52-week high price this morning of $87.00. The stock has traded today between $75.66 and $87.00 per share and is currently trading at $84.28 (+$17.59, +26.38%).
Sign up for our FREE newsletter at: www.streetwisereports.com/get-news
Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
( Companies Mentioned: MRNA:NASDAQ,
)