Vir Shares Head Higher as Phase 3 COVID-19 Trial with GSK Achieves 85% Reduction in Hospitalization and Death
Source: Streetwise Reports
March 12, 2021 (Investorideas.com Newswire) Vir Biotechnology shares traded 30% higher after the company together with its development partner GlaxoSmithKline reported that in the Phase 3 COMET-ICE trial VIR-7831 was shown to reduce hospitalization and risk of death in early treatment of adults with SARS-CoV-2.
Clinical-stage immunology firm Vir Biotechnology Inc. (VIR:NASDAQ) and global pharmaceutical and vaccine development company GlaxoSmithKline Plc. (GSK:NYSE; GSK:LSE), today announced that an "Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy."
The firms advised that the IDMC's instruction was predicated upon data from 583 patients in the Phase 3 COMET-ICE trial who demonstrated an 85% reduction in hospitalization or death after receiving VIR-7831 as monotherapy versus placebo. The company noted that the study is still ongoing with patients being followed for 24 weeks.
Based on the results from the interim report, Vir and GSK advised that "they plan to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) and for authorizations in other countries." The companies mentioned that they also intend to utilize the data from the COMET-ICE trial as a basis in their presentation to the FDA for a Biologics License Application (BLA) submission.
The firms also reported today "the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the U.K., South African and Brazilian variants, based on in vitro data from pseudotyped virus assays." The company commented that compared with other monoclonal antibodies, "VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop."
Vir Biotechnology's CEO George Scangos, Ph.D., commented, "These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics. These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus."
GlaxoSmithKline's Chief Scientific Officer and President of R&D Hal Barron added, "We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings."
The company stated that "VIR-7831 and VIR-7832 are both investigational dual-action SARS-CoV-2 monoclonal antibodies and that preclinical data suggest the each have the potential to both block viral entry into healthy cells and clear infected cells."
The report indicated that in April 2020, Vir and GSK began collaborating on research and development of treatments for coronaviruses. The joint efforts employ Vir's monoclonal antibody platform technology to identify and accelerate new or existing anti-viral antibodies that might be able to be used therapeutically or preventively to address the COVID-19 pandemic as well as for future potential outbreaks. The companies stated that GSK will bring its expertise in functional genomics, vaccine research and other technical capabilities to identify anti-coronavirus compounds that target cellular host genes.
In addition to its work with Vir, GSK is also working with CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 which will also strive to add protections against multiple emerging variants. GSK also has agreed to assist in manufacturing up to 100 million doses of CureVac's first generation COVID-19 vaccine assuming it receives regulatory approval.
Vir Biotechnology is headquartered in San Francisco and is a clinical-stage immunology company focused on treating and preventing serious infectious diseases. The company noted that it has developed four technology platforms created to stimulate and enhance the immune system and identify and observe natural immune processes. The company stated that its product pipeline candidates are being developed to target hepatitis B (HBV), human immunodeficiency virus (HIV), influenza A, SARS-CoV-2 and tuberculosis (TB).
GSK is based in London and is a leading global healthcare company with a market cap of approximated US$90 billion that focuses on the development and marketing of vaccines and pharmaceuticals. The company is presently highly focused on COVID-19 related treatments and vaccines and is involved in numerous other areas of research including respiratory diseases, HIV and infectious diseases, vaccines, immuno-inflammation, oncology and rare diseases. GSK's pharmaceutical portfolio includes hundreds of medicines with more than 40 more currently in development along with 17 separate new vaccine candidates in its pipeline.
Vir Biotech started off the day with a market capitalization of around $6.0 billion with approximately 127.8 million shares outstanding and a short interest of about 6.3%. VIR shares opened around 44.5% higher today at $67.69 (+$20.87, +44.57%) over yesterday's $46.82 closing price. The stock has traded today between $55.00 and $68.20 per share and is currently trading at $61.35 (+$14.53, +31.03%).
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.
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 decision to publish an article until three business days after the publication of the 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.
This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders
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.
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