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%).[NLINSERT]
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