Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
· COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalisation or death due to COVID-19.
· COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.
George Scangos, Ph.D., Chief Executive Officer of Vir said: "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."
Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "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 Phase 3 portion of the COMET-ICE trial assessed the safety and efficacy of a single intravenous infusion of VIR-7831 (500 mg) or placebo in non-hospitalised participants globally, and this interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation for at least 24 hours or death within 29 days of randomisation. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. According to the Centers for Disease Control and Prevention these populations are approximately three times more likely to be hospitalised[1] and approximately two times more likely to die[2] of COVID-19.
VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralising antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.
Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.
VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any oth
Thu, 11th Mar 2021 07:00
RNS Number : 8877R
GlaxoSmithKline PLC
11 March 2021
Issued: 11 March 2021, London UK and San Francisco US - LSE announcement
Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19
· Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalisation or death.
· Vir and GSK plan to immediately seek Emergency Use Authorization in the US and authorisations in other countries.
· Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants.
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) 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 hospitalisation be stopped for enrolment due to evidence of profound efficacy.
The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.
Based on these results, Vir and GSK plan to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) and for authorisations in other countries. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.
The companies also announced 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 UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays. In contrast to 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.
In addition to COMET-ICE, the full COMET clinical development programme for VIR-7831 includes:
· COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity and pharmacokinetics between VIR-7831 manufactured by different processes.
· COMET-TAIL: A Phase 3 tr
GlaxoSmithKline PLC - GSK and Vir share positive VIR-7831 data in COVID #GSK @GSK https://www.**********.co.uk/rns/announcement/bdafe344-ff49-4aed-92d3-f1deefe950b9 #**********
Supply@ME Capital plc
(The "Company" or "SYME")
Restoration of Listing and Resumption of Trading
Following confirmation from the Financial Conduct Authority, received earlier today, the Company is pleased to announce the restoration of its Listing on the Standard List of The London Stock Exchange and the resumption of dealings in its Ordinary shares.
SYME also confirms that it will be issuing a Trading Update to the market before the end of this month.
Never again will I complain about the spread on a share! However this is a very handy warning sign - whatever you do, do not invest in this share!!!!!
BONKERS I TELL YOU!!!
SP starting to look a little perky https://media.giphy.com/media/EC5GJBGtBNpuM/giphy.gif
Look at the share trades list. If you sell now someone with more patience than you will happily buy your shares on the cheap (and possibly at a loss for you) and hold them for when this starts making big money. This isn't hugely volatile so sit on your hands and don't make a rash decision. Think about whether you need the money right away or can wait for it to go back up. If you do sell to chase an opportunity don't get caught in the cycle of rainbow chasing.
Those saying this is another KNB are rainbow chasers hoping for a quick buck - it's clear this is more stable and will rise with the drip of good news. Remember though with no news this will drift lower - that's just how things happen and with confidence and spare cash you can top up just like those with deep pockets and patience will do. Just think why they have deep pockets - they know how to make money.
This tweet isn't faked. checked it myself: https://twitter.com/JimPrice83/status/1366299499656851460
And it's a sea of blue buys. There was a very big buy of £500k soon after the bell this morning so there is big interest here.
Hold your nerve and watch this bounce!