beludavimab (VIR-7832) / GSK, Vir Biotech, Biogen, WuXi AppTec - LARVOL DELTA

AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - P1/2 | N=600 | Active, not recruiting | Sponsor: University of Liverpool | Trial completion date: Apr 2024 ➔ Jul 2025 | Trial primary completion date: Dec 2023 ➔ Jul 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Randomized, Adaptive Phase I Study to Determine the Phase II Dose of VIR-7832: AGILE CST5 (CROI 2024) - P1/2 | "VIR-7832 is a novel mAb derived from the same parental antibody as sotrovimab with addition of an Fc domain XX2 modification to enhance effector function and modulate immune response. This is the first report of the safety, tolerability and viral outcomes for VIR-7832, a novel mAb for treating SARS-CoV-2. These data suggest VIR-7832 is safe and well tolerated at doses up to 500mg. SARS-CoV-2 PCR data are presented for each cohort; however, these data are limited by the small number of participants."

Clinical • P1 data • P2 data • Dermatology • Hematological Disorders • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - P1/2 | N=600 | Active, not recruiting | Sponsor: University of Liverpool | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Comparative Binding Ability of Human Monoclonal Antibodies against Omicron Variants of SARS-CoV-2: An In Silico Investigation. (PubMed, Antibodies (Basel)) - "Furthermore, the cDNA of chimeric mAb was cloned in silico within pET30ax for recombinant production. In conclusion, the present study represents the candidature of human mAbs (beludavimab and adintrevimab) and the therapeutic potential of designed chimeric mAb for treating Omicron-infected patients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - P1/2 | N=600 | Recruiting | Sponsor: University of Liverpool | Trial completion date: Apr 2022 ➔ Apr 2024 | Trial primary completion date: Nov 2021 ➔ Nov 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "The European Medicines Agency’s (EMA) CHMP is conducting a rolling review of data on sotrovimab to support a forthcoming marketing authorization application (MAA). The rolling review process is expected to be complete in the fourth quarter of 2021...The Company and GSK now plan to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2022...The United Kingdom’s National Health Service-supported AGILE initiative evaluating VIR-7832 in a Phase 1b/2a trial of adults with mild-to-moderate COVID-19 remains ongoing. To date, no safety signals have been reported for either the 50mg or 150mg dose cohorts. Additional data are expected in the first half of 2022...the FDA cleared the investigational new drug (IND) application for VIR-7832."

BLA • European regulatory • P1/2 data • Infectious Disease • Novel Coronavirus Disease

XENCOR INC Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) (Market Screener) - "We are eligible to receive a mid-single digit percentage royalty on the net sales of both sotrovimab and VIR-7832...The COVID-19 pandemic has not adversely affected our revenues for The quarter ended September 30, 2021. During this quarter, for example, we generated approximately $19.7 million in revenue...recognizing $6.3 million, $6.3 million, and $5.8 million of revenue...We earned $6.3 million and $7.2 million in royalties from Vir for the three and nine months ended September 30, 2021, respectively." "

Commercial • Infectious Disease • Novel Coronavirus Disease

Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2021 Financial Results (GlobeNewswire) - "During and after the quarter, sotrovimab was authorized for emergency use in...Qatar, Singapore...In April, the first patient was dosed in the United Kingdom National Health Service-supported AGILE initiative....Initial safety data are expected in the second half of 2021....In July, the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for VIR-7832....European Medicines Agency’s (EMA) CHMP initiated a rolling review of data on sotrovimab...The rolling review process is expected to be complete in the second half of 2021....The Phase 2 COMET-PEAK...Enrollment is complete and initial data are expected in the fall of 2021....The Phase 3 COMET-TAIL...Data are now expected in the second half of 2021."

European regulatory • Non-US regulatory • P1/2 data • P2 data • P3 data • Infectious Disease • Novel Coronavirus Disease

Xencor Reports Second Quarter 2021 Financial Results (Businesswire) - "VIR-7832, a second antibody licensed to Vir, which targets the SARS-CoV-2 virus in addition to incorporating Xtend technology and other XmAb Fc technologies, is currently enrolling patients to a Phase 1b/2a study."

Trial status • Infectious Disease • Novel Coronavirus Disease

VIR-7832: Data from AGILE trial (NCT04746183) for COVID-19 in H2 2021 (Vir Biotech) - EASL ILC 2021

P1 data • Novel Coronavirus Disease

Emerging antibody-based therapeutics against SARS-CoV-2 during the global pandemic. (PubMed, Antib Ther) - "As of 11 October 2020, 13 human monoclonal antibodies targeting the SARS-CoV-2 spike protein have entered clinical trials with three (REGN-COV2, LY3819253/LY-CoV555, and VIR-7831/VIR-7832) in phase 3...A cocktail strategy such as REGN-COV2, or engineered multivalent and multispecific molecules, combining two or more antibodies might improve the efficacy and protect against resistance due to virus escape mutants. Besides the receptor-binding domain, other viral antigens such as the S2 subunit of the spike protein and the viral attachment sites such as heparan sulfate proteoglycans that are on the host cells are worth investigating."

Clinical • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

First patient dosed in latest stage of AGILE COVID-19 drug trial (Mirage News) - "The University of Liverpool, Liverpool School of Tropical Medicine, and the NIHR Southampton Clinical Trials Unit at the University of Southampton have announced the first ever patient dosed in the latest trial of potential new COVID-19 treatments as part of the UK’s COVID-19 drug testing platform, AGILE....The latest candidate to be tested, VIR-7832, will be given to patients who have tested positive for COVID-19 and have mild to moderate symptoms....The AGILE study marks the first in-human phase 1 trial of VIR-7832, which aims to establish an optimal dose. When established, the trial will seamlessly move into a second phase with another monoclonal antibody (VIR-7831)..."

Trial status • Infectious Disease • Novel Coronavirus Disease

AGILE (Early Phase Platform Trial for COVID-19) (clinicaltrials.gov) - P1/2; N=600; Recruiting; Sponsor: University of Liverpool; N=200 ➔ 600; Trial completion date: Dec 2021 ➔ Apr 2022; Trial primary completion date: Jun 2021 ➔ Nov 2021

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Second COVID-19 Antibody from Vir, GSK Enters Phase 1b Trial - "'We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 for the treatment and potential prevention of COVID-19,' George Scangos, PhD...said in the announcement. 'This study will be critical to our efforts as we work to understand whether the modifications we have made to this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis,' Scangos continued."

Media quote

"@Vir_Biotech y @GSK anuncian el estudio AGILE respaldado por el #NHS de #ReinoUnido para evaluar VIR-7832 como tratamiento #COVID19 en fases tempranas #salud #PiscisComunicacion @alsoldelacosta @cuquita1982" (@Acedotor)

Infectious Disease • Novel Coronavirus Disease

GSK and Vir Biotechnology to initiate NHS-backed Covid-19 trial - "...George Scangos said: 'We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 for the treatment and potential prevention of Covid-19. 'This study will be critical to our efforts as we work to understand whether the modifications we have made to this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis.'"

Media quote

Vir Biotechnology and GSK announce NHS-supported AGILE study to evaluate VIR-7832 in the early treatment of COVID-19 (GSK Press Release) - "Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial....The AGILE trial platform, which will be the first to test VIR-7832 in humans...The trial is due to begin in the first quarter of 2021....A total of 24 study participants will be randomised 3:1 to VIR-7832 or placebo."

Licensing / partnership • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19 (GlobeNewswire) - "Patient enrollment underway; Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the global expansion to Phase 3 of the COMET-ICE....COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe....Interim analyses are planned to evaluate safety, futility and efficacy, the results of which may be available as early as the end of 2020. Results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021....The companies also expect to start a Phase 1b/2a trial in the second half of 2020 evaluating VIR-7832..."

Enrollment status • New P1/2 trial • P3 data: top line • Infectious Disease • Novel Coronavirus Disease

Vir Biotechnology and GSK Start Phase 2/3 Study of COVID-19 Antibody Treatment (GlobeNewswire) - "Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced that the first patient was dosed last week in a Phase 2/3 study with VIR-7831....Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021....The first part (the Lead-In phase) will serve as the first-in-human assessment....Following this initial safety assessment, the second part (the Expansion phase) will progress with the aim of reducing the need for hospitalization....Later this year, the companies expect to start a Phase 2 trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832..."

New P2 trial • P2/3 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Vir Biotechnology proceeding with two clinical development candidates for COVID-19 (GlobeNewswire, Vir Biotechnology, Inc.) - “Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19…In an effort to save time, Vir’s lead development candidate was transferred at-risk to WuXi Biologics (stock code: 2269.HK) and Biogen Inc. (Nasdaq: BIIB) several weeks ago, and Vir anticipates that human trials can begin within 3-5 months.”

Clinical • New trial