VIR-1111 / Vir Biotech, Oregon Health & Science University - LARVOL DELTA

Phase 1 first-in-human study of VIR-1111, a prototype CMV-HIV vaccine vector (AIDS 2024) - P1, P1a | "BACKGROUND: Despite progress increasing antiretroviral treatment and PrEP utilization, HIV transmission persists globally. VIR-1111 was generally safe and well-tolerated in healthy participants. While VIR-1111 did not elicit sustained Gag-specific immune responses, a gene signature associated with vaccine responses was identified in 5/20 participants. This study provides foundational safety data supporting further CMV-HIV vaccine development."

P1 data • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease

Vir Biotechnology Receives Expanded Support to Develop Its Novel T Cell Vaccine Platform with New $10 Million Grant for HIV Prevention (GlobeNewswire) - "Vir Biotechnology, Inc...announced that it received a new $10 million grant from the Bill & Melinda Gates Foundation to support Vir’s novel T cell vaccine development program. The new grant will support the Phase 1 clinical development of VIR-1388, an investigational novel T cell vaccine for the prevention of human immunodeficiency virus (HIV)...Through close scientific partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN), the Phase 1 trial of VIR-1388 (HVTN 142) is expected to begin in the second half of 2023. The trial will also be funded in part by NIAID, part of the National Institutes of Health, through grant funding to HVTN. NIAID has provided funding throughout the product development lifecycle of VIR-1388....The Company expects safety and immunology data from the highest dose cohort 3 in the proof-of-concept Phase 1 trial of VIR-1111 in the first half of 2023."

Clinical • Licensing / partnership • P1 data • Human Immunodeficiency Virus • Infectious Disease

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers (clinicaltrials.gov) - P1a | N=27 | Completed | Sponsor: Vir Biotechnology, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Dec 2022

Trial completion • Trial completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease • CCR7 • CD27 • CD40LG • CD8 • FAS • IFNG • IL2 • TNFA

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers (clinicaltrials.gov) - P1a | N=26 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Immunology • Infectious Disease • CCR7 • CD27 • CD40LG • CD8 • FAS • IFNG • IL2 • TNFA

Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "The Company is conducting a proof-of-concept Phase 1 trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV), to evaluate whether this new approach can elicit potentially protective immune responses that differ from other HIV vaccines. Initial clinical data from the first cohort are expected in the fourth quarter of 2021."

P1 data • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease

Vir Biotechnology Provides Corporate Update and Reports First Quarter 2021 Financial Results (GlobeNewswire) - "...the Company initiated a Phase 1 clinical trial of VIR-1111, an investigational HIV T cell vaccine based on human cytomegalovirus (HCMV)...Initial clinical data are anticipated in the second half of 2021."

P1 data • Trial status • Cytomegalovirus Infection • Human Immunodeficiency Virus • Infectious Disease

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers (clinicaltrials.gov) - P1a; N=26; Recruiting; Sponsor: Vir Biotechnology, Inc.

Clinical • New P1 trial • Human Immunodeficiency Virus • Immunology • Infectious Disease • CCR7 • CD27 • CD40LG • FAS • GZMB • IFNG • IL17A • IL2 • PCR • TNFA

Vir Biotechnology Announces Initiation of Phase 1 Clinical Trial to Evaluate a Novel Vaccine Platform (PipelineReview) - "Vir Biotechnology, Inc....announced that the first patient was dosed in late December 2020 in a Phase 1 clinical trial of VIR-1111, an investigational human immunodeficiency virus (HIV) T cell vaccine....The trial is enrolling healthy adults (ages 18 to 50) who are considered to be at low risk of HIV infection and who were previously infected with human cytomegalovirus (HCMV)."

Trial status • Human Immunodeficiency Virus • Infectious Disease

Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2020 Financial Results (Streetinsider.com) - "The Company expects to initiate a Phase 1 clinical trial for VIR-1111, an HIV T cell vaccine...in the fourth quarter of this year. This trial is designed to determine whether VIR-1111 elicits a specific type of T cell immune response to HIV, known as an HLA-E restricted immune response....Research and development expenses were $70.7 million for the quarter ended September 30, 2020, which includes $4.2 million of non-cash stock-based compensation expense...The increase for the quarter was primarily due to...clinical costs due to activities related to...VIR-1111."

Commercial • New P1 trial • Human Immunodeficiency Virus

Vir Biotechnology Provides Corporate Update and Reports Second Quarter 2020 Financial Results (GlobeNewswire) - "In the second half of the year, the Company expects to start a Phase 1 clinical trial for VIR-1111, an HIV T cell vaccine based on human cytomegalovirus. This trial is designed to determine whether VIR-1111 elicits a specific type of T cell immune response to HIV, known as an HLA-E restricted immune response....Research and development expenses were $79.7 million for the quarter ended June 30, 2020...The increase for the quarter was primarily due to...clinical trial startup activities related to...VIR-1111."

Clinical • New P1 trial • Human Immunodeficiency Virus