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Vir Biotechnology Announces Initiation of Phase 2 Clinical Trial Evaluating VIR-2218, Selgantolimod and Nivolumab for the Treatment of Chronic Hepatitis B Virus Infection
December 09, 2021 08:30 ET | Source: Vir Biotechnology, Inc.
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– Trial to evaluate antigen suppression combined with immunomodulation as a functional cure regimen for chronic HBV –
SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating novel therapeutic combinations for the treatment of chronic hepatitis B virus (HBV) infection. The multi-arm trial, which is being conducted in collaboration with Gilead Sciences, Inc., is assessing various combinations of VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi); selgantolimod (GS-9688), Gilead Sciences’ investigational TLR-8 agonist; and nivolumab, an approved PD-1 inhibitor, in both nucleos(t)ide (NUC)-suppressed patients and viremic patients. Patients with HBV treatment experience also may receive tenofovir alafenamide fumarate (TAF).
“For the majority of patients with chronic HBV, a functional cure will likely require a sustained reduction in hepatitis B surface antigen and restoration of the immune response,” said Carey Hwang, MD, PhD, senior vice president, clinical research, head of chronic infection for Vir Biotechnology. “We believe the combination of VIR-2218 and two immunomodulatory agents has the potential to improve the HBV-specific immune response and possibly achieve a functional cure. With the initiation of this trial, Vir now has four ongoing HBV trials evaluating VIR-2218, the foundation of our combination approaches, with other immunomodulatory agents as part of our ongoing pursuit of a functional cure.”
The multi-center, open-label Phase 2 clinical trial is designed to evaluate the safety, tolerability and efficacy of various combinations of VIR-2218, selgantolimod, nivolumab and TAF in adults with chronic HBV. The trial will enroll approximately 120 patients ages 18 to 65 who are either viremic or are virally suppressed on an approved HBV nucleos(t)ide reverse transcriptase inhibitor. Patients who are hepatitis B e antigen (HBeAg)-positive (an indicator of acute viral replication), as well as those who are HBeAg-negative, will be enrolled. The primary efficacy endpoint is the proportion of patients who achieve a functional cure (defined as HBsAg loss and HBV DNA <20 IU/mL at follow-up week 24).
Vir and Gilead retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial. The safety and efficacy of VIR-2218 and selgantolimod have not been established. They are investigational compounds, and not approved by the US Food and Drug Administration (FDA) or any other regulatory authority.
About Vir’s Broad Clinical Program for the Functional Cure of Chronic HBV Infection
Vir’s broad clinical development program for the functional cure of chronic HBV infection aims to develop effective therapies that lead to a functional cure. Ongoing trials include:
Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, an investigational HBV-neutralizing monoclonal antibody that has been Fc engineered to include the XX2 “vaccinal mutation,” enabling it to potentially function as a T cell vaccine
Phase 2 trial of VIR-2218 in combination with pegylated interferon-alfa (PEG-IFN-α)
Phase 2 trial of VIR-2218 in combination with Brii Biosciences’ BRII-179 (VBI-2601), an investigational T cell vaccine (led by Brii Biosciences)
Phase 2 trial of VIR-2218 in combination with selgantolimod, nivolumab and/or TAF
Phase 1 trial of VIR-3434 monotherapy
About VIR-2218
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV in infected patients, as well as to have an extended half-life.
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发表于 2021-12-10 13:12
