Vir Biotechnology to Provide Pipeline Update at 38th Annual J.P. Morgan Healthcare Conference
“In 2020, we plan to double the number of clinical programs in our pipeline and announce key data from our ongoing hepatitis B and influenza A programs,” said
Dr. Scangos will present new data from the company’s clinical programs and provide an update on anticipated milestones across Vir’s development pipeline, which includes two candidates for the functional cure of hepatitis B virus (HBV), a universal prophylaxis for influenza A, and a T cell vaccine for human immunodeficiency virus (HIV).
New data from the ongoing Phase 2 trial of VIR-2218, an HBV-targeting small interfering ribonucleic acid (siRNA) being developed for the functional cure of HBV, continue to show substantial reductions in HBV surface antigen (HBsAg) and that VIR-2218 continues to be generally well-tolerated.
- All HBeAg negative and positive patients who received two doses of 200 mg of VIR-2218 (n=6) achieved at least a 1.0 log10 decline in HBsAg. At Day 85, a mean decline of 1.5 log10 was observed in both HBeAg negative and positive patients.
- No alanine aminotransaminase (ALT) abnormalities greater than or equal to three times the upper limit of normal have been observed in any person treated with VIR-2218, including the 37 healthy volunteers given up to 900 mg of VIR-2218 and the 24 patients who received up to two doses of 200 mg of VIR-2218.
- Data through at least week 16 on all VIR-2218 dose cohorts are expected to be available in the first half of 2020.
The company anticipates that two new trials with VIR-2218 will start later this year, including a Phase 2 trial of VIR-2218 in
VIR-2482, a mAb antibody being developed as universal prophylaxis for influenza A, continues to progress in the clinic, with all four dose cohorts (60mg, 300 mg, 1200 mg, and 1800 mg) in healthy volunteers completed and regulatory approvals on track to commence Phase 2 dosing in the southern hemisphere in the second quarter of 2020.
The company continues to anticipate data from the first flu season of the trial to be available in the second half of 2020 and from the second flu season of the trial to be available in the first half of 2021.
VIR-1111, an HIV T cell vaccine based on human cytomegalovirus (HCMV), continues to be on track for an investigational new drug (IND) submission in the first half of 2020.
Presentation at 38th Annual
Vir will webcast its presentation from the conference tomorrow,
VIR-2218 is a subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. Currently in a Phase 1/2 clinical trial, VIR-2218 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. Initial data suggest that VIR-2218 is generally well-tolerated in healthy volunteers given as a single dose up to 900 mg and in patients with chronic HBV on nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) given VIR-2218 as two doses of 20 mg, 50 mg, 100 mg or 200 mg each dose. Initial data also demonstrate substantial reductions in HBsAg in patients at doses ranging from 20 mg to 200 mg. VIR-2218 is the first asset in the company’s collaboration with
VIR-3434 is a subcutaneously administered HBV-neutralizing mAb designed to block entry of all 10 genotypes of HBV into hepatocytes, to reduce the level of virions and subviral particles in the blood, and potentially function as a T cell vaccine against HBV in infected patients. It has also been engineered to have an extended half-life. Vir anticipates CTA approval for VIR-3434 in the first half of 2020 and anticipates clinical data from this trial to be available in the first half of 2021.
VIR-2482 is an intramuscularly administered influenza A-neutralizing mAb currently in a Phase 1/2 clinical trial. VIR-2482 is designed to act as a universal prophylaxis for influenza A. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season, which is typically five to six months long. Vir anticipates clinical data from the first flu season of the Phase 1/2 clinical trial to be available in the second half of 2020 and from the second flu season of this trial to be available in the first half of 2021.
VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV that has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response. VIR-1111 is designed to establish proof of concept in a Phase 1 clinical trial to determine whether the unique immune response observed in preclinical studies can be replicated in humans. Vir plans to submit an IND for VIR-1111 in the first half of 2020.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of program updates and data disclosures for Vir’s clinical trials and the anticipated timing of IND and CTA submissions and/or approvals for its product candidates, among others. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the
Vir Biotechnology, Inc.Investors Neera Ravindran, MD Head of Investor Relations & Strategic Communicationsnravindran@vir.bio +1-415-506-5256 Media Lindy DevereuxScient PR firstname.lastname@example.org +1-646-515-5730
Source: Vir Biotechnology, Inc.