EX-99.1 3 d887412dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Vir Biotechnology Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for Dual Masked T-Cell Engagers VIR-5818 in Solid Tumors and VIR-5500 in mCRPC Compelling early clinical response signals for VIR-5818 and VIR-5500 in heavily pretreated patients with various solid tumors VIR-5818: In patients receiving doses ≥400 µg/kg, tumor shrinkage observed in 50% (10/20) of participants with various HER2-expressing cancers; confirmed partial responses in 33% (2/6) of participants with HER2-positive CRC VIR-5500: PSA declines in 100% (12/12) and PSA50 response confirmed in 58% (7/12) of mCRPC patients with first step dose ≥120 µg/kg Promising safety profile with MTD not yet reached for VIR-5818 or VIR-5500 and no dose-limiting cytokine release syndrome (CRS) observed; no CRS greater than grade 2 reported Initial clinical data demonstrate PRO-XTEN™ masking technology may lead to minimal systemic unmasking and unlocks expanded therapeutic index ──────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────…
Open exhibit ↗Current Report · Items 7.01, 8.01, 9.01 · 8-K
Vir Biotechnology, Inc.
VIRNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure. As previously announced, Vir Biotechnology, Inc. (the “Company”) is holding a virtual investor event at 5:00 a.m. PT / 8:00 a.m. ET on January 8, 2025, to discuss initial data from Phase 1 clinical studies evaluating its dual masked T-cell engagers:…
Company context
VIR-5818, VIR-5500, VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN™ masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively. TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN™ masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.