Business
Bolt Biotherapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
Comprehensive BDC-1001 clinical safety and efficacy data as a single agent and in combination with nivolumab, including RP2D, to be presented at ASCO
About this update from Bolt Biotherapeutics, Inc.
[{"type":"text","content":"Comprehensive BDC-1001 clinical safety and efficacy data as a single agent and in combination with nivolumab, including RP2D, to be presented at ASCO 2023BDC-1001 Phase 2 program expected to initiate in 2023 in HER2+ colorectal, endometrial, gastroesophageal, and breast cancerCash balance of $171.0 million anticipated to fund key clinical milestones through 2025 REDWOOD CITY, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2023 and provided a business update. “We are pleased to be advancing our lead Boltbody™ ISAC, BDC-1001, into a broader Phase 2 program in four different HER2-positive solid tumor types, following the recent positive topline results from our Phase 1 dose-escalation trial. We are looking forward to presenting a comprehensive dataset at ASCO from this first-in-human study, in which BDC-1001 achieved target drug exposure levels, was well tolerated from a safety perspective and demonstrated objective clinical responses and long-term durability both as a single agent and in combination with nivolumab,” said Randall Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. “As we prepare for Phase 2 studies in the U.S. and internationally, we look forward to investigating the benefits of BDC-1001 and our novel ISAC mechanism to aid HER2-positive cancer patients who are not benefitting from current therapeutic options. Additionally, the Bolt team is excited to be advancing our next program, BDC-3042, a proprietary Dectin-2 agonist antibody, into the clinic later this year.” Recent Highlights and Anticipated Milestones Topline BDC-1001 Phase 1 dose-escalation clinical data unveiled from a multi-center, multi-dose clinical trial in more than 100 patients. The data demonstrated BDC-1001 was well-tolerated at all dose levels and schedules. BDC-1001 achieved objective clinical responses as a monotherapy and in combination with the PD-1 inhibitor nivolumab across a diverse range of solid tumor types. Target drug exposure levels were achieved at or near the recommended Phase 2 dose (RP2D) by more frequent administration including every other week (q2w) and weekly (q1w) administration schedules. Comprehensive...