Bolt Biotherapeutics Says Phase 1 Data Supports Advancing Into Phase 2 Studies

Bolt Biotherapeutics Inc BOLT reported topline data from the dose-escalation study of BDC-1001 in HER2-expressing solid tumors that support advancing into two Phase 2 studies.
BDC-1001 was well tolerated at all dose levels and schedules evaluated, both as monotherapy and combined with Bristol Myers Squibb & Co BMY Opdivo (nivolumab).
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.
Anti-tumor activity was observed in the form of multiple partial responses (PRs), tumor shrinkage, and long-term stable disease at or near the RP2D across multiple HER2-expressing solid tumor types in monotherapy and combination with nivolumab.
Moreover, biomarker data demonstrate that corresponding clinical and safety data are related to the ISAC mechanism.
Bolt Biotherapeutics also entered into a clinical supply agreement with Roche Holdings AG RHHBY to evaluate pertuzumab (Perjeta) in combination with BDC-1001.
Price Action: BOLT shares are down 2.33% at $1.26 on the last check Thursday.