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.
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