Bolt Biotherapeutics reports interim Phase 1/2 BDC-1001 data: safe, 1 durable PR at 52 weeks, no CRS

Bolt Biotherapeutics, Inc.

BDC-1001 showed favorable safety in 57 patients; no dose-limiting toxicities up to 20 mg/kg Q3W and 12 mg/kg Q2W.
One durable partial response maintained through 52 weeks; multiple patients with stable disease >12 weeks in 40 evaluable subjects.
No cytokine release syndrome (CRS) observed; maximum tolerated dose not yet reached.
Plasma/tissue biomarkers confirm TLR7/8 activation and myeloid cell infiltration consistent with mechanism of action.
Company plans to continue monotherapy dose escalation, evaluate weekly dosing, and initiate combination with nivolumab by year-end 2021.

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