BOLT - Bolt Biotherapeutics reports iBDC-1001 data from mid-stage study in solid tumors

Bolt Biotherapeutics (NASDAQ:BOLT) announces interim clinical data from its Phase 1/2 study of BDC-1001, the company’s lead immune-stimulating antibody conjugate (ISAC) at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021. The company reported data from 57 subjects, across 16 different types of HER2-expressing solid tumors. BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. Early signs of clinical activity are noted in 13 of 40 tumor evaluable subjects with one durable partial response maintained through 52 weeks and multiple subjects achieving stable disease for >12 weeks. The pharmacokinetic (PK) data demonstrate increasing peak drug levels with increasing dose, and linearity of PK above the 5 mg/kg dose level. Clinical PK modeling predicts that target exposure levels can be achieved with weekly dosing. The data also support

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Bolt Biotherapeutics reports iBDC-1001 data from mid-stage study in solid tumors