by Chris Wack
Bolt Biotherapeutics Inc. said it saw positive interim clinical data from its phase 1/2 study of BDC-1001, an immune-stimulating antibody conjugate.
The data included 57 subjects with 16 different types of HER2-expressing solid tumors, the biotechnology company said.
Bolt stated that BDC-1001 exhibited a favorable safety and tolerability profile at all evaluated doses and schedules, with associated biomarker changes in the tumor microenvironment of tumor biopsies after treatment showing early signs of clinical activity. Yes, Bolt said.
Data showed new safety, pharmacokinetic/pharmacodynamic and efficacy results for the Phase 1 dose-escalation portion of the BDC-1001 monotherapy trial. Fifty-seven subjects were treated by increasing the dosage levels to 20 mg/kg every three weeks and 12 mg/kg every two weeks.
The company said the favorable safety profile of BDC-1001 allows for continued enrollment in the dose-escalating portion of the study, and the company’s sophisticated PK model based on data from more than 50 patients predicts that weekly administration of BDC-1001 will provide exposure. or above the target exposure limit. The data also support the initiation of combination therapy studies with the PD-1 inhibitor nivolumab.
Bolt’s shares rose 5% to $11 in premarket trading.
Write to Chris Wack at [email protected]