- Bolt Biotherapeutics Inc BOLT announced the presentation of interim clinical data from its Phase 1/2 study of BDC-1001.
- BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist.
- The data were shared 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 showed a favorable safety and tolerability profile with mild infusion-related reactions in some patients and no dose-limiting toxicities at dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks.
- There was no indication of cytokine release syndrome, and a maximum tolerated dose has not been reached.
- 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 over 12 weeks.
- Related Link: Innovent Biologics, Bolt Join Forces To Develop Anti-Cancer Candidates.
- Price Action: BOLT shares are down 14.3% at $9 premarket on the last check Monday.
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