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Bolt Biotherapeutics Studying BDC-1001 With Genentech's Perjeta in HER2-Positive Breast Cancer

NEW YORK – Bolt Biotherapeutics said on Tuesday that it has treated the first HER2-positive breast cancer patient in its Phase II trial of BDC-1001 with or without Genentech's Perjeta (pertuzumab).

In the 66-patient Phase II trial, Redwood City, California-based Bolt is studying BDC-1001, a type of immune-stimulating antibody conjugate it calls a Boltbody, either alone or in combination with Perjeta, as treatment for HER2-positive advanced breast cancer. To partake in the trial, patients must have previously received AstraZeneca and Daiichi Sankyo's antibody-drug conjugate Enhertu (trastuzumab deruxtecan).

According to Bolt, BDC-1001 has a unique mechanism of action compared to other available agents, and preclinical research has suggested an additional advantage when combining the agent with the HER2-targeted monoclonal antibody Perjeta. The new Phase II study is the firm's first opportunity to test this combination in the clinic.

In addition to the new breast cancer study, Bolt is studying BDC-1001 with Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) in a basket trial involving patients with HER2-positive colorectal, endometrial, and gastroesophageal cancers.