On September 8, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) to investigate Bolt Biotherapeutics’ BDC-1001 in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab) (Press release, Bolt Biotherapeutics, SEP 8, 2021, View Source [SID1234618695]). BDC-1001 is a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors .

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"We look forward to working with BMS in our continued development of BDC-1001, which has shown promising results in preclinical and early clinical studies," said Randall Schatzman, CEO of Bolt Biotherapeutics. "Our unique ISAC approach initiates an innate and an adaptive immune response that may be synergistic with BMS’ innovative PD-1 inhibitor Opdivo. The combination of BDC-1001 and Opdivo holds potential as a treatment for cancer patients, and we welcome the opportunity to investigate this in a clinical setting." He added, "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Bolt’s clinical studies."

BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists with an intervening non-cleavable linker, for the treatment of patients with HER2-expressing solid tumors. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with solid tumors, including breast, gastroesophageal and colorectal, that are HER2+ or HER2-low, for which Bolt recently presented preliminary data detailing safety, tolerability, and signs of activity at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The trial is being conducted in four parts, with dose-escalation and dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. The combination dose escalation is expected to start later in 2021.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.