Bolt Biotherapeutics Presents BDC-1001 Ongoing Clinical Trial Design and Supportive Preclinical Data at Society for Immunotherapy of Cancer Annual Meeting
REDWOOD CITY, Calif., Nov. 10, 2020 /PRNewswire/ -- Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, today presented the trial design of its ongoing Phase 1/2 clinical trial and preclinical data demonstrating proof-of-concept of its lead clinical drug candidate, BDC-1001. The clinical observations and preclinical data are now available in three posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held virtually November 9-14.
"We are proud to present our recent scientific advances at the SITC Annual Meeting highlighting that systemically-delivered trastuzumab ISACs induce a robust, target-dependent activation of the immune system in preclinical models as well as further mechanistic insight for the observed robust anti-tumor activity," said David Dornan, senior vice president of research and manufacturing at Bolt. "We hope to confirm the promising results from our preclinical work in our clinical trial that is currently ongoing."
The in-progress clinical trial poster titled, "Phase 1/2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 with or without immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors," highlighted the framework of Bolt's Phase 1/2 clinical trial, an actively enrolling global study in patients with refractory HER2-expressing solid tumors. The primary objectives of the study are to evaluate safety and tolerability and determine the recommended Phase 2 dose for both monotherapy and combination with a checkpoint inhibitor. BDC-1001 is a novel treatment which combines the targeting and antitumor effect of trastuzumab with localized stimulation of the immune system via dual TLR7 and TLR8 agonism.
The preclinical results were shown in two posters. The first titled, "Covalent attachment of a TLR7/8 agonist to tumor-targeting antibodies drives potent anti-tumor efficacy by synergistically activating FcgR- and TLR- signaling and enables safe systemic administration," demonstrated that Bolt's immune stimulating antibody conjugates (ISACs) are safe and well-tolerated in mice and non-human primates. The ISACs enable potent toll-like receptor (TLR) agonists to be safely administered systemically in preclinical models. ISACs provided distinct and unexpected biological advantage over unconjugated TLR agonists leading to more robust and effective anti-tumor efficacy.
The final poster titled, "Systemically administered HER2-targeted ISACs provoke a rapid, local response that engages the innate and adaptive arms of the immune system to eradicate tumors in preclinical models," demonstrated that within 24 hours of administration, HER2-directed ISACs induced robust, target-dependent activation of the immune system. There was robust activation of immune cells following anti-HER2 ISAC treatment. In contrast to other immune therapies, such as anti-PD1/PD-L1 and anti-CD40, systemically administered ISACs locally engage both the innate and adaptive immune system to eradicate tumors.
"These preclinical data further validate our tumor-targeting BDC-1001 Boltbody ISAC as a promising candidate to treat HER2-expressing solid tumors in our ongoing Phase 1/2 trial. Recruitment is going well thanks to our dedicated investigators and patients," said Edith Perez, M.D., Chief Medical Officer at Bolt. "We look forward to reporting the initial data readout of our clinical trial soon."
About Bolt Biotherapeutics' Immune Stimulating Antibody Conjugate (ISAC) Platform Technology
About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
About Bolt Biotherapeutics, Inc.
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