On December 9, 2020 Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, reported the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020 (Press release, Bolt Biotherapeutics, DEC 9, 2020, View Source [SID1234572555]). The poster will be presented today, Wednesday, Dec. 9, at 8:00 a.m. CT/9:00 a.m. ET.
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The in-progress clinical trial poster titled, "Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors," discusses the framework of Bolt’s Phase 1/2 clinical trial. The actively enrolling global clinical study is for patients with refractory HER2-expressing solid tumors and its primary objectives are to evaluate safety, tolerability and to 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 stimulation of the immune system via TLR 7/8 agonism. Based on initial clinical observations to date, there have been no dose-limiting toxicities and no drug-related severe adverse events.
Edith Perez, M.D., Chief Medical Officer at Bolt, commented, "Preclinical data support that BDC-1001 may enable a patient to recruit their own immune system to fight their cancer with intravenous administration of BDC-1001. We continue to see strong interest in participation in our trial from both investigators and potential patients based on our compelling preclinical data and ongoing clinical observations."
About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.
About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.