Bolt Biotherapeutics, Inc. (NASDAQ:BOLT), a clinical-stage biopharmaceutical company pioneering novel immuno-oncology therapeutics for the treatment of cancer, today announced that it will present a poster with clinical data from its completed Phase 1 dose-escalation study of BDC-1001 at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting. The conference is being held at McCormick Place in Chicago, Illinois and virtually from June 2-6, 2023.
BDC-1001 is an investigational Immune-Stimulating Antibody Conjugate (ISAC) in development for the treatment of patients with HER2-expressing cancer. The ASCO presentation will include comprehensive results from the company’s Phase 1 single-agent and combination dose-escalation trial of BDC-1001 that enrolled more than 100 patients.
“We look forward to presenting a comprehensive data set at ASCO that provides detailed safety, efficacy, pharmacokinetic and pharmacodynamic results from our recently completed Phase 1 dose-escalation trial evaluating BDC-1001 as a single agent and in combination with nivolumab,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “These data support the recommended Phase 2 dose and schedule for BDC-1001. We are making steady progress towards initiating two Phase 2 studies in 2023 evaluating BDC-1001 in multiple single-agent solid tumor settings, and in combination with nivolumab supplied by our partner BMS and with pertuzumab supplied by our partner Roche.”
Details about the presentation can be found below and on the ASCO website. Additionally, a copy of the poster will be available on the Publications page of the Bolt Biotherapeutics website following the conference.
- Title: A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors
- Presenter: Bob Li, M.D., Ph.D., MPH, medical oncologist, and principal investigator at Memorial Sloan Kettering Cancer Center (MSK)
- Abstract Presentation Number: 2538
- Poster Session: Developmental Therapeutics—Immunotherapy
- Details: Saturday, June 3, 2023, 8:00 a.m. – 11:00 a.m. CDT
About BDC-1001
Bolt Biotherapeutics’ lead program, BDC-1001, is a human epidermal growth factor receptor 2 (HER2) ISAC comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist.
Following the completion of the BDC-1001 dose-escalation trial for the treatment of patients with HER2-expressing solid tumors, BDC-1001 is entering two Phase 2 clinical trials (NCT04278144) in patients with HER2-positive solid tumors. Despite the availability of multiple HER2-targeted agents, patients with advanced disease and many with early disease require multiple lines of therapy to achieve disease control, improve quality of life and extend survival. This includes patients with tumor types other than breast cancer, where HER2 protein overexpression or gene amplification have been well documented in a wide range of malignancies. The Phase 2 clinical plan for BDC-1001 includes two distinct studies to be conducted in U.S., Europe, and South Korea, each using a Simon two-stage design. A Phase 2 dose-expansion will initially investigate BDC-1001 as a monotherapy, enrolling three separate cohorts for patients with HER2-positive colorectal, endometrial, and gastroesophageal cancer; combination arms with nivolumab are expected to initiate in each indication following demonstration of monotherapy anti-tumor activity. The second study is a randomized two-arm Phase 2 clinical trial investigating BDC-1001 as monotherapy and in combination with pertuzumab in patients with HER2-positive metastatic breast cancer whose disease has progressed following treatment with Enhertu.
About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.
