Bolt Biotherapeutics (Nasdaq: BOLT) has initiated its first-in-human Phase 1/2 clinical trial by dosing the inaugural patient with BDC-3042, a monoclonal antibody designed to repolarize tumor-associated macrophages (TAMs) for the purpose of combating cancer. This significant milestone marks the commencement of a study aimed at evaluating the safety, pharmacokinetics, pharmacodynamics, and anti-tumor effects of BDC-3042 in patients with advanced triple-negative breast cancer (TNBC), colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer (NSCLC), or ovarian cancer.

BDC-3042 to revolutionize cancer treatment. BDC-3042 is a unique Dectin-2 agonist monoclonal antibody targeting TAMs, which play a critical role in establishing an immune-suppressive environment conducive to tumor growth across various solid tumor types. This immunotherapy has the potential to benefit a wide range of cancer patients.

TAMs are a significant component of the immune system in most cancers and contribute to the establishment of an environment that fosters tumor progression. Preclinical research has demonstrated that BDC-3042 has the ability to transform TAMs from a tumor-supportive state to a tumor-destructive state.

The Phase 1 trial (NCT06052852) is a multi-center, open-label study conducted in the United States, enrolling patients with various advanced malignancies. It consists of four parts: Part 1 focuses on dose escalation of BDC-3042 as a single agent to establish the recommended Phase 2 dose (RP2D) for Part 3, where the selected dose will be administered as monotherapy to patients with specific advanced malignancies. Part 2 involves dose escalation of BDC-3042 combined with a checkpoint inhibitor to determine the RP2D for Part 4, where the selected dose will be administered in combination with a checkpoint inhibitor to patients with select malignancies.

BDC-3042, Bolt Biotherapeutics' myeloid-modulating antibody, activates myeloid cells, leveraging Dectin-2, an immune-activating receptor expressed by TAMs commonly found in tumor microenvironments. These TAMs typically create an immune-suppressive environment favorable for tumor survival and growth. BDC-3042, by targeting Dectin-2, prompts TAMs to produce pro-inflammatory substances and transforms them into immune-stimulating macrophages. Additionally, BDC-3042 encourages the expression of essential antigen presentation machinery, aiding in the expansion of tumor-reactive T cells and the induction of anti-tumor immunity.

Source: globenewswire.com