Release Date: 23-Jan-2025
BL-B01D1 is a novel and potentially first-in-class bispecific antibody-drug conjugate (ADC) developed by SystImmune. It is designed to target both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), two critical receptors that are often overexpressed in a variety of epithelial tumors. The therapeutic construct consists of a proprietary bispecific antibody linked to a potent cytotoxic payloadandmdash;a topoisomerase inhibitorandmdash;which is delivered directly to cancer cells expressing both EGFR and HER3.
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The mechanism of action of BL-B01D1 leverages SystImmune's Specificity Enhanced Bi-specific Antibody (SEBA) platform, which provides an advanced method for targeting cancer cells. This platform is part of a broader class of HIRE moleculesandmdash;Heterogeneity Overcoming, Immunogenic Death Inducing, Resistance Antagonizing, and Enhanced Specificity. HIRE molecules enable precise targeting of cancer cells, while simultaneously counteracting resistance mechanisms and inducing cell death. BL-B01D1's tetravalent structure allows it to engage both EGFR and HER3, blocking the proliferative and survival signals that drive cancer growth. This dual inhibition is critical in reducing tumor cell proliferation and survival, particularly in cancers resistant to other therapies.
After binding to EGFR and HER3 on the surface of cancer cells, BL-B01D1 is internalized and transported to lysosomes, where its cytotoxic payload is released. The topoisomerase inhibitor induces genotoxic stress, disrupting the DNA replication process and triggering cell death pathways, ultimately leading to the demise of the cancer cells. This dual mechanism of targeted delivery and payload-mediated cell killing enhances the therapeutic potential of BL-B01D1 in treating a variety of solid tumors.
Currently, BL-B01D1 is undergoing phase 3 clinical trials as a single agent for several EGFR+ and HER3+ solid tumors, including small cell lung cancer, triple-negative breast cancer, nasopharyngeal carcinoma, and esophageal squamous cell carcinoma. In 2023, SystImmune entered into a global strategic collaboration agreement with Bristol Myers Squibb to further develop and commercialize BL-B01D1, signaling strong confidence in its clinical potential.