On October 12, 2023 SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, reported that the first patient was treated on October 10th, 2023 with BL-B01D1, a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3, as part of the global, multi-center Phase 1 study, BL-B01D1-LUNG-101, that is underway to evaluate the safety, tolerability, and efficacy of BL-B01D1 in individuals with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) (Press release, SystImmune, OCT 12, 2023, View Source [SID1234635906]). The study, anticipated to enroll around 100 participants, includes two dosing schedules (Cohort A and Cohort B) and three phases (dose escalation, dose finding, and dose expansion).
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"This study underscores our commitment to advancing medical science and improving the lives of those affected by NSCLC. We look forward to the results of BL-B01D1-LUNG-101 in diverse populations and its potential impact on NSCLC care," stated Dr. Martin S. Olivo, Chief Medical Officer at SystImmune.
This registered study is titled "A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer," and this research represents a significant step forward in NSCLC treatment possibilities. NCT05983432
About BL-B01D1
BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) developed by SystImmune, targeting both EGFR and HER3, proteins that are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 possesses two binding domains blocking each Growth Factor Receptor, which both drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 effectively blocks EGFR and HER3 signals to cancer cells, thereby reducing proliferation and survival signals. Upon antibody-mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.
The two targets of BL-B01D1 are broadly expressed in epithelial tumors, including NSCLC, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Gastrointestinal tumors, Gynecological tumors, and others. The therapeutic conjugated toxin of BL-B01D1 comprises SystImmune’s Ex-0115 linker-payload platform, a proprietary Top1 inhibitor conjugated to the bi-specific antibody by a stable, cleavable linker. Each BL-B01D1 carries 7-8 units of SystImmune’s proprietary ED-04 toxin.