On July 1, 2023 SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of BL-B01D1 in the Investigational New Drug (IND) application on June 30, 2023 (Press release, SystImmune, JUL 1, 2023, View Source [SID1234633013]). This milestone paves the way for Phase 1 clinical trials of BL-B01D1 in subjects with metastatic or unresectable Non-Small Cell Lung Cancer (NSCLC) in the United States.

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The clearance of this IND application marks a significant milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Yi Zhu, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to invent therapies that offer meaningful clinical benefit to patients, and the FDA green light of our IND application for BL-B01D1 is a testament to our commitment. Together, with all our clinical partners, trial treatment centers, and global regulatory agencies, we hope to provide significant and global contributions to the cancer treatment landscape."

"We are excited to receive FDA clearances for the IND application of Bl-B01D1, the first-in-class bi-specific ADC. This novel therapy holds tremendous promise in addressing the urgent need for improved treatment options for patients with advanced NSCLC," stated Dr. Martin S. Olivo, Chief Medical Officer at SystImmune. "Following encouraging results from clinical studies involving over 100 patients in the China-based first-in-human study, we eagerly anticipate commencing the clinical investigation of BL-B01D1 in diverse global population groups."

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.

Clinical studies conducted thus far have demonstrated compelling results for BL-B01D1. In subjects with EGFR-mutated NSCLC that have progressed on up to three lines of Standard of Care (SOC) treatments, BL-B01D1 achieved an overall response rate (ORR) exceeding 40%. Furthermore, in subjects with NSCLC with mutated EGFR, BL-B01D1 exhibited an ORR of over 60%. These findings were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, and the abstract of the clinical study can be accessed at the following link: BL-B01D1 ASCO (Free ASCO Whitepaper) Abstract. These results underscore the potential of BL-B01D1 as an effective treatment option for patients with different molecular profiles.