[ad_1]
REDMOND, Wash., July 1, 2023 /PRNewswire/ — SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced 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. 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.
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…
[ad_2]
