SystImmune, Inc., a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1. This antibody-drug conjugate (ADC) incorporates a novel linker and payload technology and is slated for evaluation in a Phase 1 clinical trial for patients with advanced or metastatic solid tumors.
The Phase 1 clinical trial, named BL‑M17D1-ST-101, is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1. The study will be conducted in the United States and will enroll patients with advanced or metastatic solid tumors who have exhausted standard treatment options.
Novel ADC Technology
BL-M17D1 leverages SystImmune's next-generation linker and payload technology, representing a significant advancement in ADC development. This innovative approach aims to enhance the drug's efficacy while minimizing off-target toxicities, potentially leading to improved clinical outcomes for patients.
"Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients," said Dr. Jie D’Elia, Chief Executive Officer of SystImmune. "As BL-M17D1 is developed using our next generation linker and payload technology, the initiation of clinical development for BL-M17D1 demonstrates our ability to continue to innovate in the ADC space and bring potentially best-in-class products to patients."
SystImmune's Pipeline
SystImmune is dedicated to developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and ADCs. The company has several assets in various stages of clinical trials for solid tumor and hematologic indications. In addition to ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
