FDA Clears SystImmune's IND Application for BL-M17D1 in Solid Tumors

REDMOND, Wash., Nov. 8, 2024 – SystImmune, Inc, a biotechnology company in the clinical stage, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for BL-M17D1. This antibody-drug conjugate (ADC) incorporates a novel linker and payload technology. The IND approval allows SystImmune to begin a Phase 1 clinical trial, designated BL-M17D1-ST-101, to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 in patients with advanced or metastatic solid tumors in the United States.

This approval represents a significant milestone for SystImmune, furthering the company's efforts to bring new therapeutic candidates into clinical trials. Dr. Jie D'Elia, the Chief Executive Officer of SystImmune, expressed the company's commitment to delivering therapies that can provide substantial clinical benefits to patients. Dr. D'Elia highlighted that BL-M17D1, developed with their advanced linker and payload technology, marks their ongoing innovation in the ADC field, aiming to offer potentially leading products to patients.

SystImmune is based in Redmond, Washington, and focuses on developing novel cancer treatments through its established drug development platforms. These platforms emphasize bi-specific and multi-specific antibodies, as well as ADCs. The company has multiple assets currently in different stages of clinical trials targeting both solid tumor and hematologic conditions. In addition to their clinical trials, SystImmune maintains a strong preclinical pipeline of potential cancer treatments that are either in the discovery phase or in stages enabling IND applications. This pipeline signifies the forefront of biologics development.