REDMOND, WA, USA I November 8, 2024 I SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology. The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors in the United States.
The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, “Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients. 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.”
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and ADCs. SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside 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.
For additional information about the company, please visit https://systimmune.com/.
SOURCE: SystImmune
Post Views: 910
REDMOND, WA, USA I November 8, 2024 I SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology. The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors in the United States.
The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, “Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients. 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.”
About SystImmune
SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and ADCs. SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside 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.
For additional information about the company, please visit https://systimmune.com/.
SOURCE: SystImmune
Post Views: 910
