REDMOND, Wash., Oct. 14, 2024 /PRNewswire/ -- 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-M11D1, an antibody-drug conjugate (ADC) binding CD33, a protein on myeloid cells. The IND supports the initiation of a Phase 1 clinical trial, BLM11D1-HM-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1 for the treatment of patients with relapsed/refractory Acute Myeloid Leukemia (AML) 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 continue to bring therapies that can provide clinical benefit to patients. The initiation of clinical development for BL-M11D1 emphasizes that commitment.”
“We are excited to receive the FDA Study-May-Proceed letter enabling the initiation of our Phase 1 study with BL-M11D1. We believe that this novel, potentially best-in-class ADC can offer an important therapeutic option for patients with relapsed/refractory AML and look forward to implementing this study,” expressed Dr. Jonathan Cheng, Chief Medical Officer at SystImmune.
About BL-M11D1
The company is developing BL-M11D1, an ADC comprising a monoclonal antibody component binding CD33 and a linker-payload component that is composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. BL-M11D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to CD33 on cancer cells. In addition, the binding to CD33 causes its internalization followed by the release of the payload, which then kills the tumor cell.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.Forward-Looking Statements
Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider.This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company’s goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as “anticipates,” “believes,” “expects,” “estimates,” “could,” “intends,” “may,” “plans,” “potential,” “projects,” “will,” “would” and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements.
While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company’s reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
For additional information about the company, please visit https://systimmune.com/.
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SOURCE SystImmune, Inc.
