Clearance marks SystImmune’s first IND enabled by pioneering New Approach Methodologies (NAMs), underscoring global innovation and translational leadership

REDMOND, Wash., Sept. 22, 2026 /PRNewswire/ — SystImmune Inc. (SystImmune), a clinical-stage biotechnology company advancing next-generation multi-specific antibodies and antibody-drug conjugates (ADCs), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms.

The FDA clearance marks SystImmune’s first IND application utilizing New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. It also underscores the company’s role at the forefront of the global paradigm shift toward modern, human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.

“We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies,” said Dr. Jahan Khalili, Senior Vice President of Research at SystImmune. “Human-relevant models gave us a more direct read on a molecule designed to engage multiple human pathways in the nonclinical package, built around New Approach Methodologies.”

“Patients with advanced solid tumors refractory to standard therapies remain in urgent need of novel therapeutic options with coordinated mechanisms of action,” said Dr. Anand Achanta, Senior Vice President, Regulatory Affairs and Medical Writing. “We look forward to initiating the Phase 1/1b trial to determine optimal dosing and characterize the clinical activity of SI-B037, while continuing to collaborate closely with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies.”

About SystImmune
SystImmune is a clinical-stage biotechnology 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 antibody-drug conjugates (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
This press release contains forward-looking statements within the meaning of private securities litigation reform acts, including statements regarding the initiation and design of the Phase 1/1b clinical trial of SI-B037, the therapeutic potential of SI-B037, and the continued application and advancement of New Approach Methodologies (NAMs). Forward-looking statements are subject to risks, uncertainties, and assumptions that may cause actual results or outcomes to differ materially from those projected. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law.

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SOURCE SystImmune, Inc.