Xencor Begins Phase 1/2 Study of XmAb®942 for Inflammatory Bowel Disease

PASADENA, CA, USA I November 04, 2024 I Xencor, Inc. (NASDAQ: XNCR), a biopharmaceutical company at the clinical stage that focuses on the development of engineered antibodies to treat cancer and other severe illnesses, announced the initiation of dosing healthy volunteers in its first-in-human study of XmAb®942. This investigational treatment is a high-potency, extended half-life anti-TL1A antibody. The company anticipates initial data from this ongoing study to be available in the first half of 2025.

Dr. Kenneth Hung, M.D., Ph.D., senior vice president of clinical development at Xencor, remarked on the potential of XmAb942. He highlighted that an anti-TL1A antibody designed for enhanced target coverage and long-lasting action could revolutionize treatment options for inflammatory bowel disease. Dr. Hung expressed excitement about the first dosing in healthy participants, noting that XmAb942's characteristics, such as potential leading potency, might provide a therapeutic option with significant clinical benefits and a more convenient dosing schedule compared to other anti-TL1A antibodies under clinical development.

The Phase 1/2 study of XmAb942 is structured into three parts and is randomized, double-blind, and placebo-controlled. In Phase 1, Part A involves enrolling healthy volunteers into single-ascending dose (SAD) cohorts, with additional healthy volunteers set to receive repeat dosing in Part B. Phase 2, Part C, will enroll patients diagnosed with ulcerative colitis, who will receive doses determined from Parts A and B.

Xencor presented a poster detailing the preclinical characterization of XmAb942 at the United Europe Gastroenterology Week (UEGW) in October 2024. This presentation is available on the company's website under the "Publications" and "Events & Presentations" sections.

XmAb®942 is an investigational anti-TL1A antibody with high potency and an extended half-life, aimed at treating inflammatory bowel disease, including ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies was designed to inhibit the interaction between the death receptor 3 (DR3) receptor and its ligand, tumor necrosis factor (TNF)-like cytokine 1A (TL1A). These antibodies have shown reduced disease activity in UC and CD patients in multiple clinical studies. XmAb942’s extended half-life is achieved through Xencor’s Xtend™ Fc domain, potentially supporting an eight- to twelve-week dosing interval in humans. Xencor commenced a Phase 1 dose-escalation study of XmAb942 in healthy volunteers in the fourth quarter of 2024.

Xencor is known for developing engineered antibodies aimed at treating cancer and other serious diseases. The company currently has more than 20 XmAb®-engineered candidates in clinical development, with several XmAb medicines already marketed by partners. Xencor's XmAb engineering technology introduces small structural changes to proteins, resulting in new therapeutic action mechanisms. 

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