Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease

Rhea-AI Summary

Xencor (NASDAQ: XNCR) has initiated dosing of healthy volunteers in the first-in-human study of XmAb®942, a high-potency extended half-life anti-TL1A antibody for inflammatory bowel disease. The Phase 1/2 randomized, double-blind, placebo-controlled study will be conducted in three parts: Phase 1 Part A for single-ascending dose cohorts, Part B for repeat doses in healthy volunteers, and Phase 2 Part C for ulcerative colitis patients. Initial data is expected in the first half of 2025. The company believes XmAb942's properties may offer improved clinical benefits and more convenient dosing compared to other anti-TL1A antibodies in development.

Positive

• Initiation of Phase 1/2 clinical trial for XmAb942
• Potential for improved clinical benefits and convenient dosing regimen
• Clear development timeline with initial data expected in H1 2025

Negative

• None.

Insights

Medical Research Analyst

The initiation of Phase 1/2 clinical trials for XmAb942 represents a significant milestone in Xencor's inflammatory bowel disease (IBD) program. The study's design, incorporating both healthy volunteers and ulcerative colitis patients, follows a robust three-part approach. The antibody's engineered properties for enhanced potency and extended half-life could potentially address key limitations of current IBD treatments. While the initial data expected in H1 2025 makes this a longer-term catalyst, successful development could position Xencor competitively in the growing IBD market, estimated to reach $20 billion by 2025. The emphasis on improved clinical benefits and convenient dosing could differentiate XmAb942 from other anti-TL1A antibodies in development, though market impact remains contingent on clinical results.

PASADENA, Calif.--(BUSINESS WIRE)-- Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today announced that it has initiated dosing of healthy volunteers in the first-in-human study of XmAb^®942, an investigational high-potency extended half-life anti-TL1A antibody. Xencor continues to expect initial data from the ongoing study during the first half of 2025.

“An anti-TL1A antibody engineered for improved target coverage with long duration of action could transform the clinician’s therapeutic toolbox in inflammatory bowel disease,” said Kenneth Hung, M.D., Ph.D., senior vice president, clinical development at Xencor. “We are excited to announce this first dosing of XmAb942 in healthy participants and believe that XmAb942’s properties, including potentially class-leading potency, may result in a therapeutic option with improved clinical benefit and a more convenient dosing regimen than other anti-TL1A antibodies currently in clinical development.”

The Phase 1/2 randomized, double-blind, placebo-controlled study of XmAb942 will be conducted in three parts. In Phase 1, Part A will enroll healthy volunteers into single-ascending dose (SAD) cohorts, and additional healthy volunteers would receive repeat doses in Part B. In Phase 2, Part C will enroll patients with ulcerative colitis who would receive the dosing determined from Parts A and B. (ClinicalTrials.gov Identifier: NCT06619990)

Xencor’s poster with preclinical characterization of XmAb942 was presented at the United Europe Gastroenterology Week (UEGW) in October 2024. The poster is archived under the “Publications” and the "Events & Presentations" pages of the Company's website located at www.xencor.com.

About XmAb^®942

XmAb^®942 is a high-potency, extended half-life, investigational anti-TL1A antibody in development for patients with inflammatory bowel disease, such as ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies, designed to block the interaction between the death receptor 3 (DR3) receptor and its ligand tumor necrosis factor (TNF)-like cytokine 1A (TL1A), have reduced disease activity in patients with UC and CD in multiple clinical studies. XmAb942’s half-life is enabled by Xencor’s validated Xtend™ Fc domain and could potentially support an eight- to twelve-week dosing interval in humans. Xencor initiated a Phase 1 dose-escalation study of XmAb942 in healthy volunteers in the fourth quarter of 2024.

About Xencor

Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious diseases. More than 20 candidates engineered with Xencor's XmAb^® technology are in clinical development, and multiple XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding expectations for clinical progress, planned receipt and presentations of clinical data, including the timing thereof, planned clinical trials, the quotations from Xencor's senior vice president, clinical development, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, and risks related to delays in receiving data from clinical trials, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2023 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241104306659/en/

Charles Liles

cliles@xencor.com

(626) 737-8118

For Media:

Cassidy McClain

Inizio Evoke

cassidy.mcclain@inizioevoke.com

(619) 694-6291

Source: Xencor, Inc.

FAQ

When will Xencor (XNCR) release initial data for XmAb942 trial?

Xencor expects to release initial data from the XmAb942 trial during the first half of 2025.

What is the design of Xencor's (XNCR) XmAb942 Phase 1/2 clinical trial?

The trial is a randomized, double-blind, placebo-controlled study conducted in three parts: Phase 1 Part A for single-ascending doses in healthy volunteers, Part B for repeat doses in healthy volunteers, and Phase 2 Part C for ulcerative colitis patients.

What condition is Xencor's (XNCR) XmAb942 being developed to treat?

XmAb942 is being developed for the treatment of inflammatory bowel disease, specifically including ulcerative colitis patients in Phase 2 of the trial.