Xencor Presents Preclinical Data on XmAb942, a High-Potency Extended Half-Life Anti-TL1A Antibody, to be Developed for Patients with Inflammatory Bowel Diseases

Rhea-AI Summary

Xencor (NASDAQ: XNCR) has announced preclinical data on XmAb942, a high-potency, extended half-life anti-TL1A antibody for inflammatory bowel diseases. The data will be presented at UEG Week in Vienna. XmAb942 aims to be a best-in-class next-generation anti-TL1A antibody, offering superior potency and less frequent dosing compared to first-generation antibodies.

Key points:

• First subject dosing in Phase 1 healthy volunteer study expected in Q4 2024
• Initial data from single-ascending dose portion anticipated in H1 2025
• Preclinical data shows comparable or superior in vitro potency to first-generation anti-TL1A antibodies
• 23-day half-life in non-human primates, potentially supporting 8-12 week dosing in humans

Positive

• XmAb942 shows comparable or superior in vitro potency to first-generation anti-TL1A antibodies
• Extended half-life of 23 days in non-human primates, potentially allowing for 8-12 week dosing in humans
• Phase 1 healthy volunteer study on track to begin in Q4 2024
• Initial data from single-ascending dose portion expected in H1 2025

Negative

• None.

Insights

Medical Research Analyst

XmAb942, Xencor's new anti-TL1A antibody, shows promising preclinical results for inflammatory bowel diseases (IBD). Key points:

• High potency and extended half-life compared to first-generation anti-TL1A antibodies
• 23-day half-life in non-human primates, potentially allowing for 8-12 week dosing in humans
• Comparable or superior in vitro potency to existing anti-TL1A antibodies
• Phase 1 healthy volunteer study planned for Q4 2024, with initial data expected in H1 2025

This development is significant for IBD treatment, potentially offering improved efficacy and convenience. However, it's important to note that clinical trials are yet to begin and success in humans is not guaranteed. The extended dosing interval could be a major differentiator if proven effective in clinical trials.

Biotech Industry Analyst

Xencor's XmAb942 represents a strategic move in the competitive IBD market. Key considerations:

• TL1A is a validated target in IBD, with first-generation antibodies showing efficacy
• XmAb942 aims for "best-in-class" status, potentially capturing market share if successful
• Extended dosing interval could improve patient compliance and quality of life
• Timeline to market is still long, with Phase 1 starting in Q4 2024

For investors, this pipeline addition enhances Xencor's portfolio in autoimmune diseases. However, it's early-stage and faces competition from established players and other emerging therapies. The IBD market is lucrative but crowded, so differentiation will be crucial. Financial impact is long-term and depends on clinical success and market positioning.

-- XmAb942 on track for first subject dosing in Phase 1 healthy volunteer study in Q4 2024 --

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 preclinical data on XmAb942 were published in a poster to be presented during United European Gastroenterology (UEG) Week on Tuesday, October 15 in Vienna, Austria.

XmAb942 is a high-potency, extended half-life, investigational anti-TL1A antibody to be developed for patients with inflammatory bowel diseases, such as ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies, designed to block the interaction between the DR3 receptor and its ligand TL1A, have reduced disease activity in patients with UC and CD in multiple clinical studies. Xencor anticipates dosing the first subject in a first-in-human study of XmAb942 in healthy volunteers during the fourth quarter of 2024 and expects to present initial data from the single-ascending dose portion of the study in the first half of 2025.

“We are aiming for XmAb942 to be the potential best-in-class next-generation anti-TL1A antibody, providing leading potency and less frequent dosing relative to the first generation TL1A-targeted antibodies, which have validated TL1A as an important inflammatory axis,” said John Desjarlais, Ph.D., executive vice president and chief scientific officer at Xencor. “Our preclinical data suggest that in vitro potency of XmAb942 is comparable or superior to first-generation anti-TL1A antibodies. XmAb942 also demonstrates superior pharmacokinetics with a half-life of 23 days in non-human primates, which we believe supports a potential eight- to twelve-week dosing regimen in humans and could improve convenience and potentially compliance within the TL1A class.”

Xencor’s poster, titled “Discovery and Characterization of a Novel High-Affinity Anti-TL1A Monoclonal Antibody with Extended Half-life for the Treatment of Inflammatory Bowel Disease,” will be archived under the “Publications” and the "Events & Presentations" pages of the Company's website located at www.xencor.com.

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 presentations of clinical data, new XmAb candidates, planned clinical trials, the quotations from Xencor's chief scientific officer, 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, 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/20241010530780/en/

For Investors:

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

What is XmAb942 and what is it being developed for?

XmAb942 is a high-potency, extended half-life, investigational anti-TL1A antibody being developed by Xencor for patients with inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease.

When is Xencor (XNCR) expecting to begin the Phase 1 trial for XmAb942?

Xencor anticipates dosing the first subject in a Phase 1 healthy volunteer study of XmAb942 during the fourth quarter of 2024.

What advantages does XmAb942 offer compared to first-generation anti-TL1A antibodies?

XmAb942 aims to provide leading potency and less frequent dosing relative to first-generation TL1A-targeted antibodies. Preclinical data suggest comparable or superior in vitro potency and a longer half-life, potentially supporting an 8-12 week dosing regimen in humans.

When does Xencor (XNCR) expect to present initial data from the XmAb942 Phase 1 trial?

Xencor expects to present initial data from the single-ascending dose portion of the XmAb942 Phase 1 study in the first half of 2025.