Werewolf Therapeutics Presents New Preclinical Data Further Characterizing its IL-10 INDUKINE Molecule, WTX-921, for the Treatment of Inflammatory Bowel Disease (IBD) at AAI Annual Meeting
- Data reveal WTX-921 is efficacious in a mouse colitis model, resulting in reduced tissue damage and inflammatory cytokine production -
- Findings offer a more detailed understanding of WTX-921's anti-inflammatory impact on the immune landscape in the inflamed colon -
WATERTOWN, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (NASDAQ:HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body's immune system for the treatment of cancer and other immune-mediated conditions, today announced a poster presentation further characterizing its conditionally-activated IL-10 INDUKINE molecule, WTX-921, at IMMUNOLOGY2025, the annual meeting of the American Association of Immunologists (AAI) taking place May 3-7 in Honolulu, Hawaii.
Werewolf's findings are summarized in a poster titled, "Development of WTX-921, A Conditionally Active IL-10 INDUKINETM Molecule for the Treatment of Inflammatory Bowel Disease" (Board #1230). The results build on initial data presented at the 2024 AAI Annual Meeting, which revealed preliminary proof-of-concept for its IL-10 INDUKINE molecule as a potential prodrug for IBD treatment.
The data corroborate the preferential cleavage of inflammatory disease linkers by inflamed human IBD tissue samples and reduced colitis in a murine IBD model as previously observed. New results also highlight WTX-921's effective masking of IL-10 via its optimized IL-10 blocking domain, which prevents the peripheral off-tissue pharmacodynamic effects of IL-10. The CDC estimates that 7 million people worldwide had IBD in 2024, and while clinical studies in IBD involving IL-10 have shown promise, they are consistently hampered by dose-dependent adverse events.
"Our findings validate the potential of WTX-921, a first-of-its-kind targeted IL-10 therapy, to modulate disease-driving innate and adaptive immune responses implicated in IBD," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "WTX-921 is a novel IL-10 INDUKINE molecule specifically engineered to overcome the significant toxicities associated with systemic IL-10 therapy and deliver this potent anti-inflammatory agent to inflamed colon tissue, which has clear implications for IBD patients in need of better treatment options."
WTX-921 treatment demonstrated efficacy in the ACT animal model of colitis over a duration of 4 weeks, preventing weight loss and resulting in reduced Disease Activity Index (DAI) scores. WTX-921 also inhibited inflammation, evidenced by a decrease in the infiltration/expansion of immune cells (including CD4+ effector T cells and myeloid cells) and reduced RNA levels of inflammatory cytokines within the colon of treated animals.
The poster can be viewed in person on Tuesday, May 6, 2025, on board number 1230, with Werewolf delegates present from 1:15-2:30pm to answer questions. The poster will also be available on our website at https://investors.werewolftx.com/news-and-events/scientific-resources.
About WTX-921:
WTX-921 is a novel, first-of-its-kind IL-10 INDUKINE™ molecule being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory diseases. Engineered to overcome the significant toxicities associated with systemic IL-10 delivery, WTX-921 is conditionally activated and is specifically designed for the selective delivery of native IL-10 to inflamed tissues, providing therapeutically-relevant exposure while minimizing systemic toxicity in preclinical models. Preclinical data demonstrate that WTX-921 has the potential to block several disease-driving effector molecules and cytokines, eliciting a multipronged effect by inhibiting disease-driving innate and adaptive immune cell populations.
About Werewolf Therapeutics:
Werewolf Therapeutics, Inc., is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body's immune system for the treatment of cancer and other immune-mediated conditions. The Company is leveraging its proprietary PREDATOR® platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Werewolf's INDUKINE molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. The Company's most advanced clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of solid tumors. Werewolf is advancing WTX-124 in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor and WTX-330 in multiple tumor types or Non-Hodgkin Lymphoma as a single agent. To learn more visit www.werewolftx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Werewolf's strategy, future operations, prospects, plans, and objectives of management; the expected timeline for the preclinical and clinical development of product candidates and the availability of data from such preclinical and clinical development; the potential activity and efficacy of product candidates in preclinical studies and clinical trials; and the anticipated safety profile of product candidates constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "aim," "anticipate," "believe," "contemplate," "continue," "could," "design," "designed to," "engineered," "estimate," "expect," "goal," "intend," "may," "might," "objective," "ongoing," "plan," "positioning itself to," "potential," "predict," "project," "promise," "should," "target," "will," "working to," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the development of product candidates, including the conduct of research activities, and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; as well as the risks and uncertainties identified in the "Risk Factors" section of the Company's most recent Form 10-K filed with the Securities and Exchange Commission (SEC), and in subsequent filings the Company may make with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.
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