Werewolf Therapeutics Unveils Innovative IL-10 INDUKINE Molecule, WTX-921, for Inflammatory Diseases

On October 31, 2024, Werewolf Therapeutics, Inc. (Nasdaq: HOWL), a trailblazing biopharmaceutical company, announced the inclusion of WTX-921, a groundbreaking IL-10 INDUKINE candidate, in their portfolio for the treatment of Inflammatory Bowel Disease (IBD) and potentially other inflammatory conditions. This new addition underscores the potential of Werewolf’s PREDATOR® platform to apply its innovative INDUKINE approach beyond oncology.

Werewolf's INDUKINE molecules are currently demonstrating strong safety and efficacy in ongoing oncology trials. Their validated approach involves discovering unique protease-cleavable linkers that allow for the conditional activation of wild-type cytokines. This ensures maximum efficacy in disease tissues while protecting healthy tissues from adverse effects. For IBD treatment, Werewolf used this distinct drug design technique to find the optimal cytokine masking and disease-selective linkers for IL-10 delivery to inflammatory disease tissues, particularly the colon. This innovation underscores the platform’s ability to create superior, conditionally active therapeutics with exceptional therapeutic windows, addressing critical needs in various medical fields.

Daniel J. Hicklin, Ph.D., President and CEO of Werewolf, emphasized the importance of this development, stating, “The introduction of WTX-921 for IBD is a significant milestone that not only represents a crucial step forward for us but also highlights the versatility of our PREDATOR platform in addressing other critical medical needs. We are committed to developing therapies that target the underlying mechanisms of diseases, as evidenced by this new candidate, WTX-921.”

IBD, which currently has no cure and limited symptom management options, represents a significant unmet medical need. According to the Centers for Disease Control and Prevention, IBD includes Crohn’s disease and ulcerative colitis, both of which are characterized by chronic inflammation of the gastrointestinal tract. This prolonged inflammation can lead to GI tract damage. While the exact cause of IBD remains unknown, autoimmune and immune-mediated factors contribute significantly to the disease's severity. In the U.S., more than 0.7% of the population is diagnosed with IBD, equating to approximately 721 cases per 100,000 people, or 1 in 100 individuals.

Werewolf Therapeutics, Inc. is at the forefront of developing therapeutics designed to activate the immune system to treat cancer and other immune-mediated conditions. Utilizing their proprietary PREDATOR platform, Werewolf designs conditionally activated molecules that stimulate both adaptive and innate immunity, aiming to overcome the limitations of traditional proinflammatory immune therapies. The company’s INDUKINE molecules are designed to remain inactive in peripheral tissues, activating selectively within the tumor microenvironment. Werewolf’s leading clinical stage product candidates, WTX-124 and WTX-330, are systemic, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for solid tumor treatment. WTX-124 is being developed for use in multiple tumor types as a standalone agent and in combination with an immune checkpoint inhibitor, while WTX-330 is being developed for a range of tumor types or Non-Hodgkin Lymphoma as a standalone agent.

The innovative pipeline of Werewolf Therapeutics, including the newly announced WTX-921 for IBD, reflects the company's dedication to addressing critical medical needs through advanced therapeutic solutions.