Werewolf Therapeutics Announces 2025 Milestones for IL-2 and IL-12 INDUKINE Programs
Key Insights
Werewolf Therapeutics anticipates sharing preliminary monotherapy data for WTX-124 in H1 2025, potentially guiding regulatory engagement for accelerated approval.
A Phase 1/2 clinical trial of WTX-330, an IL-12 (search) INDUKINE molecule, is expected to begin in Q1 2025, targeting immunotherapy-resistant cancers (search).
Interim data from combination expansion arms of WTX-124 with pembrolizumab are expected in Q4 2025, further evaluating its efficacy in solid tumors (search).
Werewolf Therapeutics, Inc. (Nasdaq: HOWL) has outlined its strategic objectives for 2025, focusing on advancing its conditionally activated therapeutics designed to stimulate the body’s immune system for cancer treatment. The company plans to release key data from its WTX-124 and WTX-330 clinical programs and initiate new trials.
WTX-124: Advancing IL-2 INDUKINE Molecule
WTX-124, a systemically delivered, conditionally activated IL-2 INDUKINE molecule, is being evaluated both as a monotherapy and in combination with pembrolizumab across various solid tumor types. The ongoing Phase 1/1b clinical trial has demonstrated promising monotherapy activity and improved tolerability compared to high-dose IL-2 in heavily pretreated patients, including those refractory to immune checkpoint inhibitors.
The company has selected 18 mg administered intravenously every two weeks (IV Q2W) as the recommended dose for monotherapy expansion arms in metastatic melanoma (search), renal cell carcinoma (search) (RCC), and cutaneous squamous cell carcinoma (search) (CSCC), as well as combination expansion arms in metastatic melanoma, RCC, and non-small cell lung cancer (search) (NSCLC). In the first half of 2025, Werewolf plans to report interim data from monotherapy expansion arms in less heavily pre-treated patient populations. These data are expected to guide discussions with regulators regarding potential registrational pathways, including strategies for accelerated approval as a monotherapy. Interim data from combination expansion arms are anticipated in the fourth quarter of 2025.
WTX-330: Initiating Phase 1/2 Trial for IL-12 INDUKINE
WTX-330, another systemically delivered, conditionally activated IL-12 (search) INDUKINE molecule, is being developed for advanced or metastatic solid tumors (search). An interim update from the Phase 1 clinical trial, presented at SITC 2024, highlighted the tolerability profile and monotherapy efficacy signals of WTX-330. Werewolf plans to initiate a Phase 1/2 dose- and regimen-finding clinical trial in the first quarter of 2025 to optimize the delivery of WTX-330 to the tumor microenvironment. Pending data, expansion arms in selected tumor types will be opened.
Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf, stated, “WTX-330, our IL-12 (search) INDUKINE molecule, has the potential to be a first-in-class therapy for immunotherapy-resistant cancers (search).”
Preclinical Portfolio and Financial Outlook
Werewolf's preclinical portfolio includes WTX-712 (IL-21 INDUKINE), WTX-518 (binding protein resistant IL-18 INDUKINE), and WTX-921 (IL-10 INDUKINE). The company plans to complete ongoing preclinical work to support IND-stage programs and seek strategic partnerships to advance these programs.
Werewolf anticipates that its current cash and cash equivalents will fund operational expenses and capital expenditure requirements through at least the second quarter of 2026.