Werewolf Therapeutics (HOWL) The Citizens JMP Life Sciences Conference 2025 summary

Company overview and platform

• Founded in 2017 to develop pro-inflammatory cytokine-based therapies with improved tolerability and efficacy.

• Developed a modular PREDATOR platform using wild-type cytokines, half-life extenders, and protease-cleavable linkers for tumor specificity.

• Expanded beyond oncology to include IL-10 for IBD and a T-Cell Engager (TCE) platform.

Clinical development and data highlights

• Lead program WTX-124 (IL-2) completed dose escalation; now in dose expansion for melanoma, renal cell, cutaneous squamous cell, and non-small cell lung cancer.

• Demonstrated monotherapy activity, including a durable complete response in a patient with cutaneous squamous cell carcinoma post-checkpoint inhibitor failure.

• Biomarker studies showed dose-dependent increases in CD8+ T-cells and pro-inflammatory markers in tumor biopsies.

• Enrollment for melanoma monotherapy expansion to complete by end of current quarter; combination arm by year-end, with plans to present data to FDA for potential accelerated approval.

Pipeline expansion and future plans

• WTX-330 (IL-12) showed tolerability and anti-tumor activity in phase 1; regimen-finding study ongoing with potential data by end of year or early next year.

• Preclinical IL-10 program for IBD uses distinct linkers; seeking partners for further development.

• T-Cell Engager platform expects a development candidate by end of current quarter, with IND filing targeted for 2026.

• Partnership with Jazz Pharmaceuticals for interferon alpha molecule, now under Jazz's development.