Werewolf Therapeutics Receives FDA Fast Track Designation for WTX-124 in Advanced Melanoma
Thursday, October 09, 2025
Werewolf Therapeutics, Inc. a company developing immune-stimulating therapies for cancer and other immune-related conditions, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy WTX-124. The designation applies to the potential treatment of patients with locally advanced or metastatic cutaneous melanoma following standard immunotherapy.
WTX-124 is a conditionally activated interleukin-2 (IL-2) INDUKINE therapy designed to deliver IL-2 selectively to the tumour microenvironment, stimulating a potent anti-tumour immune response while minimising systemic toxicities associated with other IL-2 treatments.
The therapy is currently being evaluated in a Phase 1/1b open-label, multicentre study, which includes both single-agent and combination arms with pembrolizumab for multiple advanced solid tumours (NCT05479812). Early data in patients previously treated with immune checkpoint inhibitors demonstrated clinically meaningful anti-tumour activity and a tolerable safety profile.
Fast Track Designation is intended to accelerate the development and review of therapies that address serious or life-threatening conditions with unmet medical needs. It provides opportunities for more frequent interactions with the FDA, rolling Biologics License Application (BLA) submission, priority review, and potential eligibility for accelerated approval.
Werewolf anticipates sharing preliminary Phase 1/1b data, including results in cutaneous melanoma patients, in the fourth quarter of 2025 and engaging with the FDA regarding the potential registration pathway for WTX-124.
Source: globenewswire.com
