Werewolf Therapeutics Says FDA Grants Fast Track For WTX-124 In Advanced Melanoma Treatment

(RTTNews) - Werewolf Therapeutics, Inc. (HOWL) announced Wednesday that the Company has received Fast Track Designation for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy.

The Fast Track designation for WTX-124 was granted based on data in cutaneous melanoma patients previously treated with immune checkpoint inhibitor therapy who demonstrated clinically meaningful anti-tumor activity with a tolerable safety profile. The designation could enable Werewolf to interact more frequently with the FDA to discuss WTX-124's development path.

WTX-124 is a conditionally activated interleukin 2 (IL-2) INDUKINE therapy. Werewolf is evaluating WTX-124 in a Phase 1/1b open-label, multicenter study including single-agent and combination arms with pembrolizumab for the treatment of multiple advanced solid tumors (NCT05479812).

WTX-124 was designed to stimulate a powerful anti-tumor immune response by providing IL-2 selectively to the tumor microenvironment while decreasing the systemic toxicities that have been observed with other IL-2 immune therapies.

Product candidates with Fast Track designation are eligible for priority review, the opportunity for a rolling Biologics License Application (BLA), and accelerated approval if relevant criteria are met.