Werewolf Therapeutics, Inc. announced clinical data for its two conditionally activated INDUKINE molecules, WTX-124 and WTX-330, at the Society for Immunotherapy of Cancer’s 2026 Annual Meeting held from November 6 to 8. The data were presented in a Phase 1/1b trial for WTX-124 and a Phase 1b/2 trial for WTX-330, both targeting solid tumors.
Regarding the Phase 1/1b trial of WTX-124, the company reported that the drug was administered safely at a recommended Phase 2 dose of 18 mg intravenously every two weeks (Q2W) in an outpatient setting. The trial included 155 patients with relapsed or refractory, immunotherapy-sensitive solid tumors. In the dose escalation portion, WTX-124 as a monotherapy produced three objective responses, including one durable confirmed complete response in a patient with cutaneous squamous cell carcinoma. In the combination arm with pembrolizumab, the company reported a confirmed complete response and a confirmed partial response in patients with cutaneous melanoma. In the dose expansion phase, the combination with pembrolizumab achieved a 37.5% response rate in non-small cell lung cancer patients who had prior chemoimmunotherapy.
Werewolf stated that it has aligned with the U.S. Food and Drug Administration (FDA) on the WTX-124 recommended Phase 2 dose of 18 mg IV Q2W for both monotherapy and combination with pembrolizumab. Analysis of tumor biopsies indicated that WTX-124 increased the expression of T cell and T cell activation genes.
In the Phase 1b/2 trial of WTX-330, the company reported data from 24 patients treated at doses ranging from 0.016 mg/kg to 0.032 mg/kg. The data showed that WTX-330 was well tolerated and was administered primarily in the outpatient setting. The company noted a dramatic reduction in the frequency of treatment-related adverse events compared to first-in-human material. The molecule produced evidence of intratumoral IL-12/STAT4 signaling in 7 of 9 patients contributing paired tumor biopsies. A confirmed partial response per RECIST 1.1 was observed in a patient with gallbladder cancer whose best prior response was progressive disease.
