Shares of Werewolf Therapeutics, Inc. (HOWL) are down more than 42% on Thursday morning hours, following an announcement highlighting recent clinical progress and upcoming milestones across its INDUKINE and INDUCER programs. The Company said it will be seeking strategic partnerships for further development of WTX-124 and WTX-330 INDUKINE programs and looking for additional funding to initiate further development.
The company emphasized progress in its lead programs WTX-124 and WTX-330, while also introducing two new T-cell engager candidates.
WTX-124 is a conditionally activated IL-2 molecule being developed for the treatment of advanced or metastatic melanoma and other solid tumors. In the ongoing Phase 1/1b trial, WTX-124 has demonstrated objective and durable responses both as monotherapy and in combination with pembrolizumab.
Among heavily pretreated melanoma patients, monotherapy achieved a 21% objective response rate, consistent with historic high-dose IL-2 activity. In patients who had previously responded to immunotherapy, the response rate rose to 30%. Importantly, the FDA has accepted 18 mg as the recommended dose for further development and provided initial guidance for a monotherapy registration path in relapsed or refractory melanoma.
Completion of the Phase 1/1b trial and an additional data update are expected in the first half of 2026.
WTX-330, a conditionally activated IL-12 molecule, is being evaluated in a Phase-1b/2 trial for immunotherapy-resistant solid tumors. Early results showed favorable tolerability and antitumor activity, including a confirmed partial response in metastatic gall bladder cancer.
The optimized manufacturing process introduced in this study improved safety and pharmacokinetics, with free IL-12 levels kept as 0.12% of prodrug exposure.
Results from Part A of the Phase 1b/2 trial are expected in the first half of 2026.
Werewolf also announced progress in its INDUCER platform, designed to improve therapeutic index of T-cell engagers through proprietary masking and linker technology.
The first candidate, WTX-1011, targets STEAP1 for prostate cancer, while second, WTX-2022, targets CDH6 for ovarian and kidney cancers.
Preclinical data demonstrated silencing, reversible masking, and potent anti-tumor activity in xenograft models, with IND filings planned for mid-2027, pending additional funding.
The company is seeking strategic partnerships to support further development of WTX-124 and WTX-330. Werewolf emphasized that its proprietary PREDATOR platform has validated tumor-activated immunotherapy and is now being extended to the INDUCER program.
Werewolf noted that additional funding will be required to initiate registration-enabling trials for WTX-124 and WTX-330, as well as IND-enabling studies for WTX-1011 and WTX-2022. The company continues to explore strategic collaborations to advance its pipeline.
HOWL has traded between $0.58 and $2.38 over the past year. The stock is currently trading at $0.61, down 42.20%.
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December 12, 2025 15:14 ET Central bank decisions dominated the economic news flow this week led by the Federal Reserve. Trade data from the U.S. also gained attention. The Canadian and Swiss central banks also announced their interest rate decisions. Inflation data from China was in focus as the country released the latest consumer price and producer price data.