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Werewolf Therapeutics Inc, an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, announced 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. WTX-124 is a conditionally activated interleukin 2 (IL-2) Indukine therapy. Fast Track Designation is intended to expedite the development of drugs to address a serious unmet medical need and provide opportunities for frequent US FDA interactions.
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.
“At Werewolf we are focusing on efforts to address the high unmet need of cancer patients, and we believe there is significant opportunity with WTX-124 for the potential treatment of advanced cancers,” said Daniel J. Hicklin, PhD, president and chief executive officer of Werewolf. “We are encouraged by this Fast Track Designation as an important milestone for the WTX-124 programme and because it underscores the urgent need for patients with relapsed/refractory melanoma where treatment options are limited. In the fourth quarter, we anticipate sharing preliminary data from the ongoing WTX-124 phase 1/1b clinical trial, including in patients with cutaneous melanoma, and engaging with the FDA regarding the potential registration strategy for this agent.”
The US FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. 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. 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 US FDA to discuss WTX-124’s development path.
The company is leveraging its proprietary Predator platform to design conditionally activated Indukine and Inducer molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Werewolf’s Indukine molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. The company’s most advanced clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) Indukine molecules, respectively, for the treatment of solid tumors. Werewolf is advancing WTX-124 in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor and WTX-330 in multiple solid tumor types as a single agent. Werewolf is leveraging positive data from its Indukine molecules to advance the development of Inducer molecules. Werewolf’s first Inducer development candidate, WTX-1011, targets STEAP1 for prostate cancer.
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