Benzinga | Aug 18, 2021 07:31AM EDT

Werewolf Therapeutics Announces Clinical Trial Collaboration With Merck On Its WTX-124 INDUKINE Program

Werewolf Therapeutics, Inc. (NASDAQ:HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body's immune system for the treatment of cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside the United States and Canada, to evaluate WTX-124, a systemically-delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE product candidate, in combination with KEYTRUDA(r) (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy. The planned clinical trial will be conducted by Werewolf Therapeutics and is designed to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.



"Werewolf Therapeutics is delighted to be partnering with Merck to study the combination of KEYTRUDA and WTX-124, a molecule designed to deliver IL-2 preferentially to the tumor microenvironment and the first of Werewolf's INDUKINE portfolio to enter the clinic," said Randi Isaacs, M.D., Chief Medical Officer of Werewolf Therapeutics. "The clinical benefit of targeting IL-2 as a treatment for cancer has long been established; however, its utility has been limited by challenging toxicities. We believe WTX-124 has the potential to enhance therapeutic options for cancer patients as a monotherapy and when combined with checkpoint inhibitors like KEYTRUDA."

WTX-124 is a systemically-delivered, conditionally activated IL-2 INDUKINE molecule that has been engineered to minimize the severe toxicities that have been observed with recombinant IL-2 therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors in multiple tumor types. Werewolf Therapeutics plans to submit an investigational new drug (IND) application for WTX-124 to the U.S. Food and Drug Administration (FDA) in the first half of 2022. Subject to FDA clearance of the IND application, Werewolf Therapeutics expects to promptly initiate a Phase 1 clinical trial evaluating WTX-124 as a monotherapy and as a combination therapy with KEYTRUDA for the treatment of solid tumors.