Werewolf Therapeutics Announces Initiation of Patient Dosing in Phase 1/1b Clinical Trial of WTX-124 for the Treatment of Patients with Selected Solid Tumors

- First clinical candidate of a new class of systemically delivered conditionally activated INDUKINE™ therapeutics developed by Werewolf

- WTX-124 is designed to target delivery of a highly potent, wild-type IL-2 cytokine to the tumor microenvironment

WATERTOWN, MA, USA I September 01, 2022 I Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (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 the first patient has been dosed in a Phase 1/1b clinical trial evaluating WTX-124, the Company’s lead INDUKINETM molecule targeting IL-2 for the treatment of solid tumors. The Phase 1/1b clinical trial is a first-in-human, multi-center, open-label trial that will evaluate WTX-124 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy in patients with immunosensitive advanced or metastatic solid tumors who have failed standard of care, including checkpoint inhibitor therapy.

“We are thrilled to share this important milestone for Werewolf of dosing the first patient in our Phase 1/1b trial of WTX-124,” shared Daniel J. Hicklin, Ph.D., Werewolf’s Founder and Chief Executive Officer. “WTX-124 is the first program from our portfolio of novel INDUKINE molecules to enter the clinic, and its progress into clinical investigation further highlights our team’s ability to execute efficiently and move our pipeline forward. We believe WTX-124 presents a tremendous opportunity, not only to improve outcomes for patients with hard-to-treat solid tumors but also to validate our novel approach of developing conditionally activated cytokines as innovative cancer therapy.”

The WTX-124 design consists of a wild-type IL-2 cytokine tethered to an inactivation domain to prevent activation in off-target tissue, a tumor protease-sensitive linker to allow for activation in the tumor micro-environment (TME) and a half-life extension domain to improve tumor exposure. The selective release of IL-2 in the TME induces anti-tumor immune responses resulting in tumor regressions in preclinical models while minimizing the toxicities associated with systemic delivery of recombinant IL-2.

“We are pleased to begin patient dosing in our Phase 1/1b clinical trial with WTX-124, a novel tumor-selective IL-2 candidate with the potential to increase the therapeutic benefit of IL-2 while decreasing the systemic toxicities often seen with high-dose IL-2 therapy,” said Randi Isaacs, M.D., Chief Medical Officer of Werewolf Therapeutics. “WTX-124 has been designed to be active only within the TME, with the goal of reducing toxicity and enhancing anti-tumor activity. We look forward to advancing this trial to further our understanding of WTX-124 as a potential therapy for the treatment of people living with cancer.”

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05479812.

About Werewolf Therapeutics:
Werewolf Therapeutics, Inc., is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. We are leveraging our proprietary PREDATOR™ platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Our INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Our most advanced 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. We expect to advance both WTX-124 and WTX-330 in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

SOURCE: Werewolf Therapeutics

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