Werewolf Therapeutics, Inc. announced that the first patient has been dosed in a Phase 1 clinical trial evaluating WTX-330, the Company's lead INDUKINETM molecule targeting Interleukin-12 (IL-12). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate WTX-330 in patients with advanced or metastatic solid tumors or lymphoma resistant to checkpoint inhibitors or for which checkpoint inhibitors are not approved.
IL-12 has historically been an extremely attractive immuno-oncology mechanism, having the ability to regulate antitumor immunity through numerous innate and adaptive immune pathways, but to-date has been undruggable due to serious toxicities when administered systemically. WTX-330 is specifically designed to maximize clinical benefit and minimize the severe toxicities that have been observed with recombinant IL-12 therapy by including high affinity blockade of IL-12 – IL-12R interaction in systemic circulation and non-tumor tissues, half-life extension for optimal tumor exposure and proprietary tumor-selective protease activation. In preclinical studies, WTX-330 exhibited excellent anti-tumor activity and a favorable pharmacokinetic and tolerability profile. WTX-330 was designed to mediate robust anti-tumor activity through stimulation of innate and adaptive antitumor immune responses, including dendritic cell maturation and cross-presentation, Th1 differentiation and amplification of antitumor T effector cell responses.