Werewolf Therapeutics Highlights Initial Safety and Efficacy Data from its Ongoing Phase 1 Clinical Trial Evaluating WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

Core Insights - The administration of WTX-330 has shown therapeutically relevant exposure levels of IL-12 prodrug with improved tolerability compared to historical data for rhIL-12 [1][2] - The company is focused on advancing a pipeline of next-generation immunostimulatory medicines, with preliminary clinical data indicating promising tolerability and efficacy signals in heavily pretreated patients with late-stage solid tumors [1][3] Clinical Trial Results - As of June 12, 2024, eleven patients with relapsed or refractory solid tumors have been dosed in dose escalation cohorts, with doses of 0.016 mg/kg (n=3), 0.024 mg/kg (n=3), and 0.032 mg/kg (n=5) [1] - At the 0.024 mg/kg dose, WTX-330 demonstrated a 23-fold higher systemic drug concentration of IL-12 prodrug compared to previous IL-12 strategies, with low free IL-12 levels across all dose levels [2] - One patient with metastatic melanoma achieved an unconfirmed partial response after treatment with 0.024 mg/kg WTX-330, with no evidence of disease on biopsy [2] - Two patients with microsatellite stable colorectal cancer achieved stable disease, with one showing evidence of tumor biomarker activity [2] Immune Response and Tolerability - Evidence of robust activation of immune biomarkers, including increased antitumor CD8+ T and NK cell expansion, was observed in patients with stable disease [2] - All patients experienced mild to moderate treatment-related toxicities, primarily associated with the first dose, with no Grade 4 or Grade 5 adverse events reported [2] - Two patients experienced reversible dose-limiting toxicities at the 0.032 mg/kg dose level, including Grade 3 mucositis and Grade 3 AST increase [2] Future Developments - The company has opened two expansion arms for further evaluation of WTX-330 in patients with immune checkpoint inhibitor-sensitive solid tumors [2][3] - Additional results are anticipated in the fourth quarter of 2024, with a focus on safety, biomarker, and antitumor activity [3] Company Overview - Werewolf Therapeutics is pioneering the development of therapeutics designed to stimulate the immune system for cancer treatment, leveraging its proprietary PREDATOR® platform [5] - The company's INDUKINE™ molecules are engineered to remain inactive in peripheral tissues and activate selectively in the tumor microenvironment [5][10]