Drugs / WTX-124
last change Jul 2026 re-read 3 minutes ago

WTX-124

Developed for
metastatic neoplasm · neoplasm
Investigated by
Merck Sharp & Dohme LLC · Werewolf Therapeutics, Inc.

Trials 1

2023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT05479812 May 2022 → Jul 2026 overdue metastatic neoplasm, neoplasm Werewolf Therapeutics, Inc. Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 10

DateIssuerRelease
2025-12-18 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Announces Pipeline and Business Updates werewolftx.com ↗
WTX-124 initial Phase 1b expansion arm data showed 30% overall response rate as a monotherapy in a defined subset of post-ICI advanced or metastatic cutaneous melanoma patients, with potential best-in-class tolerability profile
2025-11-07 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Presents Data Expanding Its PREDATOR® Platform at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting werewolftx.com ↗
These strategies are supported by first-in-kind pharmacokinetic data that provided a real-time assessment of WTX-124’s selective activation and immune engagement within the tumor.
2025-10-08 Werewolf Therapeutics, Inc. Regulatory Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer werewolftx.com ↗
today 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.
2024-06-01 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics to Present Data from Ongoing Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid Tumors werewolftx.com ↗
WTX-124 was shown to be clinically active and generally well-tolerated in patients who were relapsed/refractory to immune checkpoint inhibitor therapy
2024-05-23 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics to Present Updated Data from Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid Tumors at 2024 ASCO Annual Meeting werewolftx.com ↗
Updated single agent dose escalation data continues to demonstrate that WTX-124 is well tolerated and clinically active in patients with checkpoint inhibitor therapy relapsed/refractory cancers
2023-11-14 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update werewolftx.com ↗
Preliminary data from the WTX-124 monotherapy dose-escalation arm of the ongoing Phase 1/1b clinical trial provide compelling early evidence of dose-dependent anti-tumor and biomarker activity
2023-11-03 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Presents Preliminary Monotherapy Data from Phase 1/1b Clinical Trial Establishing Proof of Mechanism for WTX-124 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting werewolftx.com ↗
Preliminary data support the potential of WTX-124 to be a differentiated next-generation IL-2 compound by showing immune cell activation in the tumor microenvironment (TME) and monotherapy clinical activity in an outpatient setting
2022-08-11 Werewolf Therapeutics, Inc. Regulatory Werewolf Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Highlights werewolftx.com ↗
During the second quarter of 2022, Werewolf received clearance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for WTX-124.
2022-04-08 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Presents Promising Preclinical Data on its Two Lead INDUKINE™ Molecules at AACR 2022 Annual Meeting werewolftx.com ↗
WTX-124 demonstrated high tumor selectivity and generated significant anti-tumor activity in a CD8+ T cell-dependent manner
2022-03-16 Werewolf Therapeutics, Inc. Results Werewolf Therapeutics Announces Publication of Data Demonstrating the Preclinical Efficacy of WTX-124 in Delivering IL-2 Selectively to the Tumor Microenvironment werewolftx.com ↗
The article, entitled “Discovery of a Conditionally Activated Interleukin-2 that Promotes Anti-tumor Immunity and Induces Tumor Regression,” includes preclinical data that demonstrate the efficacy of the design of WTX-124 in delivering IL-2 selectively to the tumor microenvironment where it stimulates a potent anti-tumor immune response.

All press releases naming this drug 15 releases

DateIssuerRelease

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as WTX-124 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05479812 ↗