Werewolf Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. The firm offers Predator Technology which focuses on immune targeting and activation. The company was founded by Daniel J. Hicklin, Patrick A. Baeuerle, and Luke B. Evnin on October 19, 2017 and is headquartered in Watertown, MA.
Clinical Trials
3
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2017
Active, not recruiting
1
33.3%
Completed
2
66.7%
No approval data available
- Werewolf Therapeutics and Ambros Therapeutics entered into a definitive all-stock merger to create a Nasdaq-listed, late-stage biotech focused on neridronate for CRPS-1. - The combined company secured an oversubscribed $150 million private placement co-led by RA Capital Management and Janus Henderson Investors, funding operations into the first half of 2029. - Neridronate, a bisphosphonate with Breakthrough Therapy, Fast Track, and Orphan Drug designations, is being evaluated in the pivotal CRPS-RISE Phase 3 trial with topline data expected in 2028. - CRPS-1 is a debilitating orphan disease affecting an estimated 65,000 newly diagnosed U.S. patients annually with no currently FDA-approved therapy.
- Werewolf Therapeutics' WTX-124 demonstrated a 30% overall response rate as monotherapy in post-immunotherapy advanced melanoma patients with favorable tolerability profile. - WTX-330 Phase 1b/2 trial showed additional evidence of antitumor activity and highly favorable tolerability, including a confirmed partial response in metastatic gallbladder cancer. - The company announced two new INDUCER T cell engager candidates, WTX-1011 targeting STEAP1 and WTX-2022 targeting CDH6, with IND filings planned for mid-2027. - FDA accepted 18 mg as the recommended dose for WTX-124 and provided initial guidance for a registration path in post-ICI melanoma patients.
• A 73-year-old patient with advanced cutaneous squamous cell carcinoma has remained cancer-free for over a year following treatment with WTX-124, a novel conditionally activated IL-2 pro-drug, in a clinical trial at HonorHealth Research Institute. • The investigational drug is engineered to remain inactive until it reaches the tumor microenvironment, potentially delivering the benefits of IL-2 therapy with significantly reduced toxicity compared to conventional treatments. • This breakthrough offers new hope for the nearly 40,000 U.S. patients annually who develop advanced cutaneous squamous cell carcinoma, particularly those who have failed standard treatments including checkpoint inhibitor therapy.
- Werewolf Therapeutics anticipates sharing preliminary monotherapy data for WTX-124 in H1 2025, potentially guiding regulatory engagement for accelerated approval. - A Phase 1/2 clinical trial of WTX-330, an IL-12 INDUKINE molecule, is expected to begin in Q1 2025, targeting immunotherapy-resistant cancers. - Interim data from combination expansion arms of WTX-124 with pembrolizumab are expected in Q4 2025, further evaluating its efficacy in solid tumors. - Werewolf's cash position is expected to fund operations through at least the second quarter of 2026, supporting ongoing clinical development.
