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Werewolf Therapeutics Announces Pipeline and Business Updates

1. WTX-124 shows 30% response rate in melanoma patients. 2. WTX-330 data demonstrates favorable tolerability and antitumor activity. 3. Phase 1/1b trial updates for WTX-124 and WTX-330 expected in H1 2026. 4. Werewolf seeks partnerships for further development of INDUKINE programs. 5. IND filings for WTX-1011 and WTX-2022 anticipated by mid-2027.

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FAQ

Why Bullish?

The positive data on WTX-124 and WTX-330 may attract investor interest, similar to other biotech firms with successful clinical trial results like Moderna and BioNTech during their COVID vaccine trials.

How important is it?

The article provides significant insights into drug development progress, which is crucial for investor assessments of HOWL’s future.

Why Long Term?

The anticipated data updates and potential regulatory approvals in 2026 and 2027 could lead to sustained investor confidence and further funding opportunities.

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Werewolf Therapeutics (HOWL) Announces Key Pipeline and Business Updates

WATERTOWN, Mass., December 18, 2025 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc. (Nasdaq: HOWL), a pioneering biopharmaceutical company, has provided significant updates regarding its clinical pipeline and business strategy for 2026. The company's announcements highlight promising developments in its INDUKINE™ programs, particularly concerning the therapeutics WTX-124 and WTX-330, which exhibit encouraging antitumor activity and tolerability in advanced cancer treatment.

Promising Data from WTX-124 and WTX-330

Werewolf's recent data reveal a 30% overall response rate in a specific subset of post-ICI advanced or metastatic cutaneous melanoma patients treated with WTX-124. This monotherapy showcases a potential best-in-class tolerability profile, supporting its progression to further clinical phases. Additionally, initial data from the Phase 1b/2 trial of WTX-330 demonstrated further antitumor activity and a favorable tolerability profile.

  • 30% objective response rate for WTX-124 in post-ICI melanoma patients.
  • Encouraging tolerability and early efficacy for WTX-330 in resistant cancer types.
  • Data updates for both programs are expected in the first half of 2026.

Future Development Goals

As part of its 2026 strategy, Werewolf Therapeutics plans to complete the Phase 1/1b trial for WTX-124 and gather additional data that could lead to registration-enabling trials. The company's CEO, Dr. Dan Hicklin, emphasized the encouraging clinical responses observed with both WTX-124 and WTX-330, underscoring their potential role in improving outcomes for patients with refractory cancers.

In a recent End of Phase 1 meeting with the FDA, WTX-124's recommended dose of 18 mg received acknowledgment for its potential pathway towards registration. This sets the stage for future advancements in immunotherapy.

Strategic Partnerships and Funding Needs

To support the ongoing development of its INDUKINE programs, Werewolf is actively seeking strategic partnerships. These collaborations would aid in the advancement of WTX-124 and WTX-330, ensuring potential new therapeutic options for patients with difficult-to-treat cancers.

  • Funding required for further advancement of WTX-124 and WTX-330.
  • Plans for two INDs by mid-2027 for development candidates targeting STEAP1 and CDH6.

About Werewolf Therapeutics

Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing immunotherapies that engage the body’s immune system against cancer and immune-mediated diseases. With a strong emphasis on advancing its INDUCER T cell engager platform, Werewolf aims to establish itself as a leader in the field of immunotherapy.

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