Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer
Werewolf Therapeutics (NASDAQ: HOWL) announced that the U.S. FDA granted Fast Track Designation for WTX-124, its conditionally activated IL-2 INDUKINE therapy, for potential treatment of locally advanced or metastatic cutaneous melanoma after standard-of-care immunotherapy.
WTX-124 is being evaluated in a Phase 1/1b open-label, multicenter study including single-agent and pembrolizumab combination arms (NCT05479812). The company said the designation was based on prior melanoma patients who showed clinically meaningful anti-tumor activity with a tolerable safety profile. Werewolf expects to share preliminary Phase 1/1b data in Q4 2025 and plans FDA engagement on potential registration strategy.
Werewolf Therapeutics (NASDAQ: HOWL) ha annunciato che la FDA degli Stati Uniti ha concesso Fast Track Designation per WTX-124, la sua terapia INDUKINE a base di IL-2 attivata in modo condizionato, per un potenziale trattamento del melanoma cutaneo localmente avanzato o metastatico dopo l'immunoterapia di standard-of-care.
WTX-124 è in valutazione in uno studio di Fase 1/1b aperto, multicentrico che comprende bracci in monoterapia e in combinazione con pembrolizumab (NCT05479812). L’azienda ha detto che la designazione è basata su pazienti con melanoma che hanno mostrato attività antitumorale clinicamente significativa con un profilo di sicurezza tollerabile. Werewolf prevede di condividere dati preliminari di Fase 1/1b nel Q4 2025 e pianifica un dialogo con la FDA su una possibile strategia di registrazione.
Werewolf Therapeutics (NASDAQ: HOWL) anunció que la FDA de EE. UU. otorgó la Designación de Ruta de Despacho Rápido para WTX-124, su terapia IL-2 INDUKINE activada condicionalmente, para un posible tratamiento del melanoma cutáneo localmente avanzado o metastásico tras la inmunoterapia de referencia.
WTX-124 se está evaluando en un estudio multicéntrico, abierto de Fase 1/1b que incluye brazos en monoterapia y en combinación con pembrolizumab (NCT05479812). La compañía indicó que la designación se basó en pacientes con melanoma que mostraron actividad antitumoral clínicamente significativa con un perfil de seguridad tolerable. Werewolf espera compartir datos preliminares de la Fase 1/1b en Q4 2025 y planea realizar un compromiso con la FDA sobre una posible estrategia de registro.
Werewolf Therapeutics (NASDAQ: HOWL)는 미국 FDA가 WTX-124에 대해 패스트 트랙 지정을 부여했다고 발표했다. 이는 조건부 활성화 IL-2 INDUKINE 치료제로, 표준 치료 면역요법 후 국소 진행성 또는 전이성 피부 흑색종의 잠재적 치료를 위한 것이다.
WTX-124는 단일제 및 pembrolizumab 병용군을 포함한 다기관 공개 라벨 1상/1b 연구(NCT05479812)에서 평가 중이다. 회사는 이 지정이 임상적으로 의미 있는 항종양 활성을 보이고 안전성 프로파일이 허용 가능한 melanoma 환자들을 바탕으로 이루어졌다고 밝혔다. Werewolf는 1상/1b의 예비 데이터를 2025년 4분기에 공유할 예정이며, 잠재적 등록 전략에 대해 FDA와 논의할 계획이다.
Werewolf Therapeutics (NASDAQ: HOWL) a annoncé que la FDA américaine a accordé la Designation de voie rapide pour le WTX-124, sa thérapie IL-2 INDUKINE activée conditionnellement, en vue d’un éventuel traitement du mélanome cutané localement avancé ou métastatique après l’immunothérapie de référence.
WTX-124 est évalué dans une étude multicentrique en open-label de phase 1/1b comprenant des bras en monothérapie et en association avec le pembrolizumab (NCT05479812). La société a déclaré que la designation reposait sur des patients atteints de mélanome qui ont montré une activité antitumorale cliniquement significative avec un profil de sécurité tolérable. Werewolf prévoit de partager des données préliminaires de la phase 1/1b au Q4 2025 et prévoit un engagement avec la FDA sur une éventuelle stratégie d’enregistrement.
Werewolf Therapeutics (NASDAQ: HOWL) kündigte an, dass die US-amerikanische FDA für WTX-124, seine konditionell aktivierte IL-2 INDUKINE-Therapie, die Fast-Track-Zulassung gewährt hat, zur potenziellen Behandlung von lokal fortgeschrittenem oder metastasiertem kutanen Melanom nach der Standardtherapie mit Immuntherapie.
WTX-124 wird in einer offenen, multizentrischen Phase-1/1b-Studie bewertet, die Monotherapie- und Pembrolizumab-Kombinationsarme umfasst (NCT05479812). Das Unternehmen erklärte, die Zulassung basiere auf früheren Melanom-Patienten, die klinisch signifikante antitumorale Aktivität bei verträglichem Sicherheitsprofil gezeigt hätten. Werewolf rechnet damit, im Q4 2025 vorläufige Daten der Phase 1/1b zu präsentieren und plant eine FDA-Beteiligung an einer potenziellen Registrierungsstrategie.
Werewolf Therapeutics (NASDAQ: HOWL) أعلنت أن إدارة الغذاء والدواء الأمريكية (FDA) منحت تصنيف المسار السريع لـ WTX-124، علاجي IL-2 INDUKINE المُفعَّل شرطًا، لعلاج محتمل لسرطان الجلد الميلانوما الموضعي المتقدم أو المتضاعف بعد العلاج المناعي القياسي.
يُقيَّم WTX-124 في دراسة مفتوحة باللغة 1/1b متعددة المراكز تشمل أذرع أحادية الدواء وأذرع تجمع بينه وبين pembrolizumab (NCT05479812). ذكرت الشركة أن التصنيف استند إلى مرضى الورم الميلانيني الذين أظهروا نشاطًا مضادًا للأورام ذا معنى سريريًا مع ملف أمان قابل للتحمل. تتوقع Werewolf مشاركة بيانات المرحلة 1/1b الأولية في الربع الرابع من 2025 وتخطّط للتواصل مع FDA حول استراتيجية تسجيل محتملة.
Werewolf Therapeutics (NASDAQ: HOWL) 宣布，美国食品药品监督管理局已为 WTX-124 授予 快速通道（Fast Track）认定，这是其条件激活的 IL-2 INDUKINE 治疗，用于在标准护理免疫治疗后潜在治疗局部进展期或转移性皮肤黑色素瘤。
WTX-124 正在一项开放标签、跨中心的 1/1b 期研究中评估，包含单药治疗组和与 pembrolizumab 联合治疗组（NCT05479812）。公司表示，该认定基于此前黑色素瘤患者显示出具有临床意义的抗肿瘤活性且安全性可接受的证据。Werewolf 预计在 2025 年第四季度公布 1/1b 期初步数据，并计划就潜在注册策略与 FDA 进行接触。
- FDA granted Fast Track designation for WTX-124
- WTX-124 eligible for priority review and rolling BLA opportunities
- Preliminary Phase 1/1b data expected in Q4 2025
- WTX-124 remains investigational in a Phase 1/1b study
- Fast Track designation is not an approval or guarantee of success
Insights
Fast Track for WTX-124 signals regulatory acceleration potential and confirms early clinical activity in relapsed/refractory cutaneous melanoma.
Werewolf won
The immediate business mechanism is clearer regulatory engagement and potential shorter review timelines for a registration pathway if pivotal data support benefit and safety. Risks remain: the designation does not change the existing evidentiary burden, and Phase 1/1b results must translate into robust, confirmatory outcomes. Key items to watch are the preliminary Phase 1/1b data expected in
Fast Track Designation underscores the promise of Werewolf’s INDUKINE™ platform
WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, 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. WTX-124 is a conditionally activated interleukin 2 (IL-2) INDUKINE therapy. Fast Track Designation is intended to expedite the development of drugs to address a serious unmet medical need and provide opportunities for frequent FDA interactions.
Werewolf is evaluating WTX-124 in a Phase 1/1b open-label, multicenter study including single-agent and combination arms with pembrolizumab for the treatment of multiple advanced solid tumors (NCT05479812). WTX-124 was designed to stimulate a powerful anti-tumor immune response by providing IL-2 selectively to the tumor microenvironment while decreasing the systemic toxicities that have been observed with other IL-2 immune therapies.
“At Werewolf we are focusing on efforts to address the high unmet need of cancer patients, and we believe there is significant opportunity with WTX-124 for the potential treatment of advanced cancers,” said Daniel J. Hicklin, PhD, President and Chief Executive Officer of Werewolf. “We are encouraged by this Fast Track Designation as an important milestone for the WTX-124 program and because it underscores the urgent need for patients with relapsed/refractory melanoma where treatment options are limited. In the fourth quarter, we anticipate sharing preliminary data from the ongoing WTX-124 Phase 1/1b clinical trial, including in patients with cutaneous melanoma, and engaging with the FDA regarding the potential registration strategy for this agent.”
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review, the opportunity for a rolling Biologics License Application (BLA), and accelerated approval if relevant criteria are met. The Fast Track designation for WTX-124 was granted based on data in cutaneous melanoma patients previously treated with immune checkpoint inhibitor therapy who demonstrated clinically meaningful anti-tumor activity with a tolerable safety profile. The designation could enable Werewolf to interact more frequently with the FDA to discuss WTX-124’s development path.
A description of the Fast Track criteria and process is available on the FDA website:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
About Werewolf Therapeutics
Werewolf Therapeutics, Inc., is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions. The Company is leveraging its proprietary PREDATOR® platform to design conditionally activated INDUKINETM and INDUCERTM molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Werewolf’s INDUKINE molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. The Company’s most advanced clinical stage product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of solid tumors. Werewolf is advancing WTX-124 in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor and WTX-330 in multiple solid tumor types as a single agent. Werewolf is leveraging positive data from its INDUKINE molecules to advance the development of INDUCER molecules. Werewolf’s first INDUCER development candidate, WTX-1011, targets STEAP1 for prostate cancer. To learn more visit www.werewolftx.com.
WEREWOLF®, the WEREWOLF logo, PREDATOR®, INDUKINETM, INDUCERTM, and other Werewolf trademarks, service marks, graphics and logos are trade names, trademarks or registered trademarks of Werewolf Therapeutics, Inc., in the United States or other countries. All rights reserved.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Werewolf’s strategy, future operations, prospects, plans, and objectives of management; the expected timeline for the preclinical and clinical development of product candidates and the availability of data from such preclinical and clinical development; the timing of anticipated regulatory engagement; the potential benefits of Fast Track Designation for WTX-124 for the potential treatment of advanced or metastatic cutaneous melanoma, including the potential to expedite development and enable frequent interactions with the FDA; the potential activity and efficacy of product candidates in preclinical studies and clinical trials; and the anticipated safety profile of product candidates constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “design,” “designed to,” “engineered,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “promise,” “should,” “target,” “will,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the development of product candidates, including the conduct of research activities, and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; whether preliminary or interim data from a clinical trial will be predictive of the future results of the trial and future clinical trials; the Company’s ability to manage cash resources and obtain additional cash resources to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in the “Risk Factors” section of the Company’s most recent Form 10-Q filed with the Securities and Exchange Commission (SEC), and in subsequent filings the Company may make with the SEC. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Dan Ferry
LifeSci Advisors
617.430.7576
daniel@lifesciadvisors.com
Media Contact:
Amanda Sellers
Deerfield Group
301.332.5574
amanda.sellers@deerfieldgroup.com
Company Contact:
Timothy Trost
Chief Financial Officer
Werewolf Therapeutics
ttrost@werewolftx.com
FAQ
What did FDA Fast Track designation mean for Werewolf Therapeutics (HOWL) and WTX-124?
What clinical trial is evaluating WTX-124 for HOWL and where can I find it?
When will Werewolf (HOWL) report clinical data for WTX-124?
Why was Fast Track granted for WTX-124 in cutaneous melanoma?
Does Fast Track designation mean WTX-124 is approved for melanoma?
