Werewolf Therapeutics Announces Promising New Development Candidate, WTX-921, a first-of-its-kind IL-10 INDUKINE™ Molecule for Inflammatory Diseases
Werewolf Therapeutics (Nasdaq: HOWL) has announced WTX-921, a novel IL-10 INDUKINE development candidate for Inflammatory Bowel Disease (IBD) and other inflammatory diseases. This expansion leverages their PREDATOR® platform technology, which has shown promising safety and efficacy in oncology trials. The platform enables conditional activation of cytokines specifically in disease tissues while protecting healthy tissues. WTX-921 represents the company's strategic move beyond oncology into inflammatory diseases, targeting IBD which affects approximately 0.7% of Americans (721 cases per 100,000 people). The development addresses a significant unmet medical need, as IBD currently has no cure, only symptom management options.
Werewolf Therapeutics (Nasdaq: HOWL) ha annunciato WTX-921, un nuovo candidato allo sviluppo IL-10 INDUKINE per la Malattia Infiammatoria Intestinale (IBD) e altre malattie infiammatorie. Questa espansione sfrutta la loro tecnologia di piattaforma PREDATOR®, che ha dimostrato sicurezza e efficacia promettenti nei trial oncologici. La piattaforma consente l'attivazione condizionale delle citochine specificamente nei tessuti malati, proteggendo i tessuti sani. WTX-921 rappresenta una mossa strategica dell'azienda per espandersi oltre l'oncologia verso le malattie infiammatorie, mirando all'IBD che colpisce circa lo 0,7% degli americani (721 casi ogni 100.000 persone). Lo sviluppo affronta un significativo bisogno medico non soddisfatto, poiché attualmente l'IBD non ha una cura, ma solo opzioni per la gestione dei sintomi.
Werewolf Therapeutics (Nasdaq: HOWL) ha anunciado WTX-921, un nuevo candidato para el desarrollo de IL-10 INDUKINE para la Enfermedad Inflamatoria Intestinal (IBD) y otras enfermedades inflamatorias. Esta expansión aprovecha su tecnología de plataforma PREDATOR®, que ha mostrado seguridad y eficacia prometedoras en ensayos oncológicos. La plataforma permite la activación condicional de citoquinas específicamente en tejidos enfermos, protegiendo los tejidos sanos. WTX-921 representa un movimiento estratégico de la empresa más allá de la oncología hacia las enfermedades inflamatorias, apuntando a la IBD que afecta aproximadamente al 0,7% de los estadounidenses (721 casos por cada 100,000 personas). El desarrollo aborda una necesidad médica significativa no satisfecha, ya que actualmente la IBD no tiene cura, solo opciones de manejo de síntomas.
Werewolf Therapeutics (Nasdaq: HOWL)은 염증성 장 질환(IBD) 및 기타 염증성 질환을 위한 새로운 IL-10 INDUKINE 개발 후보 WTX-921을 발표했습니다. 이번 확장은 그들의 PREDATOR® 플랫폼 기술을 활용하며, 이 기술은 종양학 임상 시험에서 안전성과 효능이 유망하게 나타났습니다. 이 플랫폼은 질병 조직에서만 사이토카인을 조건부로 활성화할 수 있으며, 건강한 조직은 보호합니다. WTX-921은 종양학을 넘어 염증성 질환으로의 회사의 전략적 이동을 나타내며, 약 0.7%의 미국인(10만명당 721건)에 영향을 미치는 IBD를 목표로 하고 있습니다. 이번 개발은 IBD에 대한 치료법이 현재 존재하지 않고 증상 관리 옵션만 있는 중대한 의료적 필요를 해결합니다.
Werewolf Therapeutics (Nasdaq: HOWL) a annoncé WTX-921, un nouveau candidat de développement IL-10 INDUKINE pour la Maladie Inflammatoire Intestinale (IBD) et d'autres maladies inflammatoires. Cette expansion s'appuie sur leur plateforme technologique PREDATOR®, qui a montré des résultats prometteurs en termes de sécurité et d'efficacité lors des essais en oncologie. La plateforme permet l'activation conditionnelle des cytokines spécifiquement dans les tissus malades tout en protégeant les tissus sains. WTX-921 représente un mouvement stratégique de l'entreprise au-delà de l'oncologie vers les maladies inflammatoires, visant l'IBD qui touche environ 0,7 % des Américains (721 cas pour 100 000 personnes). Le développement répond à un besoin médical important non satisfait, car l'IBD n'a actuellement pas de traitement curatif, mais seulement des options de gestion des symptômes.
Werewolf Therapeutics (Nasdaq: HOWL) hat WTX-921 angekündigt, einen neuartigen IL-10 INDUKINE-Entwicklungskandidaten für Entzündliche Darmerkrankungen (IBD) und andere entzündliche Erkrankungen. Diese Expansion nutzt ihre PREDATOR® Plattformtechnologie, die in Onkologie-Studien vielversprechende Sicherheit und Wirksamkeit gezeigt hat. Die Plattform ermöglicht eine bedingte Aktivierung von Zytokinen speziell in erkranktem Gewebe und schützt gleichzeitig gesundes Gewebe. WTX-921 stellt den strategischen Schritt des Unternehmens dar, über die Onkologie hinaus in entzündliche Erkrankungen zu expandieren und IBD zu adressieren, die etwa 0,7% der Amerikaner betrifft (721 Fälle pro 100.000 Menschen). Die Entwicklung befasst sich mit einem erheblichen, nicht erfüllten medizinischen Bedarf, da es gegenwärtig kein Heilmittel für IBD gibt, sondern nur Optionen zur Symptombewältigung.
- Expansion into new therapeutic area (IBD) broadening market opportunities
- Platform technology showing promising safety and efficacy in ongoing clinical trials
- Targeting large market with 721 cases per 100,000 Americans
- Addressing significant unmet medical need with no current cure available
- None.
Insights
The development of WTX-921 represents a significant strategic expansion for Werewolf Therapeutics, moving beyond oncology into inflammatory diseases. The INDUKINE platform's application to IBD is particularly noteworthy as it addresses a substantial market opportunity with over 2.3 million IBD patients in the U.S. alone.
The conditional activation mechanism is technically sophisticated and could provide a important advantage over existing IBD treatments by potentially reducing systemic side effects - a common limitation of current therapies. The IL-10 targeting approach is well-validated in immunology, but the selective tissue delivery could be a game-changing differentiator. However, it's important to note that this is still in early development stages, with no human clinical data yet available.
WATERTOWN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced the addition of WTX-921, a novel IL-10 INDUKINE development candidate for Inflammatory Bowel Disease (IBD) and potentially other inflammatory diseases, to the Company’s pipeline. This pipeline expansion underscores the transformative promise of the Werewolf’s PREDATOR® platform to apply the INDUKINE approach to therapeutic areas outside of oncology.
Werewolf’s INDUKINE molecules have shown promising safety and efficacy results in ongoing oncology clinical trials. Their validated approach entails the identification of novel protease-cleavable linkers that enable the conditional activation of wild-type cytokines, optimizing efficacy in disease tissues while shielding healthy tissues from on-target/off-tissue effects. To address IBD, Werewolf leveraged this unique drug design approach and identified the optimal cytokine masking and disease selective linkers for delivery of IL-10 to inflammatory disease tissue, in this case the colon. This achievement highlights the platform’s exceptional ability to generate best-in-class, conditionally active therapeutics with unparalleled therapeutic windows, addressing critical needs across diverse medical areas.
“The unveiling of our novel drug candidate WTX-921 for IBD represents a key milestone that not only marks a pivotal moment in our trajectory forward, but also showcases our PREDATOR platform’s versatility in other critically unmet medical needs,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. “We are dedicated to pioneering therapies that target the root mechanisms of diseases evident by this new development candidate, WTX-921.”
IBD is characterized by considerable unmet need as currently there is no cure, only medications that control symptoms. According to the Centers for Disease Control and Prevention, IBD encompasses Crohn’s disease and ulcerative colitis, two conditions that are characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. While the exact cause of IBD is unknown, autoimmune and immune-mediated factors have been shown to contribute to the severity of the disease. IBD is diagnosed in more than
To learn more about the Company’s platform and immunology approach, visit www.werewolftx.com.
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. Werewolf is leveraging its proprietary PREDATOR platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. The Company’s INDUKINE molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Werewolf’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 tumor types or Non-Hodgkin Lymphoma as a single agent. To learn more visit www.werewolftx.com.
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, objectives of management, and the potential activity and efficacy of product candidates in preclinical studies and clinical trials, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “approach,” “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, 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; the timing of and the Company’s ability to submit and obtain regulatory approval for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; the Company’s ability to obtain sufficient 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.
WEREWOLF®, the WEREWOLF logo, PREDATOR®, INDUKINE™ 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.
Investor Contact:
John Norton
Precision AQ
212.362.1200
John.Norton@precisionaq.com
Media Contact:
Amanda Sellers
Deerfield Group
301.332.5574
amanda.sellers@deerfieldgroup.com
Company Contact:
Ellen Lubman
Chief Business Officer
Werewolf Therapeutics
elubman@werewolftx.com
FAQ
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