HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
HCW Biologics (NASDAQ: HCWB) has received FDA clearance for its Investigational New Drug Application to begin a first-in-human Phase 1 dose escalation clinical trial for HCW9302, targeting moderate-to-severe alopecia areata. This autoimmune disease causes sudden hair loss and currently lacks curative FDA-approved treatments.
HCW9302 is an injectable IL-2 fusion protein complex developed using the Company's TOBI platform technology. It works by binding to IL-2αβγ receptors on regulatory T cells (Treg), activating and expanding them to suppress unwanted immune and inflammatory responses. The drug has shown efficacy in treating autoimmune diseases through subcutaneous injections in preclinical models.
The initial trial aims to establish a safe dose that effectively increases Treg cell activity. Upon success, the company plans to expand into Phase 2 studies for other autoimmune diseases and inflammatory conditions, including dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases.
HCW Biologics (NASDAQ: HCWB) ha ricevuto l'approvazione della FDA per la sua Richiesta di Nuovo Farmaco Sperimentale (Investigational New Drug Application) per iniziare un trial clinico di fase 1 con dose escalation per HCW9302, mirato ad alopecia areata da moderata a grave. Questa malattia autoimmune provoca una perdita improvvisa di capelli e attualmente non dispone di trattamenti curativi approvati dalla FDA.
HCW9302 è un complesso proteico fusione IL-2 iniettabile sviluppato utilizzando la tecnologia della piattaforma TOBI dell'azienda. Funziona legandosi ai recettori IL-2αβγ sulle cellule T regolatorie (Treg), attivandole e espandendole per sopprimere risposte immunitarie e infiammatorie indesiderate. Il farmaco ha dimostrato efficacia nel trattamento di malattie autoimmuni attraverso iniezioni sottocutanee in modelli preclinici.
Il trial iniziale mira a stabilire una dose sicura che aumenti efficacemente l'attività delle cellule Treg. Se avrà successo, l'azienda prevede di espandere gli studi nella fase 2 per altre malattie autoimmuni e condizioni infiammatorie, comprese quelle dermatologiche, il rigetto di innesti, l'artrosclerosi, il diabete e le malattie neurodegenerative.
HCW Biologics (NASDAQ: HCWB) ha recibido la aprobación de la FDA para su Solicitud de Nuevo Medicamento en Investigación para comenzar un ensayo clínico de fase 1 con escalación de dosis para HCW9302, dirigido a la alopecia areata de moderada a severa. Esta enfermedad autoinmune causa una pérdida repentina de cabello y actualmente carece de tratamientos curativos aprobados por la FDA.
HCW9302 es un complejo proteico de fusión IL-2 inyectable desarrollado utilizando la tecnología de la plataforma TOBI de la empresa. Actúa uniéndose a los receptores IL-2αβγ en las células T reguladoras (Treg), activándolas y expandiéndolas para suprimir respuestas inmunitarias e inflamatorias no deseadas. El fármaco ha mostrado eficacia en el tratamiento de enfermedades autoinmunes a través de inyecciones subcutáneas en modelos preclínicos.
El ensayo inicial tiene como objetivo establecer una dosis segura que aumente efectivamente la actividad de las células Treg. Si tiene éxito, la empresa planea expandirse a estudios de fase 2 para otras enfermedades autoinmunes y condiciones inflamatorias, incluidas condiciones dermatológicas, el rechazo de injertos, la artriosclerosis, la diabetes y las enfermedades neurodegenerativas.
HCW Biologics (NASDAQ: HCWB)는 중증 탈모증을 목표로 하는 HCW9302에 대한 첫 번째 인체 1상 용량 증량 임상 시험을 시작하기 위한 연구 신약 신청서에 대해 FDA 승인을 받았습니다. 이 자가면역 질환은 갑작스러운 탈모를 유발하며 현재 FDA 승인 치료법이 없습니다.
HCW9302는 회사의 TOBI 플랫폼 기술을 사용하여 개발된 주사 가능한 IL-2 융합 단백질 복합체입니다. 이는 조절 T 세포(Treg)上的 IL-2αβγ 수용체에 결합하여 Treg을 활성화하고 확장하여 원치 않는 면역 및 염증 반응을 억제합니다. 이 약물은 전임상 모델에서 피하 주사를 통해 자가면역 질환 치료에서 효과를 보여주었습니다.
초기 시험은 Treg 세포 활성을 효과적으로 증가시키는 안전한 용량을 확립하는 것을 목표로 합니다. 성공하면 회사는 피부과적 질환, 이식 거부, 동맥경화증, 당뇨병 및 신경퇴행성 질환 등을 포함한 다른 자가면역 질환 및 염증성 상태에 대한 2상 연구로 확대할 계획입니다.
HCW Biologics (NASDAQ: HCWB) a reçu l'autorisation de la FDA pour sa Demande de Nouveau Médicament d'Essai (Investigational New Drug Application) afin de commencer un essai clinique de phase 1 avec escalade de doses pour HCW9302, visant l'alopécie areata modérée à sévère. Cette maladie auto-immune provoque une perte de cheveux soudaine et ne dispose actuellement d'aucun traitement curatif approuvé par la FDA.
HCW9302 est un complexe protéique de fusion IL-2 injectable développé grâce à la technologie de plateforme TOBI de l'entreprise. Il agit en se liant aux récepteurs IL-2αβγ sur les cellules T régulatrices (Treg), les activant et les élargissant pour supprimer les réponses immunitaires et inflammatoires indésirables. Le médicament a montré son efficacité dans le traitement des maladies auto-immunes par injections sous-cutanées dans des modèles précliniques.
L'essai initial vise à établir une dose sûre qui augmente efficacement l'activité des cellules Treg. En cas de succès, l'entreprise prévoit d'élargir ses études de phase 2 à d'autres maladies auto-immunes et conditions inflammatoires, y compris les affections dermatologiques, le rejet de greffe, l'arthrosclérose, le diabète et les maladies neurodégénératives.
HCW Biologics (NASDAQ: HCWB) hat die Genehmigung der FDA für seinen Antrag auf ein neues experimentelles Medikament (Investigational New Drug Application) erhalten, um eine erste klinische Studie der Phase 1 mit Dosissteigerung für HCW9302 zu beginnen, die auf mittelschwere bis schwere Alopecia areata abzielt. Diese Autoimmunerkrankung verursacht plötzlichen Haarausfall und hat derzeit keine zugelassenen heilenden Behandlungen von der FDA.
HCW9302 ist ein injizierbarer IL-2-Fusionsproteinkomplex, der mit der TOBI-Plattformtechnologie des Unternehmens entwickelt wurde. Es wirkt, indem es an die IL-2αβγ-Rezeptoren auf regulatorischen T-Zellen (Treg) bindet, diese aktiviert und erweitert, um unerwünschte Immun- und Entzündungsreaktionen zu unterdrücken. Das Medikament hat in präklinischen Modellen durch subkutane Injektionen Wirksamkeit bei der Behandlung von Autoimmunerkrankungen gezeigt.
Die anfängliche Studie zielt darauf ab, eine sichere Dosis zu bestimmen, die die Treg-Zellaktivität effektiv erhöht. Bei Erfolg plant das Unternehmen, in Phase 2-Studien für andere Autoimmunerkrankungen und entzündliche Erkrankungen zu expandieren, einschließlich dermatologischer Erkrankungen, Transplantatabstoßung, Arteriosklerose, Diabetes und neurodegenerativer Erkrankungen.
- FDA clearance received for Phase 1 clinical trial
- Potential first-in-kind treatment for alopecia areata with no current cure
- Successful preclinical results in multiple autoimmune disease models
- Platform technology with potential expansion to multiple conditions
- Early-stage clinical development with no proven efficacy in humans yet
- Faces competition from existing off-label treatments
Insights
The FDA clearance for HCW9302's Phase 1 trial represents a significant milestone for HCWB, marking their strategic entry into the growing autoimmune disease market. The focus on alopecia areata is particularly noteworthy as this condition affects approximately 6.8 million people in the U.S., presenting a substantial market opportunity.
The technical approach using their proprietary TOBI platform to create an IL-2 fusion protein complex is innovative. The subcutaneous delivery method and selective targeting of Treg cells could provide key advantages over existing treatments, potentially offering improved safety profiles compared to broad immunosuppressants. The mechanism of action through IL-2αβγ receptors suggests a more precise immunomodulation approach.
The company's strategy to start with alopecia areata before expanding into other autoimmune indications is shrewd for several reasons:
- Lower regulatory hurdles for non-life-threatening conditions
- Faster patient recruitment due to high disease prevalence
- Clearer efficacy endpoints through visible hair growth assessment
- Potential for rapid expansion into multiple lucrative markets
The development timeline is critical - Phase 1 dose-escalation studies typically take 12-18 months. Success here could accelerate development in other indications through the established safety profile. The company's pipeline expansion strategy into conditions like diabetes and neurodegenerative diseases indicates ambitious long-term growth plans, though investors should note that each indication will require separate clinical trials.
The Phase 1 trial design reveals a sophisticated clinical development strategy. The focus on dose escalation with Treg cell activity as a biomarker is particularly clever, as it will provide both safety data and early efficacy signals through a measurable biological response. This dual-purpose approach could accelerate the development timeline.
Key clinical development advantages include:
- Clear biomarker strategy through Treg cell monitoring
- Visible efficacy endpoints through hair regrowth assessment
- Well-defined patient population with established diagnostic criteria
- Potential for shorter trial duration due to rapid response assessment
The preclinical efficacy data in multiple autoimmune models suggests broad therapeutic potential, though investors should note that transition rates from preclinical to approved drugs in autoimmune conditions historically hover around 15%. The company's rapid expansion plans into Phase 2 studies across multiple indications will require substantial resources and careful pipeline prioritization.
This study will evaluate HCW9302 in patients with moderate to severe alopecia areata
MIRAMAR, Fla., Feb. 03, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, today announced that it has received clearance of its Investigational New Drug Application (“IND”) from the U.S. Food and Drug Administration (“FDA”) to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein complex constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2αβγ receptors predominantly expressed on regulatory T (“Treg”) cells, thereby activating and expanding Treg cells that can suppress unwanted immune and inflammatory responses.
Chronic inflammation is believed to be a significant contributing factor in many diseases and conditions including those that have a major impact on quality-of-life but are not life-threatening. In multiple relevant preclinical models, HCW9302 has shown efficacy in treating autoimmune diseases at well-tolerated dose levels by activating and expanding Treg cells through subcutaneous injections. Protein-based therapies, whether as direct inhibitors or immunomodulatory agents, have revolutionized the management of autoimmune and inflammatory conditions. The Company believes that HCW9302, with its subcutaneous injectable approach, has the potential to activate and expand Treg cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression.
Dr. Hing C. Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our Company, and the beginning of clinical development of treatments for quality-of-life indications. While not life-threatening, alopecia areata has no cure. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. For those who suffer from this disease, it can negatively impact their quality-of-life.” Dr. Wong continued, “The goal of this initial trial is to establish the safe dose of HCW9302 that effectively increases Treg cells activity in patients. Once we achieve this objective, we will rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with other autoimmune diseases and inflammatory conditions, including other dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases where HCW9302 has been shown to have activity in relevant animal models.”
About Alopecia Areata:
Alopecia areata (“AA”) is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of
About HCW Biologics:
HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 30 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/.
Forward Looking Statements:
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the Company’s ability to develop new immunotherapeutic treatments for auto-immune indications; the Company’s ability to enter into agreements with clinical sites to participate in the study; the successful initiation of a clinical trial; the Company’s ability to enroll the required number of patients for the study; that the clinical study will proceed with no adverse effects to any patients participating in the trial; that the study will not be put on a clinical hold by the FDA for any reason; and that the clinical study will reach its endpoints successfully; the efficacy of HCW9302 for autoimmune conditions; and the ability of HCW9302 to activate and regulate Treg cells in patients. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, the latest Form 10-Q filed with the SEC on November 14, 2024, and in other filings filed from time to time with the SEC.
Company Contact:
Peter Rhode, PhD.
Vice President of Clinical Operations and Chief Scientific Officer
HCW Biologics Inc.
peterrhode@hcwbiologics.com
FAQ
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