HCW Biologics Announces Positive Results of Studies of Proprietary Compound, HCW9206 and Availability for Commercialization
HCW Biologics (NASDAQ: HCWB) has announced positive results for its proprietary fusion protein HCW9206, demonstrating superior performance in generating CAR-T cells for immunotherapy. The compound shows significant advantages over standard methods using anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction.
Research presented at the 2025 Annual Meeting of American Association of Immunologists revealed that HCW9206 effectively expands stem cell-like memory T cells (Tscm) carrying CAR constructs, which exhibit better persistence and targeted cell killing. In experimental humanized mouse models, HCW9206-generated CAR-Ts showed enhanced potency in suppressing HIV-1 and leukemic cells compared to standard methods.
The company has completed the GMP master cell bank and manufacturing process for HCW9206, with its drug master file submitted to the FDA. HCWB is now seeking commercial partnerships for reagent sales and integration into CAR-T manufacturing processes.
HCW Biologics (NASDAQ: HCWB) ha annunciato risultati positivi per la sua proteina di fusione proprietaria HCW9206, dimostrando prestazioni superiori nella generazione di cellule CAR-T per l'immunoterapia. Il composto presenta vantaggi significativi rispetto ai metodi standard che utilizzano reagenti anti-CD3/anti-CD28 e IL-2 per la trasduzione lentivirale CAR.
La ricerca presentata al 2025 Annual Meeting of American Association of Immunologists ha rivelato che HCW9206 espande efficacemente le cellule T con memoria a stampo staminale (Tscm) contenenti costrutti CAR, che mostrano una migliore persistenza e capacità di uccisione mirata delle cellule. In modelli sperimentali di topi umanizzati, le CAR-T generate con HCW9206 hanno mostrato una potenza superiore nella soppressione di HIV-1 e cellule leucemiche rispetto ai metodi standard.
L'azienda ha completato la banca cellulare master GMP e il processo di produzione per HCW9206, con il file master del farmaco già presentato alla FDA. HCWB è ora alla ricerca di partnership commerciali per la vendita dei reagenti e l'integrazione nei processi di produzione CAR-T.
HCW Biologics (NASDAQ: HCWB) ha anunciado resultados positivos para su proteína de fusión patentada HCW9206, demostrando un rendimiento superior en la generación de células CAR-T para inmunoterapia. El compuesto muestra ventajas significativas sobre los métodos estándar que utilizan reactivos anti-CD3/anti-CD28 e IL-2 para la transducción lentiviral CAR.
La investigación presentada en la Reunión Anual 2025 de la Asociación Americana de Inmunólogos reveló que HCW9206 expande eficazmente las células T con memoria tipo célula madre (Tscm) que portan constructos CAR, las cuales exhiben mejor persistencia y capacidad de eliminación celular dirigida. En modelos experimentales de ratones humanizados, las CAR-T generadas con HCW9206 mostraron una potencia mejorada para suprimir el VIH-1 y células leucémicas en comparación con los métodos estándar.
La empresa ha completado el banco maestro de células GMP y el proceso de fabricación para HCW9206, con el expediente maestro del medicamento presentado a la FDA. HCWB ahora busca asociaciones comerciales para la venta de reactivos y la integración en procesos de fabricación de CAR-T.
HCW Biologics (NASDAQ: HCWB)는 독자적인 융합 단백질 HCW9206에 대해 긍정적인 결과를 발표했으며, 면역치료용 CAR-T 세포 생성에서 우수한 성능을 입증했습니다. 이 화합물은 CAR 렌티바이러스 전달을 위한 anti-CD3/anti-CD28 및 IL-2 시약을 사용하는 기존 방법에 비해 상당한 이점을 보입니다.
2025년 미국 면역학회 연례회의에서 발표된 연구에 따르면, HCW9206는 CAR 구조체를 지닌 줄기세포 유사 기억 T세포(Tscm)를 효과적으로 확장시키며, 이 세포들은 더 나은 지속성과 표적 세포 살상 능력을 보여줍니다. 인간화 마우스 모델 실험에서 HCW9206로 생성된 CAR-T는 기존 방법에 비해 HIV-1 및 백혈병 세포 억제에서 향상된 효능을 나타냈습니다.
회사는 HCW9206의 GMP 마스터 세포주 및 제조 공정을 완료했으며, 약물 마스터 파일을 FDA에 제출했습니다. HCWB는 현재 시약 판매 및 CAR-T 제조 공정 통합을 위한 상업적 파트너십을 모색 중입니다.
HCW Biologics (NASDAQ : HCWB) a annoncé des résultats positifs pour sa protéine de fusion propriétaire HCW9206, démontrant une performance supérieure dans la génération de cellules CAR-T pour l'immunothérapie. Le composé présente des avantages significatifs par rapport aux méthodes standard utilisant des réactifs anti-CD3/anti-CD28 et IL-2 pour la transduction lentivirale CAR.
Des recherches présentées lors de la réunion annuelle 2025 de l'American Association of Immunologists ont révélé que HCW9206 étend efficacement les cellules T à mémoire de type cellule souche (Tscm) portant des constructions CAR, qui montrent une meilleure persistance et une capacité de destruction ciblée des cellules. Dans des modèles expérimentaux de souris humanisées, les CAR-T générées avec HCW9206 ont montré une puissance accrue pour supprimer le VIH-1 et les cellules leucémiques par rapport aux méthodes standard.
L'entreprise a finalisé la banque de cellules maîtresse GMP et le processus de fabrication pour HCW9206, avec le dossier maître du médicament soumis à la FDA. HCWB cherche désormais des partenariats commerciaux pour la vente des réactifs et l'intégration dans les processus de fabrication CAR-T.
HCW Biologics (NASDAQ: HCWB) hat positive Ergebnisse für sein proprietäres Fusionsprotein HCW9206 bekannt gegeben, das eine überlegene Leistung bei der Herstellung von CAR-T-Zellen für die Immuntherapie zeigt. Die Verbindung weist deutliche Vorteile gegenüber Standardmethoden mit Anti-CD3/Anti-CD28- und IL-2-Reagenzien für die CAR-Lentivirus-Transduktion auf.
Forschungsergebnisse, die auf dem Jahrestreffen 2025 der American Association of Immunologists vorgestellt wurden, zeigten, dass HCW9206 Stammzell-ähnliche Gedächtnis-T-Zellen (Tscm) mit CAR-Konstrukten effektiv expandiert, die eine bessere Persistenz und gezielte Zellabtötung aufweisen. In experimentellen humanisierten Mausmodellen zeigten mit HCW9206 erzeugte CAR-T-Zellen eine erhöhte Wirksamkeit bei der Unterdrückung von HIV-1 und Leukämiezellen im Vergleich zu Standardmethoden.
Das Unternehmen hat die GMP-Masterzellbank und den Herstellungsprozess für HCW9206 abgeschlossen und die Arzneimittel-Masterdatei bei der FDA eingereicht. HCWB sucht nun nach kommerziellen Partnerschaften für den Verkauf von Reagenzien und die Integration in CAR-T-Herstellungsprozesse.
- HCW9206 demonstrates superior performance compared to standard CAR-T cell production methods
- Successfully expands stem cell-like memory T cells (Tscm) with better persistence and cell killing capabilities
- Shows enhanced potency in suppressing HIV-1 and leukemic cells in experimental models
- GMP master cell bank and manufacturing process already established
- Drug master file submitted to FDA
- None.
Insights
HCW Biologics' novel HCW9206 protein shows superior CAR-T cell generation with improved persistence and function over standard methods.
HCW Biologics has unveiled compelling data for their proprietary fusion protein HCW9206, which represents a significant advancement in CAR-T cell manufacturing technology. This novel immunotherapeutic delivers synergistic signals from three different immune-stimulatory cytokines in a single molecule, offering a streamlined approach to CAR-T production.
The studies presented at the 2025 Annual Meeting of American Association of Immunologists demonstrate that HCW9206 outperforms standard methods using anti-CD3/anti-CD28 and IL-2 for CAR lentiviral transduction and subsequent expansion. Most importantly, the technology effectively expands stem cell-like memory T cells (Tscm) carrying CAR constructs – a critical advancement since Tscm cells exhibit superior persistence and targeted cell killing capabilities compared to other T cell subsets.
In experimental humanized mouse models, the HCW9206-generated CAR-Ts demonstrated enhanced potency in suppressing both HIV-1 and leukemic cells, with significantly improved persistence compared to CAR-Ts produced through conventional methods. This addresses a fundamental limitation in current CAR-T therapy – maintaining long-term effectiveness after administration.
From a manufacturing perspective, HCW9206 could potentially disrupt current CAR-T production processes. The company has completed critical development milestones: establishing the GMP master cell bank, developing the manufacturing process, and filing the drug master file with the FDA as an ex vivo reagent. This positions them to commercialize the technology through partnerships.
The significance extends beyond just incremental improvement – by enhancing CAR-T persistence and functionality while potentially reducing manufacturing complexity and costs, HCW9206 could expand access to these breakthrough therapies and improve outcomes across blood cancers, with potential applications in autoimmune and age-related diseases.
Addresses key challenges for CAR-T therapies
Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells
Data Shared at 2025 Annual Meeting of American Association of Immunologists
MIRAMAR, Fla., May 13, 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, announced today presentation of studies showing that its proprietary fusion protein, HCW9206, provides a new pathway for generating chimeric T-cell receptor - T cells (CAR-Ts) for immunotherapy with increased function. HCW9206 is a novel class of immunotherapeutic that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. The activity of HCW9206 was significantly superior compared to standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of human CAR-Ts. CAR-Ts represent a revolutionary technology with several CD19-specific CAR-T therapies approved by the FDA for the treatment of B-cell malignancies, and CAR-Ts continue to play an increasingly pivotal and expanding role in the treatment of cancer and has significant potential to treat autoimmune diseases and age-related diseases.
The Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, recently presented findings of these studies at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The poster presentation reported that HCW9206 is not only a better reagent than the current anti-CD3/anti-CD28/IL-2 method for CAR-T viral transduction, it also effectively expanded stem cell-like memory T cells (Tscm) carrying the CAR constructs. It is well established that the Tscm subset of T cells exhibits more in vivo persistence and targeted cell killing than other subsets of T cells, including memory T cells, following adoptive transfer into patients. In experimental humanized models in mice, adoptively transferred HCW9206-generated HIV- and CD19-specific CAR-Ts displayed more potency in suppressing HIV-1 and leukemic cells with enhanced persistence, respectively, when compared with the same CD-19-specific CAR-Ts generated with standard methods. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a Tscm cell phenotype, which should enhance the persistence of CAR-Ts in patients. This strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases.
Dr. Hing C. Wong, the Founder and CEO of the Company, commented, “HCW9206 is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade. Also, it provides us with an in-road opportunity to participate in the development of the highly promising, emergent “in-vivo CAR-T manufacturing technology”.
The GMP master cell bank of HCW9206 and its manufacturing process has been established, and its drug master file as an ex vivo reagent has also been filed with the US Food and Drug Administration. The Company is now seeking commercial partnerships for HCW9206 reagent sale and/or integration into CAR-T based manufacturing processes.
You could find more about the presentation on HCW9206 at AAI 2025, entitled, “Generation of HIV- and CD19-Specific TSCM CAR-T Cells by a Novel Cytokine-Based Scaffold,” using the link below: AAI2025
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 50 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 efficacy of HCW9206 for generating CAR-T’s for immune cell therapy; and the ability of HCW9206 preclinical studies to translate into human trials to activate Tscm cells in patients; the ability of HCW9206 to improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases. 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 filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025 and in other filings filed from time to time with the SEC.
Company Contact:
Peter Rhode, PhD.
Chief Scientific Officer and Vice President Clinical Operations
HCW Biologics Inc.
peterrhode@hcwbiologics.com
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