HCW Biologics Designates One of Its Proprietary TRBC-Pembrolizumab-Based Immune Checkpoint Inhibitors as its Franchise Immunotherapeutic for Internal Clinical Development
HCW Biologics (NASDAQ: HCWB) has selected HCW11-040, one of its proprietary pembrolizumab-based immune checkpoint inhibitors, as its lead product candidate for solid tumor treatment. The molecule combines pembrolizumab (Keytruda®) with IL-7, IL-15, and TGF-β receptor components.
In preclinical studies, HCW11-040 demonstrated superior performance compared to pembrolizumab monotherapy in several key areas: immune-cell activation, tumor infiltration, and cancer cell cytotoxicity. Notably, the compound showed the ability to expand TPEX cells without triggering cytokine storm when administered subcutaneously at projected efficacious doses.
The company will now advance HCW11-040 to late-phase IND-enabling studies, including manufacturing cell bank creation, chemistry manufacture control process development, and preclinical GLP toxicology studies.
HCW Biologics (NASDAQ: HCWB) ha selezionato HCW11-040, uno dei propri inibitori checkpoint immunitari basati su pembrolizumab, come candidato principale per il trattamento dei tumori solidi. La molecola combina pembrolizumab (Keytruda®) con componenti legati a IL-7, IL-15 e al recettore TGF-β.
Negli studi preclinici, HCW11-040 ha mostrato prestazioni superiori rispetto alla monoterapia con pembrolizumab in diverse aree chiave: attivazione delle cellule immunitarie, infiltrazione tumorale e citotossicità delle cellule tumorali. In particolare, il composto ha dimostrato la capacità di espandere le cellule TPEX senza innescare una tempesta di citokine quando somministrato per via sottocutanea a dosi efficaci previste.
L'azienda porterà ora HCW11-040 in studi di fase avanzata in grado di abilitare l'IND, inclusa la creazione della banca cellulare di produzione, lo sviluppo del processo di produzione chimica e studi tossicologici GLP preclinici.
HCW Biologics (NASDAQ: HCWB) ha escogido HCW11-040, uno de sus inhibidores de puntos de control inmunitarios basados en pembrolizumab, como candidato principal para el tratamiento de tumores sólidos. La molécula combina pembrolizumab (Keytruda®) con componentes de IL-7, IL-15 y del receptor TGF-β.
En los estudios preclínicos, HCW11-040 demostró un rendimiento superior a la monoterapia con pembrolizumab en varias áreas clave: activación de células inmunitarias, infiltración tumoral y citotoxicidad de las células cancerosas. En particular, el compuesto mostró la capacidad de expandir células TPEX sin provocar una tormenta de citoquinas cuando se administra por vía subcutánea a dosis efectivas previstas.
La empresa ahora avanzará con HCW11-040 a estudios de fase avanzada que habilitan IND, incluyendo la creación de un banco de células para fabricación, el desarrollo del proceso de fabricación química y estudios toxicológicos GLP preclínicos.
HCW Biologics (NASDAQ: HCWB)는 pembrolizumab 기반의 독점적 면역 체크포인트 억제제 중 하나인 HCW11-040을 고형 종양 치료를 위한 선도 candidates로 선정했습니다. 이 분자는 pembrolizumab (Keytruda®)를 IL-7, IL-15, 및 TGF-β 수용체 구성 요소와 결합합니다.
전임상 연구에서 HCW11-040은 면역 세포 활성화, 종양 침투, 암세포 세포독성 등 여러 핵심 영역에서 pembrolizumab 단독 치료보다 우수한 성능을 보였습니다. 특히 이 화합물은 피하 주사로 예상 유효 용량으로 투여했을 때 사이토카인 폭풍을 일으키지 않으면서 TPEX 세포를 확장하는 능력을 보여주었습니다.
이제 이 회사는 IND 허용 가능성 있는 후기 단계 연구로 HCW11-040을 진행하고, 제조용 세포 은행 구축, 화학적 제조 공정 개발, 및 GLP 전임상 독성 연구를 포함한 연구를 수행합니다.
HCW Biologics (NASDAQ: HCWB) a sélectionné HCW11-040, l’un de ses inhibiteurs des points de contrôle immunitaires basés sur le pembrolizumab, comme candidat phare pour le traitement des tumeurs solides. La molécule associe pembrolizumab (Keytruda®) à des composants IL-7, IL-15 et du récepteur TGF-β.
Dans les études précliniques, HCW11-040 a démontré des performances supérieures par rapport à la monothérapie au pembrolizumab dans plusieurs domaines clés : activation des cellules immunitaires, infiltration tumorale et cytotoxicité des cellules cancéreuses. Notamment, le composé a montré sa capacité à étendre les cellules TPEX sans déclencher de tempête cytokinique lorsqu’il est administré par voie sous-cutanée à des doses efficaces prévues.
L’entreprise va maintenant faire progresser HCW11-040 vers des essais de phase avancée habilitants l’IND, incluant la création d’une banque cellulaire de fabrication, le développement du processus de fabrication chimique et des études toxologiques GLP précliniques.
HCW Biologics (NASDAQ: HCWB) hat HCW11-040 ausgewählt, eines ihrer proprietären pembrolizumab-basierten Immun-Checkpoint-Inhibitoren, als Lead-Produktkandidaten zur Behandlung solider Tumore. Das Molekül kombiniert Pembrolizumab (Keytruda®) mit IL-7-, IL-15- und TGF-β-Rezeptor-Komponenten.
In präklinischen Studien zeigte HCW11-040 eine überlegene Leistungsfähigkeit im Vergleich zur Pembrolizumab-Monotherapie in mehreren Schlüsselbereichen: Aktivierung von Immunzellen, Tumor-Infiltration und zytotoxische Aktivität von Krebszellen. Bemerkenswert ist, dass die Verbindung die Fähigkeit zeigte, TPEX-Zellen zu erweitern, ohne eine Zytokinsturm auszulösen, wenn sie subkutan an voraussichtlich wirksamen Dosen verabreicht wird.
Das Unternehmen wird HCW11-040 nun in fortgeschrittene IND-fähige Studien vorantreiben, einschließlich der Herstellung einer Zellbank, Entwicklung des chemischen Herstellungsprozesses und GLP-präklinischer Toxikologie-Studien.
HCW Biologics (NASDAQ: HCWB) قد اختارت HCW11-040، أحد مثبطات نقاط التفتيش المناعي القائمة علىPembrolizumab، كمرشح المنتج الرائد لعلاج الأورام Solid. تجمع الجزيء Pembrolizumab (Keytruda®) مع مكونات IL-7، IL-15، ومستقبل TGF-β.
في الدراسات ما قبل السريرية، أظهر HCW11-040 أداءً أعلى من العلاج الأحادي بPembrolizumab في مجالات رئيسية عدة: تنشيط الخلايا المناعية، تسلل الورم، والسيتوتوكسيتي للخلايا السرطانية. بشكل ملحوظ، أظهر المركّب قدرة على توسيع خلايا TPEX دون إحداث عاصفة سيتوكينات عند إعطائه تحت الجلد بجرعات فعّالة متوقعة.
الشركة ستمضي الآن قدماً بـ HCW11-040 إلى دراسات متقدمة تسمح بـ IND، بما في ذلك إنشاء بنك خلايا الإنتاج، وتطوير عملية التصنيع الكيميائية، ودراسات سميّّة GLP قبل السريرية.
HCW Biologics (NASDAQ: HCWB) 已选择 HCW11-040 作为其基于 pembrolizumab 的专有免疫检查点抑制剂之一，作为治疗实体瘤的首要候选药物分子。该分子将 pembrolizumab (Keytruda®) 与 IL-7、IL-15 及 TGF-β 受体成分结合。
在前临床研究中，HCW11-040 在免疫细胞激活、肿瘤浸润和癌细胞细胞毒性等关键领域显示出优于 pembrolizumab 单药治疗的性能。值得注意的是，在按预计有效剂量经皮下给药时，该化合物还显示了 在不引发细胞因子风暴的情况下扩增 TPEX 细胞的能力。
公司现在将把 HCW11-040 推进到能够实现 IND 的晚期阶段研究，包括制造细胞库、化学制造工艺开发以及前临床 GLP 毒理研究。
- Superior performance compared to pembrolizumab monotherapy in preclinical studies
- Demonstrated ability to expand TPEX cells without triggering cytokine storm
- Advancement to late-phase IND-enabling studies indicates development progress
- Novel combination of cytokines shows potential for improved cancer treatment
- Still in preclinical stage with no human trial data yet
- Significant development and regulatory hurdles remain before potential commercialization
Insights
HCW Biologics selects pembrolizumab-based immunotherapy HCW11-040 as lead candidate for solid tumors with promising TPEX cell expansion mechanism.
HCW Biologics has strategically selected HCW11-040 as its lead product candidate, marking a significant advancement in their immunotherapy pipeline. This multi-functional fusion protein combines pembrolizumab (Keytruda®) with interleukin-7, interleukin-15, and TGF-β receptor components in a novel configuration that targets the expansion of Progenitor Exhausted T (TPEX) cells.
The preclinical data shared at Nova Southeastern University reveals the scientific rationale behind this selection. TPEX cells, which reside in draining lymph nodes and tumors, are key responders to immune checkpoint inhibitor therapy. What's particularly notable about HCW11-040 is its demonstrated ability to expand these TPEX cells without triggering cytokine storm at projected efficacious doses when administered subcutaneously - a significant safety advantage over many immunotherapies.
The preclinical results show HCW11-040 outperformed pembrolizumab monotherapy in several critical mechanisms: immune-cell activation, expansion, tumor infiltration, and cytotoxicity against cancer cells. This suggests potential for superior efficacy compared to the established blockbuster drug Keytruda®.
The company's advancement to late IND-enabling studies represents a material step forward in their development timeline. These studies include manufacturing cell bank creation, chemistry manufacturing control process development, and GLP toxicology studies - all required steps before filing an Investigational New Drug application with the FDA. The selection of this candidate as their "franchise-building molecule" indicates HCW Biologics is prioritizing this asset in their portfolio and positioning it as a potential cornerstone therapy for solid tumors.
Lead product candidate will be advanced to late IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors
Discovery of unique combination of cytokines in multi-functional fusion protein molecule that exhibits ability to expand TPEX cells without cytokine storm in preclinical studies
Definitive data from preclinical studies shared at Scientific Seminar Series held at Nova Southeastern University on September 12, 2025, in Fort Lauderdale, Florida
MIRAMAR, Fla., Sept. 16, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced data highlights of its TRBC-based second-generation, pembrolizumab-based immunotherapeutics presented by Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, at a scientific seminar series held at Nova Southeastern University on September 12, 2025 in Fort Lauderdale, Florida. The presentation featured data on which the Company based its selection of one of its pembrolizumab-based immune checkpoint inhibitors (“ICI”) derived from its proprietary TRBC drug discovery and development platform as its lead product candidate to advance as a clinical development program for the treatment of solid tumors.
Dr. Wong’s presentation featured the Company’s lead product candidate, known as HCW11-040, which is a multi-functional fusion protein constructed with pembrolizumab, commonly known as Keytruda® (a registered trademark of Merck Sharp & Dohme LLC), along with interleukin (IL)-7, IL-15, and TGF-β receptor components (TGF-β traps). Progenitor Exhausted T (TPEX) cells, located in the draining lymph nodes and tumors of the patients, have been implicated as the primary responders to ICI therapy. TPEX cells have self-renewal capacity and vigorously differentiate into effector T cells for providing anti-tumor effects under ICI therapy. In preclinical studies, the Company’s scientists recently discovered that IL-7, IL-15, and TGF- β traps in combination can expand the TPEX cells as well as stimulate them to differentiate into anti-cancer effector T cells independent of ICI therapy. Thus, the Company believes that the components of HCW11-040 are able to achieve synergistic effects to expand the TPEX-cell reservoir and promote a larger number of them to differentiate into anti-cancer effector T cells, potentially resulting in a better cancer treatment.
In the presentation, Dr. Wong also highlighted the results of preclinical studies showing that HCW11-040 outperformed pembrolizumab monotherapy in immune-cell activation and expansion, enhancement of immune-cell infiltration into the tumors, and immune-cell cytotoxicity against cancer cells. In other preclinical models, the Company showed that HCW11-040 is not likely to overstimulate the immune system resulting in a cytokine storm when administered by subcutaneous injection using the Company’s projected efficacious dose levels.
Dr. Wong stated, “The preclinical data we shared with our colleagues at Nova Southeastern University showed our discovery and selection of HCW11-040 as our franchise-building molecule as a second generation pembrolizumab – namely, preclinical data that demonstrated the ability of HCW11-040 to expand TPEX cells without triggering cytokine storm once administered. Based on this strong data, we will advance HCW11-040 into late phase IND-enabling studies, including the creation of high-expression manufacturing cell bank, chemistry manufacture control process development, and preclinical Good Laboratory Practice toxicology studies.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. and the company is not affiliated with HCWB.
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 potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many 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 a versatile scaffold that 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, HCW11-006, HCW11-018 and HCW11-040. Further preclinical evaluation studies are currently being conducted for these molecules the Company has selected based on promising preclinical 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 actual success and potency of pembrolizumab-based TRBC fusion molecules; whether pembrolizumab-based TRBC fusion molecules will exhibit potent anti-pancreatic cancer activities and continue to outperform pembrolizumab both in vitro and in humanized mouse models; or whether pembrolizumab-based TRBC fusion molecules are effective in treatment of solid tumors and pancreatic cancers. 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, the latest Form 10-Q filed with the SEC on August 18, 2025 and in other filings filed from time to time with the SEC.
Company Contact:
Dr. Peter Rhode
Chief Scientific Officer and Vice President of Clinical Operations
HCW Biologics Inc.
PeterRhode@HCWBiologics.com
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