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HCW Biologics to Showcase Important Updates on IND-Enabling Studies and Preclinical Success of Its Novel Multi-Specific T-Cell Engagers Against Solid Tumors

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HCW Biologics (NASDAQ: HCWB) announced successful development of second-generation, multi-specific T-cell engagers targeting solid tumors, particularly pancreatic cancer, using their proprietary TRBC platform technology. The company's lead T-cell engagers target tissue factor and mesothelin, demonstrating potent anti-pancreatic cancer activities in preclinical studies.

The breakthrough technology not only targets cancer antigens and activates T cells but also reduces immunosuppression in the tumor microenvironment. In preclinical studies, 100% survival was observed in tumor-bearing mice treated with TRBC-based T-cell engagers, while untreated mice did not survive. Dr. Hing C. Wong, Founder and CEO, will present these IND-enabling study results at the Phoenix Best Science Series on June 27, 2025.

HCW Biologics (NASDAQ: HCWB) ha annunciato lo sviluppo riuscito di una seconda generazione di T-cell engager multi-specifici rivolti ai tumori solidi, in particolare al cancro del pancreas, utilizzando la loro esclusiva tecnologia piattaforma TRBC. I principali T-cell engager dell'azienda mirano al fattore tissutale e alla mesotelina, dimostrando potenti attività anti-cancro pancreatico negli studi preclinici.

Questa tecnologia innovativa non solo riconosce gli antigeni tumorali e attiva le cellule T, ma riduce anche l'immunosoppressione nel microambiente tumorale. Negli studi preclinici, è stata osservata una sopravvivenza del 100% nei topi portatori di tumore trattati con T-cell engager basati sulla piattaforma TRBC, mentre i topi non trattati non sono sopravvissuti. Il dott. Hing C. Wong, fondatore e CEO, presenterà questi risultati degli studi abilitanti IND alla Phoenix Best Science Series il 27 giugno 2025.

HCW Biologics (NASDAQ: HCWB) anunció el desarrollo exitoso de una segunda generación de enganchadores de células T multi-específicos dirigidos a tumores sólidos, especialmente cáncer de páncreas, utilizando su exclusiva tecnología de plataforma TRBC. Los principales enganchadores de células T de la compañía se dirigen al factor tisular y a la mesotelina, demostrando potentes actividades anti-cáncer de páncreas en estudios preclínicos.

Esta tecnología innovadora no solo apunta a los antígenos cancerígenos y activa las células T, sino que también reduce la inmunosupresión en el microambiente tumoral. En estudios preclínicos, se observó una supervivencia del 100% en ratones con tumores tratados con enganchadores de células T basados en TRBC, mientras que los ratones no tratados no sobrevivieron. El Dr. Hing C. Wong, fundador y CEO, presentará estos resultados de estudios habilitantes para IND en la Phoenix Best Science Series el 27 de junio de 2025.

HCW Biologics (NASDAQ: HCWB)는 독자적인 TRBC 플랫폼 기술을 활용하여 고형 종양, 특히 췌장암을 표적으로 하는 2세대 다중 특이성 T세포 엔게이저 개발에 성공했다고 발표했습니다. 회사의 주요 T세포 엔게이저는 조직 인자와 메소텔린을 표적으로 하여 전임상 연구에서 강력한 췌장암 항암 효과를 입증했습니다.

이 획기적인 기술은 암 항원을 표적화하고 T세포를 활성화할 뿐만 아니라 종양 미세환경 내 면역억제도 감소시킵니다. 전임상 연구에서 TRBC 기반 T세포 엔게이저로 치료받은 종양 보유 마우스에서 100% 생존율이 관찰된 반면, 치료받지 않은 마우스는 생존하지 못했습니다. 창립자 겸 CEO인 Dr. Hing C. Wong은 2025년 6월 27일 Phoenix Best Science Series에서 이 IND 승인 지원 연구 결과를 발표할 예정입니다.

HCW Biologics (NASDAQ : HCWB) a annoncé le développement réussi d'une deuxième génération d'engageurs de cellules T multi-spécifiques ciblant les tumeurs solides, en particulier le cancer du pancréas, en utilisant leur technologie propriétaire de plateforme TRBC. Les principaux engageurs de cellules T de la société ciblent le facteur tissulaire et la mésothéline, démontrant une puissante activité anti-cancer du pancréas lors d'études précliniques.

Cette technologie révolutionnaire cible non seulement les antigènes cancéreux et active les cellules T, mais réduit également l'immunosuppression dans le microenvironnement tumoral. Lors des études précliniques, une survie de 100 % a été observée chez des souris porteuses de tumeurs traitées avec des engageurs de cellules T basés sur TRBC, tandis que les souris non traitées n'ont pas survécu. Le Dr Hing C. Wong, fondateur et PDG, présentera ces résultats d'études permettant l'IND lors de la Phoenix Best Science Series le 27 juin 2025.

HCW Biologics (NASDAQ: HCWB) gab die erfolgreiche Entwicklung der zweiten Generation von multi-spezifischen T-Zell-Engagern bekannt, die sich gegen solide Tumore, insbesondere Bauchspeicheldrüsenkrebs, richten und ihre proprietäre TRBC-Plattformtechnologie nutzen. Die führenden T-Zell-Engager des Unternehmens zielen auf Gewebsfaktor und Mesothelin ab und zeigen in präklinischen Studien starke anti-pankreatische Krebsaktivitäten.

Die bahnbrechende Technologie zielt nicht nur auf Krebsantigene ab und aktiviert T-Zellen, sondern reduziert auch die Immunsuppression im Tumormikroumfeld. In präklinischen Studien wurde bei mit TRBC-basierten T-Zell-Engagern behandelten tumortragenden Mäusen eine 100% Überlebensrate beobachtet, während unbehandelte Mäuse nicht überlebten. Dr. Hing C. Wong, Gründer und CEO, wird diese IND-fähigen Studienergebnisse am 27. Juni 2025 auf der Phoenix Best Science Series präsentieren.

Positive
  • Achieved 100% survival rate in tumor-bearing mice during preclinical trials
  • Successfully developed novel T-cell engagers that simultaneously target cancer and reduce immunosuppression
  • Technology shows potential to expand treatment options for difficult-to-treat solid tumors
  • Demonstrated well-tolerated dose levels in preclinical studies
Negative
  • Still in preclinical stage, requiring further clinical trials and FDA approval
  • Results limited to animal studies, human efficacy yet to be demonstrated

Insights

HCW Biologics reports impressive preclinical results for novel T-cell engagers with 100% survival in pancreatic cancer mouse models.

HCW Biologics has developed a potentially significant advancement in cancer immunotherapy with their second-generation multi-specific T-cell engagers. The company's proprietary TRBC platform has enabled them to create tetra-functional T-cell engagers with dual mechanisms - they both activate T cells against cancer cells and reduce immunosuppression in the tumor microenvironment, addressing a critical challenge in solid tumor treatment.

Their lead candidates target tissue factor and mesothelin, two well-validated solid tumor antigens highly expressed in pancreatic cancer. The preclinical data is particularly compelling, showing 100% survival in tumor-bearing mouse models versus 0% survival in untreated controls, at doses that were well-tolerated.

This approach could overcome major limitations of current T-cell engagers, which have shown impressive results in blood cancers but limited efficacy against solid tumors due to immunosuppressive microenvironments. By simultaneously targeting cancer antigens, activating T cells, and reducing immunosuppression, HCW's approach addresses multiple failure points in current immunotherapy approaches for solid tumors.

The focus on pancreatic cancer is especially notable, as this remains one of the most treatment-resistant malignancies with dismal survival rates. The company is also exploring applications in glioblastoma, another highly aggressive cancer with few effective treatments.

While these results are preclinical and many promising cancer therapies fail in human trials, the unique mechanism and impressive survival data warrant attention. The company is conducting IND-enabling studies, suggesting they're moving toward clinical trials, though timelines weren't specified.

Tetra-functional T-cell engagers activate T cells and simultaneously reduce immunosuppression, with potent and antigen-specific anti-pancreatic cancer activities at dose levels that are well tolerated

Presentation at the Phoenix Best Science Series by HonorHealth Research Institute
on June 27, 2025 in Scottsdale, Arizona

MIRAMAR, Fla., June 27, 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 today that its scientists have successfully developed second-generation, multi-specific T-cell engagers against solid tumors, particularly for pancreatic cancer, using its novel proprietary TRBC product discovery and development platform technology.

The TRBC technology enabled the Company to construct T-cell engagers that not only target cancer antigens and CD3 activation of effector T cells, but also simultaneously reduce the immunosuppression in tumor microenvironment. Such immunosuppression plays a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. The Company’s two lead T-cell engagers target tissue factor and mesothelin, which are proven solid tumor antigens. These product candidates exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at dose levels that are well tolerated. Dr. Hing C. Wong, Founder and CEO of the Company, will present the details of these IND-enabling studies as an invited speaker for the Phoenix Best Science Series, hosted by HonorHealth Research Institute, located at HonorHealth Scottsdale Shea Medical Center in Scottsdale, Arizona, on June 27, 2025.

Dr. Wong stated, “T-cell engagers revolutionized the immunotherapeutic approach against cancer. Currently, T-cell engagers have approval from the U.S. Food and Drug Administration to be used in the treatment of a small number of indications, including various hematological and solid tumors. Now, we are very excited to report that our proprietary TRBC product discovery platform can be used to create potentially highly effective T-cell engagers against difficult-to-treat solid tumors by using exceptional targets while managing immunosuppression.   In our preclinical studies, after treatment with our TRBC-based T-cell engagers, there was 100% survival among tumor-bearing mice in the test group, whereas none of the untreated mice survived. We believe our approach could expand the number of indications that can be treated with T-cell engagers, including enhancing health span for patients suffering with solid tumors, especially diseases such as pancreatic cancer and glioblastoma.”

Dr. Wong continued, “I am very honored to be invited to present at the Phoenix Best Science Series, organized by HonorHealth Research Institute, and join a renowned group of medical and research experts who are at the forefront of the treatment of pancreatic cancer. I look forward to sharing, with this esteemed group, our findings and the basis for our confidence in the potential of our innovative TRBC technology and its derived T-cell engagers against pancreatic cancer and other solid tumors. We believe we are at the cutting edge for expanding the indications that may be treated with T-cell engagers.”

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 HCW11-027. 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 potential for a future transaction and sharing proceeds therefrom; the actual success and potency of T-cell engagers; whether T-cell engagers have antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models at dose levels that are well tolerated; whether T-cell engagers 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 May 15, 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 


FAQ

What breakthrough did HCW Biologics (NASDAQ: HCWB) announce in their cancer treatment research?

HCW Biologics announced the successful development of second-generation, multi-specific T-cell engagers that target solid tumors, particularly pancreatic cancer, using their proprietary TRBC platform technology. The technology showed 100% survival rate in treated tumor-bearing mice.

How does HCW Biologics' new T-cell engager technology work?

The technology targets cancer antigens and CD3 activation of effector T cells while simultaneously reducing immunosuppression in the tumor microenvironment. It specifically targets tissue factor and mesothelin, which are proven solid tumor antigens.

What were the results of HCWB's preclinical studies for their cancer treatment?

In preclinical studies, the treatment achieved 100% survival rate in tumor-bearing mice, while untreated mice did not survive. The treatment showed potent and antigen-specific anti-pancreatic cancer activities at well-tolerated dose levels.

When will HCW Biologics present their research findings?

Dr. Hing C. Wong, Founder and CEO, will present the IND-enabling study details at the Phoenix Best Science Series on June 27, 2025 at HonorHealth Scottsdale Shea Medical Center in Arizona.

What types of cancer does HCW Biologics' new treatment target?

The treatment primarily targets solid tumors, particularly pancreatic cancer, with potential applications for other solid tumors including glioblastoma.
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