HCW Biologics to Showcase its Novel Second-Generation Immune Checkpoint Inhibitor Identified as a Potential Gateway to a Multi-Billion Dollar Market
HCW Biologics (NASDAQ: HCWB) has developed a breakthrough second-generation pembrolizumab-based immune checkpoint inhibitor (ICI) using its proprietary TRBC platform technology. The company's novel immunotherapeutic has shown superior performance against solid tumors, particularly pancreatic and ovarian cancer, in preclinical studies.
The new therapy addresses key limitations of current ICIs, which have less than 20% response rates despite generating $40 billion in worldwide sales in 2024. HCWB's enhanced version not only blocks checkpoint receptors but also neutralizes TGF-β and promotes immune cell infiltration into tumors, demonstrating better efficacy than standard pembrolizumab in preclinical trials.
Dr. Hing C. Wong, CEO, will present detailed IND-enabling study results at Nova Southeastern University on September 12, 2025.
HCW Biologics (NASDAQ: HCWB) ha messo a punto un innovativo inibitore del checkpoint immunitario (ICI) di seconda generazione basato su pembrolizumab, sviluppato con la sua piattaforma proprietaria TRBC. Questo nuovo immunoterapico ha mostrato, negli studi preclinici, prestazioni superiori contro tumori solidi, in particolare pancreas e ovaio.
La terapia affronta i limiti principali degli ICI attuali, che presentano tassi di risposta inferiori al 20% nonostante abbiano generato 40 miliardi di dollari di vendite globali nel 2024. La versione potenziata di HCWB non si limita a bloccare i recettori di checkpoint, ma neutralizza anche il TGF-β e favorisce l'infiltrazione delle cellule immunitarie nei tumori, dimostrando maggiore efficacia rispetto al pembrolizumab standard nei test preclinici.
Il CEO, Dr. Hing C. Wong, presenterà i risultati dettagliati degli studi IND-enabling alla Nova Southeastern University il 12 settembre 2025.
HCW Biologics (NASDAQ: HCWB) ha desarrollado un innovador inhibidor de puntos de control inmunitario (ICI) de segunda generación basado en pembrolizumab, utilizando su tecnología propietaria TRBC. El nuevo inmunoterapéutico ha mostrado en estudios preclínicos un rendimiento superior frente a tumores sólidos, especialmente cáncer de páncreas y de ovario.
Esta terapia aborda las limitaciones clave de los ICI actuales, que tienen tasas de respuesta inferiores al 20% a pesar de generar 40.000 millones de dólares en ventas mundiales en 2024. La versión mejorada de HCWB no solo bloquea los receptores de checkpoint, sino que también neutraliza la TGF-β y favorece la infiltración de células inmunitarias en los tumores, demostrando mayor eficacia que el pembrolizumab estándar en ensayos preclínicos.
El director ejecutivo, Dr. Hing C. Wong, presentará los resultados detallados de los estudios IND-enabling en Nova Southeastern University el 12 de septiembre de 2025.
HCW Biologics (NASDAQ: HCWB)는 자사 고유의 TRBC 플랫폼 기술을 활용해 펨브롤리주맙 기반의 2세대 면역관문억제제(ICI)를 개발했습니다. 이 신규 면역치료제는 전임상 연구에서 특히 췌장암과 난소암 등 고형암에 대해 우수한 성능을 보였습니다.
이 치료법은 반응률 20% 미만이라는 현재 ICI의 주요 한계를 해결합니다. 현재 ICI는 2024년 전세계 매출 400억 달러를 기록했습니다. HCWB의 강화된 버전은 단순히 체크포인트 수용체를 차단하는 것을 넘어 TGF-β를 중화하고 종양으로의 면역세포 침투를 촉진해 전임상 시험에서 표준 펨브롤리주맙보다 더 나은 효능을 보였습니다.
CEO인 Hing C. Wong 박사는 2025년 9월 12일 Nova Southeastern University에서 IND 허가용 연구 결과를 상세히 발표할 예정입니다.
HCW Biologics (NASDAQ: HCWB) a mis au point un inhibiteur de point de contrôle immunitaire (ICI) de deuxième génération reposant sur le pembrolizumab, développé grâce à sa technologie propriétaire TRBC. Ce nouvel immunothérapeutique a montré, en études précliniques, des performances supérieures contre les tumeurs solides, en particulier les cancers du pancréas et de l'ovaire.
Le traitement vise à pallier les limites essentielles des ICI actuels, qui présentent des taux de réponse inférieurs à 20% malgré 40 milliards de dollars de ventes mondiales en 2024. La version optimisée de HCWB ne se contente pas de bloquer les récepteurs de checkpoint : elle neutralise également le TGF-β et favorise l'infiltration des cellules immunitaires dans les tumeurs, montrant une meilleure efficacité que le pembrolizumab standard en préclinique.
Le PDG, Dr Hing C. Wong, présentera les résultats détaillés des études IND-enabling à la Nova Southeastern University le 12 septembre 2025.
HCW Biologics (NASDAQ: HCWB) hat einen bahnbrechenden, auf Pembrolizumab basierenden Immun-Checkpoint-Inhibitor (ICI) der zweiten Generation entwickelt, der auf der firmeneigenen TRBC-Plattformtechnologie beruht. Das neue Immuntherapeutikum zeigte in präklinischen Studien überlegene Wirksamkeit gegen solide Tumore, insbesondere Bauchspeicheldrüsen- und Eierstockkrebs.
Die Therapie geht zentrale Einschränkungen aktueller ICIs an, die trotz unter 20% Ansprechrate im Jahr 2024 weltweit 40 Milliarden Dollar Umsatz erzielten. HCWBs verbesserte Variante blockiert nicht nur Checkpoint-Rezeptoren, sondern neutralisiert auch TGF-β und fördert die Infiltration von Immunzellen in Tumoren, wodurch sie in präklinischen Versuchen wirksamer als Standard-Pembrolizumab war.
Dr. Hing C. Wong, CEO, wird die detaillierten IND-fähigen Studiendaten am 12. September 2025 an der Nova Southeastern University vorstellen.
- Novel immunotherapeutic outperformed pembrolizumab in preclinical studies
- Technology addresses current ICIs' low response rate (under 20%)
- Targeting multi-billion dollar market opportunity ($40B in 2024)
- Potential applications extend to age-related diseases as senomorphic drugs
- Product still in preclinical stage, requiring full clinical trials
- Will face competition from established player Merck's Keytruda
- Efficacy in human trials yet to be demonstrated
Insights
HCW Biologics reports promising preclinical results for their second-generation pembrolizumab-based immunotherapy targeting solid tumors.
HCW Biologics has made a potentially significant breakthrough in cancer immunotherapy by enhancing the effectiveness of immune checkpoint inhibitors (ICIs). The company has developed a pembrolizumab-based fusion molecule using their proprietary TRBC platform that addresses two major limitations of current ICIs: insufficient immune cell activation and poor tumor infiltration.
Current ICIs like pembrolizumab (KEYTRUDA®) have revolutionized cancer treatment but show limited efficacy, with response rates below 20% in approved indications despite generating over
The IND-enabling studies show this enhanced molecule outperformed standard pembrolizumab in preclinical models of pancreatic and ovarian cancers—two notoriously treatment-resistant tumor types. The company reports their candidate demonstrated superior immune cell activation, tumor infiltration, and cytotoxicity against cancer cells at well-tolerated doses.
This approach represents a significant advance in immunotherapy design, effectively taking "the foot off the brake and simultaneously hitting the gas" in the immune response. The company is also exploring applications for age-related diseases, as ICIs have shown potential as senomorphic drugs that can remove senescent cells.
With IND-enabling studies completed, HCW Biologics appears to be positioning for clinical development, with their CEO scheduled to present detailed results at Nova Southeastern University on September 12. This positions the company to potentially enter the lucrative ICI market with a differentiated, potentially more effective product.
Company’s pembrolizumab-based immune checkpoint inhibitor exhibited success
against solid tumors in IND-enabling studies by simultaneously activating immune cells and promoting their infiltration into solid tumors
Presentation at Nova Southeastern University
on September 12, 2025, in Fort Lauderdale, Florida
MIRAMAR, Fla., Aug. 25, 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, pembrolizumab-based immunotherapeutics against solid tumors, particularly for pancreatic and ovarian cancer, using its novel proprietary TRBC product discovery and development platform technology.
Since their introduction to the treatment of cancer in 2011, immune checkpoint inhibitors (“ICIs”) have been hailed as a breakthrough cancer therapy. Immune checkpoint proteins are expressed on the surface of T cells as the acting regulators for inhibiting the over-activation of T cells. By using ICIs, the immune response of T cells can be largely activated to re-establish the immune effects of anti-tumor exhausted T cells. However, there is vast evidence in preclinical and clinical studies suggesting that the lack of immune-cell costimulatory activities on ICIs diminishes their anti-tumor efficacy.
Dr. Hing C. Wong, Founder and CEO of the Company, stated, “Immune checkpoint inhibitors revolutionized the immunotherapeutic approach against cancer. Unfortunately, it has been reported they only induce an overall response in less than
Pembrolizumab, known as KEYTRUDA® (a registered trademark of Merck Sharp & Dohme LLC), is the leading FDA-approved ICI. HCWB’s TRBC technology enables its scientists to construct pembrolizumab-based fusion molecules that not only have the potential to release the tumor immune surveillance blockade of immune cells by cancer cells and neutralize the most immunosuppressive cytokine, TGF-β, in the tumor microenvironment, but also simultaneously activate immune cells and promote their infiltration into solid tumors. The Company’s pembrolizumab-based fusion molecule has been selected as leading clinical product candidate because in preclinical studies it exhibits potent anti-pancreatic cancer activities and outperform pembrolizumab as monotherapy for cancer both in vitro and in humanized mouse models at dose levels that are well tolerated. This novel fusion immunotherapeutic is designed to block the checkpoint receptors and engages the costimulatory receptors, analogous to taking the foot off the brake and simultaneously hitting the gas, thus, representing a breakthrough second-generation ICI which revives anti-tumor function of T cells.
Dr. Wong continued, “We are very excited to report that our research indicates our proprietary TRBC product discovery platform can be used to create such a second-generation immune checkpoint inhibitor against difficult-to-treat solid tumors. In our preclinical studies, our second-generation checkpoint inhibitor outperformed pembrolizumab in immune-cell activation and expansion, enhancement of immune cell infiltration into the tumors, and immune cell cytotoxicity against cancer cells. Since immune checkpoint inhibitors have also recently been implicated as effective senomorphic drugs for senescent cell removal to treat age-related diseases, we are also intensively exploring this opportunity for the Company’s pembrolizumab-based second-generation immune checkpoint inhibitor.”
Dr. Wong will present the details of IND-enabling studies as an invited speaker for the College of Pharmacy Seminar Series, hosted by Nova Southeastern University, located in Fort Lauderdale, Florida, on September 12, 2025.
Dr. Wong continued, “I am very honored to be invited to present at the College of Pharmacy Seminar Series, organized by Nova Southeastern University, and join a renowned group of medical and research experts who are at the forefront of the treatment of cancer and neurodegenerative diseases. I look forward to sharing the results of our IND-enabling studies with this esteemed group, as well as our findings and the basis for our confidence in the potential of our innovative TRBC technology and its derived second-generation immune checkpoint inhibitor.”
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 potential for a future transaction and sharing proceeds therefrom; 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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