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2025 EHA: Henselbio's KSD-101 DC Vaccine Breakthrough Data Unveiled, Expanding New Boundaries for EBV Hematoma Treatment

Corporate News News Center 187

2025 EHA

Hensel Biologics Italy - Milan

The 30th Annual Meeting of the European Hematology Association (EHA 2025) was successfully concluded from June 12 to 15 in Milan, Italy. As a global top event in the field of hematology, EHA gathered the world's top experts, scholars and industrial pioneers to discuss the latest breakthroughs and future direction of blood disease diagnosis and treatment.

In this international academic feast.Hengsai BiotechnologyAs an outstanding representative of innovative biotechnology in ChinaSecond consecutive yearShining on the stage with its self-developed core product - Dendritic Cell (DC) Vaccine PlatformKSD-101The latest research results of the company were brilliantly presented. Its demonstration in a wide range ofEBV-related lymphoproliferative disorders (EBV-LPDs)The positive data and unique therapeutic potentials in the conference attracted the attention of the participating experts, highlighting the innovative strength of China's wisdom at the forefront of immunotherapy for hematological tumors.

KSD-101:
An Innovative Platform to Break the EBV-LPDs Treatment Dilemma

Facing the clinical challenges driven by latent EBV type II infection with significant immune escape properties and lack of standard therapies, Hengsai Bio's KSD-101 platform shows great promise. At the EHA, Hengsai Bio announced its ongoingPhase I clinical trial data, which enrolled patients with multiple types of EBV-LPDs, covering angioimmunoblastic T-cell lymphoma (AITL), nasal/peripheral NK/T-cell lymphoma (ENKTL), chronic active EBV infection (CAEBV), EBV-associated hemophagocytic lymphohistiocytosis (HLH), diffuse large B-cell lymphoma (DLBCL) and Hodgkin's lymphoma (HL).

:: Excellent safety

Treatment-related adverse events (AEs) were predominantly mild (e.g., injection site reactions, fever, lymph node enlargement), theNo grade ≥3 toxicity observed, showing good tolerance.

:: Recommended measurement establishment

Based on experimental data.Recommended Phase II clinical dose (RP2D) of 5 × 10⁶ DCs/doseThe

:: Initial results are encouraging

At a median follow-up of 42.7 weeks, the study showed that KSD-101 treatment resulted in positive disease remission, theMost patients achieved complete remission (CR) and were able to maintain theThe

:: Validation of immunization mechanisms

It was observed that the LMP2-specific CD8⁺ T-cell response peaked at 6 weeks postvaccination and was accompanied by aDecreased EBV DNA levels and significant reduction in regulatory T cells (Treg), strongly supporting the mechanism of action of KSD-101.

The core breakthrough of KSD-101 lies in its innovative design concept:

1.Breaking through HLA limitations and antigenic homogeneity: Use of autologous DC cell loadingEBV-related tumor-like complex antigenthat efficiently presented the LMP2, EBNA1, and otherMultiple viral epitopes, significantly broadening the scope of immune recognition.

2.Induces a potent, synergistic immune response: The design is capable of simultaneousEffective activation of CD4⁺ helper T cells and CD8⁺ cytotoxic T cells, designed to produce a more comprehensive and robust antiviral and antitumor immune response.

3.Great potential for platformization: Its technology principle is significantly scalable, laying a solid foundation for future expansion into other virus-driven tumors (e.g., HPV-associated head and neck cancer, HBV-associated liver cancer, KSHV-associated hematological tumors, etc.).

Chinese wisdom, global vision:
Accelerating clinical translation and international layout

leave it (to sb)Led by Prof. Chunrui Li, Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.The data from this clinical study generated a high level of interest from international clinical experts at the EHA venue. Hengsai Bio teamMeeting with experts from Europe, America and Asia.Active exchanges were held on topics such as the research progress of KSD-101, potential of indications, exploration of immune mechanisms, preliminary efficacy/safety data, and future directions for clinical development.

Founder and Chief Scientific Officer, Hensel BiologicsDr. Huining Liuup toMr. Chen Wei, Commercial DirectorPersonally led the core team to participate in the conference. The company actively utilizes this international platform to discuss KSD-101 with the world's top experts.Future development strategies, clinical pathway optimization (based on RP2D identified in Phase I) and potential international collaboration opportunitiesWe are committed to accelerating the global development process of this original Chinese therapy with a view to benefiting patients worldwide.

Looking ahead:
Deepening Immunotherapy and Delivering on the Patient Promise

Hengsai Biotechnology always adheres to the core concept of "patient-centeredness" and focuses on solving unmet clinical needs in the field of virus-associated oncology.The continuous development and optimization of the KSD-101 platform, in particular its demonstratedGood safety and preliminary efficacy signals, is a key step for the company to translate from basic mechanism discovery to clinical value. In the future, Hengsai Bio will continue to investNext Generation Immunotherapy ProductsIt will deepen the global cooperation network, promote the integration of innovations into the global health system, and contribute China's power to reshape the landscape of tumor disease treatment.

Hengsai Bio, with innovation as its engine, is committed to becoming a global explorer and promoter of precision immunotherapy for tumors.

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