AvenCell Japan, a wholly owned subsidiary of AvenCell Therapeutics, has secured a significant funding milestone with the announcement of a grant worth up to $40 million from the Japan Agency for Medical Research and Development (AMED). The non-dilutive funding will support the worldwide development of the company's AVC203 candidate, an IND-stage, dual-antigen allogeneic CAR-T therapy targeting both CD19 and CD20 antigens for applications in B-cell lymphomas.
Breakthrough Allogeneic Technology Platform
AvenCell's proprietary allogeneic technology distinguishes itself from previous cell engineering approaches through the application of multiple gene editing steps designed to address two critical challenges in the field. The technology ensures that a patient's immune system, including both innate and adaptive components, cannot reject the donor cells while simultaneously preserving the healthy donor T-cell fitness and potency throughout the manufacturing process.
According to the company, these dual requirements have represented a significant impasse to progress in allogeneic CAR-T development that has not been surmounted by other "first generation allo" approaches. The preservation of T-cell functionality while achieving immune evasion represents a key technical advancement in the field.
Clinical Validation in AML Program
Early clinical data from AvenCell's AVC201 clinical dose-escalation program in relapsed and refractory acute myeloid leukemia (AML) patients provide validation for the company's approach. The data confirm that these allogeneic cells expand robustly and consistently, achieving levels well above those typically seen in similar autologous CAR-T experiences.
Critically, the cells demonstrate persistence well beyond the typical one-month "rejection hurdle" where most other allogeneic candidates have historically failed to maintain activity. This extended persistence represents a significant advancement over existing allogeneic approaches and suggests the potential for sustained therapeutic benefit.
Strategic Partnership with Japanese Ecosystem
The AMED grant positions AvenCell to participate in Japan's program to strengthen the pharmaceutical startup ecosystem. Andrew Schiermeier, Ph.D., President and CEO of AvenCell Therapeutics, emphasized the significance of this collaboration: "We are thrilled to have been selected by AMED to participate in its program to strengthen the Japan Pharmaceutical Startup Ecosystem. Lymphomas and leukemias remain an area of high unmet medical need in all parts of the world, including Japan, and we are delighted to collaborate directly with many key opinion leaders and a broad set of stakeholders in this region to bring forward a truly paradigm-shifting therapeutic with meaningful benefit to patients."
Addressing Unmet Medical Needs
The funding comes at a time when lymphomas and leukemias continue to represent areas of significant unmet medical need globally, including in Japan. AvenCell's dual-antigen approach targeting both CD19 and CD20 represents a comprehensive strategy for addressing B-cell malignancies, potentially offering improved efficacy over single-target approaches.
The company's focus on developing best-in-class CAR-T therapies extends beyond hematologic cancers to include autoimmune diseases, suggesting a broader therapeutic platform with multiple potential applications. The substantial AMED funding will enable AvenCell to advance its clinical programs while building strategic partnerships within the Japanese healthcare ecosystem.
