Hicent Biotech Files Prospectus Highlighting Its Proprietary STAR-T Cell Therapy Platform and Pipeline Progress

STAR (Synthetic T cell receptor and Antigen Receptor)-T, an innovative technology independently developed by the founding team of Huaxia Yingtai, was first published in a Science subsidiary journal in March 2021. The study revealed its superior efficacy over conventional CAR-T cells in various solid tumor models and elucidated its mechanism of action, laying a solid scientific foundation for the development of innovative cell therapy products based on STAR-T technology. In April 2022, clinical study data from 18 patients treated with CD19 STAR-T were published in the American Journal of Hematology. STAR-T employs an innovative T-cell receptor–antibody complex structure, offering the structural advantage of natural dual-targeting. By integrating the antigen recognition domain with the constant region of the TCR and its activation pathway, STAR-T exhibits high affinity and strong specificity, demonstrating promising clinical application prospects and broad market potential in cell therapy for both hematologic malignancies and solid tumors.

Currently, Huaxia Yingtai has developed a robust product pipeline targeting acute B-cell leukemia, non-Hodgkin lymphoma, acute myeloid leukemia, liver cancer, gastric cancer, and pancreatic cancer, leveraging its pioneering STAR-T cell therapy technology platform and an industrialized platform with mature process development and quality control systems. Preliminary preclinical studies and filed “First-in-Human” clinical trials have yielded confirmatory safety and efficacy data, which have been successively presented at international academic conferences and published in journals. The company’s first product, CD19/20 STAR-T (development code: HXYT-001) cell injection, received Investigational New Drug (IND) approval in September 2022 and is currently accelerating its Phase I clinical study. Another candidate product for the treatment of acute myeloid leukemia (AML), LILRB4 STAR-T, was granted Orphan Drug Designation by the U.S. FDA in December 2022. Its preclinical data were recently presented at the AACR Annual Meeting, and the company is advancing the IND application for this project. Capitalizing on the advantages of STAR-T in treating solid tumors, the company has also initiated multiple investigator-initiated trials (IITs) of cell therapies for solid tumors.

Huaxia Yingtai completed its Series B+ financing round in July 2022. The round was led by Huakong Fund, with existing shareholders Hankang Capital and Hetang Venture Capital continuing their support.