First-in-Human Dosing Completed for A-SEEDS’ EPHB4-Targeted CAR-T Cell Product (Product Code: AP8901)

A-SEEDS Co., Ltd. is pleased to announce that the first human dosing (First-in-Human) of its investigational genetically engineered T cell therapy, AP8901, has been successfully completed in an investigator-initiated clinical trial.

The Phase 1 clinical trial is being conducted by a research team led by Dr. Shigeki Yagyu of Shinshu University and Kyoto Prefectural University of Medicine, in collaboration with the National Cancer Center Hospital East. The trial is designed to evaluate the safety and efficacy of AP8901 in patients with Ewing sarcoma and other malignant solid tumors expressing the EPHB4 antigen.

In this trial, A-SEEDS is responsible for the development of the manufacturing process, manufacturing support, and quality control of the investigational CAR-T cell product.

■Website of Shinshu University (in Japanese)
https://www.shinshu-u.ac.jp/topics/2025/05/ephb4.html

■About AP8901:
AP8901 is equivalent to ACS2015, the investigational product planned for use in A-SEEDS’ upcoming clinical trial in Australia. Both are CAR-T cells engineered to target EPHB4 using the piggyBac (PB) transposon system—a non-viral gene modification method. This approach helps preserve T cell memory and minimize immune exhaustion by avoiding viral vectors, which can often compromise long-term cell function. Additionally, ACS2015 incorporates optimized manufacturing processes, further enhancing its suitability for clinical application.

■ A-SEEDS Co., Ltd.
A-SEEDS, an innovative biotech company sprouted from Shinshu University, is dedicated to pioneering advanced treatments for life-threatening cancers. Harnessing the potential of non-viral genetic engineering, our cutting-edge immune cell therapy opens up new horizons of hope for patients seeking effective and transformative solutions.