A-SEEDS Co has initiated a Phase I/Ib clinical trial in Australia to evaluate ACS2015, its investigational CAR-T cell therapy designed to target EPHB4-positive solid tumors.

 

This marks a major step forward in the company’s efforts to develop advanced cell therapies for hard-to-treat cancers.

 

The multicenter CARTiEr E312 study will assess ACS2015 in patients with three types of EPHB4-positive solid tumors: colorectal cancer, hepatocellular carcinoma, and bone and soft tissue sarcomas. The trial aims to enroll up to 48 patients and will evaluate the therapy’s safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of clinical efficacy.

 

The study is being conducted in Australia, with further details available through the Australian New Zealand Clinical Trials Registry (ANZCTR).

 

ACS2015 is a CAR-T cell therapy engineered to target EPHB4, a protein known to be overexpressed across multiple tumor types. The therapy’s manufacturing process has been optimized to use cryopreserved patient-derived blood cells, providing greater flexibility in the timing of blood collection and product manufacturing.

 

To support the CARTiEr E312 trial, ACS2015 is manufactured by Cell Therapies Pty Ltd, a contract development and manufacturing organization specializing in advanced cell and gene therapies. The company’s expertise in GMP manufacturing of cellular therapeutics is expected to support consistent, high-quality production of the investigational therapy.

 

A-SEEDS is advancing a broader pipeline of clinical-stage cell therapy programs built on its platform technology. Its EPHB4-targeting CAR-T product AP8901 is currently being evaluated in the CARTiEr E211 Phase I trial at National Cancer Center Hospital East in patients with Ewing sarcoma and other solid tumors. The study is assessing tolerability, safety, and preliminary efficacy.

 

The company is also developing AS116, a CAR-T cell product targeting the GM-CSF receptor (GMR). The CARTiEr G111 Phase I/II clinical trial is underway at Shinshu University Hospital for patients with acute myeloid leukemia (AML), evaluating safety, tolerability, and preliminary efficacy.