Cell Therapies to Manufacture CAR-T Therapy for Phase 1/2b Solid Tumor Trial in Australia

Key Points

• Cell Therapies has been selected as the CDMO for the Australian Phase I/Ib trial of A-SEEDS’ CAR-T therapy for EPHB4-positive solid tumors.
• The trial will enroll up to 48 patients with colorectal cancer, hepatocellular carcinoma, and bone and soft tissue sarcomas.

Cell Therapies, an Australian CDMO, has been selected as the GMP manufacturing partner for the CARTiEr E312 Phase I/Ib clinical trial investigating a CAR-T THERAPY, ACS2015, made by Japanese biotech company A-SEEDS. The study is evaluating the treatment in patients with EPHB4-positive solid tumors.

The multicenter trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. It is expected to enroll up to 48 patients across three cancer groups:

• Colorectal cancer
• Hepatocellular carcinoma
• Bone and soft tissue sarcomas

Therapy and Manufacturing

ACS2015 is an autologous (sourced from the patient) CAR-T cell therapy designed to target EPHB4, a protein the company identifies as overexpressed in multiple solid tumor types. A-SEEDS mentioned that the therapy is manufactured from cryopreserved autologous blood cells, which may allow greater flexibility in collection and production scheduling.

They’ve just announced that Cell Therapies is the GMP manufacturing partner in Australia, and will provide the infrastructure, technical capabilities, and quality systems needed to support clinical-stage cell therapy manufacturing.

A-SEEDS Pipeline

The company has a broader pipeline in solid and hematological cancers; here’s a screenshot from their site:

More information on the Australian CARTiEr E312 study is available through the Australian New Zealand Clinical Trials Registry. A-SEEDS’ original announcement is available here.

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