A-SEEDS Initiates Phase I/Ib Clinical Trial in Australia for ACS2015, CAR-T Therapy Targeting Three Solid Tumor Types
A-SEEDS Co., Ltd. (Headquarters: Matsumoto, Nagano; CEO: Shigeki Yagyu, hereinafter referred to as “the Company”) is pleased to announce the initiation of CARTiEr E312 study in Australia using ACS2015, a CAR-T cell product.
This study is a Phase I/Ib trial for patients with EPHB4-positive solid tumors and will target three tumor types: colorectal cancer, hepatocellular carcinoma, and bone and soft tissue sarcomas. The objective of this study is to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The study plans to enroll up to 48 patients. It is conducted at multicenter in Australia. Further details are available on ANZCTR.
For details of this study on ANZCTR, please visit the following website:
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390315&isReview=true
(ANZCTR: Australian New Zealand Clinical Trials Registry, a clinical trial information registry database for Australia and New Zealand)
ACS2015 is a CAR-T cell product targeting EPHB4 which is known to be overexpressed in many tumor types and its manufacturing process is well-optimized such as manufacturing from cryopreserved patient-derived blood cells, allowing flexibility of patient’s blood sampling and manufacturing timing.
Furthermore, ACS2015 is manufactured by Cell Therapies Pty Ltd, a leading contract development and manufacturing organisation (CDMO) specialising in advanced cell and gene therapies. Cell Therapies brings extensive experience in the GMP manufacture of cellular therapeutics to support CARTiEr E312 study, ensuring high-quality and reliable production of the investigational product.
A-SEEDS also has two clinical-stage products using its platform technology.
AP8901 is a comparable product to ACS2015, targeting EPHB4 and CARTiEr E211, a Phase I trial in patients with Ewing sarcoma and other solid tumors, is ongoing ahead of CARTiEr E312 at the National Cancer Center Hospital East in Japan, where tolerability, safety, and preliminary efficacy are evaluated.
AS116 is another CAR-T cell product targeting the GM-CSF receptor (GMR) and CARTiEr G111, a Phase I/II clinical trial in patients with acute myeloid leukemia (AML) is ongoing at Shinshu University Hospital in Japan, where safety, tolerability, and preliminary efficacy are assessed.
■ A-SEEDS Co., Ltd.
| Company name | A-SEEDS Co., Ltd. |
| Location | 3-1-1 CSMIT, Asahi, Matsumoto, Nagano |
| Representative | Shigeki Yagyu |
| Establishment | April 2020 |
| Capital | 161,972,101 yen |
| Home page URL | https://www.a-seeds.co.jp/en-home |
■ Contact Info.
A-SEEDS Co., Ltd.
E-mail: info@a-seeds.co.jp
■ Cell Therapies Pty Ltd
| Company name | Cell Therapies Pty Ltd |
| Location | 300 Grattan Street, Melbourne, 3000 VIC, Australia |
| Representative | Josh Downing |
| Establishment | 2003 |
| Home page URL | https://celltherapies.com/#talk-to-us |
■ Contact Info.
Cell Therapies Pty Ltd.
E-mail: enquiries@celltherapies.com