Chimeric Therapeutics Ltd (ASX:CHM) has entered into a strategic manufacturing partnership with WuXi Advanced Therapies, a global contract testing and manufacturing organisation, to support its CAR T cell programs.
Under the agreement, CHM will transfer certain manufacturing and analytical testing technologies to WuXi ATU, which will support process development, analytical development, and cGMP (Good Manufacturing Practices) manufacturing and testing activities for Chimeric’s CAR T cell programs.
Promisingly, the new partnership will enable Chimeric to accelerate clinical manufacturing readiness for new CAR T assets and to scale CAR T manufacturing to support multiple, simultaneous, multicentre CAR T clinical trials in the future.
“Uniquely positioned”
Chimeric Therapeutics CEO Jennifer Chow said: “We are very excited to enter into this partnership with WuXi ATU.
“With its extensive experience in cGMP manufacturing and analytical testing, as well as its seamless platform process for CAR T-cell production, WuXi ATU is uniquely positioned to support the acceleration and expansion of the CHM 1101 and CHM 2101 development programs.”
Agreement summary
The initial focus under the agreement will be on Chimeric’s two autologous CAR T-cell therapies for solid tumours:
- CHM 2101 (CDH17 CAR T) – currently in late preclinical development for multiple gastrointestinal (GI) cancers, including colorectal cancer, gastric cancer, pancreatic cancer, and GI neuroendocrine tumours (NETs) – will leverage WuXi ATU’s end-to-end platform process for CAR T manufacturing and testing to enable accelerated cGMP manufacturing readiness for the planned first-in-human study of CHM 2101.
- CHM 1101 (CLTX CAR T) – currently being evaluated in a single-site phase 1 clinical trial to treat patients with recurrent or progressive glioblastoma – will leverage WuXi ATU’s scalable manufacturing and analytical testing capacity to enable future expansion of the program to multiple additional clinical trial sites and additional solid tumour indications, including metastatic melanoma.
Commenting on the partnership, WuXi CEO David Chang said: “We’re delighted to partner with Chimeric Therapeutics to accelerate the development of two of their autologous CAR T-cell programs.
“These treatments offer much needed hope to patients with gastrointestinal cancers or glioblastoma, and we are honored to support Chimeric Therapeutics as they prepare these treatments for further clinical testing.”
About WuXi ATU
WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organisation (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialisation of cell and gene therapies for customers worldwide.
The company’s technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance.