Nucelion Therapeutics and Hyderabad-based VeGen Bio have joined forces to advance the manufacturing of next-generation cell therapies in India.

 

Both have signed a strategic collaboration covering technology transfer, clinical manufacturing and commercial production of an innovative CAR-T therapy for multiple myeloma.

 

Under the agreement, Nucelion, a wholly owned subsidiary of Bharat Biotech, will support the technology transfer and clinical- and commercial-stage manufacturing of VeGen Bio’s lead candidate, VL-2511 — a first-in-class, dual BCMA/CD19 autologous CAR-T therapy targeting multiple myeloma.

 

The therapy will be manufactured at Nucelion’s single-site, Good Manufacturing Practice (GMP) facility, which is designed to meet regulatory standards set by India’s Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

 

The partnership is focused on translating scientific innovation into scalable manufacturing capability, rather than marketing or distribution. It brings together Nucelion’s manufacturing infrastructure, technical expertise and production capabilities with VeGen Bio’s scientific expertise and therapeutic pipeline.

 

Beyond VL-2511, the companies intend to use the collaboration as a platform for advancing additional cell therapy candidates from VeGen Bio’s pipeline.

 

A key priority will be to optimise production processes, improve manufacturing yields and strengthen operational efficiency. The companies aim to lower production costs and improve access to advanced cell therapies for patients in India.

 

The collaboration also addresses a critical challenge in cell therapy development: moving promising treatments from research and process development into reliable clinical and commercial manufacturing.

 

“Many CAR-T programs stall between a promising construct and a product that can be made reliably at scale. As one of India’s first dedicated cell and gene therapy CRDMOs, Nucelion closes that gap, taking partners like VeGen from process development through clinical and commercial manufacturing. 

 

"Our work on VeGen’s dual-target CAR-T program shows that model in action and builds the capacity India needs to bring these therapies to more patients. As our facility is designed to meet US FDA and EMA standards, companies can also commercially launch their products worldwide," said Raghu Malapaka, Nucelion Therapeutics.

 

For VeGen Bio, the partnership is intended to provide a manufacturing pathway for its lead CAR-T programme while supporting the expansion of its broader therapeutic pipeline.

 

“CAR-T cell therapy holds significant promise for patients with serious cancers, but realizing its full potential requires a coordinated approach to technology transfer, manufacturing, scalability, and commercialization. VL-2511 is a key program in VeGen Bio’s mission to advance innovative therapies for unmet medical needs. 

 

"This partnership combines complementary strengths, providing VeGen Bio with a pathway to technology transfer, manufacturing, and pipeline expansion, while enabling our CDMO partner to establish and grow its cell therapy manufacturing capabilities. Together, we aim to build an end-to-end ecosystem for Indian cell therapy innovation that creates sustainable value while making next-generation treatments more accessible and affordable for Indian patients," said Prashant Bhavar, Director, VeGen Bio.

 

The agreement positions manufacturing readiness, production efficiency and affordability as central priorities in the companies’ effort to advance CAR-T innovation in India. Its longer-term ambition is to establish a scalable manufacturing framework that can support additional cell therapy programmes and help bring advanced cancer treatments closer to patients.