Contract development and manufacturing organisation and vaccine maker Bharat Biotech’s subsidiary Nucelion Therapeutics and VeGen Bio, a Hyderabad-based precision oncology company, will collaborate for the technology transfer, clinical manufacturing and commercial production of innovative cell therapies in India.
As part of the agreement, Nucelion will serve as the technology transfer and clinical as well as commercial stage manufacturing partner for VeGen Bio’s lead candidate, VL-2511, a first-in-class dual BCMA/CD19 autologous CAR-T therapy for multiple myeloma into its single-site GMP manufacturing facility. A first-in-India Phase 1/2 trial followed by targeted commercialisation of the product in 2028 figure in their plans.
Therapeutic translation, process development and manufacturing scale-up, rather than marketing or distribution, will be at the core of their collaboration on the back of Nucelion’s manufacturing infrastructure, technical expertise and production capabilities and VenGEN Bio’s scientific expertise and therapeutic pipeline. Over time, the framework is expected to serve as a platform for additional cell therapy candidates across VeGen Bio’s pipeline, the companies said on Wednesday (October 21, 2026).
Closing the gap
“Many CAR-T programmes stall between a promising construct and a product that can be made reliably at scale. As a dedicated cell and gene therapy CRDMO, Nucelion closes that gap, taking partners like VeGen from process development through clinical and commercial manufacturing,” Nucelion CBO Raghu Malapaka said.
Nucelion’s facility is designed to meet U.S. FDA and EMA standards that will be an enabling feature for companies planning commercial launch of products globally, he said. Through synchronised technology transfer and process development, the two companies will be establishing the technical and operational foundations necessary to navigate clinical and regulatory milestones.
“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 commercialisation. This partnership combines complementary strengths... 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 of VeGen Bio, which is a subsidiary of VeGen Labs.
Beyond multiple myeloma
With clinical experience in China and ongoing clinical development in the U.S., VL-2511 has demonstrated differentiated clinical activity, with exceptionally promising and potentially best-in-class activity in patients with extramedullary disease (EMD), alongside a favourable safety profile. Beyond multiple myeloma, VL-2511 is also being clinically investigated in POEMS syndrome and selected autoimmune disorders, including systemic lupus erythematosus (SLE), the companies said.
Published - October 21, 2026 03:19 pm IST