Bharat Biotech’s Nucelion Therapeutics Partners with VeGen Bio for Dual-Target CAR-T Therapy

Nucelion Therapeutics will handle technology transfer and clinical- and commercial-stage manufacturing, with production taking place at Nucelion’s single-site GMP facility in Hyderabad.

Bharat Biotech’s contract research, development and manufacturing organisation (CRDMO) arm, Nucelion Therapeutics, has partnered with Hyderabad-based VeGen Bio to develop and manufacture VL-2511, a dual-target CAR-T cell therapy candidate for multiple myeloma.

The collaboration aims to advance the therapy into Phase I and II clinical trials and work towards commercialisation by 2028.

Nucelion Therapeutics, a wholly owned subsidiary of Bharat Biotech, will handle technology transfer and clinical- and commercial-stage manufacturing under the agreement.

Production will take place at Nucelion’s single-site Good Manufacturing Practice (GMP) facility in Hyderabad, which is designed to meet regulatory standards set by India’s Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA).

“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,’’ Raghu Malapaka, PhD, CBO, Nucelion Therapeutics.

VL-2511 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy designed to target two antigens, B-cell maturation antigen (BCMA) and CD19, associated with multiple myeloma.

The approach is intended to address antigen escape, in which cancer cells evade immune recognition by reducing or losing the expression of a targeted antigen.

VeGen Bio said VL-2511 has clinical experience in China, ongoing development in the United States, and a recommended Phase II dose.

The companies plan to work across process development, analytical testing, GMP cell processing, vector-enabled transduction, aseptic fill-finish, cryopreservation, quality control and product-release testing.

The collaboration will also focus on improving manufacturing yields, operational efficiency and production economics. These efforts are intended to support more cost-effective production and potentially widen access to advanced cell therapies in India.

Prashant Bhavar, director of VeGen Bio, said the partnership would establish a coordinated pathway for technology transfer, manufacturing, scalability and pipeline expansion. He added that the objective was to build an end-to-end ecosystem for Indian cell therapy innovation while making next-generation treatments more accessible and affordable.

Beyond multiple myeloma, VeGen Bio is also studying VL-2511 for POEMS syndrome and selected autoimmune conditions, including systemic lupus erythematosus.

Nucelion Therapeutics said the manufacturing platform could subsequently support additional VeGen candidates targeting blood cancers and immune-mediated diseases.

The partnership brings together Bharat Biotech’s manufacturing subsidiary and VeGen Bio’s cell therapy development programme, with the next stages of clinical development and manufacturing scale-up expected to shape the candidate’s path towards potential commercial availability.

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