Nucelion Therapeutics, VeGen Bio collaborate on CAR-T cell therapy manufacturing

Nucelion Therapeutics, a cell and gene therapy contract research, development and manufacturing organisation (CRDMO), and VeGen Bio Pvt. Ltd. (VeGen Bio / VeGen Labs), a Hyderabad-based precision oncology company, have announced a strategic collaboration for the technology transfer, clinical manufacturing and commercial production of cell therapies in India.

Under the agreement, Nucelion, a wholly owned subsidiary of Bharat Biotech, will serve as the technology transfer and clinical- and commercial-stage manufacturing partner for VeGen Bio’s lead candidate, VL-2511, a dual BCMA/CD19 autologous CAR-T therapy for multiple myeloma. The programme will be transferred to Nucelion’s single-site GMP manufacturing facility, designed to meet CDSCO, US FDA and EMA regulatory standards.

The collaboration will focus on therapeutic translation, process development and manufacturing scale-up, rather than marketing or distribution. The partnership combines Nucelion’s manufacturing infrastructure, technical expertise and production capabilities with VeGen Bio’s scientific expertise and therapeutic pipeline. The framework is intended to support additional cell therapy candidates across VeGen Bio’s pipeline.

The companies will also focus on process optimisation, manufacturing yields and operational efficiency, with the aim of reducing manufacturing costs and improving access to cell therapies in India.

“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, PhD, CBO, Nucelion Therapeutics Pvt. Ltd.

“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 Pvt. Ltd.

VL-2511 is a Phase II clinical-stage, dual-target autologous CAR-T cell therapy with an established recommended Phase II dose (RP2D), designed to target BCMA and CD19 simultaneously. Multiple myeloma remains a haematological malignancy associated with unmet medical needs and treatment-access challenges in India.

By targeting two antigens, VL-2511 is designed to address antigen escape, a mechanism through which malignant cells evade immune recognition by losing or downregulating a targeted antigen.

With clinical experience in China and ongoing clinical development in the United States, VL-2511 has demonstrated clinical activity, including activity in patients with extramedullary disease (EMD), alongside a safety profile described by the company as favourable. Its manufacturing process is designed to offer opportunities to improve treatment affordability and accessibility, particularly in India.

VL-2511 is also being clinically investigated in POEMS syndrome and selected autoimmune disorders, including systemic lupus erythematosus (SLE). These programmes reflect the potential applications of dual-target CAR-T technology across haematological malignancies and immune-mediated diseases, while creating opportunities for further clinical development and commercial value creation.

Through technology transfer and process development, VeGen Bio and Nucelion aim to establish the technical and operational foundations required to address manufacturing complexity, process consistency, quality systems and supply economics during the development process.

Nucelion’s facility features segregated cell processing suites, continuous environmental monitoring, and chain-of-identity and chain-of-custody tracking systems for patient-linked cellular materials. Its technical scope for the VL-2511 programme includes process development and analytical testing to establish assays and quality controls; GMP cell processing and vector-enabled transduction under aseptic conditions; aseptic fill-finish and clinical-grade cryopreservation to ensure product stability; and quality control and release testing in line with global advanced therapy standards.

The collaboration is structured to align scientific development, manufacturing and commercial viability. For VeGen Bio, access to technology-transfer and manufacturing infrastructure is intended to support the development of VL-2511 and allow the company to allocate scientific resources to pipeline expansion without independently replicating capital-intensive manufacturing facilities.

For Nucelion, applying its infrastructure and expertise to the dual-target CAR-T candidate will support the development of a cell therapy manufacturing product line spanning plasmid DNA, viral vectors and advanced cellular processing.

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