Hyderabad (Telangana) [India], October 21 (ANI): Hyderabad-based Nucelion Therapeutics Pvt. Ltd. (“Nucelion”), a subsidiary of Bharat Biotech, a specialised 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, today announced a strategic collaboration for the technology transfer, clinical manufacturing, and commercial production of innovative 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 first-in-class dual BCMA/CD19 autologous CAR-T therapy for multiple myeloma, at its single-site GMP manufacturing facility, designed to meet CDSCO, US FDA, and EMA regulatory standards.
The collaboration centres 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 VenGen Bio’s scientific expertise and therapeutic pipeline. Over time, the collaborative framework is intended to serve as a platform for additional cell therapy candidates across VeGen Bio’s pipeline.
The companies will also focus on process optimisation, manufacturing yields and operational efficiency to improve production economics, with the aim of reducing manufacturing costs and improving access to advanced cell therapies in India.
Raghu Malapaka, PhD, CBO, Nucelion Therapeutics Pvt. Ltd said, “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.”
Prashant Bhavar, Director, VeGen Bio Pvt. Ltt. said, “CAR-T cell therapy holds significant promise for patients with serious cancers, but realising its full potential requires a coordinated approach to technology transfer, manufacturing, scalability, and commercialisation. 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.”
Multiple myeloma remains a serious haematological malignancy associated with significant unmet medical needs and substantial treatment-access challenges in India. 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 simultaneously target BCMA and CD19.
By targeting two distinct 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 differentiated clinical activity, with exceptionally promising and potentially best-in-class activity in patients with extramedullary disease (EMD), alongside a favorable safety profile. Its efficient and potentially scalable manufacturing process offers opportunities to improve treatment affordability and accessibility, particularly in India.
Beyond multiple myeloma, VL-2511 is also being clinically investigated in POEMS syndrome and selected autoimmune disorders, including Systemic Lupus Erythematosus (SLE). These programmes reflect the broader potential of dual-target CAR-T technology to address unmet medical needs across haematological malignancies and immune-mediated diseases, while creating opportunities for further clinical development and commercial value creation.
Translating advanced cell therapy research into scalable clinical solutions requires addressing manufacturing complexity, process consistency, quality systems, and supply economics early in the development lifecycle.
Through synchronised technology transfer and process development, VeGen Bio and Nucelion are establishing the technical and operational foundations necessary to navigate clinical and regulatory milestones.
Nucelion’s facility features segregated cell processing suites, continuous environmental monitoring, and full chain-of-identity and chain-of-custody tracking systems for patient-linked cellular materials.
Nucelion’s end-to-end technical scope for the VL-2511 program encompasses process development and analytical testing, establishing optimised assays and quality controls. It also includes GMP cell processing and vector-enabled transduction under strict aseptic conditions, with Aseptic fill-finish and clinical-grade cryopreservation to ensure product stability and quality control and release testing compliant with global advanced therapy standards.
The collaboration is built upon a complementary business structure tailored to align scientific ambition, manufacturing excellence, and long-term commercial viability.
For VeGen Bio, access to specialised technology-transfer and manufacturing infrastructure enables the company to advance VL-2511 efficiently and allocate scientific resources toward pipeline expansion without independently replicating capital-intensive manufacturing facilities.
For Nucelion, applying its technical infrastructure and expertise to a dual CAR-T candidate allows the CDMO to establish and grow a dedicated cell therapy manufacturing product line spanning plasmid DNA, viral vectors, and advanced cellular processing. (ANI)
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