Hyderabad, October 22, 2026: Nucelion Therapeutics Pvt. Ltd., a cell and gene therapy contract research, development and manufacturing organisation and a wholly owned subsidiary of Bharat Biotech, will handle the technology transfer and clinical and commercial manufacturing of VeGen Bio’s lead CAR-T therapy candidate for multiple myeloma under a new agreement between the companies.
The candidate, VL-2511, is an autologous CAR-T cell therapy designed to target two proteins, BCMA and CD19, associated with cancer cells. The agreement will bring the programme into 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 collaboration focuses on transferring the technology, developing the manufacturing process and preparing for production at clinical and commercial stages. It does not cover marketing or distribution, according to the companies.
The work will combine Nucelion’s manufacturing infrastructure and technical capabilities with Hyderabad-based VeGen Bio’s scientific expertise and drug development pipeline. The companies also intend to use the arrangement as a foundation for manufacturing other cell therapy candidates from VeGen Bio’s pipeline.
A central objective is to improve manufacturing efficiency and yields while reducing production costs. These factors are important for CAR-T therapies, which involve modifying a patient’s immune cells and returning them to the body to recognise and attack cancer cells. Producing personalised cell therapies requires specialised facilities, tightly controlled processes and systems to ensure that each product is linked to the correct patient.
Nucelion to Build Manufacturing Capacity for Advanced Cell Therapies, Join Hands with VeGEN Bio
“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.
“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” — Prashant Bhavar, Director, VeGen Bio stated.
VL-2511 is a Phase II clinical-stage autologous CAR-T therapy with an established recommended Phase II dose, according to the information provided by the companies. Its dual-target design aims to address antigen escape, a process in which cancer cells evade immune recognition by losing or reducing the expression of the antigen targeted by a therapy.
Multiple myeloma is a blood cancer that develops from plasma cells, a type of immune cell found in the bone marrow. Although treatment options have expanded, the disease remains a significant clinical challenge, particularly for patients whose cancer returns or stops responding to existing treatments.
CAR-T therapy involves collecting a patient’s T cells, modifying them to recognise specific targets on cancer cells, multiplying them and infusing them back into the patient. In VL-2511, the two targets are B-cell maturation antigen (BCMA) and CD19. The approach is intended to give the modified cells two targets through which they can recognise malignant cells.
The companies say VL-2511 has clinical experience in China and is undergoing clinical development in the United States. They report promising activity in patients with extramedullary disease, in which multiple myeloma affects tissues outside the bone marrow, along with a favourable safety profile. These claims require assessment against the underlying clinical trial data; comparative claims about its performance cannot be established from the announcement alone.
The candidate is also being investigated in POEMS syndrome and selected autoimmune disorders, including systemic lupus erythematosus. These are separate areas of clinical investigation, and the reported work does not establish that VL-2511 is approved or effective for these conditions.
Under the agreement, Nucelion’s manufacturing responsibilities will include process development, analytical testing, genetically modifying cells through vector-enabled transduction, aseptic filling, cryopreservation, quality control and release testing. The facility has segregated cell-processing suites, continuous environmental monitoring and chain-of-identity and chain-of-custody systems designed to track patient-linked cellular material throughout manufacturing.
For VeGen Bio, access to an established manufacturing facility could reduce the need to build its own capital-intensive infrastructure, allowing it to focus resources on developing its therapy and expanding its pipeline. For Nucelion, the programme adds a dual-target CAR-T candidate to its manufacturing work and supports the development of capabilities across plasmid DNA, viral vectors and cellular therapies.
Nucelion is a wholly owned subsidiary of Bharat Biotech International Ltd. and operates independently under its own leadership and governance. Its manufacturing platform covers process development, analytical testing and GMP production for plasmid DNA, viral vectors, cell therapies and lipid nanoparticle-based messenger RNA technologies.
The agreement establishes a manufacturing pathway for VL-2511, but the candidate’s progress will continue to depend on clinical development, regulatory requirements and the ability to produce the therapy consistently at scale. For patients in India, improvements in manufacturing efficiency could help address cost and access barriers, although any reduction in treatment costs will need to be demonstrated.
