Hyderabad, October 22, 2026: Nucelion Therapeutics, a wholly owned subsidiary of Bharat Biotech, has entered into a strategic collaboration with Hyderabad based precision oncology company VeGen Bio to support the technology transfer, clinical manufacturing and commercial production of VL 2511, an investigational CAR T cell therapy for multiple myeloma.
The partnership will bring VeGen Bio’s lead candidate into Nucelion’s single site good manufacturing practice (GMP) facility. The arrangement covers technology transfer, process development and manufacturing, rather than marketing or distribution, as the companies work towards establishing the production capabilities needed to advance the therapy through clinical development and potential commercialisation.
VL 2511 is a Phase II clinical stage autologous CAR T cell therapy designed to target two antigens, B cell maturation antigen (BCMA) and CD19. The dual target approach is intended to address antigen escape, a process through which cancer cells evade immune recognition by losing or reducing the expression of the antigen targeted by a therapy.
The agreement combines Nucelion’s manufacturing infrastructure and technical capabilities with VeGen Bio’s scientific expertise and oncology pipeline. The companies also plan to optimise manufacturing processes, improve yields and increase operational efficiency, with the objective of lowering production costs and improving access to advanced 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, chief business officer at Nucelion Therapeutics.
Nucelion to Manufacture VeGen Bio’s VL 2511 CAR T Therapy for Multiple Myeloma
Multiple myeloma is a blood cancer that develops from plasma cells in the bone marrow. Although treatment options have expanded, the disease remains a significant clinical challenge, particularly for patients whose cancer returns after treatment or becomes resistant to available therapies.
VL 2511 is designed to recognise both BCMA and CD19, two targets associated with the malignant cell population and its biological environment. By directing engineered T cells towards two antigens rather than one, the therapy aims to reduce the risk of cancer cells escaping treatment through the loss or downregulation of a single target.
According to the companies, VL 2511 has an established recommended Phase II dose and has been evaluated in clinical development in China, with development also under way in the United States. The programme has reported encouraging clinical activity in patients with extramedullary disease, in which multiple myeloma affects tissues outside the bone marrow, alongside a favourable safety profile. These findings will require assessment against the full clinical evidence as development progresses.
The therapy is also being investigated for POEMS syndrome and selected autoimmune conditions, including systemic lupus erythematosus. These programmes extend the potential scope of the technology beyond multiple myeloma, although their clinical and commercial prospects will depend on further evidence from ongoing studies.
Prashant Bhavar, director of VeGen Bio, said the collaboration addresses the manufacturing and development requirements that can determine whether a cell therapy advances beyond the research stage.
“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,” Bhavar said.
Cell therapies present manufacturing challenges that differ from those associated with conventional medicines. Autologous CAR T treatments use a patient’s own T cells, which are collected, genetically modified, processed and returned for treatment. Maintaining product quality, patient identity and traceability throughout this process is essential.
Under the agreement, Nucelion will support technology transfer and process development, alongside clinical and commercial stage manufacturing activities for VL 2511. Its technical scope includes analytical testing and quality control, GMP cell processing, vector enabled genetic modification, aseptic fill finish, cryopreservation and product release testing.
The company’s facility includes segregated cell processing suites, continuous environmental monitoring and chain of identity and chain of custody systems to track patient linked cellular material through manufacturing. Nucelion says the facility is designed to meet standards associated with India’s Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Such design standards do not, by themselves, establish regulatory approval for a specific therapy or manufacturing process.
For VeGen Bio, the arrangement provides access to specialised manufacturing infrastructure without the need to independently establish an equivalent production facility. This could allow the company to concentrate more resources on clinical development and expanding its therapeutic pipeline.
For Nucelion, the programme provides an opportunity to develop its capabilities in advanced cellular therapies while expanding its manufacturing portfolio across the broader cell and gene therapy sector. Its areas of work include plasmid DNA, viral vectors and cell based products, alongside other advanced therapy manufacturing technologies.
The economics of CAR T cell therapy depend on several factors, including the complexity of production, manufacturing success rates, quality control requirements, infrastructure utilisation and the logistics involved in handling patient specific material. Improving yields and standardising processes can help reduce costs, but the extent of any savings will depend on manufacturing performance and the eventual scale of production.
For India, expanding domestic manufacturing capacity could support the development of advanced therapies closer to the patients who may need them. However, manufacturing is only one part of the access challenge. Treatment affordability will also depend on clinical outcomes, regulatory requirements, hospital infrastructure, patient monitoring and reimbursement arrangements.
The Nucelion and VeGen Bio agreement places manufacturing development at the centre of their effort to advance VL 2511. The companies also intend to use the collaboration as a framework for potential future cell therapy programmes within VeGen Bio’s pipeline.
The next steps will involve translating the technology into a consistent manufacturing process and supporting the therapy’s clinical development. The partnership’s longer term impact will depend on the programme’s clinical results, regulatory progress, production reliability and ability to deliver treatment at a sustainable cost.
Nucelion operates independently under its own leadership and governance as a wholly owned subsidiary of Bharat Biotech International. VeGen Bio, a subsidiary of VeGen Labs, is based in Hyderabad and focuses on precision oncology and next generation cellular therapies.
