Some cancers learn to hide. Multiple myeloma, a cancer of the plasma cells in the bone marrow, can shed the very surface marker a treatment is designed to hunt — and when the flag disappears, the therapy goes blind. On Wednesday, two Hyderabad companies announced they are closing that escape hatch together: by aiming at two targets at once.
The alliance pairs Nucelion Therapeutics, the wholly owned subsidiary of Bharat Biotech and a specialised cell and gene therapy contract research, development and manufacturing organisation, with VeGen Bio, a Hyderabad-based precision oncology company. Together they are taking VL-2511 — described by the companies as a first-in-class dual BCMA/CD19 autologous CAR-T therapy for multiple myeloma — through technology transfer, clinical manufacturing and eventual commercial production in India, with an Indian Phase 1/2 trial and commercialisation targeted for 2028.
CAR-T therapy is among the most personalised forms of cancer treatment ever built. A patient’s own immune T cells are collected from the blood and genetically reprogrammed in a specialised laboratory so they can recognise and attack cancer cells, then infused back into the patient. It has already changed the outlook for certain blood cancers — but every dose is a bespoke living medicine, and making one reliably demands extraordinary manufacturing discipline. That is exactly the gap this partnership attacks.
VL-2511 is already a Phase II clinical-stage therapy with an established recommended Phase II dose. The companies say it has clinical experience in China and is undergoing clinical development in the United States, with promising activity reported in patients with extramedullary disease — where myeloma spreads beyond the bone marrow — and a favourable safety profile. Its defining idea is the second target: by hunting both BCMA and CD19, the therapy is designed to counter antigen escape, the process by which malignant cells evade immune recognition by losing or downregulating a single targeted antigen.
Making a dual-target cell therapy at clinical and commercial scale is where Nucelion comes in. Headquartered in Genome Valley, Hyderabad, the company runs development labs, GMP suites, quality control and fill-finish under one roof — built to FDA and EMA standards — and says it can handle ten to twenty CAR-T lots a month. Its single-site GMP facility features segregated cell processing suites, continuous environmental monitoring and full chain-of-identity and chain-of-custody tracking for patient-linked cellular materials, designed to meet CDSCO, US FDA and EMA regulatory standards. Its technical scope runs the full journey: process development and analytical testing, GMP cell processing and vector-enabled transduction, aseptic fill-finish, cryopreservation and release testing against global advanced-therapy standards.
“Many CAR-T programs stall between a promising construct and a product that can be made reliably at scale,” said Dr Raghu Malapaka, Chief Business Officer of Nucelion Therapeutics. “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.”
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For VeGen Bio, the partnership provides a manufacturing pathway without replicating capital-intensive facilities — freeing its scientific team to expand the pipeline. VL-2511 is also being clinically investigated in POEMS syndrome and selected autoimmune disorders, including systemic lupus erythematosus, reflecting the broader potential of dual-target CAR-T technology. “This partnership combines complementary strengths, providing VeGen Bio with a pathway to technology transfer, manufacturing, and pipeline expansion,” said Prashant Bhavar, Director of VeGen Bio. “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.”
Cost is the other mountain. The partners say they will focus on process optimisation, manufacturing yields and operational efficiency to drive down production economics and widen patient access in India — and because the facility is designed to global standards, the same capacity could eventually serve the world. For Bharat Biotech, the deal marks a bold push beyond vaccines into advanced biologicals manufacturing services. Two Hyderabad companies, one therapy engineered to give cancer nowhere to hide, and a manufacturing engine built to carry it to patients — India is stepping firmly onto the cell-therapy map.
CAR-T immune cells engaging a cancer cell. Image: Nucelion Therapeutics
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