New CAR-T therapy for multiple myeloma to enter India trials soon

Patients with multiple myeloma, a cancer of plasma cells in the bone marrow, could eventually have another treatment option as Hyderabad-based Nucelion Therapeutics and VeGen Bio join hands to advance an experimental CAR-T cell therapy in India.

Nucelion, a wholly owned subsidiary of Bharat Biotech, will help transfer the manufacturing technology and produce VeGen Bio's investigational therapy VL-2511 for clinical trials and, subject to approvals, potential commercial use. The companies are targeting an Indian Phase I/II clinical trial and commercialisation in 2028.

For patients and their families, however, the immediate takeaway is that the treatment is not yet available in India. Its safety, effectiveness, eligibility criteria and eventual cost will depend on further clinical development and regulatory review.

What is CAR-T therapy?

CAR-T, or chimeric antigen receptor T-cell therapy, is a form of personalised cancer treatment that uses a patient's own immune cells.

Doctors collect T cells from the patient's blood and genetically modify them in a specialised laboratory so they can recognise and attack cancer cells. The modified cells are then infused back into the patient.

Also Read: FSSAI ‘advisory’ orders stricter labelling of herbal supplements, flags 16 entries

CAR-T therapies have emerged as an important treatment option for certain blood cancers, particularly in patients whose disease has returned or has not responded adequately to earlier treatments. However, these therapies require specialised manufacturing and medical supervision, and can cause serious side effects.

How is the new treatment different?

VL-2511 is designed to recognise two targets, BCMA and CD19, associated with cells involved in multiple myeloma.

The idea behind targeting two proteins is to reduce the chances of cancer cells escaping treatment by losing or lowering the expression of one target. This is known as antigen escape.

Also Read: FSSAI’s new pesticide residue limits for tea: What consumers and industry need to know

VeGen Bio says the candidate has clinical experience in China and is being developed in the US. The company has also reported promising activity in patients with extramedullary disease, in which myeloma affects areas outside the bone marrow.

These claims need to be assessed against detailed clinical data. It is not yet established that VL-2511 is more effective than existing treatments or that it will benefit all patients with multiple myeloma.

CAR-T manufacturing in India

Explaining the manufacturing challenge, Raghu Malapaka, chief business officer of Nucelion Therapeutics, said, “Many CAR-T programmes stall between a promising construct and a product that can be made reliably at scale.”

He said Nucelion's role was to support partners from process development through clinical and commercial manufacturing, adding that the collaboration would help build India's capacity to bring advanced cell therapies to more patients.

If clinical trials establish its safety and effectiveness and regulators approve its use, VL-2511 could potentially offer another option for selected patients with multiple myeloma.

Also Read: Drug price controls: Protecting patients without distorting the market

Patients should not interpret the announcement as a recommendation to change their current treatment. Anyone considering CAR-T therapy should consult their treating haematologist or oncologist about approved options and eligibility for clinical trials.

Cheaper drugs

The companies say they aim to improve manufacturing efficiency and reduce production costs. Manufacturing CAR-T cells is complex and requires specialised facilities, quality controls and patient-specific tracking systems.

Also Read: What cheaper cancer drugs, tighter ad rules mean for patients and the pharma industry

Producing the therapy in India could potentially support local availability and reduce some supply-chain costs. However, there is no confirmed price for VL-2511, and it is too early to determine whether it will be more affordable than existing CAR-T treatments.

The partnership also gives VeGen Bio access to specialised manufacturing infrastructure while allowing Nucelion to expand its cell therapy business.

The 2028 commercialisation target will depend on clinical results, regulatory approvals and manufacturing readiness. Until those milestones are achieved, VL-2511 remains an investigational treatment rather than an available cancer therapy.