Biotech start-up Cellogen Therapeutics is awaiting a nod from the Central Drugs Standard Control Organisation (CDSCO) to start its first-in-human (Phase I) trials on its indigenous “bi-specific 3rd generation” CAR-T product, targeting B cell leukemia, said Gaurav Kharya, clinician and Cellogen Therapeutics’ founder. He expected the approvals in about six to eight weeks.
This puts Cellogen among a handful of Indian companies that are at the forefront of research in this segment.
Explaining the significance of this product, Kharya told businessline, “It addresses challenges facing existing CAR-T products, including antigen escape and relapse of the disease it treats. At present, (chances of a) relapse or a recurrence of the disease is about 40- 50 per cent.”
CAR-T therapy involves taking T cells from a patient, genetically modifying it to destroy cancer cells, and reinfusing them back into the patient’s body. This personalised approach uses the body’s immune system to combat malignant tumour more effectively, a note from the company said.
“Unlike conventional CAR-T cell therapies, which target a single antigen, Cellogen’s bi-specific platform engages two tumour-specific antigens simultaneously, enhancing treatment precision and reducing the risk of side effects such as cytokine release syndrome and neurotoxicity,” it added.
The human trials on Cellogen’s product will be done at CMC Vellore, and Phase I would involve about nine patients; subsequently Phase II would be done on about 35 to 40 patients, he said.
Pricing expectation
While a final product is still a couple of years way, Kharya said, the expectation is to price it at about ₹25 lakh per therapy, which would be less than the existing products today. The two approved products from ImmunoAct and Immuneel are pegged at about ₹40 lakh – 10 per cent of the price of similar global products (at ₹4 crore for a shot). Drugmaker Natco Pharma holds 5.38 per cent stake in Cellogen Therapeutics.
