Siddhartha Mukherjee’s start-up to file trial data for cancer therapy
THE MOVE AIMS TO MAKE THE ADVANCED CAR-T CELL THERAPY FOR CANCERS COMMERCIALLY AVAILABLE IN INDIA
NEW DELHI: Immuneel Therapeutics, co-founded by Indianborn oncologist Siddhartha Mukherjee, is likely to submit safety and efficacy data from clinical trials of its breakthrough cell therapy for cancer patients to India’s drugs regulator in the second quarter of 2023, the Pulitzer Prize winner said.
“By April or May, we should we able to submit the relevant data to the drugs controller general of India, seeking market authorization,” Dr Mukherjee said. “We cannot talk of a definitive launch time as the regulator may ask us to submit more information, and it could take some time before necessary approvals for its commercial use come through.” The move is an attempt to make the advanced Chimeric Antigen Receptor (CAR)-T cell therapy for hard-totreat cancers such as leukaemias, lymphomas, and multiple myeloma commercially available in India.
The other founders of Immuneel are Kiran Mazumdar Shaw, executive chairperson of bio pharmaceutical company Biocon, and Kush Parmar, managing partner of Boston-based 5AM ventures, a venture capital firm. Dr Mukherjee was awarded the Pulitzer Prize for general non-fiction for his 2010 book, The Emperor of All Maladies: A Biography of Cancer.
The study underway in India is labelled IMAGINE, which builds on phase 1 clinical data from Spain developed by Hospital Clinic in Barcelona. It is currently a phase 2B study testing the safety and efficacy of the drug varnimcabtagene autoleucel. The interim data from the study were presented last month at American Society of Haemotology’s annual meeting that said 77% of overall responses at day 90 in patients with multilined treated leukaemia and lymphoma who received the drug under clinical trial were positive. “83% of acute leukaemia patients who achieved complete response… continued to be in remission at a median follow-up of 112 days. The data set for safety in IMAGINE was favourable, without severe neurotoxicity… Median CAR-T cell manufacturing time was 11 days (range 10-18) with 100% manufacturing success,” the company said in a statement. Results from the first 10 patients of the planned 24 patients to be enrolled in India are likely to be presented before the central drugs standard control organisation. Both adult and children with acute leukaemia as well as lymphoma patients post median two lines of treatment, including in post-transplant setting, were enrolled. At day 90, the results from IMAGINE showed an overall response rate of 77%, with six out of nine patients demonstrating complete responses.
“This phase 2 clinical data has high impact in a patient population with limited treatment options and historically poor outcomes,” read the statement.
Cell-based immunotherapy strategies use immune cells from the patient (or donor) that are then genetically altered outside the body and re-infused into the patient, the company said. Since live cells are re-engineered to fight the disease, cellular immunotherapies are considered living drugs. As part of the process, T cells (or memory cells of the immune system) are collected from a patient’s blood.
These cells are genetically engineered to find and kill cancer cells. The re-engineered cells, or CAR-T cells, are multiplied until there are millions of these attacker cells, and these re-engineered cells are then infused into the patient and multiply further in number.