Siddhartha Mukherjee’s start-up to file trial data for cancer therapy

The move is an attempt to bring the advanced Chimeric Antigen Receptor (CAR)-T cell therapy for hard-to-treat cancers such as leukaemias, lymphomas, and multiple myeloma commercially available in India.

Immuneel Therapeutics, co-founded by Indian-born 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.

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. (AP)

“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 bring the advanced Chimeric Antigen Receptor (CAR)-T cell therapy for hard-to-treat 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 multi-lined treated leukaemia and lymphoma who received the drug under clinical trial were positive.

“83% of acute leukaemia patients, both children and adults, 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. These cells will recognize and kill cancerous cells, and help guard against reoccurrence.

The therapy is being provided under clinical trial mode in select centres, including Narayana Health Bengaluru, in the country. A total of 22 participants have been recruited so far for the trials in India. The trial in Spain has about 120 participants.

In 2021, Immuneel inaugurated its integrated cell therapy development and manufacturing facility in Bengaluru.

“The data that we have generated so far is promising and shows that it is going to be more effective alternative largely for patients of blood cancers who have had a relapse despite trying the already available modalities,” Dr Mukherjee said.

Apart from regulatory clearances, the challenge for Immuneel will be to keep the treatment price affordable.

“A lot of innovations have been made to bring down the product cost. Even though it will be too early to give a number, but it should be available for Indian patients at a fraction of the cost that it is available for in the West,” said Arun Anand, director and chief operating officer, Immuneel Therapeutics.

Cancer experts, however, said that cost of such therapies will remain high for poor patients.

“CAR-T cell therapy has proven to be useful in blood cancers, but we don’t have much data available on its impact on solid tumours for which immunotherapy seems to be working well,” said Dr PK Julka, principal director, Max Institute of Cancer Care. “That aside, these targeted therapies may have picked up well, but it is still out of reach for poor patients because of the high cost. I don’t see most patients in public hospitals paying for these cancer therapies unless it is provided for free.”