Cell-therapy treatment for cancer in India may come at 10% of US cost

Pharma companies and start-ups working to launch it within two years

Indian pharmaceutical companies and start-ups may soon offer cell therapy-based treatment for cancers at nearly one tenth of the cost in the US.

Immuneel Therapeutics, backed by Biocon Chairperson Kiran Mazumdar-Shaw and US oncologist Siddhartha Mukherjee; Dr Reddy’s Laboratories and Chinese firm Shenzhen Pregene Biopharma; and ImmunoACT, an IIT-Bombay spin-off, are among firms working to bring CAR T-cell therapy for cancers, especially blood cancers, to India within the next two years.

Treating leukaemia, a cancer of the blood cells, with CAR T-cell therapy costs $800,000-900,000 (about Rs 6-7 crore) in the US.

CAR T-cells, or chimeric antigen receptor T-cells, are genetically engineered to produce artificial T-cell receptors. In simple terms, the immune system is the body’s natural defence against infections and old or abnormal cells (including those that make up cancer). Cellular immunotherapy strategies utilise the patient’s immune cells, which are then genetically altered outside the body and re-infused into it.

The results start to show within weeks, and last for years.

Since live cells are re-engineered to fight the disease, cellular immunotherapies are considered ‘living drugs’. A living drug is not a pill, but a process that is personalised to the needs of the patient.

A little more than one million new cases of cancer are diagnosed every year in India -- about 8 per cent of the world’s cancer patients are in India. Despite a lower incidence of cancer, India suffers a higher mortality rate. Without access to advanced interventions, this number is estimated to rise to over 1.3 million by 2040.

However, the cancer landscape in India may change soon.

Arun Anand, director and chief operating officer, Immuneel Therapeutics, says CAR T-cell therapy for cancers like leukaemia has the potential to reduce the three-year conventional treatment (using oral drugs, chemotherapy, bone marrow transplant, etc) to just three weeks. Immuneel, which started its journey in 2019, has set up an integrated GMP (good manufacturing practice)-certified facility in Bengaluru.

Apart from Mazumdar-Shaw and Mukherjee, Immuneel has Kush Parmar, co-founder and managing partner of 5AM Ventures, a venture capital firm focused on next-generation life science companies, in its leadership team.

Immuneel is not only doing trials in India (it has begun patient dosing in a phase 2 CAR-T trial named “IMAGINE” here), it also has collaborated with Hospital Clinic de Barcelona for trials in Europe. Phase 2 trials have also begun in several European countries.

Anand also explains that this therapy costs around $450,000 in the US. “However, together with before and after care for the patient, the cumulative cost comes to $800,000 to $900,000 in the US,” he says, adding that they aim to offer it in India at one tenth of the US costs.

India could become a medical tourism hub, the go-to country for cell therapy-based cancer treatment.

Rahul Purwar, founder and chairman of ImmunoACT, agrees. The firm’s product, H-CAR T-19, is set for phase 2 trials. Purwar says the results start showing in around one week’s time, and the cancer cells are killed. Moreover, this is a one-time treatment that would cost around Rs 20-30 lakh per patient, Purwar said.

Dr Reddy’s Laboratories, which had licensed the technology from Shenzhen Pregene Biopharma last year, is in the process of setting up a manufacturing facility. “The product is likely to go into clinical trials next year. We are setting up a unit in Bengaluru, and it is two to three years before the product or therapy can be available in the market,” said G V Prasad, co-chairman and MD of DRL.

In the US, insurance companies cover immunotherapy costs. In India, once this product is available, one would have to work out these nuances.

ImmunoACT is also working on two more cancer products using this technology – one for neuroblastoma and another for brain cancer. Purwar says the technology has no limitations and can be adapted for various kinds of cancers. At the moment, they have set up a GMP facility in Mumbai, which can process H-CAR T-19 for 100 patients a month, or around 1,200 a year.

Success rate of CAR T-cell therapy

A 2017 review published in the National Center for Biotechnology Information suggests that up to 90 per cent of people with a specific form of leukaemia fully recovered following this type of treatment. Success rates, however, vary with the type of cancer and the stage of the disease. Globally, at least 40-50 per cent patients show no disease recurrence after many years.

Anand says almost 85 per cent of the cell therapies are tested on terminally ill or stage-4 cancer. Therefore, the success rates may vary. “This, however, has the potential to become the first line of therapy for patients, and then the success rates should be better, because when the first and second line treatments fail, the patient’s bone marrow is already fatigued,” Anand says, adding that over a 10-year period around 30 per cent patients may show signs of a disease relapse.

Side-effects of CAR T-cell therapy

Purwar says there are no side-effects like what we witness in chemotherapy, but sometimes there is cytokine release syndrome as there are several dead cancer cells in the body, which can be managed. “So far we have not seen any patient with an uncontrolled cytokine release syndrome,” he said.

Anand says that over time as cells die, they are replaced by healthy cells, and within two to three weeks, the symptoms usually go away.

Joining the bandwagon

Big pharma is definitely seeing an opportunity in this line of therapy. While start-ups seem to lead the way, global players like AbbVie Inc, Gilead, Novartis AG, Pfizer have all joined the bandwagon. In India, Shaw is the co-founder and director of Immuneel. DRL is actively involved in developing an affordable therapy for Indian patients, and Laurus Labs has picked up a 26 per cent stake in ImmunoAct, and its promoters have picked up around 5-6 per cent in personal capacity.

Satyanarayana Chava, founder and CEO, Laurus Labs, said, “I feel there is a lot of promise this therapy offers in India, especially the price is way below the global standards. We have spoken to several oncologists and they are waiting for this tool to be available to them. Several NGOs also work in this space that help patients with treatment costs.”

Globally, more than 300 clinical trials of CAR T-cell therapies have been approved by drug regulatory agencies spanning Europe, the US, Israel, China, Australia, among others.