Bengaluru-based Indian biotech start-up Immuneel Therapeutics recently announced that it has started a Chimeric Antigen Receptor T cell therapy (CAR-T) trial named ‘IMAGINE’.
This Phase II trial is India’s first industry-sponsored CAR-T trial. The trial is being conducted in Narayana Hrudayalaya, Bengaluru, and patients are being enrolled.
Founded jointly by Biocon founder and chairperson Kiran Mazumdar-Shaw, Dr. Siddhartha Mukherjee, eminent US oncologist, and Dr. Kush Parmar, Immuneel, in 2019, aims to bring cell and gene therapy to India at an affordable cost.
Moneycontrol interacted with Dr. Arun Anand, Director and Chief Operating Officer, Immuneel Therapeutics, on the biotech start-up’s vision for cell therapy treatment, and other cellular immunotherapies for the management and treatment of cancers in India.
Could you walk us through the Phase II trial of CAR-T therapy at Narayana Hrudayalaya by Immuneel Therapeutics?
The IMAGINE trial is a first of its kind in India. This is the first industry-sponsored clinical study by a company, the first advanced phase clinical trial for cell therapies in India.
We are particularly excited because this marks the beginning of an access to a patient. This is different from academic and early phase trials. This is a very important step in getting cell therapies to patients in India.
How many patients are enrolled in IMAGINE trials, and what is the basic history of these patients?
We're looking at enrolling about 24 patients for this trial. The traditional history would be a patient who has failed at least one line of therapy and or is not eligible for bone marrow transplantation or cannot take on bone marrow transplantation.
So, these are the patients with definitive bone marrow disease.
What is the timeline of IMAGINE for the clinical trials which have been started in paediatric and adult cancer patients?
The trial is ongoing and I don’t want to report on potential outcomes because it is for the regulators to decide.
We are very keen to see the results of this trial in the next 12, 15 months.
We're very keen to discuss with the regulators what it means for a country like India, how we can work with them to identify pathways of access, and then bring this to the market in a responsible way.
Could you tell us about the efficacy of CAR-T therapy in treating patients with blood cancer abroad? Could that serve as a model for India?
Our immune system contains T cells, which have the ability to bind and kill the tumours.
We collect the T cells from the patient, and genetically engineer those T cells to express a receptor binding protein that specifically binds to a protein on the tumour cells.
In this case, IMAGINE looks at a CD19 CAR-T. It binds to CD19 on tumour cells. When the T cells bind to the tumour cells, they kill the tumour cells.
It does not come with the traditional toxicity associated with chemotherapy. There is no hair loss, there's no nausea, vomiting of your traditional chemotherapy.
What does the recovery process of CAR-T therapy entail?
Most patients will receive three infusions, and they would be in hospital for up to 28 days. This is primarily for safety monitoring. Most patients will have a 10-12-day recovery process, and then the follow-ups will start. Patients who receive cell therapies need to mandatorily follow up for 15 years to make sure that they are safe and they continue to have whatever response that they do.
Does the CAR-T therapy have any side effects?
When cells kill cells, they release cytokines, they release proteins that will call for an increased fever, drop in blood pressure. These combine to form the cytokine release syndrome.
So, cytokine release syndrome is the most common adverse event associated with cell therapies.
There are many more. There are some neurological deficits that can be seen in some patients. But so far, we haven't seen any, including in the Phase I trial. We are very, very confident that the product we're working towards is going to be a very safe product.
How affordable or expensive is the CAR-T therapy for Indian patients?
Immuneel is trying to bring down the cost of CAR-T therapy for patients in India. We are looking at providing the therapy to patients at one-fifth to one-seventh the cost. We're also looking at ways in which we can scale this up to provide access to more patients from the existing footprint.
The goal is to achieve sustainable innovation.
What kind of intervention is required in India, given the history and caseload of cancer patients in the country?
I think, it is time for India to recognise that public health policy and innovation do not need to be at loggerheads with each other.
We have reached a point where we're looking at longevity. So, cancer is an important area of intervention.
We need to have investors who can think and play the long-term game. Right now, Indian investors are focused primarily on playing the short-term game, and therefore, investing in technologies or investing in e-commerce, investing in areas where you have immediate returns, seems to be the case. But healthcare takes a long time for investments to breakeven or start giving returns.
How crucial are regulators in supporting innovation in healthcare?
We do need to see our regulators support innovation, especially in case of terminally ill patients as they can't wait.
If I take six months for a clinical trial to get registered, then there's a problem with this innovation because in those six months there could be several eligible patients who may not be able to participate in the trial because they've either progressed or they've died.
So, there has to be a balanced outlook, where you are looking at risk, keeping patient safety as the top priority. We can look at speeding up the entire regulatory process, single window clearances, allowing experts to review the material, and allowing for a timed response.