In 2019, when Immuneel Therapeutics Ltd, founded by Pulitzer winning author and US oncologist Dr Siddhartha Mukherjee and leading biotech entrepreneur Kiran Mazumdar Shaw, planned to set up a breakthrough cell therapy facility for cancer treatment in India, its top team never imagined the world would be hit by Covid-19. It faced the brunt of the pandemic, but the team adapted fast — from vacating its one-room office in Bengaluru to locating the construction crew near the hospital and finding Indian vendors instead of outsourcing the project to a global firm — through the last two years to get the facility up and running.

“No amount of preparation would have helped us plan for something like this. There were several challenges: one, you are building something in a hospital, two, it’s a cancer facility, three, there were restrictions on the number of people you could bring in at a time, four, the entire supply chain was disrupted, and you couldn’t get anything shipped from any of the usual suppliers. And we had to ensure high quality GMP (good manufacturing practices) production of cell therapies in a country like India where this had never been done before,” said Dr Arun Anand, Chief Operating Officer, Immuneel Therapeutics.

A similar therapy has also been indigenously developed by Mumbai’s Tata Memorial hospital and IIT Bombay. It is at an early Phase I clinical trial stage.

Not only did Immuneel have to design the centre with GMP (good manufacturing practices), but the team conducting the trial also had to ensure adequate training for the staff, with many posted on Covid-19 duty. The centre is located on the eighth floor of Mazumdar Shaw Medical Center at Narayana Hrudayalaya Health City in Bengaluru.

The centre would conduct Phase II trial of a Spanish CAR-T therapy for treating patients with leukaemia and lymphoma. It has a strategic collaboration with Spain-based Hospital Clinic de Barcelona (HCB) and it has successfully conducted remote tech transfer with HCB on manufacturing protocols. The therapy modifies the patient’s T-cells using an inactivated HIV virus to “weaponise” them to fight the cancer cells. “In CAR-T cell therapy, we extract t cells from a cancer patient’s body and use a virus — a modified version of HIV virus that has no risk for HIV — to deliver genes to the cells that weaponise the T-cells and can attack the cancer cells,” said Dr Mukherjee.

“We wanted to be in a hospital ecosystem for the team to feel connected to the mission of serving patients. A feeling of empathy is necessary to do something creative; to come up with solutions. We are on the eighth floor in the hospital, and the bone marrow transplant centre is on the seventh floor. Every day when patients go up and down the elevators, we are also travelling, and we see the patients and physicians. This is unique for a company; most companies prefer to set up in lovely ecosystems, glass-façade buildings, outside of the city, far from where the real work happens,” said Dr Anand.

Explaining the process, Dr Mukherjee said, “We remove the T-cells from the body through apheresis, they go into an extremely sterile laboratory where everyone is working with hoods and masks, no one is allowed to enter except for the people manipulating them, these T-cells are then weaponised using this gene therapy, and then they are grown in the lab in incubators until they increase to a large number, then they are frozen. This process takes about ten to fourteen days.”

“Then you have to do very careful quality control, which involves making sure that the product is sterile, that the gene therapy has actually worked, that the product has actually expanded and expanded in the right way. And, then it is released. In the hospital, it is transfused back into patients,” he said.

With trials and innovations in India, the team hopes to bring down the cost of the therapy from the current US $350,000 to $400,000. “The clinical trial has already started, and we have dosed several patients,” said Dr Mukherjee who was in India recently for the project.

“We were a small team then – just 20 people – and we occupied a small room on the seventh floor of the hospital. And one evening I was informed by the hospital administrator that they needed the entire floor because they wanted to convert that into a Covid-19 ward. They did it in the next two days. So, overnight we did not even have a room to sit in. What that meant is we implemented an early work-from-home plan,” said Dr Anand.

“When our construction started in early 2020, we arranged for the contractor to house the entire crew very close to the hospital. The entire crew was in 3-4 houses taken on long-term lease just a kilometre away from the hospital. The crew did not need to travel by bus or public transport, they could just walk. And all of them were tested on a periodic basis (for Covid-19),” he said.
“We did a session with the workmen and the contractor, telling them what we are trying to do. When they realised their work would save the lives of children, they were motivated. I am a firm believer if the purpose is noble, there will be support from the ecosystem to make it happen,” he said.

The construction period was stretched to accommodate for breaks and shorter shifts in view of protective equipment being worn by the workers. Instead of nine months, the project was completed in 12. The crew was also trained on wearing masks, and were regularly tested, but still ended up getting the infection,” said Anand.

Dr Sharat Damodar, one of the principal investigators of the clinical trial, said, “Training the staff took some time – till recently Covid-19 was the priority, so most of our nurses and doctors were posted on Covid-19 duty – so to pull them out in the middle of it for training for such a new therapy was obviously difficult. Most of the people were drawn from a pool of nurses and doctors who were not doing Covid-19 duty, who were helping in bone marrow transplant and high-end chemotherapy.”

He said it was good the clinical trial started as soon as the Covid-19 cases dropped because patients were happy to come in for the new therapy, which promised a better outcome than existing therapies. Emphasising the need to bring the technology to India, he said prior to the pandemic, many Indians travelled to China for treatment, at a lower cost.

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