USA CAR-T cell experts so kind to let India researchers shadow them and come up with much cheaper and better CAR-T cell therapy for blood cancers

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During their time at the NIH Clinical Center, this team shadowed leading experts in CAR T-cell therapy at NCI’s Center for Cancer Research. The training provided by NCI scientists—including Nirali Shah, M.D., who studies CAR T-cell therapies for children with blood cancers—proved invaluable, Dr. Dwivedi said. The visit helped guide Dr. Dwivedi and her co-investigators in designing an effective CAR-T cell therapy, actalycabtagene autoleucel (NexCAR19), that could be manufactured in India, made available at a reasonable cost, and meet the needs of patients in India’s health care system.

In October 2023, India’s counterpart to the US Food and Drug Administration, the Central Drugs Standard Control Organization, made NexCAR19 India’s first approved CAR-T cell therapy.

https://www.cancer.gov/news-events/...19-car-t-cell-therapy-india-nci-collaboration

 

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The approval was based on the results of two small clinical trials conducted in IndiaExit Disclaimer in 64 people with advanced lymphoma or leukemia. According to trial results presented in December 2023 at the American Society of Hematology meeting, 67% of patients (36 out of 53) in the two trials had a notable decrease in the extent of their cancer (objective response), with the cancer disappearing altogether in about half (complete response).

ImmunoACT, a spin-off company of IIT Bombay, funded the trial and will be manufacturing actalycabtagene autoleucel and bringing it to market.

“This is a big achievement for India,” said Dr. Dwivedi, who is now continuing her training in NCI’s Center for Cancer Research. “It’s the team effort that brought us here.”

“This is like a dream come true and an incredible win for the patients in [India],” Dr. Purwar, who was Dr. Dwivedi’s graduate advisor at IIT Bombay and is founder and CEO of ImmunoACT, said in a statement. “Now our patients in India and [other] countries with limited resources will have access to this lifesaving drug at an affordable cost.”

 

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Learning from the leaders​

The researchers came to NCI near the end of 2017 through a visiting scientist program sponsored by NCI’s Center for Global Health. In addition to working with Dr. Shah, Terry Fry, M.D., and their colleagues to learn more about designing CAR T cells, the group also worked with Steven L. Highfill, Ph.D., David F. Stroncek, M.D., and their team from NIH’s Center for Cellular Engineering to get advanced training on manufacturing cellular therapies.

“They wanted to learn the entire process,” said Dr. Shah. That included everything from how to manufacture CAR T cells that are of high-enough quality to be used in humans to how to design a clinical trial to test their therapy.

Dr. Dwivedi said that the experience of shadowing NCI scientists was a turning point for her team. When they returned to India, they successfully manufactured several versions of a humanized CAR T-cell therapy. Dr. Shah and her NCI colleagues also made numerous trips to India to help the IIT Bombay/Tata team as they moved through the manufacturing process.

 

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Impressive clinical trial results​

On June 4, 2021, a patient at Tata Memorial Hospital in Mumbai received the first infusion of actalycabtagene autoleucel, the CAR T-cell therapy that would become NexCAR19. This first part of the clinical trial only included 14 patients, all of whom had B-cell acute lymphoblastic leukemiaExit Disclaimer that had returned or did not respond to standard treatments.

Based on promising results from the first 14 patients, a somewhat larger trial was quickly launchedExit Disclaimer. The combined trials included 64 people with B-cell lymphoma or leukemia.

At the American Society of Hematology meeting, ImmunoACT cofounder Atharva Karulkar, Ph.D., and Hasmukh Jain, M.D., of Tata Memorial Centre, who led the clinical trial, presented data from the trials. Among 53 patients who could be evaluated (38 with lymphoma and 15 with leukemia), 26 of 38 patients with lymphoma (68%) and 10 of 15 patients with leukemia (72%) responded to the treatment. All of the responses in the leukemia group were complete responses—that is, they had no signs of cancer.

None of the 53 participants had the neurologic side effects that are often seen in people treated with the CAR T-cell therapies approved in the United States, and only a small portion (5%) had a severe form of an immune-relate side effects known as cytokine release syndrome.

Only five patients required hospitalization because of side effects. A pediatric trial in B-cell acute lymphoblastic leukemia is ongoing

 

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A model for global team science​

Dr. Karulkar noted during his presentation that, in the United States, an infusion of CAR T-cell therapy costs about $400,000. By contrast, NexCAR19 is expected to cost around $50,000. ImmunoAct will manufacture the CAR T cells in a facility that’s being built in Mumbai and has plans to develop additional manufacturing sites across India. Initially, their hope is to treat around 1,200 patients a year.

“It is remarkable that they were able to generate a brand new CAR T-cell [therapy] that matched the results … being seen in the United States,” Dr. Shah said. “The fact that they have been able to keep the costs low and come up with a [treatment] that is relatively well tolerated—which is important for the patient population they're going to be treating in India—means that they’re going to [improve] the lives of so many people.”

Dr. Shah pointed out that this achievement goes far beyond developing India’s first CAR T-cell therapy. Through this collaborative effort, Dr. Dwivedi and her colleagues have built something that other low- and middle-income countries can model.

“What Dr. Dwivedi and the team there developed is an entire [cellular therapy] infrastructure,” Dr. Shah said. They’ve proven to public health agencies in other countries that they too are “able to now build [these therapies] from the bottom up.”

 

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26 of 38 patients with lymphoma (68%) and 10 of 15 patients with leukemia (72%) responded to the treatment. All of the responses in the leukemia group were complete responses—that is, they had no signs of cancer.

Wow over 68% of patients responded to treatment, certainly beat the vitamin c treatment response rate. And looks very effective for leukemia with all patients that responded to treatment become cancer free.

 

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None of the 53 participants had the neurologic side effects that are often seen in people treated with the CAR T-cell therapies approved in the United States,

Wow without serious side effects often seen in USA CAR-T cell therapies ie better.

 

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in the United States, an infusion of CAR T-cell therapy costs about $400,000. By contrast, NexCAR19 is expected to cost around $50,000.

And over 80% cheaper than USA CAR-T cell therapy.

 

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During their time at the NIH Clinical Center, this team shadowed leading experts in CAR T-cell therapy at NCI’s Center for Cancer Research. The training provided by NCI scientists—including Nirali Shah, M.D., who studies CAR T-cell therapies for children with blood cancers—proved invaluable, Dr. Dwivedi said. The visit helped guide Dr. Dwivedi and her co-investigators in designing an effective CAR-T cell therapy, actalycabtagene autoleucel (NexCAR19), that could be manufactured in India, made available at a reasonable cost, and meet the needs of patients in India’s health care system.

In October 2023, India’s counterpart to the US Food and Drug Administration, the Central Drugs Standard Control Organization, made NexCAR19 India’s first approved CAR-T cell therapy.

https://www.cancer.gov/news-events/...19-car-t-cell-therapy-india-nci-collaboration

This is how USA reported the news

India’s First Homegrown CAR T-Cell Therapy Has Roots in NCI Collaboration​

Subscribe
February 7, 2024, by Linda Wang

Following India's recent approval of NexCAR19, patients with cancer there will soon have access to an affordable CAR T-cell therapy.
Credit: iStock

 

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And this is how India reported the news with zero mention zero credit to USA

‘First’ patient free of cancer: Indigenous CAR-T cell therapy brings treatment cost down from Rs 4 crore to Rs 40 lakh​

Developed by ImmunoAct, IIT Bombay and Tata Memorial Hospital, the therapy has been administered to 15 patients in India. Three of them have successfully achieved cancer remission. Dr Gupta, the first commercial patient to be declared free of cancer, speaks of his experience exclusively to The Indian Express​

https://indianexpress.com/article/c...ow-available-for-commercial-use-9147148/lite/

 

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Express View on India’s CAR T-cell therapy: Taking cancer on​

Homegrown therapy against the disease holds promise. Researchers and planners must work to cut costs​

For decades, oncologists have relied on chemotherapy, radiation and surgery to treat cancer patients. These are still the primary methods to treat the dreaded disease. In the past two decades, however, research has extended the frontiers of anti-cancer interventions. Drugs have been developed to home in on the molecules cancer cells require to survive and spread. Immune system-boosting drugs have shown the ability to shrink tumours in some patients with advanced malignancy. CAR T-cell therapy is among the most promising recent developments, especially because it has shown the ability to eradicate advanced leukemias and lymphomas. Most of the early research in this field was conducted in laboratories in the US, Europe and China. In October, India joined this elite list after the country’s drug regulator approved a CAR T-cell therapy incubated at Tata Memorial Centre and IIT Bombay laboratories. Now, a 64-year-old former army doctor has become the first patient in the country to be free of cancer cells after being administered this therapy.

https://indianexpress.com/article/o...t-cell-therapy-taking-cancer-on-9149692/lite/

 

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Express View on India’s CAR T-cell therapy: Taking cancer on​

Homegrown therapy against the disease holds promise. Researchers and planners must work to cut costs​

For decades, oncologists have relied on chemotherapy, radiation and surgery to treat cancer patients. These are still the primary methods to treat the dreaded disease. In the past two decades, however, research has extended the frontiers of anti-cancer interventions. Drugs have been developed to home in on the molecules cancer cells require to survive and spread. Immune system-boosting drugs have shown the ability to shrink tumours in some patients with advanced malignancy. CAR T-cell therapy is among the most promising recent developments, especially because it has shown the ability to eradicate advanced leukemias and lymphomas. Most of the early research in this field was conducted in laboratories in the US, Europe and China. In October, India joined this elite list after the country’s drug regulator approved a CAR T-cell therapy incubated at Tata Memorial Centre and IIT Bombay laboratories. Now, a 64-year-old former army doctor has become the first patient in the country to be free of cancer cells after being administered this therapy.

https://indianexpress.com/article/o...t-cell-therapy-taking-cancer-on-9149692/lite/

CAR T-cell therapies are customised for each patient. It involves extracting T cells — they help orchestrate the immune response in a patient’s body — growing them in the laboratory, arming them against cancer via gene editing and infusing them back into the patient’s body. In other words, the patient is fortified with a living drug that’s constantly working against cancer. While it would be too early to say if the former army doctor has been cured for life, evidence from countries that have pioneered the treatment shows that CAR T-cell therapy is effective against relapse. The treatment is far less exacting for the patient compared to several sessions of chemotherapy. Laboratory and animal studies have shown that India’s homegrown therapy has significantly fewer side effects compared to those developed in the West.

 

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In the last decade, cancer mortality rates have declined in the developed countries. Cancer incidence and mortality, however, continue to rise, driven by spikes in the Global South. In India, where the disease claims about 8 lakh people every year, treatment is expensive for an overwhelming section of the population. The homegrown therapy costs about a tenth of the treatment in the US. However, at about Rs 40 lakh, it’s beyond the reach of most patients in the country. With more laboratories working on this oncological intervention, there is reasonable optimism that costs could come down appreciably in the next decade. The country will require inputs from its planners, scientists and policymakers to ensure that the products of such cutting-edge research reach the most vulnerable.

© The Indian Express Pvt Ltd

 

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The treatment is far less exacting for the patient compared to several sessions of chemotherapy.

So good cancer treatment only single session needed compared to multiple sessions over months or even year for chemotherapy or vitamin c infusions whatever.

 

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So good cancer treatment only single session needed compared to multiple sessions over months or even year for chemotherapy or vitamin c infusions whatever.

They should do this treatment for all cancers