CAR-T Cancer Therapy: Hope For Patients and Healthcare Industry Expansion Driver
In March, the Ministry of Health, Labour and Welfare approved Bristol Myers Squibb’s Breyanzi CAR-T cell therapy for certain types of lymphoma cancers, making it the third such treatment to have received approval in Japan. The huge domestic healthcare market, totalling approximately 43.4 trillion yen ($398 billion dollars) in FY2018, is undergoing some significant shifts.
Shortly after Shinzo Abe became prime minister for the second time in late 2012, he announced plans to position Japan as a global leader in regenerative medicine, committed to investing 110 billion yen annually to related research, and to deregulation. This followed the spotlight being shone on regenerative medicine by the joint award of the 2012 Nobel Prize in Physiology or Medicine to Kyoto University’s Shinya Yamanaka for his ground-breaking research on iPS cells.
2014 saw the Abe administration follow through on its promise of deregulation with two new laws: the Act on the Safety of Regenerative Medicine and the Pharmaceutical and Medical Devices Act. These allowed for the fast-tracking of cellular therapies to an extent that surprised even many in the industry, and has led to the creation of thousands of new potential treatments.
Obtaining Critical Government Approval
Japan has made huge strides in regenerative medicine in the years since the Abe government launched its initiatives, including the work of Hiroshima University’s Professor Mitsuo Ochi, who has helped revolutionise knee surgery with his cutting-edge techniques.
However, one of the most promising treatments – CAR-T cell (T cell) therapy – has meanwhile emerged from the US. Extracted from a patient’s blood, the chimeric antigen receptor (CAR) T cells are modified to attack the cancer and then injected back into their body.
Novartis’ Kymriah treatment secured reimbursement from national health insurance in May 2019, followed by Gilead’s Yescarta (licensed by Daiichi Sankyo) approval in January this year. With costs for each treatment running to tens of millions of yen, coming under the national health insurance system was crucial.
The latest approval should further boost the availability of CAR-T therapy and demand for professionals in the field.
Domestic Scientific Breakthroughs In The Field
The cost of CAR-T treatments could be on the verge of being drastically reduced if work on new methods of creating cells at Kyoto University’s Center for iPS Cell Research and Application (CiRA) comes to fruition.
In January, CiRA Professor Shin Kaneko reported that his lab has been able to produce T cells from iPS cells for cancer immunotherapy on a large scale. This eliminates the need to remove cells from a patient’s blood and allows for the production of huge numbers of ‘stock cells’ which can be used in CAR-T.
“The advantage of combining CAR-T therapy and iPS cells is that we can make many T cells from the iPS cell stock to attack any type of cancer,” explained Kaneko when announcing the findings. “The stock removes the need to take cells from the patient, which requires time. Instead, our goal is to make an ‘off-the-shelf’ T cell product from iPS cells that is no different than getting a blood transfusion in the hospital.”
Kaneko and his team have also devised a way to modify iPS cells so that they are not attacked by a patient’s immune system.
“It’s possible it could be applied not just with T cells, but in transplantation medicine using other cells derived from iPS cells,” Kaneko told the Mainichi Shimbun in May, shortly after the research was published in the UK science journal Nature.
Research into CAR-T therapies for other forms of cancer is also ongoing, setting the stage for further expansion in the future, something also likely to be seen across a range of regenerative medicine areas.
The Need For Talent
The rapid expansion of this promising field is leading to companies scrambling to find talent. “This is a very active area within healthcare at the moment and companies are aggressively looking to expand their capabilities in the field,” says Head of Healthcare at Slate Consulting, Yonoshin Takagi. There is very strong demand for Car-T professionals in a wide range of expertise such as QA, Marketing ,Production and Medical Affairs.
Research into CAR-T therapies for other forms of cancer is also ongoing, setting the stage for further expansion in the future, something also likely to be seen across a range of regenerative medicine areas.
By: Gavin Blair
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