Mahidol University Develops Breakthrough CAR-T Cell Drug Products for Cancer Treatment under International Standards: A Landmark Achievement for Thailand and ASEAN

Mahidol University Announcing achievements in innovation development Drug products for cancer treatment with cells and genes (CAR – T cell) under international standards, the first in ASEAN. It can be used in 10 adult and pediatric patients who are resistant to multiple chemotherapy treatments. Multiple targeted drugs

All 10 cases after receiving CAR – T cell respond until all cases are 100% cured, with Professor Banjong Mahaisavariya, M.D., President of Mahidol University, Prof. Piyamit Srithara, M.D., Dean of the Faculty of Medicine Ramathibodi Hospital. Mahidol University, Professor Dr. Suradej Honging, Department of Pediatrics Faculty of Medicine Ramathibodi Hospital Mahidol University and Mr. Somphote Ahunai, Chief Executive Officer of Energy Absolute Public Company Limited, attended a press conference at the Office of the President. Mahidol University, Salaya on April 19, 2023

Professor Banjong Mahaisavariya, M.D., President of Mahidol University, said that Mahidol University, as the “wisdom of the land”, has many important strategies that will help drive and develop the country. Supporting missions of the Ministry of Higher Education, Science, Research and Innovation especially in research which promotes the creation of new knowledge in the past, Mahidol University There are many innovations produced under the policy of promoting and supporting related departments to integrate between different disciplines together in order to strengthen the readiness to move forward in the creation of research and innovation to meet the needs of society.

success this time As part of joint research and development to produce medicines that can be used in Thailand by themselves Reduce health care expenses It also reduces drug imports from foreign countries. Each year, Thailand bears enormous expenses. This time was a breakthrough in the development of a drug to treat B-cell leukemia. with cells and genes Also known as CAR-T cell, which is currently more resistant to drugs used to treat it. And have to import drugs from foreign countries at a very high price The results of this research have begun to be used in practice in patients. and was very successful which will be an important future for the Thai medical community

Professor Piyamit Srithara, M.D., Dean of the Faculty of Medicine Ramathibodi Hospital Mahidol University said that the Faculty of Medicine Ramathibodi Hospital has a mission to produce graduates The provision of patient treatment services, including research and development of medical innovations are always present. New karma innovation. There is still a lot of pushing for drug research. But still stuck in the issue of not being able to enter the Clinical Trial, which is an important element that will allow Thailand to produce medicines on its own.

Therefore, the Faculty of Medicine Ramathibodi Hospital Mahidol University Therefore, cooperation with other institutions has been expanded. to lead to drug registration In the implementation of CAR – T cell drug products, it is considered a combination of the power of the government and the private sector in pushing for the achievement of objectives and production that can actually be used. According to EMA (European Medicines Agency) international standards and is currently bringing this drug into the research process in the IND (Investigational New Drug) process of the FDA for registration and certification according to international standards.

with cooperation from Mahidol University Institute of Technology and Innovation Management (iNT) National Science and Technology Development Agency (NSTDA) Health Systems Research Institute (HSRI) Center of Excellence in Life Sciences (Public Organization) Fund Administration and Management Unit for Enhancement of National Competitiveness (NEDA) Office of the National Higher Education, Science, Research and Innovation Policy Council and Ramathibodi Foundation For cooperating in the implementation of this project, and most importantly, Geneputik Bio Co., Ltd., which supports the project for certification of pharmaceutical production standards and many others, has resulted in the creation of Thai-made cancer medicine products. for Thai people with techniques and methods according to international standards

Professor Suradej Honging, M.D., Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University said that the research of innovative drug products used to treat cancer with cells and genes (CAR – T cell) by a team of doctors and researchers. Mahidol University Has started research since 2014 until it was successful and was able to be used in practice in 10 patients, both children and adults.

She was a patient with B-cell leukemia who was resistant to multiple chemotherapy regimens. Multiple targeted drugs as well as some people after hematopoietic stem cell transplantation. All 10 cases after receiving CAR – T cell responded until the disease was remission in all cases (100%). Patients’ parents, siblings come to culture and genetically modify in a sterile laboratory for about 2-3 weeks and then bring CAR – T cell drug products to the patient intravenously. After 2-4 weeks, it was found that the leukemia cells were gone, neither in the blood nor the bone marrow.

Currently, Mahidol University has cooperated with the private sector, with Geneputik Bio Co., Ltd. investing in a GMP (good manufacturing practice) laboratory, which is a production standard certified by the Food and Drug Administration on January 18, 2018. 2023 according to EMA (European Medicines Agency) international standards and is currently bringing this drug product into the research process in the IND (Investigational New Drug) process of the FDA for registration and certification according to international standards as well.

This increases the opportunity for Thai people to access the use of this medicinal product. because the cost is much lower which is the work of 100% Thai researchers, which has been patented covering both domestic and international Because of the molecular structure is clearly different. The ability to destroy cancer cells also works well in both test tubes and experimental animals. In addition, production preparations can be made using other than your own white blood cells. make more opportunities This is because many patients do not have enough white blood cells to be produced.

The CAR – T cell produced is not only used in patients with B-cell leukemia but can also be used in patients with B-cell lymphoma. In the future, Mahidol University is researching CAR T-cell drug products for Myeloma, bone cancer, brain cancer, adrenal gland cancer, and many others can be said that Mahidol University Has researched CAR – T cell drug products that used to be expensive To be able to enter the development and production process in the country at a lower cost in the first international standard laboratory in ASEAN. The initial treatment results were satisfactory. and is expected to be used in a wide range of patients soon Currently, we are contacted by neighboring countries to transfer such technology as well.

Mr. Somphote Ahunai, Chairman of the Board of Directors of Geneputik Bio Co., Ltd., said that the development of medical innovation and technology is very important and meaningful to the country. Especially now that we are faced with a serious disease. The CAR-T cell project through this public-private partnership will play an important role in making modern treatments more accessible to patients. Having the opportunity to support the development of gene therapy in Thailand through investment in Geneputik Bio to further develop CAR-T Cell research by a team of Thai doctors and researchers. to be able to be used to treat patients according to international standards

At present, Geneputik Bio has received GMP certification for the production of CAR-T Cell products from the Food and Drug Administration, which is another pride that has pushed Thailand. has a production plant The first GMP-compliant gene therapy product was born in Thailand. At the same time, Geneputik Bio Co., Ltd. is in the process of bringing this CAR-T Cell drug product into the clinical research process for drug registration according to international standards. This is an opportunity for both Thai and foreign patients. To have more access to quality treatment. Including the development and promotion of the medical industry in the country. This will lead to the push for Thailand to have advancement in advanced medical technology as an alternative to the health care of Thai people in the future.