China's cellular immunotherapy tumors will enter the fast lane

China's cellular immunotherapy tumors will enter the fast lane

May 04, 2017 Source: Science Network

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"Cell immunotherapy has opened up another path for humans to deal with cancer." This is a researcher at the Shanghai Cancer Institute, Renji Hospital, Shanghai Jiaotong University School of Medicine, and Li Zonghai, chairman of Keji Biomedical (Shanghai) Co., Ltd., entitled "New Generation" Views expressed in the academic report of the Development and Challenges of CAR-T Technology.

In fact, the team led by Li Zonghai completed the world's first CAR-T Phase I clinical trial for refractory or recurrent hepatocellular carcinoma in the past year. The company now has more than 60 CAR-T related domestic and foreign patents including the fourth generation of CAR-T, and has unique international clinical research and development plans and strategies on multiple targets and multiple cancers.

CAR-T cells become an international research hotspot

Gu Jianren, academician of the Chinese Academy of Engineering and honorary director of the Shanghai Cancer Institute, told the reporter that the National Cancer Center of China in 2015 showed that the average annual incidence of cancer in China was 4,921,600, and the number of people dying from cancer was 2,814,200. About 8 people are diagnosed with cancer every minute. Can cancer really be eliminated? In recent years, CAR-T cells (Carmic Antigen Receptor (CAR) have been effective in the treatment of some blood tumors such as leukemia, and transformation studies in the field of solid tumor treatment have also started.

Li Zonghai said that tumors are essentially products derived from autologous cells and interact with the immune system, colluding and compromising. The key member of the immune system, T lymphocytes, is like a law enforcement policeman in the human body, specifically identifying cells that clear abnormalities. T lymphocytes often lose the ability to effectively recognize and clear tumor cells during tumorigenesis and progression. Therefore, the ability to engineer the immune system, especially its key member T cells, to restore its ability to recognize and clear tumors becomes critical.

The Chinese name of CAR-T is "chimeric antigen receptor-modified T lymphocytes". "CAR" is a molecular modification comprising an antibody sequence that recognizes a tumor antigen, giving T lymphocytes a targeted recognition ability for the tumor. Once the T lymphocytes are modified by the CAR, it is like a satellite navigation system that can accurately identify and destroy tumor cells. "Nova Pharmaceuticals and other companies have submitted a new CAR-T drug application for leukemia or lymphoma in March this year, and it is expected to benefit patients in the near future. However, the transformation of CAR-T cells in the field of solid tumor treatment is still in its infancy."

In 2013, the US Science magazine ranked cancer immunotherapy as the top of the “Top Ten Scientific Breakthroughs of the Year” because this new treatment showed good clinical results: some leukemia patients received a miracle after injection of CAR-T cell preparations. Rehabilitate. Today, CAR-T is effective in treating leukemia (which is a blood tumor) at 94%, but it is still to be overcome for solid tumor treatment.

"Blood tumors are like scattered soldiers in the blood. Solid tumors are the enemy in the bunker. It is very difficult to fight against solid tumors with immune cells. The CAR-T cells for solid tumors must face at least three challenges: That is, target point, tumor cell heterogeneity, tumor microenvironment heterogeneity; once these three challenges are overcome, many patients may be cured," Li Zonghai said.

CAR-T treatment for solid tumors breakthrough

Therefore, he has been striving to explore in this field and has achieved remarkable results. With in-depth research on tumor targets and antibody molecular design, he led the team to make breakthroughs in the field of CAR-T treatment of solid tumors. In October 2014, they published the first international paper on CAR-T treatment of liver cancer in the academic journal Clinical Tumor Research. Animal experiments show that the CAR-T cell preparation they developed can completely eliminate liver cancer cells in mice by only one injection. In brain cancer experiments, they designed CAR-T to completely eliminate the intracranial glioma in mice.

From 2005, he became the head of the biotherapeutic research team, and in 2015, pushed the CAR-T cell preparation into the clinical trial of liver cancer and brain cancer. The Li Zonghai team can be described as “a decade of grinding a sword”. According to Li Zonghai, the patients who have been treated by CAR-T have achieved the longest disease-free survival for 20 months; the relevant clinical research results will be presented at the 2017 American Society of Clinical Oncology Annual Meeting ASCO.

Advance scientific and technological achievements to the clinic

"New drug research such as CAR-T cells requires a lot of manpower and material resources. In order to promote scientific research results as soon as possible, it will benefit patients as soon as possible." Li Zonghai told reporters that he founded the first CAR-T cell research and development enterprise in China in 2015-- - Keji Biomedical (Shanghai) Co., Ltd. and Shanghai Cancer Research Institute have established an alliance of production, education and research, dedicated to the development of original CAR-T cell therapy, and actively promote the transformation of scientific research results. According to reports, the current Koji company has more than 10 original candidate CAR-T products, covering the majority of the human body such as leukemia, lymphoma, myeloma, liver cancer, lung cancer, stomach cancer, pancreatic cancer, glioblastoma, esophageal cancer, etc. Tumors, among which CAR-T products of liver cancer, lung cancer, stomach cancer and pancreatic cancer are the first in the world, and they are in the leading position in the field of international solid tumor CAR-T cell therapy.

In 2016, Koji Biomedical (Shanghai) Co., Ltd. received $30 million in financing and its valuation reached $173 million. At present, the company has established subsidiaries in Hong Kong and the United States, and officially launched preclinical research in the United States at the end of last year. It is expected to officially obtain FDA approval for clinical research this year.

What is even more surprising is that the 3100 square meter cell preparation center established in strict accordance with the GMP standards of the State Food and Drug Administration has been officially completed. This is very important for the preparation of CAR-T cell products and safe use in human body. Facilities security. This marks a substantial step in the industrialization of the original scientific research results of solid tumor CAR-T cell therapy in China.

With the funds, the talents have also been rapidly enriched. At present, the company already has 100 talents including the national youth and thousands of people; it attaches great importance to the declaration of knowledge industry at home and abroad, and the annual intellectual property maintenance costs alone amount to several million yuan. It is gratifying to have made breakthroughs in process development, which will greatly reduce the production cost of CAR-T, thus providing affordable CAR-T cell therapy for Chinese patients. Li Zonghai admits that without the support of the unit, there is no road of production, education and research, and without the intervention of social capital, then there can be no Koji today.

According to Dai Huili, deputy dean of Renji Hospital and director of the Shanghai Cancer Institute, the development of an innovative drug in the world will cost an average of 1 billion to 1.5 billion US dollars. Taking the CAR-T clinical trial as an example, the cost of each patient's trial is as high as several hundred thousand yuan. It is impossible to complete without the intervention of enterprises and capital. She said that the Institute encouraged Li Zonghai to explore the establishment of the company in the form of a company based on his work platform and the same assessment. “The cooperation model that is beneficial to society, units, R&D teams and investors is still in the process of exploration and practice. It is hoped that the final research results will be transformed and industrialized as soon as possible, so that more cancer patients will benefit.”

As the first innovative company in China focused on CAR-T cell immunotherapy, Koji Bio has completed the early development of a dozen target CAR-T products, all of which are self-developed human or human sources. Chemotherapy; a new target for research and development of CAR-T cell therapy for gastric cancer/pancreatic cancer, will be carried out in the near future. At the same time, original universal immunocytotherapy methods have been developed.

And Li Zonghai's company's development goals are even more eye-catching: at least 5 national drug and drug regulatory authorities (CFDA) new drug clinical research approvals will be submitted by the end of 2018; 1 to 2 US Food and Drug Administration (FDA) ) Clinical research approvals; strive to bring the first CAR-T product to market by 2020. Li Zonghai said that from the perspective of the transformation of scientific research results, it is more important to develop drugs that effectively cure tumors and protect human health.

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