On September 21, 2023, RocRock Bio, Nanjing Drum Tower Hospital, and the Jiangsu Provincial Industrial Technology Research Institute's Cell Therapy Pharmaceuticals Research Institute signed a strategic clinical cooperation agreement for CAR-M - targeted treatment of autoimmune diseases. Witnessed by Jianguo Yin, Chairman of Suzhou Industrial Park Bio - industry Development Co., Ltd., this collaboration marks the first time macrophage - based drugs have entered the autoimmune disease treatment field globally, bringing new hope to patients.
（Left 3 Professor Ming Shi, Executive Director, Jiangsu Provincial Tumor Biotherapy National and Local Joint Engineering Laboratory; Left 4 Dr. Jianguo Yin, Chairman, Suzhou Industrial Park Bio - industry Development Co., Ltd.; Center Dr. Xiushan Yin, CEO, RocRock Bio; Right 4 Professor Lingyun Sun, Director, National Regional Medical Center, Nanjing Drum Tower Hospital, and President, the Second Affiliated Hospital of Anhui Medical University.）
SLE is a heterogeneous chronic autoimmune disease. The presence of various autoantibodies, especially antinuclear antibodies (ANA), in the serum and the involvement of multiple systems are its two main clinical features. Traditional treatments, such as immunosuppressants, biologics, and antimalarial drugs, have significant limitations. There is a pressing need for safer and more effective therapeutic options.
In systemic lupus erythematosus (SLE), CD19, a protein on the surface of B cells, plays a role in disease flare-ups and is a target for several CAR-T therapies that have been approved for blood cancers. Researchers at the University of Erlangen-Nuremberg in Germany have treated six lupus patients with CD19-targeted CAR-T cells, achieving remission periods of up to 17 months without the use of traditional SLE medications. This suggests that lupus may be more amenable to CAR-T therapy than B-cell tumors.
Professor Ming Shi's team at Xuzhou Medical University, known for their work in CAR-T cell development and clinical trials, has treated over 600 cancer patients. They have developed humanized CD19 CAR-T and BCMA CAR-T therapies, and pioneered the use of dual-target CAR-T cells for late-stage myeloma. The team has also explored the use of dual-target CAR-T cells for depleting pathogenic B cells in autoimmune diseases such as chronic Guillain-Barré syndrome, neuromyelitis optica, and myasthenia gravis. In January 2021, they successfully treated a Pakistani patient with multiple myeloma using a combination of CD19 CAR-T and BCMA CAR-T therapy. Long-term follow-up results published in the Journal of Clinical Oncology in 2022 showed high efficacy and good safety profiles.
Macrophages, which are key players in the innate immune system and have phagocytic and antigen-presenting functions, are being engineered to target and eliminate pathogenic B cells in autoimmune diseases like lupus. RocRock Bio, a leader in CAR-M therapy, is exploring this approach for SLE treatment, aiming to overcome the limitations of current therapies such as lymphodepletion, which is often insufficient and leads to relapse. By enhancing the targeting and infiltration capabilities of engineered macrophages, CAR-M therapies offer promise for more effective B-cell depletion and disease control in lupus.
（CAR-M）
The signing of this cooperation agreement symbolizes that RocRock Bio, Nanjing Drum Tower Hospital, and the Jiangsu Provincial Industrial Technology Research Institute's Cell Therapy Pharmaceuticals Research Institute have entered the international "frontier" in cell therapy. It reflects the transition of China's cell therapy field into a new phase characterized by original research and development. This collaboration also represents a proactive effort to bring together the expertise and resources of multiple parties in the Yangtze River Delta region, with the aim of driving scientific progress in autoimmune diseases, fast-tracking the development and clinical application of CAR-M targeted therapy, and providing enhanced treatment options for patients. This initiative is set to deepen the collaboration and exchange among the three parties in the realm of immune diseases, steering their partnership towards greater heights and superior quality. With this new beginning, they are united in their efforts to cultivate a "win-win cooperation" paradigm.
（Negotiation and exchange）
（Negotiation and exchange）
Professor Lingyun Sun is a leading figure in rheumatology and immunology at Nanjing Drum Tower Hospital and the Second Affiliated Hospital of Anhui Medical University, holding the titles of Chief Physician, Professor, and Doctoral Supervisor. With extensive international research experience in Italy, Japan, the UK, and Australia, he has made significant contributions to the field of rheumatology. Notably, he established the first laminar flow ward in China's rheumatology department and pioneered allogeneic bone marrow mesenchymal stem cell transplantation for lupus in 2007. His work has significantly advanced the treatment of lupus and other autoimmune diseases. Sun has also organized key rheumatology conferences and enjoys a special government allowance for his contributions.
Professor Ming Shi, Ph.D., holds multiple key positions in tumor biotherapy and cell therapy research institutions in Jiangsu Province, including Executive Director of the National and Local Joint Engineering Laboratory of Tumor Biotherapy and Executive Director of the Cell Therapy Pharmaceuticals Research Institute at the Yangtze River Delta National Innovation Center. As a leading figure in the field of cell therapy, Professor Shi has spearheaded the development and clinical application of CAR-T cells, successfully treating over 600 cancer patients with remarkable efficacy that meets international standards. His extensive research portfolio includes leading six National Natural Science Fund projects, a sub-topic of the National 863 Project, a sub-topic of the National Major New Drug Development Project, and a Jiangsu Provincial Key Research and Development Plan, amassing a total research funding of over 15 million yuan. Professor Shi has made significant academic contributions, evidenced by his 29 SCI publications as the first or corresponding author, contributions to two international academic monographs, translations of two academic texts, and the acquisition of five national invention patents. His work has been recognized with prestigious awards, including the first and third prizes of military technological progress and the third prize of the Chinese Anti-Cancer Association Science and Technology Award.
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