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On November 12, 2024, the Department of Radiotherapy of Sun Yat-sen University Cancer Prevention and Treatment Center (SUNYCCPC) successfully completed the first patient enrollment in the "KSD-101 Early Exploratory Clinical Study in EBV-associated Nasopharyngeal Carcinoma that Failed Standard Treatment" project.
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KSD-101 is an autologous dendritic cell vaccine (DC vaccine) independently developed by Hengsai Biotechnology, loaded with EBV-associated tumor-like complex antigens, which can activate EBV-specific CTLQ in the human body after subcutaneous injection, thus realizing the effective recognition and killing of tumor cells.KSD-101 has been successfully completed the dual reporting of the U.S.-China, and has been granted IND authorization by U.S. Food and Drug Administration. KSD-101 has successfully completed both Chinese and American reports, and has been granted IND license by the U.S. Food and Drug Administration (FDA), which is the first original dendritic cell vaccine (DC vaccine) product in China that has been granted IND license by the U.S. FDA.
The safety and efficacy of KSD-101 has been preliminarily validated in clinical IIT studies for the treatment of relapsed and refractory hematological tumors, and a multicenter clinical IIT study for nasopharyngeal carcinoma is currently underway at Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, and at Sun Yat-sen University Cancer Prevention and Control Center.
The completion of enrollment and administration of the first patient in China Swell marks a more solid step for Hengsai Bio in the new journey of DC vaccine for solid tumors. We look forward to providing EBV-related nasopharyngeal cancer patients with a safer, more convenient, and long-lasting effective treatment option with the concerted efforts of all of us.
Nasopharyngeal cancer is a relatively common malignant tumor, China is the country with the largest number of nasopharyngeal cancer patients in the world, in which the main morbidity factor is related to EBV infection, and the survival rate of early and locally advanced nasopharyngeal cancer has been significantly improved. However, there are still about 20% patients with recurrence or distant metastasis, and the prognosis of these patients is very poor, with toxic reactions such as dysphagia, neck tissue damage, skin toxicity, acute hematologic toxicity, vocal cord dysfunction, and hypothyroidism occurring during treatment. Therefore, there is a need to find an innovative treatment that reduces toxic reactions, improves quality of life and has superior efficacy.
Founded in 1964, the Radiotherapy Department of Sun Yat-sen University Cancer Center has a long history and is currently the largest radiotherapy center in Asia with the largest number of tumor patients admitted annually. The level of treatment is in the advanced ranks both at home and abroad, of which the comprehensive treatment of nasopharyngeal carcinoma is in the leading position in the world.
Founded in 2018, Hengsai Bio is a scientific and technological innovative enterprise and national high-tech enterprise dedicated to the research, development and industrialization of dendritic cell vaccines (DC vaccines). The company has successfully constructed the Eco-DCVax platform, aiming to break down the technical barriers to industrialization and develop global First-in-Class high-quality DC vaccine products with independent property rights that are safe, efficient and convenient to administer. The developed product, therapeutic dendritic cell vaccine, provides a new approach and strategy for the treatment of relapsed and refractory tumors, chronic viral infections, autoimmune diseases and other diseases that are in urgent need of effective clinical treatments.
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