On June 2, 2021 Porton Biologics Ltd. (hereinafter referred to as Portonbio) reported a strategic cooperation with Nanjing KAEDI Biotech, Inc. (hereinafter referred to as KAEDI). Portonbio will offer CMC services for KAEDI’s CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process (Press release, Porton Biopharma, JUN 2, 2021, View Source [SID1234583427]).
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According to the agreement, Portonbio, as an exclusive CDMO partner, will provide KAEDI with CMC services for multiple CAR-T projects, including the process development and manufacturing of plasmids, viral vectors and CAR-T cells and IND filling (CMC part) support services. The indication of the first project of our collaboration, KD-025 CAR-T, is liver cancer and glioma. The results of its preclinical research have been published in the leading international journal of tumor immunotherapy and ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology). At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad.
Dr. Hongjiu Dai, Chairman and CEO of KAEDI, said: "We are very pleased to have a strategic cooperation with Portonbio. KAEDI has successfully developed a pipeline of several CAR-T new drug candidates for malignant solid tumors. We believe that Portonbio’s excellent technical team and professional CDMO platform can help KAEDI quickly and efficiently promote the drug candidates in our pipeline and accelerate the development process of our cell therapy drugs."
"We are very honored to contribute to KAEDI’s innovative research in the field of cell therapy", said Mr. Nianfeng Ju, Chairman and CEO of Portonbio, "Portonbio has established an integrated CDMO service platform for plasmids, viral vectors and cell therapy products, and has an experienced expert team and unique technical advantages. We hope to accelerate the marketing process of KAEDI CAR-T products through this cooperation, jointly promote the breakthrough of cell therapy products in the field of solid tumor, and enable the patients’ early-access to the therapies."