On May 31, 2021, Porton Biologics Ltd. announced 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.

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 (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."

About KAEDI

KAEDI is a clinical stage biotech company. The company is committed to the research and development of new CAR-T cell and gene therapy drugs for malignant solid tumors. Relying on the company's advanced synthetic biology technology platform KD SmCAR?, KAEDI has successfully developed several R&D pipelines of CAR-T first-in-class drugs for malignant solid tumors, including the second generation of CAR-T, dual-targeted fourth generation CAR-T and allogeneic CAR-T, which have applied for dozens of patents at home and abroad and eight authorized.

Preclinical research results of KD-025 CAR-T products targeting NKG2DL for liver cancer and glioma were published in Journal for ImmunoTherapy of Cancer, Cancer Immunology Research and ASCO. 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. 

About Portonbio

Founded in 2018 and located in Suzhou, China, Porton Biologics Ltd. (Portonbio) is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363).  Portonbio offers global biotech companies a seamlessly integrated, cGMP-compliant manufacturing platform spanning plasmids, viral vectors and cell therapeutics to enable early to late-phase clinical trials and full commercial production.

Featuring a world-class senior management team with global experience, Portonbio's "Customer First" approach to Gene and Cell Therapeutics (GCT) manufacturing is anchored by our core principles of "Compliance, Expertise and Open Collaboration". Operating to rigorous, internationally harmonized Quality Management and IP protection standards, Portonbio is bringing innovative and highly flexible development and manufacturing solutions to the complex challenges in the GCT space – ultimately enabling the public's early access to good medicines.