Porton Biopharma Announces Strategic Collaboration with Kaidi Biotech to Accelerate CAR-T Drug Development and Manufacturing

SUZHOU, June 1, 2021 /PR Newswire/-- On May 31, 2021, Porton Biologics Ltd. (hereinafter referred to as "Porton Biologics") announced a strategic partnership with Nanjing Kaidi Biotechnology Co., Ltd. (hereinafter referred to as "Kaidi Biotechnology").Leveraging its end-to-end gene and cell therapy CDMO service platform, Porton Biologics provides CMC research and development services for Kaidi Biotechnology's novel CAR-T cell therapy, accelerating the R&D process of cell therapy drugs.

Under the agreement, Porton Biologics will serve as the exclusive CDMO partner to provide CMC research and development services for multiple CAR-T projects by Kaidi Biotechnology, including process development and manufacturing of plasmids, viral vectors, and CAR-T cells, as well as IND filing support for the CMC portion, among other services.The first collaborative project, the KD-025 CAR-T product, is indicated for liver cancer and glioma. Its preclinical research findings have been successively published in internationally authoritative journals on tumor immunotherapy and at the American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, a multi-center proof-of-concept (POC) clinical trial for KD-025 CAR-T is underway. Multiple patient infusions have been completed with no significant adverse reactions observed, demonstrating safety and efficacy. Meanwhile, domestic and international Investigational New Drug (IND) applications are being advanced.

Dr. Dai Hongjiu, Chairman and Executive President of Kaidi Biotechnology, stated:“We are very pleased to enter into a strategic partnership with Porton Biologics.Kaidi Biotech has successfully developed multiple therapeutic pipelines targeting malignant solid tumorsCAR-TClass I new drug R&D pipeline, we believe Porton Biologics' excellent technical team and professionalCDMOThe platform can help Kaidi Biotechnology rapidly and efficiently advance its R&D pipeline layout and accelerate the research and development process of cell therapy drugs.”

“We are highly honored to support Kaidi Biotechnology's innovative research in the field of cell therapy,”Mr. Ju Nianfeng, Chairman and Chief Executive Officer of Porton Biologics, stated:, "Porton Biologics has established an integrated CDMO service platform for plasmids, viral vectors, and cell therapy products, backed by a highly experienced team of experts and unique technological advantages.We hope that through this collaboration, we can accelerate Kaidi Biotechnology'sCAR-Tproduct commercialization process, jointly advance breakthroughs in cell therapy for solid tumors, and benefit more patients at the earliest opportunity.”

About Kaidi Biotechnology

Nanjing Kaidi Biotechnology Co., Ltd. is a clinical-stage novel drug R&D company. The company is dedicated to the research and development of novel CAR-T cell and gene therapy drugs for the treatment of malignant solid tumors. Leveraging its advanced synthetic biology technology platform -- KD-SmCAR™, Kaidi Biotechnology has successfully developed multiple R&D pipelines of Class 1 innovative CAR-T drugs targeting malignant solid tumors, including second-generation CAR-T, dual-targeting fourth-generation CAR-T, and allogeneic universal CAR-T. The company has filed dozens of domestic and international patents, with 8 patents granted.

The preclinical research findings of the KD-025 CAR-T product targeting NKG2D ligands for indications including hepatocellular carcinoma and glioma have been successively published in the authoritative international oncology immunotherapy journals 《Journal for ImmunoTherapy of Cancer》 and 《Cancer Immunology Research》, as well as at the American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, a multi-center proof-of-concept (POC) clinical trial for KD-025 CAR-T is underway. Multiple clinical infusions have been completed with no significant adverse reactions observed, demonstrating a safe and effective profile. Concurrently, Investigational New Drug (IND) applications for KD-025 CAR-T are being advanced both domestically and internationally, alongside the progression of multiple Investigator-Initiated Trial (IIT) clinical studies for novel CAR-T therapies.

About Porton Biologics

Porton Biologics Ltd. was founded in December 2018. Located in Suzhou Industrial Park and backed by its parent listed company, Chongqing Porton Pharmaceutical Technology Co., Ltd. (Stock Code: 300363), the company has established an integrated CDMO platform encompassing plasmids, viral vectors, and cell therapy products. It provides comprehensive services spanning early-stage research, investigator-initiated clinical trials, Investigational New Drug (IND) applications, clinical trial supplies for regulatory registration, and commercial manufacturing, thereby accelerating the translational process of drug research and development.

Focusing on gene and cell therapy, Porton Biologics builds upon the successful track record of Porton Pharma Solutions. Centered on internationally top-tier professionals and adhering to a "Customer First" service philosophy, the company embraces the brand values of "Compliance, Professionalism, Focus, and Open Collaboration." It inherits the parent company's robust intellectual property protection and project management mechanisms, alongside a comprehensive quality management system. Leveraging the core team's proven expertise in advancing gene and cell therapy products from clinical development to commercial launch, Porton Biologics delivers premium and highly efficient services to global clients, accelerating patient access to innovative therapies.