News & Activities » GenScript ProBio Extends Congratulations to InnoBation Bio on MFDS Clearance of IBC101 Program

GenScript ProBio Extends Congratulations to InnoBation Bio on MFDS Clearance of IBC101 Program

Recently, InnoBation Bio, a partner of GenScript ProBio, announced that the IND application for bivalent Chimeric Antigen Receptor T-cell (CAR-T) treatment targeting CD19 and CD22 (IBC101) was cleared by the Ministry of Food and Drug Safety (MFDS) in South Korea. GenScript ProBio, the partner providing Lentiviral vector CMC services, extends warm congratulations on reaching this significant milestone.

In close partnership, GenScript ProBio played a pivotal role by offering a comprehensive suite of services, including cell banking, plasmid and lentiviral vector process development, GMP manufacturing and IND dossier services.

The IBC101 program focuses on a bivalent CAR-T treatment designed to target both CD19 and CD22. This breakthrough treatment, named 'InDura-Cell,' aims to address patients with B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma, distinguishing itself from the four commercially approved CAR-T treatments for blood cancers. It is anticipated to enhance the initial response rate and substantially reduce recurrence rates associated with immune evasion, such as the loss of CD19 antigen in cancer cells.

Developed by InnoBation Bio, InDura-Cell showcases three distinctive features. Firstly, by targeting two cancer antigens, CD19 and CD22, it effectively eliminates cancer cells expressing either antigen. This not only makes it applicable to patients with recurrent cancer due to 'CD19 loss' after previous CAR-T treatments but is also expected to significantly improve patient survival rates by enhancing the initial response and reducing cancer recurrence through dual antigen targeting. Secondly, the use of IL-7 and IL-15 instead of IL-2 during CAR-T cell culture is anticipated to enhance the immune memory and persistence of CAR-T cells within the patient's body. Lastly, InDura-Cell maintains optimal immune activity and enables swift responses to change in the patient's condition.

GenScript ProBio CEO Dr. Li Chen stated, “We congratulate InnoBation Bio on the MFDS clearance of its IND application. We are honored to accelerate this innovative bivalent CAR-T project. The approval of this project showcases our excellence in Lentiviral vector CMC capabilities. We believe this product will bring significant benefits to patients with B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma in the future. We will undoubtedly continue our close collaboration with the InnoBation Bio team."

InnoBation Bio's CEO, Dr. Byong Chul Yoo, commented, "Thanks to the Lentiviral vector CMC contract with GenScript ProBio, we promptly initiated the clinical trial approval process. With the recent approval of IBC101 clinical trial by the Ministry of Food and Drug Safety in Korea, we anticipate a smooth progression of the clinical trial, facilitated by the reliable supply of lentivirus from GenScript ProBio's outstanding GMP facilities and skilled personnel."

About InnoBation Bio

InnoBation Bio Co., Ltd., headquartered in the Republic of Korea, is a biotechnology company having established two major platforms. Its R&D activities focus on developing antibody- and immune-cell-based cancer therapeutics and liquid biopsy-based biomarkers for screening cancer patients.

About GenScript ProBio

GenScript ProBio, a subsidiary of GenScript Biotech Corporation, is a global player dedicated to providing premium end-to-end service from discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 70 IND approvals since October 2017.