Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, has announced a strategic partnership with Vita Therapeutics to jointly develop universal iPS cells for cell transplantation therapy. The collaboration will initially focus on treating facioscapulohumeral muscular dystrophy (FSHD), a debilitating neuromuscular disease.
Universal Cell Platform Development
The partnership centers on creating GMP-grade iPS cells modified with proprietary, licensed gene editing technology to establish a base platform hypoimmune line. These cells will have Class I and II HLA genes that determine rejection depleted, creating universal cells designed to suppress immune rejection due to human leukocyte antigen (HLA) incompatibility. The hypoimmune lines can be further customized in I Peace's cGMP facilities to meet specific therapeutic requirements.
Universal cells represent a significant advancement in transplantation therapy as they can be transplanted without having to consider compatibility with the recipient's human leukocyte antigen (HLA) type. This eliminates the need for HLA matching, which has traditionally been a major barrier in allogeneic cell transplantation therapy.
Collaboration Structure and Regulatory Strategy
Under the agreement, I Peace will provide its GMP iPS cell-related technology to generate the master cell bank (MCB) for both the parent line and the modified subclones. Vita Therapeutics will contribute the technology necessary for gene editing and developing iPSC-derived universal cells. The manufactured MCB through this collaboration will be registered in the FDA Drug Master File (DMF).
The DMF filing facilitates the use of iPSCs in therapeutic development by providing a standardized data package and streamlining the regulatory submission process. This is particularly important for clinical-grade iPSC lines used in the later stages of drug development. For the FDA to review a DMF, it must be referenced in an application, with the company holding the DMF providing a Letter of Authorization to the applicant/sponsor.
Commercial Rights and Applications
I Peace will retain rights to supply MCBs of normal and gene-edited cells and to supply differentiated products generated from these lines for cell therapy purposes in all other areas beyond the specific collaboration scope. This arrangement positions I Peace to leverage the universal cell platform across multiple therapeutic applications while supporting Vita's specific focus on FSHD treatment.
Company Backgrounds
Vita Therapeutics is a biotechnology company developing cellular therapeutics for debilitating neuromuscular diseases using iPSC technology to engineer specific cell types designed to replace defective cells in patients. The company is progressing its lead program VTA-200 for FSHD treatment using its proprietary hypoimmunogenic cell line.
I Peace was founded in 2015 by Koji Tanabe, a graduate of Professor Shinya Yamanaka's laboratory at Kyoto University and second author of the paper reporting the successful establishment of the world's first human iPS cell line. The company's unique technology enables parallel production of multiple donor-derived iPS cells without contamination concerns and provides scalable iPS cell manufacturing. I Peace supports drug discovery and cell medicine development by providing iPS cells and other cell products that meet PMDA and FDA standards to pharmaceutical and cell medicine development companies.
