PALO ALTO, Calif., July 10, 2025 /PRNewswire/ -- Leading GMP cell CDMO I Peace, Inc. (https://ipeace.com/en/), specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has agreed with Vita Therapeutics (Vita) to jointly develop universal iPS cells that will be used for cell transplantation therapy.

GMP-grade iPS cells will be modified with proprietary, licensed gene editing technology to make a base platform hypoimmune line where Class I and II HLA genes that determine rejection have been depleted. These hypoimmune lines can be further customized in I Peace cGMP facilities.

I Peace will provide its GMP iPS cell-related technology to generate the MCB's for the parent line and the modified subclones, while Vita will provide 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). 

I Peace will retain rights to supply MCB's of normal and gene-edited cells and to supply differentiated products generated from these lines for cell therapy purposes in all other areas.

• What are universal cells?

These cells are designed to suppress immune rejection due to human leukocyte antigen (HLA) incompatibility, which can occur during allogeneic cell transplantation therapy and can be transplanted without having to consider compatibility with the recipient's human leukocyte antigen (HLA) type. In this collaboration project, we will create these universal cells from iPS cells, and Vita will use them for cell transplantation therapy in FSHD patients

What is a DMF (Drug Master File) A 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. The company holding the DMF must provide a Letter of Authorization (LOA) to the applicant/sponsor, allowing the FDA to refer to the DMF's contents. In summary, acceptance of a DMF for iPSCs indicates that the iPSC line and its associated information have been submitted to the FDA in a format that allows the FDA to review it in conjunction with other regulatory applications, facilitating the development and clinical use of therapies based on these cells.

Vita Therapeutics

Vita Therapeutics is a biotechnology company developing state-of-the-art cellular therapeutics for the treatment of debilitating neuromuscular diseases. Vita Therapeutics uses induced pluripotent stem cell (iPSC) technology to engineer specific cell types designed to replace those that are defective in patients. The Company is progressing its lead program VTA-200 for the treatment of facioscapulohumeral muscular dystrophy (FSHD) using its proprietary hypoimmunogenic cell line.

I Peace, Inc.

I Peace, Inc. provides GMP iPS cells globally and is an entrusted manufacturing service provider of various medical-grade cells. The company was founded in 2015 by Koji Tanabe, a graduate of Professor Shinya Yamanaka's laboratory at Kyoto University, and the second author of the paper that reported the successful establishment of the world's first human iPS cell line. Tanabe has been involved in iPS cell research since the early days of its development and is working daily on innovative technical developments to make iPS cells accessible to everyone through I Peace, Inc.

Our unique technology enables us to produce multiple donor-derived iPS cells in parallel without contamination concerns and to provide scalable iPS cell manufacturing at a reasonable price. We are also promoting the production of iPS cells for individuals so that everyone in the world can prepare for the future by preserving their own iPS cells.

We support 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 so that cell medicine can become available to patients as soon as possible. Our ultimate goal is to enhance the prevalence of regenerative medicine by establishing iPS cell banking services for individuals and making iPS cells accessible to other development companies working with this incredible technology.

I Peace, Inc.
Founder & CEO: Koji Tanabe
Established: 2015
Headquarters: Palo Alto, California, U.S.A.
Subsidiary in Japan: I Peace, Ltd., Kyoto
iPS cell manufacturing base: Peace Engine Kyoto, Kyoto
Website: https://ipeace.com/en/