Although there are key players in multiple geographies worldwide, Japan has positioned itself as a hub for induced pluripotent stem cell (iPS cell) technology. iPS cells are made by reprogramming adult cells back into an embryonic-like state. Derived from skin or blood cells, they are not controversial.
Vita Therapeutics Receives Orphan Drug Designation from FDA for Allogenic iPSC-based Therapy
BALTIMORE, July 23, 2020 — Vita Therapeutics, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).
VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. [Read more…]
Platelet BioGenesis Bags $56M to Develop Human iPSC-Derived Platelets as Nuclear Countermeasure
- Platelet BioGenesis has the world’s first technology to generate clinical-grade human platelets from induced pluripotent stem cells (iPSCs).
- Platelet BioGenesis has been awarded $56 Million Contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop donor-independent platelets as a treatment for radiological and nuclear exposure.
Non-Commercial Organizations Developing iPSC Therapies
There are diverse and ever-growing number of commercial entities supporting the development of induced pluripotent stem cell (iPSC) therapies. However, there are also government and academic entities who are pursuing therapeutic progress with the cell type.
The most notable institutions working toward this goal are:
- RIKEN Center in Kobe, Japan
- Kyoto University in Kyoto, Japan
- California Institute for Regenerative Medicine (CIRM) in California, USA
Each of these important institutions and their contributions to the development of new iPSC therapies is presented below.
FUJIFILM CDI: A New Behemoth is Entering the Cell Therapy CDMO Market
A new behemoth is entering the cell therapy CDMO market, FUJIFILM Cellular Dynamics (FUJIFILM CDI). CDMOs are companies that provide manufacturing services to cell and gene therapy companies on a contract basis. In some cases, they may also support product development, clinical trial support, or commercial supply.
FUJIFILM Cellular Dynamics, Inc. (FCDI), a US subsidiary of FUJIFILM Corporation, will be spending $21M to open a new cGMP-compliant production facility in Madison, Wisconsin. According to FCDI’s January 2019 announcement, the facility will support FCDI’s internal cell therapeutics pipeline, as well as serve as a Contract Development and Manufacturing Organization (CDMO) for iPS cell products. [Read more…]
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