The research and development of cell therapy product candidates require an exceptional team of people with scientific and clinical expertise across a range of disciplines. We seek to forge collaborations with leading strategic partners, key researchers, and top medical centers to accelerate the development of our first-in-class product candidates and proprietary iPSC platform.
We are collaborating with ONO Pharmaceutical to develop and commercialize off-the-shelf CAR-T cell product candidates for the treatment of solid tumors. The collaboration brings together ONO’s global leadership and proven track record in oncology and our expertise with induced pluripotent stem cells (iPSC) and CAR-T cell therapies. Under the collaboration, using our proprietary iPSC platform, collaboration candidates will be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, include insertion of a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality.
In June 2022, we expanded our collaboration with Ono to include the research and development of CAR-targeted natural killer (NK) cell candidates derived from engineered master induced pluripotent stem cells for the treatment of solid tumors. We are jointly conducting research and development activities under a joint development plan and are developing product candidates against two solid tumor antigen targets.
We are conducting a research collaboration with the University of Minnesota led by Jeffrey S. Miller, M.D., Deputy Director of the Masonic Cancer Center and the Deputy Director of the Clinical and Translational Science Institute at the University of Minnesota. Under the collaboration, we advanced the first-ever iPSC-derived cell therapy, FT500, and the first-ever engineered iPSC-derived cell therapy, FT516, into clinical development in the United States. We continue to work in collaboration with the University of Minnesota on the research and development of off-the-shelf, iPSC-derived CAR NK cell cancer immunotherapies.
We are conducting a research collaboration with the Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at Memorial Sloan Kettering Cancer Center, for the development of iPSC-derived T-cell immunotherapies. Through this collaboration, we have sought to leapfrog the current patient-specific approach to T-cell immunotherapy by uniting the research, preclinical and manufacturing activities of the two groups. We are developing FT819, an off-the-shelf CAR T-cell cancer immunotherapy derived from a clonal engineered master iPSC line with complete elimination of TCR expression and a novel 1XX CAR targeting CD19 inserted into the TRAC locus, under our collaboration with Memorial Sloan Kettering Cancer Center. Together, these features are intended to induce antigen-specific cytotoxicity, enhance CAR activity through TRAC-regulated expression and completely eliminate TCR expression to mitigate GvHD.
We are conducting a research collaboration with Oslo University Hospital led by Dr. Karl-Johan Malmberg, a leading expert in NK cell biology and killer cell immunoglobulin-like receptors. Our specific goals of this collaboration are to identify NK cell modifications that promote persistence and enhanced anti-tumor potency, and to create new iPSC-derived NK cell product candidates for development.