NEW YORK, July 10, 2024 -- Gameto, a biotechnology company dedicated to advancing treatment options in women's health, will present research at the 2024 International Society for Stem Cell Research (ISSCR) Annual Meeting demonstrating the reproducible differentiation of ovarian support cells (OSCs) from clinical-grade human induced pluripotent stem cells (hiPSCs). The research supports the manufacturing process for Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSCs) to mature eggs outside of the body. This represents the first clinical translation of clinical-grade hiPSCs to potentially enhance in vitro fertilization (IVF) outcomes and advance solutions for women’s health, and it builds upon research previously disclosed on biorxiv.
"This work reflects the strength of our strategic product development approach and demonstrates our ability to create OSCs of improved reproducibility, purity, and efficacy in a way that can be scaled for clinical and commercial manufacturing," said Bruna Paulsen, Ph.D., Vice President, Manufacturing and Therapeutic Development at Gameto. "This study brings us closer to clinical applications that could improve IVF and egg freezing outcomes and advance innovation in women's health."
Gameto’s novel approach uses cellular engineering to create a pure population of highly potent ovarian support cells (OSCs) from a female clinical-grade human induced pluripotent stem cell (hiPSC) line that recreates the dynamic, bidirectional follicular environment in a dish when co-cultured with immature eggs. Gameto recently showed their approach could quickly and efficiently differentiate OSCs from hiPSCs, creating a versatile platform for both basic research and clinical applications.
The results highlighted in the ISSCR poster suggest that this novel approach can generate a pure population of OSCs with key functional properties for improving IVM of human oocytes and formation of euploid embryos. Furthermore, the findings suggest that the advancements to the protocol to generate OSCs derived from clinical-grade hiPSCs lead to a consistent higher rate of oocyte maturation.
Gameto has received tentative FDA approval to proceed to Phase 3 clinical trials, subject to the completion of certain assay and manufacturing requirements.
The poster, titled "Reproducible differentiation of pure ovarian support cells from clinical-grade hiPSCs as a novel infertility treatment" (#125), will be presented at the ISSCR Annual Meeting in Hamburg, Germany on July 10, 2024 from 5:45-6:45 p.m. CEST.
To learn more about how Gameto is redefining women's healthcare, please request a meeting at comms@gametogen.com.
About Fertilo
Fertilo, Gameto’s lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Gameto’s goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. Fertilo has received different regulatory classifications in foreign jurisdictions, and after consultation with national regulators, has been cleared for commercialization in Australia, Japan and in large markets in Latin America.
About Gameto
Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.
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