NEW YORK, July 8, 2024 – Gameto, a biotechnology company dedicated to advancing treatment options in women's health, today announced new research at the 2024 European Society of Human Reproduction and Embryology (ESHRE) Annual Meeting supporting the cellular mechanisms underlying Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSCs) to mature eggs outside of the body. The results suggest that crosstalk between OSCs and immature oocytes (eggs), may contribute to an improved in vitro environment that helps oocytes mature as they would in the body.
“These results underscore our approach to recreating a natural ovarian environment in a dish to mimic the way that eggs would normally mature,” said Bruna Paulsen, Ph.D., Vice President, Manufacturing and Therapeutic Development at Gameto. “This study strengthens the core underlying mechanism of action of our ovarian support cells and we’re excited to see genetic similarities between eggs matured with OSCs in vitro and those matured in vivo.”
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 previously published results in Human Reproduction showing that co-culturing immature human eggs with OSCs results in higher rates of egg maturation and euploid embryo formation. The technology is designed to replace hormonal injections and shorten the in vitro fertilization (IVF) and egg freezing cycle from 10-14 days to less than 3 days. In May, Gameto also published results in the Journal of Assisted Reproduction and Genetics showing that eggs matured with OSCs are genetically similar to eggs that were matured in the human body.
In the results presented at ESHRE, Gameto demonstrated the ability to generate consistent and functional OSCs with a granulosa cell profile from a clinical-grade induced hiPSC line. OSCs cultured with eggs during IVM showed dynamic gene expression and a resemblance to primary cumulus cells which surround egg cells and contribute to their maturation. Additionally, eggs in the metaphase II stage treated with OSC-IVM showed a transcriptomic profile closely resembling that of eggs in metaphase II from traditional IVF, along with a pathway enrichment profile indicative of high developmental competence.
Gameto has received tentative FDA approval to proceed to Phase 3 trials, subject to the completion of certain assay and manufacturing requirements.
The poster, titled “Bidirectional signaling between oocytes and ovarian support cells during in vitro maturation results in improved oocyte gene expression,” was presented at the ESHRE 40th Annual Meeting in Amsterdam.
For more information about Gameto and how the company is redefining women's healthcare, visit the Gameto booth 11.005 in Hall 11 between July 7-10. Meeting requests can be sent to 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.
Investor Contact
Kylie Jordan
kylie@gametogen.com
Press Contact
Alexis Feinberg
GametoPR@westwicke.com
1. Piechota S, Marchante M, Giovannini A, et al. Human-induced pluripotent stem cell-derived ovarian support cell co-culture improves oocyte maturation in vitro after abbreviated gonadotropin stimulation. Hum Reprod. 2023;38(12):2456-2469. doi:10.1093/humrep/dead205
2. Paulsen B, Piechota S, Barrachina F, et al. Rescue in vitro maturation using ovarian support cells of human oocytes from conventional stimulation cycles yields oocytes with improved nuclear maturation and transcriptomic resemblance to in vivo matured oocytes. J Assist Reprod Genet. Published online May 30, 2024. doi:10.1007/s10815-024-03143-4