Gameto today provided an update on its clinical program for their lead asset, Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, and recent additions to its management team and scientific and clinical advisors.
| Company on path towards initiating Phase 3 trials for BLA approval pending completion of specific assay and manufacturing requirements Carlos Lejtik, M.D., to lead clinical adoption and medical teams as Medical Director Pietro Bortoletto, M.D., M.Sc., and Michel de Vos, M.D., Ph.D., join as scientific and clinical advisors NEW YORK, April 9, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women’s healthcare, today provided an update on its clinical program for their lead asset, Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, and recent additions to its management team and scientific and clinical advisors.
Clinical highlights Following productive discussions with the U.S. Food and Drug Administration (FDA), Gameto received tentative approval to proceed to Phase 3 trials, subject to the completion of certain assay and manufacturing requirements. This Phase 3 trial is a critical step toward a Biologic License Application (BLA) approval, with pregnancy assessed at 12 weeks of gestation as the primary efficacy endpoint. “This is a significant milestone in our journey to bring innovative treatment options to patients, and we are fully committed to meeting the rigorous standards set by the FDA to advance our product through the final phases of clinical development,” said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. “IVF is a relatively new field and navigating the regulatory pathways in this industry poses unique challenges. We are grateful to the agency for their guidance and excited to have a defined path towards a potential BLA approval and market authorization in the U.S.” As part of its discussions with the FDA, Gameto submitted preclinical animal data showing use of Fertilo did not lead to abnormalities in live births of mice. Mice born from eggs matured with Fertilo showed no genetic, developmental, or behavioral abnormalities, and overall no significant differences between live births compared to traditional IVM. Gameto presented these initial results at the 2023 American Society for Reproductive Medicine Congress. The manuscript describing these data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2024.04.04.588122v1 and Gameto is submitting it for scientific peer-review for potential publication. Strengthened management team with appointment of Carlos Lejtik, M.D., as Medical Director
Welcoming leading reproductive medicine experts Pietro Bortoletto, M.D., M.Sc., and Michel de Vos, M.D., Ph.D., as scientific and clinical advisors
“We are excited to welcome Carlos, Pietro, and Michel to the Gameto team,” added Dr. Christian Kramme, Chief Scientific Officer of Gameto. “All three bring deep expertise in human reproduction, endocrinology, and women’s health. They will be instrumental as Gameto enters commercial markets around the world, accelerates its growth and prepares to meet the FDA’s conditions for Phase 3 trial initiation. Their experience is a great complement to our team and will help us realize our mission of filling the massive gaps in fertility medicine and improving the female reproductive journey.” 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 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 Press Contact
SOURCE Gameto |
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