Gameto Announces Path Towards a U.S. Phase 3 Trial and Executive and Advisor Appointments

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

• Dr. Lejtik is a gynecologist and obstetrician, specializing in human reproduction, with over 20 years of experience. He leads the clinical adoption and medical teams at Gameto. Prior to Gameto, he had extensive experience in Medical Management at Pfizer. While at Pfizer, he planned and developed in-person and digital medical education programs for primary care physicians and specialists, collaborated with national and international key opinion leaders to develop diagnostic guidelines for various medical specialties (e.g., Women's Health, Contraception, Oncology, Central Nervous System, Dermatology, Infectious Diseases, Vaccination, and Rheumatology), successfully launched and positioned female health products such as "Duavive and Sayana," and established relationships with key associations, colleges, and medical boards.

Welcoming leading reproductive medicine experts Pietro Bortoletto, M.D., M.Sc., and Michel de Vos, M.D., Ph.D., as scientific and clinical advisors

• Dr. Bortoletto is a board-certified reproductive endocrinologist. He is currently a Reproductive Medicine Specialist, Director of Reproductive Surgery, and Co-Director of Oncofertility Program at Boston IVF in Boston, Massachusetts. He is on staff at the Beth Israel Deaconess Medical Center Department of Obstetrics & Gynecology and a clinical instructor at the Harvard Medical School. In addition to his clinical role, Dr. Bortoletto currently serves as the Interactive Associate in Chief for Fertility & Sterility as well as Media Editor for F&S Reports.
• Dr. de Vos has worked as a gynecologist since 2006 and currently is a senior medical director at the Centre for Reproductive Medicine at Universitair Ziekenhuis Brussel, Belgium and an associate professor in reproductive medicine at Vrije Universiteit Brussel. In 2011, ESHRE and the European Board and College of Obstetrics and Gynaecology (EBCOG) recognized him as a subspecialist in reproductive medicine and surgery. He is a principal investigator of the FOTO (Freezing Ovarian Tissue and Oocytes) consortium, encompassing oncofertility research projects at three universities in Brussels: Vrije Universiteit Brussel (VUB), Université Libre de Bruxelles (ULB) and Université Catholique de Louvain (UCL) and he is a founding member of the Belgian Fertility Education Initiative (BFEI).

"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.

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SOURCE Gameto