Gameto Advances to U.S. Phase 3 Trials and Expands Leadership Team

Gameto, a pioneering biotech firm at the forefront of women's health innovation, has announced significant progress toward initiating Phase 3 clinical trials for its flagship product, Fertilo. The company has received preliminary approval from the U.S. Food and Drug Administration (FDA) to advance to this stage, contingent upon fulfilling certain testing and production criteria. The pivotal Phase 3 trials will be instrumental in attaining a Biologic License Application (BLA), with the primary goal of assessing pregnancy outcomes at 12 weeks.

Gameto's CEO and co-founder, Dr. Dina Radenkovic, expressed enthusiasm about this development, highlighting the company's dedication to meeting FDA standards and advancing their product through the final stages of clinical development. She acknowledged the unique challenges in the IVF field and appreciated the FDA's guidance.

In line with FDA discussions, Gameto submitted preclinical data from animal studies indicating that Fertilo, which utilizes engineered ovarian support cells (OSC-IVM) for egg maturation outside the body, did not cause abnormalities in live births of mice. The findings, which demonstrated no significant differences between Fertilo-matured eggs and traditional IVM in terms of genetic, developmental, or behavioral aspects, were presented at a prestigious medical congress and are currently under peer-review for publication.

Strengthening its clinical and medical expertise, Gameto appointed Dr. Carlos Lejtik as Medical Director. Dr. Lejtik, a seasoned gynecologist and obstetrician with over two decades of experience in human reproduction, will oversee clinical adoption and medical initiatives. His previous role at Pfizer involved developing medical education programs and fostering relationships with key medical entities.

Additionally, Gameto welcomed renowned reproductive medicine experts Dr. Pietro Bortoletto and Dr. Michel de Vos as scientific and clinical advisors. Dr. Bortoletto, a reproductive endocrinologist, holds positions at Boston IVF and Harvard Medical School, while Dr. de Vos, a gynecologist since 2006, is a senior medical director at Universitair Ziekenhuis Brussel and a subspecialist in reproductive medicine and surgery.

Gameto's Chief Scientific Officer, Dr. Christian Kramme, emphasized the value of these new appointments, noting their expertise will be vital as the company expands into global markets and prepares for the FDA's Phase 3 trial requirements.

Fertilo, derived from induced pluripotent stem cells (iPSC), represents a novel approach to in vitro fertilization and egg freezing, aiming to simplify and enhance patient accessibility to fertility treatments. It has already received regulatory clearance for commercialization in Australia and select Latin American markets.

Gameto is committed to developing innovative solutions for women's health, with a focus on infertility. Under the leadership of Dr. Radenkovic and Martin Varsavsky, the company is poised to revolutionize fertility medicine and enhance women's reproductive experiences.