Gameto Co-founder & CEO Dina Radenkovic. Image: Gameto

In a recent study, Gameto revealed promising findings regarding their investigational in vitro maturation (IVM) solution, Fertilo. Led by CEO and co-founder Dr. Dina Radenkovic, the biotech company showcased the intricate cellular engineering and manufacturing processes behind Fertilo. The novel solution contains engineered ovarian support cells (OSCs), aimed at maturing eggs outside the body.

“This study is the first to demonstrate the end-to-end process by which a therapy developed from induced pluripotent stem cells (iPSC) has the potential to enhance in vitro fertilization (IVF) outcomes and advance women’s health, paving the way for its application in clinical settings,” said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto.

Central to Gameto’s approach is the development of highly potent OSCs from clinical-grade human induced pluripotent stem cell (hiPSC) lines. Co-culturing immature eggs with these OSCs has yielded promising results, indicating higher rates of egg maturation and embryo formation.

“This study highlights the core underlying mechanism of action of our ovarian support cells in maturing eggs outside of the body and provides a deeper look into the role that Fertilo plays in promoting high quality egg maturation for IVF treatment,” said Dr. Christian Kramme, Chief Scientific Officer of Gameto. “We are effectively creating an active cell therapy in a dish, which differs significantly from the media solutions that are currently used for in vitro maturation. These data suggest the applications of this technology could expand beyond OSC-IVM and be used to address additional women’s health and fertility issues as well.”

Gameto’s rigorous manufacturing process ensures the scalability, consistency, and safety of Fertilo for clinical use. Notably, OSCs derived from hiPSCs exhibit striking similarity to natural ovarian support cells, hinting at broader applications within women’s health and fertility medicine.

The manuscript, titled “Reproducible differentiation of pure ovarian support cells from clinical-grade hiPSCs as a novel infertility treatment,” is available on a preprint server, and Gameto is submitting it for scientific peer-review for potential publication. The company is currently engaged in rigorous preparations to meet the FDA’s conditions for Phase 3 trial initiation.

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