Gameto plans to use the iPSC line to advance its program, Fertilo, designed to improve IVF and egg freezing.
YOKOHAMA, Japan — REPROCELL Inc. today announced that it has entered into an agreement to grant Gameto Inc., a female-led biotechnology company with a mission to redefine women’s healthcare, a non-exclusive right to use REPROCELL’s StemRNA™ Clinical Seed iPSCs. The clinical-grade iPSC line will be used for the development and commercialization of Gameto’s program to improve the IVF and egg freezing process, Fertilo. Terms of the agreement were not disclosed.
Fertilo is an iPSC-derived solution to mature oocytes outside of the body. It has the potential to significantly reduce the hormonal burden on patients undergoing fertility treatments, making IVF and egg freezing safer, easier, and more accessible. The StemRNA™ Clinical Seed iPSC will be used for Fertilo’s commercial manufacturing as Gameto is transitioning Fertilo into clinical and commercial phase in various jurisdictions.
“We are thrilled to partner with Gameto to enable and support their program, Fertilo. REPROCELL, being a global leader in manufacturing GMP-grade iPSC lines for our clients, remains committed to our high quality and high standard StemRNA™ Clinical Seed iPSC platform to accelerate the stem cell-derived therapeutic programs globally,” said Chikafumi Yokoyama, Chief Executive Officer of REPROCELL Inc.
“This license agreement is a crucial step in leveraging the scientific advancement of cell engineering for a more personalized medicine approach to IVF and egg freezing across the globe,” said Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. “Women using these current services are still subject to dozens of hormonal injections and the associated side effects and complications. Modern women deserve improved fertility care, and we are honored to partner with leading companies like REPROCELL to bring cutting-edge breakthroughs to women’s health, an area that has historically lagged in biopharmaceutical innovations.”
REPROCELL manufactures iPSCs that are suitable for therapeutic use and compliant with the key regulatory standards stipulated by the U.S. Food and Drug Administration, European Medicine Agency, and Japan’s Pharmaceuticals and Medical Devices Agency. StemRNA™ Clinical iPSC Seed Clones have been evaluated, approved, and employed by numerous biopharmaceutical clients.
About REPROCELL’s StemRNA™ Clinical iPSC
Developing cellular therapies is a time-consuming and costly process. It requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL manufactures GMP iPSC MCBs that are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA.
Through the clinical network, REPROCELL procures the tissues needed for the therapeutic program and performs the necessary viral and donor profile screenings compliant with key regulatory agencies. After deriving a primary fibroblast primary culture, REPROCELL uses its proprietary footprint-free RNA reprogramming technology to generate a clinical-grade iPSC seed stock (StemRNA™ Clinical iPSC Seed Clones). Under strict quality control measures, these StemRNA™ Clinical iPSC Seed Clones are expanded in a GMP environment to manufacture a Master Cell Bank. REPROCELL’s GMP iPSCs are suitable for commercial and therapeutic programs, subject to a simple one-time commercial and therapeutic license without any limitation of therapeutic fields.
Learn more at https://www.reprocell.com/gmp-ipsc-master-cell-bank.
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 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 reducing 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.