Gameto Unveils New Data on In Vitro Maturation Product Candidate Fertilo During Four Presentations at the 2023 American Society for Reproductive Medicine

• Gameto's findings show their product candidate, Fertilo, is able to improve egg maturation and embryo development in shortened human minimal stimulation cycles.
  
  
• The group reports healthy animal live births with Fertilo, more mature human eggs with better gene expression and genetic health quality, as well as a potential use case in rescuing immature human eggs from conventional treatments.
  
  
• The combined findings are an important evidence package as a next step in advancing this reproductive technology.

NEW YORK, Oct. 19, 2023 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, presented four abstracts at the 2023 American Society for Reproductive Medicine (ASRM) Congress. The abstract topics cover the use of Fertilo, an iPSC-derived solution to mature oocytes outside of the body, for in vitro maturation (IVM) of oocytes in minimal stimulation cycles to improve oocyte maturation and human embryo development — and make this process more convenient and accessible for wider patient populations. In addition, the company reports results of the animal multigenerational repro-toxicology study; human rescue IVM of immature oocytes and gene expression of oocytes in Fertilo-IVM, MediCult IVM, and conventional in vitro fertilization (IVF).

"Women's reproductive health has been an underserved and underdeveloped area compared to its large patient population size in biotechnology research and this is just the beginning of Gameto's efforts to fill this gap," said Vice President of Cell Engineering at Gameto, Christian Kramme PhD. "Our findings make us hopeful that the reproductive journey for women can be improved and we are eager to share insights from our product candidate, Fertilo, with the broader scientific community and learn from these discussions."

The presentation summaries are as follows:

• Gameto discussed its study dedicated to investigating Fertilo-IVM with minimal stimulation cycles compared to MediCult IVM, in collaboration with one of Europe's largest and most well known fertility clinic chains, Eugin Clinic of Spain. The study found that Fertilo significantly improves maturation rates compared to media matched controls, demonstrating that Fertilo's support cells actively mature oocytes beyond any non-cellular component contribution. The study also found that matured oocytes have similar morphological health, so more mature eggs do not come at the expense of oocyte quality. They further report on a study done in collaboration with leading New York-based fertility clinics Spring Fertility of New York and Extend Fertility, where they found that Fertilo-IVM significantly improves day five and six of euploid blastocyst formation compared to industry competitors in a randomized sibling oocyte study. This is a key marker of developmental health and clinical utility. Embryos made from Fertilo's mature oocytes show normal, epigenetic health similar to conventional IVF embryos, a key safety metric. The results show that Fertilo not only matures more oocytes, but these oocytes have better developmental capacity/cytoplasmic quality compared to MediCult IVM.
   
• Gameto released findings for its multigenerational reprotoxicology model done in collaboration with Embryotools of Barcelona, which provides quality control testing and research and development for IVF products. The study found an improvement in blastocyst formation rate with Fertilo-IVM compared to control MediCult IVM. The presentation highlighted that embryo quality by immunofluorescence of cell numbers and inner cell mass is similar between groups. It noted there was no significant difference in live birth rate at F1 or F2 generation between groups and there was no difference in set ratio, pup weight or pup length between groups, along with no developmental or behavioral abnormalities. The study determined that Fertilo has been shown to be safe in a mouse reprotoxicology model.
   
• Gameto presented findings of Fertilo's use case in rescue IVM of immature oocytes that failed to fully develop from conventional stimulation. The Human rescue IVM was done in collaboration with Extend Fertility of New York. The study found that Fertilo's oocyte maturation rate is significantly higher compared to industry competitors and that the higher rate of mature eggs does not affect the oocyte morphological quality. By analyzing RNA sequencing, Gameto found that oocytes rescued by Fertilo-IVM show gene expression more similar to IVF oocytes than MediCult IVM oocytes. Fertilo-IVM shows better assembly of the spindle apparatus compared to traditional IVM. Ultimately, the findings show that Fertilo can rescue immature eggs from conventional treatment, which may be beneficial for patients who do not yield enough mature eggs through conventional treatments.
   
• Gameto shared a transcriptomics analysis of human IVM and IVF oocytes, done in collaboration with RMA of New York. The study explores the gene expression of oocytes in Fertilo-IVM, MediCult IVM, and conventional IVF. Results showed that Fertilo oocytes are more similar to IVF gold standard when compared to MediCult IVM oocytes. A significant number of MediCult IVM mature oocytes display gene expression profiles that are in an intermediate state, or not quite mature, suggesting a lack of cytoplasmic maturation. Fertilo-IVM and IVF oocytes, on the other hand, show upregulation of embryogenesis genes involved in inner cell mass development and mitochondrial energy metabolism, which is not seen in MediCult IVM oocytes. This oocyte transcriptomic technique was developed and validated in research study in partnership with established U.S.-based fertility companies Ovation Fertility, Inception Prelude and PozitivIVF. The findings show that Fertilo not only matures more eggs, but results in better gene expression and genetic health quality than traditional IVM.

For more information about Gameto and how the company is redefining women's healthcare, visit gametogen.com.

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 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.

CONTACT: Hannah Guenther, [email protected], (973) 901-4971

SOURCE Gameto