Manuscript demonstrates Gameto's manufacturing
process resulted in ovarian support cells of improved efficacy,
quality and safety for in vitro maturation applications
NEW
YORK, May 8, 2024 /PRNewswire/ -- Gameto, a
female-led biotechnology company with a mission to redefine women's
healthcare, today announced new research outlining the cellular
engineering and manufacturing techniques underlying Fertilo, their
novel investigational in vitro maturation (IVM) solution
containing engineered ovarian support cells (OSCs) to mature eggs
outside of the body. These data underscore that Gameto's quality by
design strategic product development supports the manufacturing of
OSC-IVM for clinical and commercial use.
"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.
Gameto's novel approach uses cellular engineering to create
a pure population of highly potent ovarian support cells
(OSCs) from a female clinical-grade human induced pluripotent stem
cell (hiPSC) line that recreates the dynamic, bidirectional
follicular environment in a dish when co-cultured with immature
eggs. Gameto has previously published that co-culturing immature
human eggs with OSCs results in higher rates of egg maturation and
euploid embryo formation.1
"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."
These data demonstrate how Gameto developed a clinical-grade
manufacturing process for Fertilo, including using GMP-grade raw
materials and a commercial-grade hiPSC line to yield a highly
scalable, consistent, and potent production of their OSCs for
clinical use. The researchers also found a high degree of
similarity between OSCs derived from hiPSCs and the natural support
cells of the ovary, compared with available data of in vivo
ovaries from the human cell atlas.
Additionally, using the same gene engineering method for both
research-use-only hiPSCs and clinical-grade hiPSC lines resulted in
OSCs that were similar on a molecular and functional level. These
results suggest Gameto could broaden its platform to include a
wider range of donor cells, such as those derived from patients,
for potential uses like disease modeling. This supports a potential
expansion into additional applications and indications 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 at
https://www.biorxiv.org/content/10.1101/2024.04.29.591741v1, and
Gameto is submitting it for scientific peer-review for potential
publication.
Gameto is currently engaged in rigorous preparations to meet the
FDA's conditions for Phase 3 trial initiation. For more information
about Gameto and how the company is redefining women's healthcare,
visit gametogen.com.
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.
Investor Contact
Kylie Jordan
kylie@gametogen.com
Press Contact
Alexis Feinberg
GametoPR@westwicke.com
1 Piechota S, Marchante M, Giovannini
A, et al. Human-induced pluripotent stem cell-derived ovarian
support cell co-culture improves oocyte maturation in vitro
after abbreviated gonadotropin stimulation. Hum Reprod.
2023;38(12):2456-2469. doi:10.1093/humrep/dead205
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