Manuscript demonstrates Gameto's manufacturing process resulted in ovarian support cells of improved efficacy, quality and safety for in vitro maturation applications

手稿表明，Gameto的制造過程提高了卵巢支持細(xì)胞在體外成熟應(yīng)用中的功效、質(zhì)量和安全性

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.

2024年5月8日，紐約/PRNewswire/-Gameto是一家以女性為主導(dǎo)的生物技術(shù)公司，其使命是重新定義女性的醫(yī)療保健，今天宣布了一項新的研究，概述了Fertilo的細(xì)胞工程和制造技術(shù)，F(xiàn)ertilo是他們的新型研究性體外成熟（IVM）解決方案，其中含有工程化卵巢支持細(xì)胞（OSC），可以在體外成熟卵子。

These data underscore that Gameto's quality by design strategic product development supports the manufacturing of OSC-IVM for clinical and commercial use..

這些數(shù)據(jù)強調(diào)，Gameto的按設(shè)計質(zhì)量戰(zhàn)略產(chǎn)品開發(fā)支持OSC-IVM的臨床和商業(yè)制造。。

'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首席執(zhí)行官兼聯(lián)合創(chuàng)始人迪娜·拉登科維奇（Dina Radenkovic）博士說：“這項研究首次證明了從誘導(dǎo)多能干細(xì)胞（iPSC）開發(fā)的療法具有增強體外受精（IVF）結(jié)果和促進女性健康的潛力，為其在臨床環(huán)境中的應(yīng)用鋪平了道路?！薄?。

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的新方法使用細(xì)胞工程從女性臨床級人類誘導(dǎo)多能干細(xì)胞（hiPSC）系中產(chǎn)生純高效卵巢支持細(xì)胞（OSC），當(dāng)與未成熟卵共培養(yǎng)時，該細(xì)胞系在培養(yǎng)皿中重建動態(tài)的雙向卵泡環(huán)境。

Gameto has previously published that co-culturing immature human eggs with OSCs results in higher rates of egg maturation and euploid embryo formation.1.

Gameto先前發(fā)表過，將未成熟的人類卵與OSC共培養(yǎng)會導(dǎo)致更高的卵成熟率和整倍體胚胎形成率。

'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.

Gameto首席科學(xué)官克里斯蒂安·克拉姆（ChristianKramme）博士說：“這項研究突出了我們的卵巢支持細(xì)胞在體外成熟卵子中的核心潛在作用機制，并深入研究了Fertilo在促進IVF治療中高質(zhì)量卵子成熟中的作用?！?。

'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.'.

“我們正在有效地在培養(yǎng)皿中創(chuàng)建一種活性細(xì)胞療法，這與目前用于體外成熟的培養(yǎng)基溶液有很大不同。這些數(shù)據(jù)表明，這項技術(shù)的應(yīng)用可以擴展到OSC-IVM之外，并用于解決其他女性的健康和生育問題?！薄?/p>

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..

這些數(shù)據(jù)展示了Gameto如何為Fertilo開發(fā)臨床級生產(chǎn)工藝，包括使用GMP級原料和商業(yè)級hiPSC生產(chǎn)線，以產(chǎn)生高度可擴展，一致且有效的OSC生產(chǎn)，用于臨床。研究人員還發(fā)現(xiàn)，與人類細(xì)胞圖譜中體內(nèi)卵巢的可用數(shù)據(jù)相比，源自hiPSC的OSC與卵巢的天然支持細(xì)胞之間存在高度相似性。。

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.

此外，在兩項研究中使用相同的基因工程方法，僅使用hiPSC和臨床級hiPSC系，導(dǎo)致OSC在分子和功能水平上相似。這些結(jié)果表明，Gameto可以擴大其平臺，以包括更廣泛的供體細(xì)胞，例如來自患者的供體細(xì)胞，用于疾病建模等潛在用途。

This supports a potential expansion into additional applications and indications within women's health and fertility medicine..

這有助于在女性健康和生育醫(yī)學(xué)中擴展到其他應(yīng)用和適應(yīng)癥。。

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..

該手稿名為“臨床級hiPSC中純卵巢支持細(xì)胞的可重復(fù)分化作為一種新型不孕癥治療方法”，可在預(yù)印本服務(wù)器上獲得https://www.biorxiv.org/content/10.1101/2024.04.29.591741v1，Gameto正在將其提交給科學(xué)同行評審以供潛在出版。。

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.

Gameto目前正在進行嚴(yán)格的準(zhǔn)備工作，以滿足FDA啟動第三階段試驗的條件。有關(guān)Gameto以及該公司如何重新定義女性醫(yī)療保健的更多信息，請訪問gametogen.com。

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.

Gameto的主要研究項目Fertilo是一種源自誘導(dǎo)多能干細(xì)胞（iPSC）的解決方案，旨在使卵子在體外成熟，作為體外受精和卵子冷凍的最小激素刺激周期的一部分。Gameto開發(fā)Fertilo的目標(biāo)是使生育治療更方便，更安全，更廣泛的患者群體更容易獲得。

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..

Fertilo在外國司法管轄區(qū)接受了不同的監(jiān)管分類，在與國家監(jiān)管機構(gòu)協(xié)商后，已獲準(zhǔn)在澳大利亞和拉丁美洲的大型市場進行商業(yè)化。。

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是一家為女性健康開發(fā)新型治療方案的生物技術(shù)公司，從不孕癥開始。Gameto匯集了一支經(jīng)驗豐富、富有遠(yuǎn)見和激情的科學(xué)管理團隊，開發(fā)一套產(chǎn)品套件，為女性的整個生育過程提供支持。Gameto的主導(dǎo)項目Fertilo旨在通過減少體外成熟卵子的激素注射，使體外受精和卵子冷凍更短，更安全，更容易獲得。

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..

Gameto由醫(yī)生出身的企業(yè)家Dina Radenkovic領(lǐng)導(dǎo)，Dina Radenkovic擔(dān)任首席執(zhí)行官和連續(xù)企業(yè)家，也是北美最大的生育網(wǎng)絡(luò)Prelude fertility的創(chuàng)始人，Martin Varsavsky擔(dān)任主席。有關(guān)更多信息，請訪問gametogen.com或在Twitter、Instagram@gametogen和LinkedIn上關(guān)注我們。。

Investor ContactKylie Jordankylie@gametogen.com

投資者聯(lián)系人KylieJordankylie@gametogen.com

Press ContactAlexis FeinbergGametoPR@westwicke.com

新聞聯(lián)系人AlexisFeinbergGametoPR@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

1 Piechota S，Marchante M，Giovannini A等人。人類誘導(dǎo)的多能干細(xì)胞衍生的卵巢支持細(xì)胞共培養(yǎng)可在短促性腺激素刺激后改善卵母細(xì)胞的體外成熟。嗡嗡聲。2023年；38（12）：2456-2469。doi:10.1093/humrep/dead205

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