1月15日，Axcynsis Therapeutics Pte Ltd（以下簡(jiǎn)稱(chēng)“Axcynsis”或“泰誠(chéng)思生物”）宣布，其自主研發(fā)的針對(duì)CLDN-6陽(yáng)性實(shí)體瘤患者的治療藥物AT03-65的新藥臨床研究申請(qǐng)（IND）已獲得美國(guó)食品藥品監(jiān)督管理局（FDA）的批準(zhǔn)，并計(jì)劃于2025年第一季度在美國(guó)啟動(dòng)一項(xiàng)I期多中心臨床試驗(yàn)。天津有濟(jì)醫(yī)藥科技發(fā)展有限公司（以下簡(jiǎn)稱(chēng)“有濟(jì)醫(yī)藥”）對(duì)AT03-65項(xiàng)目的快速、成功獲批表示熱烈祝賀，期盼項(xiàng)目即將在美國(guó)啟動(dòng)的臨床研究順利推進(jìn)！

泰誠(chéng)思生物是2022年注冊(cè)成立的、專(zhuān)門(mén)從事創(chuàng)新抗體偶聯(lián)藥物（ADC）設(shè)計(jì)、研發(fā)的Biotech公司。AT03-65作為泰誠(chéng)思生物的首發(fā)項(xiàng)目，承載了公司的極高重視與深切期望。AT03-65是具有差異化特性的ADC，能夠高親和力地選擇性結(jié)合CLDN6，通過(guò)采用AxcynDOT?這一專(zhuān)有載荷設(shè)計(jì)平臺(tái)，結(jié)合了已批準(zhǔn)上市的一種具有獨(dú)特作用機(jī)制和廣泛抗腫瘤活性的腫瘤治療藥物的衍生物，并與一種可裂解的親水性專(zhuān)有連接子相結(jié)合，開(kāi)發(fā)前景優(yōu)異。

有濟(jì)醫(yī)藥在ADC藥物評(píng)價(jià)方面進(jìn)行了前瞻性、國(guó)際化的戰(zhàn)略布局，在團(tuán)隊(duì)建設(shè)、硬件設(shè)施、方案設(shè)計(jì)、高效執(zhí)行以及質(zhì)量保證等多個(gè)方面，持續(xù)保持著非臨床系統(tǒng)評(píng)價(jià)和注冊(cè)申報(bào)技術(shù)支持領(lǐng)域的領(lǐng)先地位。針對(duì)AT03-65項(xiàng)目所獨(dú)有的新靶點(diǎn)、新抗體、新鏈接、新Payload特點(diǎn)，有濟(jì)醫(yī)藥與泰誠(chéng)思生物團(tuán)隊(duì)進(jìn)行了充分且深入的技術(shù)交流、探討，設(shè)計(jì)出支持中國(guó)、美國(guó)新藥臨床申報(bào)的全面性、針對(duì)性解決方案，獲得了泰誠(chéng)思生物團(tuán)隊(duì)的高度認(rèn)可，成功成為該項(xiàng)目的非臨床評(píng)價(jià)業(yè)務(wù)服務(wù)商。有濟(jì)醫(yī)藥高度重視此項(xiàng)目的執(zhí)行進(jìn)度，集結(jié)了一支由高層技術(shù)專(zhuān)家領(lǐng)銜、匯聚各專(zhuān)業(yè)項(xiàng)目執(zhí)行部門(mén)、項(xiàng)目管理部門(mén)、質(zhì)量保證部門(mén)的強(qiáng)悍團(tuán)隊(duì)，與泰誠(chéng)思生物攜手并進(jìn)、精誠(chéng)合作，高質(zhì)、高效地完成了AT03-65項(xiàng)目的非臨床藥代動(dòng)力學(xué)和安全性評(píng)價(jià)研究，以科學(xué)、標(biāo)準(zhǔn)、規(guī)范的非臨床研究數(shù)據(jù)支持該項(xiàng)目順利獲得了FDA臨床試驗(yàn)許可。

作為創(chuàng)新藥科研型CRO領(lǐng)創(chuàng)者，有濟(jì)醫(yī)藥始終恪守全球最高質(zhì)量監(jiān)管標(biāo)準(zhǔn)，支持中國(guó)和國(guó)際新藥申報(bào)，能夠?yàn)槿蛩幬镅邪l(fā)企業(yè)提供專(zhuān)業(yè)的研究技術(shù)支持。據(jù)不完全統(tǒng)計(jì)，有濟(jì)醫(yī)藥參與研究的新藥項(xiàng)目已有約50項(xiàng)通過(guò)中國(guó)NMPA、美國(guó)FDA、澳洲TGA等地區(qū)的臨床申請(qǐng)，賦能客戶產(chǎn)品贏得中國(guó)和國(guó)際市場(chǎng)，快速、成功開(kāi)發(fā)事業(yè)。

泰誠(chéng)思生物創(chuàng)始人兼首席執(zhí)行官鄒斌博士表示：

“This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT?,” said Dr. Zou Bin, CEO of Axcynsis. “We are pleased that FDA has cleared AT03-65 which leverages our AxcynDOT? technology for this first-in-human study.  We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumors as well as advancing our pipeline with  differentiated  and effective ADCs using AxcynDOT? to improve the lives of cancer patients worldwide”.

The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors.

關(guān)于AT03-65

AT03-65 is a recombinant anti-CLDN6 monoclonal antibody conjugated to AxcynDOT?, a proprietary payload developed by Axcynsis with a differentiated mechanism of action and broad anti-cancer activities.  AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumors in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available.

The antibody of AT03-65 is rationally engineered for high affinity and specificity to CLDN6.  Upon binding to CLDN6-expressing tumor cells, the ADC is internalized into lysosomes, where it releases its payload to inhibit tumor growth effectively. Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, targeting neighboring CLDN6-negative tumor cells to enhance its anti-tumor efficacy. AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates.

關(guān)于泰誠(chéng)思生物

Axcynsis Therapeutics is a pioneering biotechnology company headquartered in Singapore with operations in the United States and China. The company has developed AxcynDOT?, a proprietary linker payload platform to advance a pipeline of differentiated ADC candidates aimed at addressing key unmet medical needs. The company is committed to advance effective and targeted oncology therapeutics with breakthrough potential to improve the lives of cancer patients worldwide.