1月15日，Axcynsis Therapeutics Pte Ltd（以下簡稱“Axcynsis”或“泰誠思生物”）宣布，其自主研發(fā)的針對CLDN-6陽性實(shí)體瘤患者的治療藥物AT03-65的新藥臨床研究申請（IND）已獲得美國食品藥品監(jiān)督管理局（FDA）的批準(zhǔn)，并計劃于2025年第一季度在美國啟動一項I期多中心臨床試驗。天津有濟(jì)醫(yī)藥科技發(fā)展有限公司（以下簡稱“有濟(jì)醫(yī)藥”）對AT03-65項目的快速、成功獲批表示熱烈祝賀，期盼項目即將在美國啟動的臨床研究順利推進(jìn)！

泰誠思生物是2022年注冊成立的、專門從事創(chuàng)新抗體偶聯(lián)藥物（ADC）設(shè)計、研發(fā)的Biotech公司。AT03-65作為泰誠思生物的首發(fā)項目，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，通過采用AxcynDOT?這一專有載荷設(shè)計平臺，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有連接子相結(jié)合，開發(fā)前景優(yōu)異。

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

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)，支持中國和國際新藥申報，能夠為全球藥物研發(fā)企業(yè)提供專業(yè)的研究技術(shù)支持。據(jù)不完全統(tǒng)計，有濟(jì)醫(yī)藥參與研究的新藥項目已有約50項通過中國NMPA、美國FDA、澳洲TGA等地區(qū)的臨床申請，賦能客戶產(chǎn)品贏得中國和國際市場，快速、成功開發(fā)事業(yè)。

泰誠思生物創(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.