1月15日，Axcynsis Therapeutics Pte Ltd（以下簡稱“Axcynsis”或“泰誠思生物”）宣布，其自主研發的針對CLDN-6陽性實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督管理局（FDA）的批準，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。天津有濟醫藥科技發展有限公司（以下簡稱“有濟醫藥”）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！

泰誠思生物是2022年注冊成立的、專門從事創新抗體偶聯藥物（ADC）設計、研發的Biotech公司。AT03-65作為泰誠思生物的首發項目，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合CLDN6，通過采用AxcynDOT?這一專有載荷設計平臺，結合了已批準上市的一種具有獨特作用機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合，開發前景優異。

有濟醫藥在ADC藥物評價方面進行了前瞻性、國際化的戰略布局，在團隊建設、硬件設施、方案設計、高效執行以及質量保證等多個方面，持續保持著非臨床系統評價和注冊申報技術支持領域的領先地位。針對AT03-65項目所獨有的新靶點、新抗體、新鏈接、新Payload特點，有濟醫藥與泰誠思生物團隊進行了充分且深入的技術交流、探討，設計出支持中國、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隊的高度認可，成功成為該項目的非臨床評價業務服務商。有濟醫藥高度重視此項目的執行進度，集結了一支由高層技術專家領銜、匯聚各專業項目執行部門、項目管理部門、質量保證部門的強悍團隊，與泰誠思生物攜手并進、精誠合作，高質、高效地完成了AT03-65項目的非臨床藥代動力學和安全性評價研究，以科學、標準、規范的非臨床研究數據支持該項目順利獲得了FDA臨床試驗許可。

作為創新藥科研型CRO領創者，有濟醫藥始終恪守全球最高質量監管標準，支持中國和國際新藥申報，能夠為全球藥物研發企業提供專業的研究技術支持。據不完全統計，有濟醫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等地區的臨床申請，賦能客戶產品贏得中國和國際市場，快速、成功開發事業。

泰誠思生物創始人兼首席執行官鄒斌博士表示：

“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.