Axcynsis Receives FDA Clearance for IND of AT03-65, CLDN6-Targeting ADC

Axcynsis Therapeutics Pte Ltd (“Axcynsis”), a privately held biopharmaceutical company specialized in delivering Antibody Drug Conjugates (ADCs) with breakthrough potential, proudly announces the clearance of its Investigational New Drug application (IND) by the United States Food and Drug Administration (FDA) of AT03-65 for the treatment of patients with CLDN-6 positive solid tumors. Axcynsis is planning to initiate a Phase 1 multicentre clinical trial in the United States in 1Q 2025.

AT03-65 is a differentiated ADC that selectively binds to CLDN6 with strong affinity. It is enabled by AxcynDOT, a proprietary payload that incorporates a derivative of an approved oncology therapeutics with unique mechanism of action and broad anti-tumor activity, and coupled with a cleavable and hydrophilic proprietary linker. CLDN6 is overexpressed in many cancers including lung, ovarian, endometrial, uterine, testicular, and gastric cancers while exhibiting minimal expression in normal tissues.  AT03-65 is designed to deliver targeted therapy to improve patient outcomes with advanced or metastatic CLDN6-positive cancers.

“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.