Summary:

- Axcynsis Therapeutics, a clinical-stage biopharmaceutical company, has received FDA clearance for its Investigational New Drug (IND) application of AT03-65, a differentiated CLDN6-targeting antibody-drug conjugate (ADC) powered by the company's proprietary AxcynDOT technology.

- AT03-65 is designed to selectively target and eliminate CLDN6-expressing solid tumors, with potential applications in various cancer types such as ovarian, endometrial, and gastric cancers.

- The FDA clearance of the IND application allows Axcynsis Therapeutics to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors.