Singapore-based biopharmaceutical company Axcynsis Therapeutics Pte Ltd announced on Wednesday that its Investigational New Drug application (IND) for AT03-65 has received clearance from the US Food and Drug Administration (FDA) for the treatment of patients with CLDN-6 positive solid tumours.

The company is planning to commence a Phase 1 multicentre clinical trial in the United States in the first quarter of 2025.

AT03-65 is a differentiated Antibody Drug Conjugate (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-tumour activity, and coupled with a cleavable and hydrophilic proprietary linker. AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumours in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available.

The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumours.