Asieris received FDA IND approval for APL 2501 for the treatment of advanced Solid tumors

CAR-T Digest - August 2020

13 August 2026: Asieris received FDA IND approval for APL‑2501 for the treatment of advanced Solid tumors

Asieris Pharmaceuticals announced that the U.S. FDA has cleared the IND application for APL-2501, a CLDN6/9-targeted ADC, to initiate clinical development in patients with advanced solid tumors, marking an important step toward clinical evaluation of the company’s next-generation ADC program
The IND clearance enables Asieris to advance APL-2501 into clinical trials for patients with advanced solid tumors, following preclinical development and toxicology studies supporting the program
The program addresses an unmet need in advanced solid tumors by targeting CLDN6 and CLDN9, tumor-associated proteins that offer potential opportunities for selective delivery of cytotoxic payloads to cancer cells
APL-2501 is a CLDN6/9-directed ADC developed using Asieris’ proprietary linker technology, designed to enable targeted delivery of its cytotoxic payload to CLDN6/9-expressing tumor cells while limiting off-target exposure
Strategically, the FDA IND clearance advances Asieris’ ADC pipeline toward clinical validation and strengthens its broader oncology strategy, with APL-2501 representing a potential differentiated approach targeting CLDN6/9 across multiple solid tumors