Dong-A ST and Aptys Submit IND Application for Phase 1 Clinical Trial of ADC Novel Drug 'DA-3501'

On June 24, Dong-A ST announced that it has submitted an Investigational New Drug (IND) application for domestic Phase 1 clinical trials of 'DA-3501 (AT-211)', an antibody-drug conjugate (ADC) novel drug candidate developed by its ADC-specialized subsidiary, Aptys.

Dong-A ST and Aptys expect that this clinical trial of DA-3501 will mark the starting point of their challenge to conquer hard-to-treat solid tumors such as gastric cancer and pancreatic cancer.

'DA-3501' is an ADC candidate that targets 'Claudin 18.2', a protein exposed during the carcinogenesis of gastric mucosal cells. Its main indications are high-difficulty solid tumors such as gastric cancer and pancreatic cancer. In particular, as a next-generation ADC incorporating Aptys's proprietary platform technology 'AbClick®', it is expected to offer superior selectivity and safety profiles compared to existing ADCs.

This IND application was jointly prepared by both companies based on Aptys's non-clinical data. Dong-A ST plans to take the lead in domestic development, including future clinical trials, as well as global development strategies.

Han Taedong, CEO of Aptys, stated, "DA-3501 is a core pipeline that embodies our platform technology capabilities, and through the full-scale clinical development, we aim to usher in a new era of targeted anticancer therapies. We will accelerate the development of effective ADC therapeutics through our collaboration with Dong-A ST."

Park Jaehong, Head of R&D at Dong-A ST, commented, "We expect that innovative ADC pipelines such as DA-3501 will offer new hope to patients with gastric and pancreatic cancer, for whom treatment options are limited. By combining Aptys's outstanding platform technology with our research and development capabilities, we will develop a globally competitive ADC therapeutic."

DA-3501 is raising expectations for its future development, as its more stable and uniform drug conjugation structure compared to existing compounds may differentiate its efficacy and safety, increasing its potential to become a next-generation innovative new drug.