NEW YORK – The US Food and Drug Administration has cleared Abata Therapeutics' investigational new drug (IND) application for its lead product candidate, ABA-101, an autologous cell therapy that it's developing for progressive multiple sclerosis (MS), the company said Tuesday.
Abata expects to begin the first-in-human Phase I clinical trial by year-end.
ABA-101 is designed specifically for MS patients with progressive disease, imaging evidence of ongoing inflammatory tissue injury, and the DRB1*15:01 genetic haplotype. The cell therapy is created by engineering a patient's own regulatory T cells to express a T-cell receptor that targets immunogenic myelin fragments in the central nervous system.
"In preclinical studies, ABA-101 was shown to be safe and demonstrated tissue-specific trafficking, persistence, and robust suppression of inflammation, supporting its potential therapeutic effect," Abata President and CEO Samantha Singer said in a statement.
ABA-101 is Watertown, Massachusetts-based Abata's first product candidate to be greenlighted for clinical trials. Its second development program in type 1 diabetes, ABA-201, is in IND-enabling studies.