Pharma Focus Europe

Abata Therapeutics Gets FDA Approval to Start Clinical Trials of ABA-101 for Progressive Multiple Sclerosis

Tuesday, July 09, 2024

Abata Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a Phase 1 study of ABA-101 in patients with progressive multiple sclerosis (MS). ABA-101 is a tissue-specific TCR-Treg cell therapy aimed at treating MS, marking a significant milestone for Abata and a pioneering step in tissue-targeted Treg cell therapies for autoimmune diseases.

Abata, expressed enthusiasm for the IND clearance, highlighting ABA-101's preclinical safety profile and its potential therapeutic benefits in MS. The IND clearance, obtained in under a month, was supported by robust data and a tailored trial design emphasizing precision medicine for MS.

Abata, emphasized ABA-101's unique approach in addressing CNS-compartmentalized inflammation seen in progressive MS. With current treatments inadequately addressing this aspect, ABA-101 holds promise in targeting disease pathology and potentially improving clinical outcomes.

ABA-101, an autologous Treg therapy, is tailored for MS patients with HLA-DRB1*15:01 positivity and ongoing inflammatory tissue injury. Engineered to express a T cell receptor (TCR) that recognizes immunogenic myelin fragments in the CNS, ABA-101 aims to provide localized anti-inflammatory effects with a strong safety profile. Preclinical studies have shown it to be well-tolerated, demonstrating antigen-dependent Treg functionality and therapeutic efficacy.



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