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FDA approval
Abata Therapeutics receives IND clearance to begin Phase I trials for ABA-101 Treg cell therapy for multiple sclerosis
Precision Medicine
Jul 9, 2024
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Precision Medicine

Precision Medicine

Jul 9, 2024

Abata Therapeutics receives IND clearance to begin Phase I trials for ABA-101 Treg cell therapy for multiple sclerosis

FDA approval

  • Abata Therapeutics has received Investigational New Drug (IND) clearance from the FDA for its first product candidate, ABA-101. The investigational new drug is aimed to help patients with progressive multiple sclerosis (MS).

  • ABA-101 is a patient-derived T cell receptor (TCR)-Treg cell therapy created specifically for patients with progressive MS who have imaging proof of ongoing inflammatory tissue injury and are human leukocyte antigen (HLA)-DRB1*15:01 positive, which is a major risk factor. The treatment works by genetically modifying a patient's regulatory T-cells (Tregs) so they can specifically recognize and react to immunogenic myelin fragments in the CNS. 

  • Abata Therapeutics focuses on developing targeted therapies for autoimmune and inflammatory diseases using regulatory Treg technology. The company’s lead programs include treatments for progressive multiple sclerosis, type 1 diabetes, and inclusion body myositis. Its technology leverages Tregs to infiltrate, disrupt, and suppress inflammation at the disease site, offering targeted delivery.

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