FDA Grants Fast Track to Abata's ABA-101 for Progressive MS

Abata Therapeutics, headquartered in Watertown, Massachusetts, has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its therapy, ABA-101, intended for patients with progressive multiple sclerosis (MS). This significant milestone follows the FDA's clearance of ABA-101’s Investigational New Drug (IND) application, setting the stage for the imminent initiation of a first-in-human (FIH) Phase 1 study.

Samantha Singer, M.S., M.B.A., the president and CEO of Abata, expressed her satisfaction with this development. She emphasized the urgency of bringing new treatments to patients suffering from progressive MS, a condition for which no effective treatments currently exist. The Fast Track designation from the FDA is expected to expedite the development and review processes, potentially leading to earlier patient access to this innovative therapy.

The FDA’s Fast Track program is designed to accelerate the review of drugs aimed at treating serious conditions and addressing unmet medical needs. Drugs granted this designation benefit from more frequent interactions with the FDA and can take advantage of rolling review processes during marketing application submissions. Such benefits could lead to faster drug approvals and availability for patients. Additionally, Fast Track designation may make ABA-101 eligible for Accelerated Approval and Priority Review, contingent upon meeting specific criteria.

ABA-101 represents Abata’s autologous Treg therapy that targets progressive multiple sclerosis. This therapy is specifically designed for MS patients with imaging evidence of ongoing inflammatory tissue injury and who are HLA-DRB1*15:01 positive, a subgroup estimated to comprise about 45,000 individuals in the U.S. ABA-101 is created by engineering a patient’s own regulatory T cells (Tregs) to express a T cell receptor (TCR) that identifies immunogenic myelin fragments in the central nervous system (CNS). This tailored approach aims to provide a strong safety profile and a localized anti-inflammatory effect precisely at the disease site.

Preclinical studies conducted in vivo have shown that ABA-101 is well-tolerated, demonstrating antigen-dependent Treg functionality, anti-inflammatory cytokine production, and suppression of inflammatory cytokines. These studies also indicated a therapeutic effect, bolstering the potential of ABA-101 as a valuable treatment for progressive MS.

Abata Therapeutics, founded by experts in Treg biology, TCR and antigen discovery, disease pathogenesis, and molecular imaging biomarkers, is committed to developing transformative Treg therapies for severe autoimmune and inflammatory diseases. The company’s lead program in progressive MS is poised to begin Phase 1 clinical trials in 2024. Additionally, Abata is advancing a second program targeting type 1 diabetes, currently in IND-enabling studies. Both conditions represent tissue-specific autoimmune diseases with significant unmet medical needs, aligning with Abata’s strategic focus on Treg cell therapy.

Abata Therapeutics was established in 2021 with the support of Third Rock Ventures and is backed by a broad consortium of investors, including Lightspeed Venture Partners, Biogen, Bristol Myers Squibb, ElevateBio, Eurofarma, Invus, Samsara BioCapital, and T1D Fund (formerly JDRF T1D Fund). The company continues to leverage its unique product development platform to innovate Treg cell therapies that are tissue-specific, robust, and durable.

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