ATA188, Atara Biotherapeutics’ investigative T-cell immunotherapy, is safe, well tolerated, and able to ease disability and improve exercise capacity in patients with progressive forms of multiple sclerosis (MS), according to one-year data from a Phase 1 trial and its long-term extension study.
Findings also showed that, after one year, patients experiencing lesser disability were also more likely to feel less fatigued and have better physical function, and to show greater brain volume assessed by MRI.
According to a press release, one-year trial data and updated findings from its extension study, as well as additional findings on ATA188’s mechanism of action will be presented in several e-posters during the MSVirtual2020 meeting set for Sept. 11–13.
ATA188, a cell-based therapy, is designed to counter the harmful effects of Epstein-Barr virus (EBV). This common type of herpes virus is thought to cause immune B-cells to go awry and start producing antibodies that wrongly attack the myelin sheath that protects nerve endings, causing MS.
To counter this, ATA188 uses called T-cells, an immune cell that normally defends the body from viruses and bacteria, to specifically destroy EBV-infected B-cells. Instead of being isolated from each MS patient, T-cells used in ATA188 are obtained from healthy donors (off-the-shelf therapy), and modified to target and kill infected B-cells.
The safety, tolerability, and preliminary efficacy of ATA188 are currently being investigated in a two-part Phase 1 trial (NCT03283826) enrolling adults with primary and secondary progressive MS (PPMS and SPMS).
During the study’s first part, 25 patients were assigned to one of four intravenous doses of ATA188 containing either 5, 10, 20, or 40 million modified T-cells to assess dose which could be the most effective and safest for future studies.
In addition to safety and tolerability, investigators also evaluated patients’ ability to reach sustained disability improvement (SDI) in this part of the study. To attain SDI, patients must have had improvements in their expanded disability status scale (EDSS) scores or in their timed 25-foot walk (T25W) test at two or more consecutive time-points during the trial (three, six, and 12 months).
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