Atara Biotherapeutics Announces Presentation of Initial ATA188 Phase 1 Safety Results for Patients with Progressive Multiple Sclerosis at the 5th Congress of the European Academy of Neurology (EAN)
The primary objective of Atara’s ongoing ATA188 Phase 1 dose-escalating clinical study is to evaluate safety and tolerability for patients with progressive MS. Initial safety results showed that the first two dose cohorts of ATA188 were well tolerated with no dose-limiting toxicities and no grade ≥3 treatment-emergent adverse events. The study is continuing with the objective of identifying a recommended Phase 2 dose. In addition, a randomized double-blind, placebo-controlled dose-expansion period for this study is now planned following the completion of the dose escalation phase.
“We are encouraged by the initial ATA188 safety results from the first two dose cohorts,” said
Key secondary endpoints of the Phase 1 study include measures of clinical improvement such as expanded disability status scale (EDSS) and MRI imaging as well as other clinical activity measures. The Phase 1 dose escalation period is expected to enroll a total of 24-30 primary and secondary progressive MS (PPMS, SPMS) patients in the U.S. and Australia. For more information about the study, please visit ClinicalTrials.gov (NCT03283826).
Details of the presentation are as follows:
EPO2229: Preliminary phase 1 safety of ATA188, a pre-manufactured, unrelated donor (off-the-shelf, allogeneic) Epstein-Barr virus (EBV)-targeted T-cell immunotherapy for patients with progressive multiple sclerosis (MS)
Poster Presentation Date and Time:
Session Title: MS and related disorders 6
Location: Screen B12 in the Poster Area in the Exhibition Hall
Affiliations: 1. Faculty of Medicine, The
About Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic neurological autoimmune disease that affects more than two million people around the world. Relapsing-remitting MS (RRMS) is the most common form of MS and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Progressive MS (PMS) is a severe form of the disease for which there are few therapeutic options. There are two categories of PMS, both of which are characterized by persistent progression and worsening of MS symptoms and physical disability over time. Primary Progressive MS (PPMS) occurs when continuous progressive disease is present at diagnosis and has been reported to occur in approximately 15% of newly diagnosed cases of MS. Secondary Progressive MS (SPMS) initially begins as RRMS and develops into a progressive form. Treatment history indicates that approximately 80% of people with RRMS will eventually develop SPMS. There is substantial unmet medical need for new and effective therapies for patients with PPMS and SPMS. Most treatment options that work well in reducing flares in RRMS have not been shown to be effective in slowing or reversing disability in PMS. Scientific and clinical findings support a biologic connection between Epstein-Barr Virus (EBV) and MS.
About off-the-shelf, allogeneic ATA188 and autologous ATA190
ATA188 and ATA190 are immunotherapies that use T Cells to target Epstein-Barr Virus (EBV) antigens believed to be important for the potential treatment of multiple sclerosis (MS). Both candidates selectively target EBV-positive cells; however, ATA188 is off-the-shelf and allogeneic, whereas ATA 190 is autologous. ATA188 and ATA190 utilize T-cell immunotherapy technology pioneered by Professor
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the results from Atara’s ongoing ATA188 Phase 1 clinical study; the planned dose-expansion period for this study and identification of a recommended Phase 2 dose; and Atara’s plans to present additional safety results from this study at EAN. These forward-looking statements are subject to risks and uncertainties, including those discussed in
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Source: Atara Biotherapeutics, Inc.