Atara Biotherapeutics Reports Early Findings of Potential Efficacy from Phase 1 Study of ATA188 in Patients with Progressive Multiple Sclerosis at ECTRIMS 2019
Enrollment in the fourth and final planned Phase 1 dose escalation cohort completed
ATA188 targets Epstein-Barr Virus (EBV)-infected B cells, believed to play a role in the pathogenesis of multiple sclerosis
Conference call and webcast today at
ATA188 is an off-the-shelf, allogeneic T-cell immunotherapy that targets Epstein-Barr Virus (EBV)-infected B cells believed to play a role in the pathogenesis of MS.
“I am encouraged by the well tolerated safety profile as well as early findings of potential efficacy in the ongoing ATA188 Phase 1 study,” said Professor Amit Bar-Or, MD, FRCP, FAAN, FANA, Chief of MS Division,
The reported initial data as of
Clinical outcome classification
Clinical outcomes of ATA188 were assessed at baseline and approximately 3, 6, and 12 months follow up from initial dose using recognized scales for MS symptoms, function and disability including: Expanded Disability Status Scale (EDSS), Fatigue Severity Score, MS Impact Scale-29 (physical), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test, 12-Item MS Walking Scale (MSWS-12) and Visual Acuity (VA).
An outcome classification was developed to categorize clinical response by the following clinical criteria:
- Clinical Improvement: Clinically significant improvement or greater on 2 or more of the above MS scales compared to baseline sustained over 2 or more consecutive timepoints
- Partial Clinical Improvement: Clinically significant improvement or greater on 2 or more of the above MS scales compared to baseline at 1 or more timepoint
- Stable: Does not fulfill criteria for decline or improvement
- Clinical Decline: Clinically significant decline in 2 or more scales compared to baseline at 1 or more timepoint; clinical decline takes precedence over improvement
Safety results showed that across the 4 planned dose cohorts, ATA188 was well tolerated in patients with progressive forms of MS with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities.
At approximately 6 months from initial dose, 4 of 6 patients in cohort 1 demonstrated clinical decline which was maintained at 12 months.
In cohort 2, an outcome classification of clinical improvement or partial clinical improvement was observed in all 6 patients at 6 months. No patients showed an outcome classification of stable or clinical decline.
“The safety and efficacy results presented from our ongoing ATA188 Phase 1 study highlight the potential for an off-the-shelf, allogeneic T-cell immunotherapy targeting Epstein-Barr Virus (EBV)-infected B cells in patients with progressive forms of MS,” said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of
Atara will host a live conference call and webcast on
For more information about the ATA188 Phase 1 study, please visit ClinicalTrials.gov (NCT03283826).
Details of the ECTRIMS 2019 presentation
|Title:||Preliminary safety and efficacy of ATA188, a pre-manufactured, unrelated donor (off-the-shelf, allogeneic) Epstein-Barr virus-targeted T-cell immunotherapy for patients with progressive forms of multiple sclerosis|
|Lead Author:||Amit Bar-Or, Perelman School of Medicine, University of Pennsylvania|
|Session:||Poster Session 3|
|Date:||Friday, September 13, 2019|
|Time:||12:15-2:15 p.m. CEST|
Atara conference call and webcast information
Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 3275835. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company's website for approximately 30 days following the live webcast.
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 T-cell immunotherapies targeting Epstein-Barr Virus (EBV)-infected B cells believed to play a role in the pathogenesis of MS. Both candidates selectively target latent EBV antigens presented by B cells; however, ATA188 is off-the-shelf and allogeneic, whereas ATA190 is autologous. ATA188 and ATA190 utilize T-cell immunotherapy technology pioneered by Professor Rajiv Khanna at QIMR Berghofer. Atara is advancing an ongoing Phase 1 ATA188 study in patients with progressive MS across clinical sites in the U.S. and Australia and plans to initiate a randomized ATA190 study in progressive MS patients.
About Atara Biotherapeutics, Inc.
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 continuation of this study and identification of a recommended Phase 2 dose; the initiation of a randomized, double-blind, placebo-controlled portion of this study; and beliefs about the connection of EBV-infected B cells to MS. These forward-looking statements are subject to risks and uncertainties, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (
Editor’s note: Bar-Or is a paid consultant for
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Source: Atara Biotherapeutics, Inc.