Atara Biotherapeutics Announces Publication of Phase 1 Study Demonstrating Clinical Improvement in Progressive Multiple Sclerosis Patients Treated with ATA190, an Autologous Epstein-Barr Virus (EBV)-Specific T-Cell Immunotherapy
“We previously presented promising initial ATA190 results in patients with progressive MS, and the published results confirm our earlier observations,” said Professors
The Phase 1 open-label, uncontrolled study evaluated escalating doses of ATA190 in ten patients, five with primary and five with secondary progressive MS. Safety and efficacy were monitored for up to 27 weeks and included Expanded Disability Status Scale (EDSS) score, fatigue, cognitive and other neurological assessments as well as analysis of magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) immunoglobulin G (IgG) production. Prior to ATA190 T-cell immunotherapy, patients had experienced progressive neurological deterioration for a mean of 10.1 years.
ATA190 was well-tolerated and no severe adverse events were observed in the study. Adverse events of grade 1 or 2 severity occurred in 2 participants, with only one grade 1 dysgeusia definitely related to treatment. Seven patients in the study showed symptomatic and objective neurological improvement, which commenced two to 14 weeks after the first infusion. Reduction in fatigue, one of the most frequent and disabling symptoms of MS, was a consistent and prominent feature in patients showing neurological improvement.
Reactivity of ATA190 against target EBV antigens (EBV reactivity) as well as other mechanistic markers of T cell function were assessed. Six participants in the study who received ATA190 with strong EBV reactivity experienced clinical improvement, including three with decreased EDSS scores. One of four participants who received ATA190 with weak EBV reactivity showed improvement and no change in EDSS score was observed. One of ten patients had neurological deterioration during the study.
“We are encouraged by the published results for autologous ATA190, the first prospective clinical study of an EBV-specific T-cell immunotherapy in progressive MS,” said
The study was funded by MS Queensland, MS Research Australia,
About Progressive Multiple Sclerosis
MS is a chronic neurological autoimmune disease that affects more than two million people around the world. Progressive MS (PMS) is a severe form of the disease with few therapeutic options. PMS comprises two conditions, both 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 occurs in approximately 15% of newly diagnosed cases. Secondary Progressive MS (SPMS) initially begins as RRMS and develops into a progressive form. Up to 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.
About off-the-shelf, allogeneic ATA188 and autologous ATA190
Epstein-Barr Virus (EBV) is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis (MS). T cells are a critical component of the body's immune system and can selectively target specific EBV antigens believed to be important for the potential treatment of MS. Off-the-shelf, allogeneic ATA188 and autologous ATA190, using Atara’s complementary 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 timing, progress and results of the Company’s Phase 1 studies of ATA188 and ATA190 in patients with progressive MS; the potential advantages of ATA188 and ATA190 in the treatment of progressive MS; the Company’s ability to expand its pipeline; and the potential advantages of its other product candidates. Because such statements deal with future events and are based on
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Source: Atara Biotherapeutics, Inc.