Date: 2017-10-19
Type of information: Initiation of preclinical development
phase: 1
Announcement: initiation of the trial
Company: Atara Biotherapeutics (USA - CA)
Product: ATA188
Action mechanism:
Disease: progressive or relapsing-remitting multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases*
Country:
Trial details:
Latest news: • On October 19, 2017, Atara Biotherapeutics announced that the company initiated a multinational, multicenter Phase 1 clinical study to evaluate allogeneic ATA188 in patients with progressive or relapsing-remitting multiple sclerosis. Allogeneic ATA188, the Company's next generation T-cell immunotherapy licensed from QIMR Berghofer Medical Research Institute**lectively targets specific Epstein-Barr virus (EBV) antigens believed to play an important role in the pathogenesis of MS. "Starting the first allogeneic T-cell immunotherapy study in MS is a significant milestone for Atara," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Earlier this week, our collaborators reported that autologous ATA190 demonstrated encouraging updated results in a Phase 1 study, showing objective clinical improvements in five of eight patients with progressive MS. Development of an off-the-shelf version of ATA188 expands our allogeneic T-cell immunotherapy platform beyond oncology to autoimmune diseases and is a potential new approach to treat patients with progressive or relapsing-remitting MS." The primary objective of Atara's Phase 1 clinical study is to assess the safety of allogeneic ATA188 in subjects observed for at least 1 year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR) as well as MRI imaging. The open-label, single-arm study is expected to enroll a total of 60 patients: 30 patients with progressive forms of MS, either primary progressive MS (PPMS) or secondary progressive MS (SPMS), and 30 patients with relapsing-remitting MS (RRMS) across Australia, the US, and Europe. For more information about the study, please visit ClinicalTrials.gov (NCT03283826). About Multiple Sclerosis MS is a chronic neurological autoimmune disease that affects an estimated 2.3 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. Despite available disease-modifying treatments, most individuals with RRMS continue to experience disease activity and disability progression. 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 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. Allogeneic ATA188 and autologous ATA190, the Company's next generation T-cell immunotherapies developed by Professor Rajiv Khanna at QIMR Berghofer, have the potential to precisely recognize and eliminate EBV-infected B-cells and plasma cells in the central nervous system that may catalyze autoimmune responses and MS pathophysiology. Professor Michael Pender from The University of Queensland presented the results of the first autologous ATA190 study, which was partially funded by MS Research Australia, MS Queensland and Perpetual Foundation, at the American Academy of Neurology (AAN) meeting in April 2017. This study tested adoptive immunotherapy in patients with MS and showed that autologous ATA190, led to encouraging clinical improvements in MS symptoms that correlated with autologous ATA190's reactivity against target EBV antigens (EBV reactivity). A Phase 1 clinical study of autologous ATA190 in progressive forms of MS is ongoing, and a Phase 1 allogeneic ATA188 clinical study in patients with progressive and relapsing-remitting MS was recently initiated.
