In response to the COVID-19 pandemic, Atara Biotherapeutics has temporarily paused patient enrollment in the second and randomized part of its ongoing Phase 1 clinical trial investigating ATA188 in people with progressive forms of multiple sclerosis (MS).
People treated in the first, open-label part of this trial, however, will continue to be monitored as defined by trial protocol, and may enter an open-label extension period to continue with this immunotherapy candidate “in an appropriate setting.”
“While this is an unprecedented time in history, Atara is working hard to ensure operational continuity to serve patients whose lives are affected by severe diseases,” Pascal Touchon, president and CEO of Atara Biotherapeutics, said in a press release.
“The COVID-19 pandemic is evolving rapidly, and we are closely monitoring it to both ensure the safety and well-being of our employees, patients and communities, as well as assess the potential impacts to our business so we can continue delivering transformative medicines to patients in critical need,” Touchon added.
Infection with the Epstein-Barr virus (EBV, a common form of the herpes virus) is known to increase the risk of MS. This virus infects B-cells (immune cells involved in antibody production), making them more likely to produce antibodies that wrongly attack myelin — the protective coating of nerve fibers that is progressively damaged in MS.
T-cells, another type of immune cell, would normally be able to recognize the infected B-cells and eliminate them, but MS patients are thought to be deficient in these cells.
Atara designed ATA188 to overcome this deficiency, providing fully functional T-cells to patients to help rid their bodies of the faulty B-cells. The T-cells are isolated from partly matched donors, and cultured in the lab in a way that makes them highly specific to EBV-infected cells.
The Phase 1 trial (NCT03283826), taking place in the U.S. and Australia, is assessing the safety and effectiveness of ATA188 in 97 patients with either primary progressive MS (PPMS) or secondary progressive disease (SPMS).
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