FDA clears clinical trial on novel MS cell therapy platform

The FDA has cleared an investigational new drug application for a phase 1 clinical trial evaluating a universal, allogenic cell therapy platform intended to treat progressive MS.

According to a release from Indapta Therapeutics Inc., its g-natural killer (g-NK) cell therapy, IDP-023, consists of a potent subset of naturally occurring NK cells, known as “g minus” NK cells, which result from epigenetic changes that occur due to their exposure to cytomegalovirus.

Stanford University and the University of California, San Francisco, will lead the pending phase 1 clinical trial, in which those with progressive MS will receive IDP-023 in combination with the anti-CD20 monoclonal antibody ocrelizumab (Ocrevus, Genentech), the release stated.

“Published reports demonstrate that naturally occurring g-NK cells are not only protective against the development of MS, but also slow the progression of the disease,” Mark Frohlich, MD, CEO of Indapta Therapeutics, told Healio in an email. “In contrast to other cell therapy approaches that focus on B-cell depletion, g-NK cells have the potential to address the T-cell component of autoimmune diseases in addition to the B-cell component.”

The company additionally said in the release it is currently conducting a phase 1/2 study of IDP-023 in those with non-Hodgkin’s lymphoma and multiple myeloma.