Indapta Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application, enabling a future Phase I clinical trial of IDP-023 to treat progressive multiple sclerosis (MS).
IDP-023 is a g-natural killer (g-NK) cell therapy.
The trial will be led by Stanford University and the University of California, San Francisco (UCSF), US.
Patients with progressive MS will be administered IDP-023 in conjunction with ocrelizumab, an anti-CD20 monoclonal antibody.
The study aims to explore the biological effects of IDP-023 through a translational programme, in collaboration with Stanford and UCSF.
Indapta Therapeutics CEO Dr Mark Frohlich said: “This IND is another in a series of milestone achievements from our team in recent months.
“We look forward to the second half of the year during which we plan to initiate this trial and continue progress with our ongoing Phase I/II trial of IDP-023 in patients with haematologic cancers, where we have seen very encouraging responses to date.”
The company is concurrently executing a Phase I/II trial of IDP-023 for non-Hodgkin's lymphoma and multiple myeloma.
Its universal, allogeneic NK cell therapy platform uses a specific subset of NK cells, termed 'g minus' or 'g-NK' cells. These cells emerge from epigenetic changes due to cytomegalovirus (CMV) exposure.
To produce IDP-023, Indapta selectively expands g-NK cells from healthy donors, ensuring low variability between donors.
IDP-023 is claimed to have distinct mechanisms for killing target cells, which include antibody-dependent cell-mediated cytotoxicity (ADCC), targeting of HLA-E expressing cells via the NKG2C receptor, and the intrinsic anti-viral activity of g-NK cells, all without the need for genetic engineering.
In May this year, Indapta received a product development research award of $4.5m from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the clinical development of IDP-023, for advanced non-Hodgkin’s lymphoma and multiple myeloma.
