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.
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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.
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By GlobalData“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.
