Indapta Therapeutics Gets FDA Nod for IDP-023 Phase 1 Trial in Progressive MS

Indapta Therapeutics, Inc., a clinical stage biotechnology company specializing in innovative cell therapies for cancer and autoimmune disorders, has received U.S. FDA approval to commence a Phase 1 clinical trial of its g-natural killer (g-NK) cell therapy, IDP-023, for treating progressive multiple sclerosis (MS). This clinical trial will be spearheaded by Stanford University and the University of California, San Francisco (UCSF). Participants with progressive MS will be treated with IDP-023 in conjunction with the anti-CD20 monoclonal antibody, ocrelizumab, to evaluate the biological effects of IDP-023.

Dr. Lawrence Steinman, a Professor of Medicine and Principal Investigator at Stanford, expressed his enthusiasm for the trial, highlighting the various mechanisms through which g-NK cells could influence MS. According to Dr. Steinman, g-NK cells, when combined with a B cell-directed monoclonal antibody, can achieve B cell depletion. Additionally, these cells possess the capability to eliminate HLA-E expressing autoreactive T and B cells and offer significant anti-viral activity, potentially targeting the Epstein Barr Virus reservoir linked to the disease's progression.

Currently, Indapta is also conducting a Phase 1/2 trial of IDP-023 in patients with non-Hodgkin’s lymphoma and multiple myeloma. Dr. Mark Frohlich, CEO of Indapta, highlighted this IND approval as a significant milestone, expressing anticipation for the trial's initiation in the latter half of the year. Dr. Frohlich also noted the promising responses observed in the ongoing Phase 1/2 trial involving patients with hematologic cancers.

Indapta's unique allogeneic NK cell therapy platform features a potent subset of naturally occurring NK cells, termed "g minus" NK cells or "g-NK" cells. These cells emerge from epigenetic modifications due to cytomegalovirus (CMV) exposure. For the production of IDP-023, Indapta selectively expands g-NK cells from healthy donors, ensuring minimal variability between donors. IDP-023 employs several distinct mechanisms to target and eliminate cells, such as antibody-dependent cell-mediated cytotoxicity (ADCC), targeting HLA-E expressing cells via the NKG2C receptor, and the intrinsic anti-viral capabilities of g-NK cells.

Compared to conventional NK cells, Indapta’s g-NK cells release significantly higher amounts of immune-activating cytokines and cell-killing agents. Preclinical studies have demonstrated that IDP-023 exhibits stronger and more sustained anti-tumor activity when paired with cancer-targeting monoclonal antibodies compared to traditional NK cells. Moreover, g-NK cells in combination with a B cell-targeting antibody can deplete normal B cells from both healthy donors and patients with autoimmune diseases.

Indapta Therapeutics is a privately held entity dedicated to advancing a diverse array of cell therapies aimed at addressing the unmet medical needs of patients suffering from blood and solid-tumor cancers as well as autoimmune conditions. The company's proprietary g-NK cell platform aims to create highly potent, accessible, and scalable cell therapies.