Indapta Therapeutics and Sanofi have announced a clinical study collaboration to investigate the combination of Indapta's allogeneic g-NK cell therapy, IDP-023, with Sanofi’s CD38-targeting monoclonal antibody, Sarclisa (isatuximab), in patients with relapsed/refractory multiple myeloma. The collaboration aims to leverage the synergistic potential of these therapies to improve outcomes for patients with this challenging disease.
Trial Design and Objectives
Indapta has amended its ongoing Phase 1 study of IDP-023 to include a cohort evaluating the combination of IDP-023 and Sarclisa. The study will explore up to three dose levels of IDP-023 in combination with Sarclisa. The primary objective is to assess the safety and efficacy of the combination therapy in patients with relapsed/refractory multiple myeloma. Indapta will sponsor the clinical trial, while Sanofi will supply Sarclisa, and both parties will co-fund the study.
IDP-023: A Novel g-NK Cell Therapy
IDP-023 is an allogeneic NK cell therapy derived from a potent subset of naturally occurring NK cells, known as “g minus” NK cells, or g-NK cells. These cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). Indapta preferentially expands g-NK cells from healthy donors to generate IDP-023, ensuring low donor-to-donor variability. IDP-023 exhibits multiple mechanisms of action for killing target cells without genetic engineering, including robust antibody-dependent cell-mediated cytotoxicity (ADCC), targeting of HLA-E expressing cells via the NKG2C receptor, and inherent anti-viral activity.
Preclinical Evidence and Rationale
Preclinical studies have demonstrated that Indapta’s g-NK cells release significantly more immune-activating cytokines and cell-killing compounds compared to conventional NK cells. In these studies, IDP-023 showed more potent and durable antitumor activity when combined with cancer-targeting monoclonal antibodies. Data presented at the Society for Immunotherapy of Cancer Meeting indicated that IDP-023, administered with or without interleukin-2, achieved a mean maximum reduction in serum M-protein or light chain of 73% in eight relapsed/refractory myeloma patients, suggesting superior efficacy compared to prior NK cell trials in myeloma.
Expert Commentary
Robert Sikorski, Indapta’s Chief Medical Officer, stated, “With its deep experience in multiple myeloma and pipeline of products in hematologic malignancies and immunologic disorders, Sanofi is an excellent partner to help Indapta develop our differentiated natural killer cell product. We look forward to a close collaborative relationship and leveraging Sanofi’s expertise in the design of potential subsequent studies.”
