Indapta to Evaluate g-NK Therapy in Trial for Progressive Multiple Sclerosis
The trial evaluating the safety and tolerability of IDP-023 will be led by Stanford and UCSF.
Lawrence Steinman, MD
Credit: Stanford
The FDA has cleared Indapta Therapeutics’ investigational new drug application (IND) to evaluate its g-natural killer (g-NK) cell therapy IDP-023 in participants with progressive multiple sclerosis (MS).1
“I am excited to participate in this clinical trial because of the multiple potential mechanisms by which g-NK cells may impact the biology of MS,” Lawrence Steinman, MD, Professor of Medicine and Principal Investigator, Stanford, said in a statement.1 “In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have the ability to kill HLA-E expressing autoreactive T and B cells. In addition, g-NK cells have potent anti-viral activity, and therefore may also address the Epstein Barr Virus reservoir that contributes to the disease pathogenesis.”
The clinical trial will be led by Stanford and University of California, San Francsico. Participants will receive IDP-023 in combination with ocrelizumab.
IDP-023 is a universal, allogeneic NK cell therapy consisting of naturally occurring g minus NK cells, which arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). IDP-023 is designed to have highly robust antibody-dependent cell mediated cytotoxicity (ADCC), inherent antiviral activity, and an NKG2C receptor that targets HLA-E expressing cells. Compared with conventional NK cells, g-NK cells release more immune activating cytokines and cell-killing compounds. In preclinical studies, Indapta has demonstrated more potent and durable antitumor activity with IDP-023 when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. The company’s platform also has potential to be used for treating autoimmune disease, as g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells. Indapta is currently also assessing IDP-023 in patients with non-Hodgkin lymphoma and multiple myeloma in a phase 1/2 trial.
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“This IND is another in a series of milestone achievements from our team in recent months,” Mark Frohlich, MD,chief executive officer, Indapta, added.1 “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 1/2 trial of IDP-023 in patients with hematologic cancers, where we have seen very encouraging responses to date.”
Another trial assessing a novel therapy for MS is IASO Bio’s recently cleared phase 1/2 trial of its chimeric antigen receptor (CAR) T-cell therapy equecabtagene autoleucel (eque-cel), which received IND clearance in July 2024. Eque-cel is a fully human anti-BCMA CAR T-cell therapy initially investigated for treating multiple myeloma and also being explored for treating other forms of central nervous system autoimmunity, including neuromyelitis optica spectrum disorder, myasthenia gravis, immune-mediated necrotizing myopathy, and generalized myasthenia gravis.
"In an investigator initiated trial (IIT) conducted in China, Eque-cel has shown promising efficacy in 6 autoimmune diseases. The IND approval of Eque-cel in the treatment of MS from the FDA is another strong evidence of IASO Bio's ongoing dedication and technological advancements in the treatment of autoimmune diseases. We will continue to adhere to the research and development philosophy that prioritizes clinical value to address unmet clinical needs and will place great importance on implementing a global strategy. Through close collaboration and in-depth exchanges with international clinical research institutions, we aim to accelerate the development and commercialization of more innovative drugs, bringing greater benefits to patients worldwide,” Yongke Zhang, PhD, Chief Scientific Officer, IASO Bio, said in a statement.2
