Indapta Therapeutics Receives FDA Clearance for Phase 1 Trial of Off-the-Shelf G-NK Cell Therapy IDP-023 in Progressive Multiple Sclerosis

Aug 08, 2024 08:01 CST Updated 08:01

Indapta Therapeutics

Allogeneic Cell Therapy Developer

August 8, 2024

eMedClub News

On August 6 local time, Indapta Therapeutics (hereinafter referred to as "Indapta") announced,FDA Approves Phase I Clinical Trial Application for Indapta Therapeutics' Investigational Cell Therapy IDP-023IDP-023 is aG-NK Cell Therapy, intended to be applied in the treatment ofProgressive Multiple Sclerosis (MS)。

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MS is an inflammatory demyelinating disease of the central nervous system that affects millions of people worldwide. Its multifocal nature and relapsing-remitting course significantly impact patients' quality of life and prognosis. Known as the "disease with a thousand faces," MS can cause weakness in the limbs, vision loss, and even affect speech and cognitive abilities in young adults, eroding their ability to live independently and potentially leading to paralysis. Therefore, finding effective treatments to slow disease progression and improve patients' quality of life remains a major focus and challenge in MS research.Progressive MS is a form of MS characterized by continuous disease worsening and currently has no cure.. Current treatment methods mainly focus on slowing disease progression, alleviating symptoms, and improving patients' quality of life.

▲ Multiple Sclerosis Leads to Myelin Damage

IDP-023 is aAllogeneic Differentiated G-NK (FcRγ-deficient NK) Cell Therapy, is based on Indapta Therapeutics, Inc.Allogeneic G-NK Cell Therapy PlatformGenerated. G-NK cells are a subset of natural killer cells formed after specific epigenetic changes (such as exposure to cytomegalovirus, CMV), possessing enhanced immune activation and cytotoxic capabilities. Compared with conventional NK cells,G-NK cells can release more immune-activating cytokines and cytotoxic compounds, demonstrating higher efficacy in anti-tumor and anti-viral activities.Preclinical studies have shown that, compared with traditional NK cells, IDP-023 canReduce tumors by more than 99%。

▲ Comparison of NK Cells and G-NK Cells

During the development of IDP-023, Indapta Therapeutics utilized its proprietary cell expansion technology to preferentially expand G-NK cells from healthy donors. Through multiple mechanisms (such as antibody-dependent cell-mediated cytotoxicity (ADCC), targeting HLA-E expressing cells via the NKG2C receptor, and the intrinsic antiviral activity of g-NK cells), IDP-023 achieves highly efficient killing of target cells. Additionally, IDP-023 can be combined with anti-CD20 monoclonal antibodies (e.g., ocrelizumab) to enhance B-cell depletion, thereby further improving disease symptoms.

Dr. Lawrence Steinman, Professor of Medicine at Stanford University and Principal Investigator, said: "I am excited to be involved in this clinical trial. G-NK cells may influence the biology of MS through multiple potential mechanisms. Not only can they deplete B cells by engaging with B cell-directed monoclonal antibodies, but they can also kill autoreactive T cells and B cells expressing HLA-E. Additionally, G-NK cells have potent antiviral activity and thus may also address the EB viral reservoir that is implicated in disease onset."

Dr. Mark Frohlich, CEO of Indapta Therapeutics, stated: "The approval of this IND represents another milestone achievement for our team in recent months. We look forward to initiating this trial in the second half of this year and continuing to advance our Phase I/II trial of IDP-023 for patients with hematologic cancers."

Notably, Indapta Therapeutics, Inc. is currently conductingPhase I/II Clinical Trial of IDP-023 in Patients with Non-Hodgkin's Lymphoma and Multiple Myeloma, with Preliminary Efficacy ObservedThese clinical data not only validate the potential of IDP-023 in the treatment of hematologic malignancies but also provide strong support for its application in autoimmune diseases (such as MS). Meanwhile, this also indicates that certain "special" subsets in NK cell therapy possess significant potential and promising prospects.

References:

1.https://www.businesswire.com/news/home/20240806112913/en/Indapta-Therapeutics-Announces-FDA-Clearance-of-IND-for-Phase-1-Trial-of-IDP-023-for-Progressive-Multiple-Sclerosis

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