Indapta Therapeutics, Inc.

Company’s g-NK Cell Therapy Has Multiple Potential Mechanisms That Could Impact Biology of Multiple Sclerosis HOUSTON, TX & SEATTLE, WA, USA I August 06, 2024 I Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, today announced that the U.S. FDA has cleared the IND for the company’s Phase 1 clinical trial of its g-natural killer (g-NK) cell therapy, IDP-023, in progressive multiple sclerosis (MS). Stanford University and the University of California, San Francisco (UCSF) will lead the clinical trial. People with progressive MS will receive IDP-023 in combination with the anti-CD20 monoclonal antibody, ocrelizumab. The study will interrogate the biologic effects of IDP-023 using a translational program developed in collaboration with Stanford and UCSF. “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,” said Dr. Lawrence Steinman, Professor of Medicine and Principal Investigator at Stanford. “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.” Indapta is currently conducting a Phase 1/2 trial of IDP-023 in patients with non-Hodgkin’s lymphoma and multiple myeloma. “This IND is another in a series of milestone achievements from our team in recent months,” said Dr. Mark Frohlich, CEO of Indapta. “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.” Indapta’s Proprietary g-NK Cell Therapy Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “g minus” NK cells, or “g-NK” cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, https://doi-org.libproxy1.nus.edu.sg/10.1182/bloodadvances.2020002440 ). g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells from healthy donors or patients with autoimmune disease. About Indapta Therapeutics Indapta is a privately held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform of naturally occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit www.indapta.com . SOURCE: Indapta Therapeutics

– Company plans to for Phase 1 trial of IDP-023 in multiple sclerosis in mid-2024, expanding into autoimmune disease along with currently enrolling Phase 1 trial for non-Hodgkin’s lymphoma and multiple myeloma – HOUSTON & SEATTLE--(BUSINESS WIRE)-- Indapta Therapeutics, Inc., a privately held biotechnology company developing differentiated cell therapies for the treatment of cancer and autoimmune diseases, announced that CEO Mark Frohlich, MD, will be giving a plenary talk today titled, “g-NK cells for the treatment of cancer and autoimmune disease” at the New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference. In his talk, Dr. Frohlich will summarize the differentiated mechanisms of target cell killing for Indapta’s lead clinical program, IDP-023, a g-NK cell therapy product. These mechanisms include highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta is currently applying g-NK cells to hematologic cancers in an ongoing Phase 1 trial enrolling patients with non-Hodgkin’s lymphoma, multiple myeloma and acute myelogenous leukemia. Dr. Frohlich will also describe Indapta’s expanded focus on autoimmune disease, including its plans to investigational new drug (IND) application with the U.S. Food and Drug Administration for a clinical trial of IDP-023 in multiple sclerosis. “Based on published evidence that endogenous g-NK cells are not only protective against the development of multiple sclerosis, but also slow the progression of the disease, we plan on filing an IND in mid-2024 to initiate a clinical trial of g-NK cells for this indication,” said Dr. Frohlich. “In addition to being able to achieve B cell depletion by combining with a B cell directed monoclonal antibody, g-NK cells have additional mechanisms not shared by conventional NK cells or CAR-T cells, namely their ability to kill HLA-E expressing autoreactive T and B cells as well as address the Epstein Barr Virus reservoir that may contribute to the disease pathogenesis.” Indapta’s Differentiated g-NK Cell Therapy Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “g minus” NK cells, or “g-NK” cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, ) About Indapta Therapeutics Indapta is a privately-held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform for the selective expansion and successful cryopreservation of naturally-occurring g-NK cells for the creation of an allogeneic, on-demand cell therapy is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit .

Highly differentiated Cell Therapy in Phase 1 Trial for Lymphoma and Multiple Myeloma HOUSTON & SEATTLE--(BUSINESS WIRE)-- Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, today announced that Cancer Prevention and Research Institute of Texas (CPRIT) has granted the company a competitive product development research award. The $4.5 million grant will support Indapta’s ongoing clinical development of its lead product, IDP-023, for patients with advanced non-Hodgkin’s lymphoma and multiple myeloma. “We greatly appreciate that CPRIT has recognized the promise of Indapta’s allogeneic g-NK cell therapy for the treatment of advanced cancer patients,” said Dr. Mark Frohlich, CEO of Indapta. “We are highly encouraged to be seeing early evidence of clinical activity in the safety run-in portion of the trial at the lowest cell dose and without the addition of a monoclonal antibody. We look forward to using the CPRIT funds to treat additional patients in order to reach clinical proof-of-concept in our Phase 1 dose escalation trial.” Patients enrolled in the Phase I clinical trial to date have received up to three planned doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive escalating doses of IDP-023 in combination with the monoclonal antibodies, rituximab and daratumumab, respectively. Indapta’s Differentiated g-NK Cell Therapy Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as “g minus” NK cells, or “g-NK” cells. G‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, ) Based on evidence that endogenous g-NK cells are protective against the development of multiple sclerosis, as well as slow disease progression in patients with multiple sclerosis, Indapta plans to IND in Q3 to initiate a clinical trial of g-NK cells in patients with multiple sclerosis. About Indapta Therapeutics Indapta is a privately held company focused on developing and bringing to market a diverse pipeline of cell therapies to treat the still unmet medical needs of patients with blood and solid-tumor cancers as well as autoimmune diseases. The company’s proprietary robust platform of naturally occurring g-NK cells is specifically designed to create best-in-class, highly potent, more accessible, and scalable cell therapies. For more information, please visit .