HLA-E

HOUSTON & SEATTLE--( BUSINESS WIRE )--Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation cell therapies for the treatment of cancer and autoimmune diseases, announced today it has closed a $22.5 million round of new financing to accelerate the clinical development of its differentiated allogeneic Natural Killer (NK) cell therapy. Current investors RA Capital Management, LP, Leaps by Bayer, the impact investment arm of Bayer AG, Vertex Ventures HC, Pontifax, and the Myeloma Investment Fund, the venture philanthropy subsidiary of the Multiple Myeloma Research Foundation, completed the round. "This funding will enable us to generate significant additional data in our ongoing trial of IDP-023 in cancer as well as initial data from our first trial in autoimmune disease," said Mark Frohlich, Indapta’s CEO. "Preliminary results of IDP-023 in cancer are encouraging and we look forward to initiating our Phase 1 trial for multiple sclerosis in Q1 2025. This financing, together with our recently announced collaboration with Sanofi, highlights the promise of our differentiated platform.” Advancing Clinical Trials of Lead Product IDP-023 Indapta has completed enrollment in the safety run-in portion of the Phase 1 clinical trial of IDP-023 in Non-Hodgkin’s Lymphoma (NHL) and Multiple Myeloma (MM), in which patients received up to three doses of IDP-023 without and with interleukin (IL)-2. As presented at the Society for Immunotherapy of Cancer meeting , the mean maximum decrease in serum M-protein or light chain was 73% in responding myeloma patients with relapsed/refractory disease, with three patients achieving a reduction of 84% or greater. Enrollment of cohorts receiving IDP-023 in combination with monoclonal antibodies targeting CD20 or CD38 is underway. In August, Indapta announced FDA clearance of its IND of IDP-023 in combination with ocrelizumab in progressive MS . The company’s approach is highly differentiated from other cellular approaches to autoimmune diseases, with at least three different mechanisms that can address the biology of the disease: 1) by combining with a B cell targeting antibody like ocrelizumab, IDP-023 can deplete B cells more effectively than antibody alone; 2) g-NK cells are capable of targeting autoreactive T and B cells that are known to upregulate HLA-E; and 3) given their inherent anti-viral activity, g-NK cells can potentially address the EBV viral reservoir that contributes to the disease pathogenesis. 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 .

HOUSTON & SEATTLE--( BUSINESS WIRE )--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 a collaboration with Sanofi to explore the combination of its allogeneic g-NK cell therapy, IDP-023, with Sanofi’s CD38-targeting monoclonal antibody, Sarclisa (isatuximab). Indapta has amended its ongoing phase 1 study of IDP-023, to add a cohort of IDP-023 in combination with Sarclisa for patients with relapsed/refractory multiple myeloma. Up to three dose levels of IDP-023 will be explored in the combination. Under the agreement, Indapta will sponsor the clinical trial, Sanofi will supply Sarclisa, and the Parties will co-fund the trial. As presented at the Society for Immunotherapy of Cancer Meeting, 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. This appears to be superior to prior trials of natural killer cells in myeloma. “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,” said Robert Sikorski, Indapta’s Chief Medical Officer. “We look forward to a close collaborative relationship and leveraging Sanofi’s expertise in the design of potential subsequent studies.” 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/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 .

Preliminary clinical activity with IDP-023 in relapsed/refractory multiple myeloma observed at lowest cell dose and in absence of targeting monoclonal antibody HOUSTON, TX & SEATTLE, WA, USA I November 07, 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 the presentation of clinical and preclinical data at the Society for Immunotherapy of Cancer meeting in Houston, TX. The clinical presentation (Abstract #1483), entitled “Activity of IDP-023 Allogeneic g-NK Cells Without Antibody Targeting in First-in-Human Phase 1/2 Study in Patients with Advanced Multiple Myeloma or Non-Hodgkin Lymphoma,” summarized the data from the safety run-in of the Phase 1 trial. Patients received one to three doses of IDP-023, with or without interleukin-2 (IL-2). The treatment was generally well-tolerated, with no dose limiting toxicities. The most common adverse events were cytopenias related to the conditioning chemotherapy. Objective responses were observed in five of nine patients treated. Of the five patients treated with IDP-023 and IL-2, four achieved an objective response (one very good partial response, two partial responses, one minimal response). Of the eight relapsed/refractory myeloma patients, the mean maximum decrease in serum M-protein or light chain was 73%, with three patients achieving a reduction of 84% or greater. “We are encouraged to observe this degree of clinical activity during the safety run-in, at the lowest cell dose and without the addition of a targeting antibody,” said Dr. Robert Sikorski, Chief Medical Officer of Indapta. “We look forward to the enrollment in the antibody cohorts, in which multiple myeloma patients will receive IDP-023 in combination with a CD38-targeting monoclonal antibody, and non-Hodgkin’s lymphoma patients will receive IDP-023 in combination with a CD20-targeting monoclonal antibody. In our preclinical models, the addition of a targeting monoclonal antibody markedly increases efficacy.” In Abstract #365, entitled, “Artificial Intelligence-Based Dynamic Single-Cell Imaging Reveals Enhanced Migration and Immune Synapse Formation by IDP-023, an Allogeneic g-NK Cell Product,” researchers demonstrated that the enhanced antibody-dependent cellular cytotoxicity (ADCC) of g-NK cells is driven in part by faster cell migration and a higher frequency of synapse formation with target cells compared to conventional NK cells. Faster migration correlates with enhanced expression of CD2 (LFA-2), a protein involved in leukocyte adhesion, as a potential factor in the increased migration and cytotoxic functions of IDP-023. In Abstract #1285, entitled, “IDP-023 has superior single agent and antibody-dependent cytotoxicity against solid tumor cell lines compared to conventional NK cells,” data presented demonstrate potent activity of g-NK cells against HER2 and EGFR positive cells lines, both without and with tumor targeting antibodies. Furthermore, the analysis of publicly available datasets of patients treated with trastuzumab, a monoclonal antibody used to treat HER2-positive breast and other cancers, show that patients with increased levels of naturally occurring g-NK cells had a higher rate of pathological complete response in a neoadjuvant study and improved distant disease-free survival in an adjuvant study. “These data demonstrate both the differentiated mechanism of g-NK cells, as well as their potential efficacy in solid tumors,” said Stefanie Mandl-Cashman, Chief Scientific Officer of Indapta Therapeutics. “In addition, analyses of clinical outcomes in patients treated with trastuzumab highlight the powerful effect of naturally occurring g-NK cells on the outcome of patients undergoing therapy with monoclonal antibodies, demonstrating the strong antibody-dependent cellular toxicity of g-NK cells.” 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/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