IDP-023 / Indapta Therap - LARVOL DELTA

Indapta Therapeutics Presents Data Demonstrating Clinical Activity of its Allogeneic Natural Killer Cell Therapy in Patients with Relapsed/Refractory Multiple Myeloma (Businesswire) - "The data will be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting, taking place November 7-9, 2025, in Washington, DC....In patients treated with IDP-023 at the second dose level of 10 billion cells/dose in combination with isatuximab, confirmed responses were observed in 4 of 5 response evaluable patients. These patients were heavily pre-treated with high-risk and ultra high-risk cytogenetics; Responses included a stringent complete response in a patient with extramedullary disease who experienced prior progression following treatment with both CAR-T and T-cell engager therapy; A second cycle of IDP-023 in combination with isatuximab in select patients appeared to improve the depth and duration of response; Treatment was generally well-tolerated with no dose limiting toxicities. The most common adverse events were cytopenias related to the conditioning chemotherapy."

P1/2 data • Multiple Myeloma

IDP-023 Allogeneic g-NK-cells +/- Anti-CD38 Monoclonal Antibody for the Treatment of Relapsed/Refractory Multiple Myeloma: Safety, Efficacy and Determination of Recommended Phase 2 Dose (SITC 2025) - P1/2 | "Patients received lymphodepletion conditioning with cyclophosphamide/fludarabine followed by 1-3 doses of 5x109, 10x109, or 20x109 IDP-023 cells on either a weekly (QW) or every-other-day dosing (QOD) schedule without (n=3) or with (n=19) IL-2 cytokine support and without (n=9) or with (n=13) CD38-mAb.; IRB Approval Date ---------|-----------------------------------------------------------|------------------------|----------------------|------------------- 1104; MDACC; MDACC; IRB00000121;7/14/23 1393; NEXT Virginia; Salus IRB; IRB00006833; 9/19/23 1409; Providence Cancer Institute; Advarra; IRB00000971;2/14/24 1410; M Health Fairview - University of Minnesota Masonic Cancer| University of Minnesota| IRB00010642; 10/4/23;Center;;; 1074; Weill Medical College of Cornell University; Advarra; IRB00000971; 11/9/23 1425; SCRI Oncology Partners;Castle IRB; IRB00012054; 7/24/24 1428; Valkyrie Clinical Trials; Advarra; IRB00000971; 7/24/24Consent Written informed consent..."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology • HLA-E • IL2 • KLRC1

Selective Cytotoxicity of Allogeneic Adaptive Natural Killer Cells (IDP-023) Against CNS-Autoreactive B and T Cells for the Potential Prevention and Treatment of Multiple Sclerosis (ECTRIMS 2025) - "Our findings support the selective cytotoxic activity of IDP-023 against autoreactive immune cells in PwMS. The phenotypic profile and functional consistency of IDP-023 suggest that it could serve as a novel allogeneic adoptive cell therapy for the prevention and treatment of MS . A clinical study is currently being planned to assess the feasibility, safety, and biological impact of IDP-023 in newly diagnosed PwMS."

Late-breaking abstract • CNS Disorders • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Multiple Sclerosis • CD4 • CD8 • CRYAB • IL12A • IL15 • IL18 • KLRC1 • NKG2D

FcεRIγ-Negative Natural Killer (g-NK) Cells Potentiate Cetuximab in Treating EGFR-Positive Head and Neck Cancer SCC-4 Lung Metastases Mouse Xenografts (ASGCT 2025) - "FcεRIγ-negative, g-NK cells and cetuximab combination therapy showed potential in treating preclinical solid tumor HNSCC metastases. These data demonstrate the potential complimentary MOAs of antibody-based competitive inhibitors and cell-based ADCC to effectively target solid tumors. g-NK cells are currently being evaluated in hematologic-based diseases and these data suggest their potential therapeutic application in solid tumors when combined with monoclonal antibodies."

Late-breaking abstract • Preclinical • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • IL15

IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=34 | Suspended | Sponsor: Indapta Therapeutics, INC. | Initiation date: Jan 2025 ➔ Jun 2026 | Recruiting ➔ Suspended

Trial initiation date • Trial suspension • CNS Disorders • Immunology • Multiple Sclerosis

Response to g-NK is associated with higher CD8+ T cells and lower MDSC in bone marrow of multiple myeloma patients (AACR 2025) - "Collectively, these data suggest that g-NK cell therapy can alter the TME and may promote MM control by influx of non-exhausted T cells. Furthermore, the amount of MDSC in the bone marrow at time of treatment may be inversely correlated with anti-tumor activity."

Clinical • IO biomarker • Myeloid-derived suppressor cells • Hematological Malignancies • Multiple Myeloma • Oncology • CD8 • CXCR3 • HLA-E • KLRC1 • PD-1

AdventHealth recruiting for study of IDP-023 in progressive MS (Multiple Sclerosis News Today) - "The AdventHealth Neuroscience Institute is recruiting patients for a Phase 1b clinical trial testing IDP-023, an off-the-shelf cell-based treatment that Indapta Therapeutics is developing for primary or nonactive secondary progressive multiple sclerosis (MS). The company delayed the study’s expected launch in the second half of last year, but recruitment into the clinical trial (NCT06677710) is now open to adults with a diagnosis of primary or nonactive secondary progressive MS at AdventHealth in Orlando. Four additional sites are expected to open in the U.S. The trial, dubbed IDP023-2-101, is recruiting an estimated 34 patients, ages 18-65, who’ve been treated with Ocrevus (ocrelizumab) in the past six months."

Trial status • Multiple Sclerosis

IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=34 | Recruiting | Sponsor: Indapta Therapeutics, INC. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology • Multiple Sclerosis • IL2

Indapta Therapeutics Secures $22.5 Million to Advance Clinical Trials of Innovative Cancer and Autoimmune Treatments (Businesswire) - "Indapta Therapeutics, Inc...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...'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.'....'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.'"

Financing • Trial status • Hematological Malignancies • Multiple Sclerosis

Indapta Therapeutics Announces Clinical Study Collaboration With Sanofi on Multiple Myeloma Program (Businesswire) - "Indapta Therapeutics...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)....Under the agreement, Indapta will sponsor the clinical trial, Sanofi will supply Sarclisa, and the Parties will co-fund the trial."

Commercial • Hematological Malignancies • Multiple Myeloma • Oncology

IDP-023 has superior single agent and antibody-dependent cytotoxicity against solid tumor cell lines compared to conventional NK cells (SITC 2024) - P1/2 | "Combination with g-NK-cells could enhance efficacy of cetuximab without exacerbating side effects.The mAb trastuzumab targets HER2 and is approved in HER2+ breast and gastric cancers. Values are mean ± SE, N=7. #p<0.001 for differences between g-NK and cNK cells"

Preclinical • Tumor cell • Breast Cancer • Gastric Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HLA-E • IFNG • KLRC1 • TNFA

IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov) - P1 | N=34 | Not yet recruiting | Sponsor: Indapta Therapeutics, INC.

New P1 trial • CNS Disorders • Immunology • Multiple Sclerosis • IL2

Artificial intelligence-based dynamic single-cell imaging reveals enhanced migration and immune synapse formation by IDP-023, an allogeneic g-NK cell product (SITC 2024) - P1/2 | "Methods Artificial intelligence-powered Time-lapse Imaging Microscopy In Nanowell Grids (TIMING™) was applied to compare cNK and g-NK cell interaction dynamics and cytotoxicity kinetics at a single-cell level with the human multiple myeloma cell line, LP-1, with or without daratumumab, an anti-CD38 monoclonal antibody (mAb). IDP-023 is currently in clinical trials for the treatment of advanced hematologic cancers (NCT06119685). Ethics Approval All human materials utilized in these studies were obtained through commercial sources which adhere to all relevant ethical and legal requirements."

Hematological Malignancies • Multiple Myeloma • Oncology

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 (SITC 2024) - P1/2 | "Methods This is an open label, Phase 1/2, first-in-human, multiple ascending dose escalation, and dose-expansion study of IDP-023 administered as monotherapy +/- interleukin-2 (IL-2), and in combination with daratumumab or rituximab.; Site Name; IRB Name; IRB Registration No.; IRB Approval Date; 1104; MDACC; MDACC; IRB00000121; 7/14/23 1393; NEXT Virginia; Salus IRB; IRB00006833; 9/19/23 1409; Providence Cancer Institute; Advarra; IRB00000971; 2/14/24 1410; M Health Fairview - University of Minnesota Masonic Cancer| University of Minnesota| IRB00010642; 10/4/23; Center; 1074; Weill Medical College of Cornell University; Advarra; IRB00000971; 11/9/23 1425; SCRI Oncology Partners; Castle IRB; IRB00012054; 7/24/24 1428; Valkyrie Clinical Trials; Advarra; IRB00000971; 7/24/24"

Clinical • Late-breaking abstract • Metastases • P1/2 data • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • FCER1G • HLA-E • IL2 • KLRC1

Indapta Therapeutics Presents Clinical...Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting (Businesswire) - P1/2 | N=128 | NCT06119685 | Sponsor: Indapta Therapeutics, INC. | "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."

P1/2 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Indapta Therapeutics Presents...Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting (Businesswire) - "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; 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."

Preclinical • Breast Cancer • Hematological Malignancies • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology

Indapta Therapeutics Announces FDA Clearance of IND for Phase 1 Trial of IDP-023 for Progressive Multiple Sclerosis (Businesswire) - "Indapta Therapeutics, Inc...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)."

IND • Immunology • Multiple Sclerosis

Indapta Therapeutics to Highlight its g-NK Cell Platform for the Treatment of Cancer and Autoimmune Disease in a Plenary Session at New York Academy of Sciences Frontiers in Cancer Immunotherapy Conference (Businesswire) - "Indapta Therapeutics, Inc...announced that CEO Mark...will be giving a plenary talk today...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...Dr. Frohlich will also describe Indapta’s expanded focus on autoimmune disease, including its plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for a clinical trial of IDP-023 in multiple sclerosis...Indapta is currently applying g-NK cells to hematologic cancers in an ongoing Phase 1 trial enrolling patients....'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...'"

Clinical • IND • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Multiple Sclerosis • Non-Hodgkin’s Lymphoma • Oncology

Indapta Therapeutics Awarded $4.5 Million by CPRIT to Advance Clinical Development of its Allogenic Natural Killer Cell Therapy (Businesswire) - "Indapta Therapeutics, Inc...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."

Financing • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Indapta Therapeutics Receives U.S. FDA Fast Track Designation for Lead Clinical Drug Candidate IDP-023 for Non-Hodgkin’s Lymphoma and Myeloma (Businesswire) - "Indapta Therapeutics...announced that the U.S. FDA has granted Fast Track designation for its lead clinical program, IDP-023, for the treatment of patients with non-Hodgkin’s lymphoma and multiple myeloma....Highly Differentiated Allogeneic Natural Killer Cell Therapy in Phase 1 Trial, with Initial Data Expected in Second Half of 2024."

Fast track designation • P1 data • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Indapta Therapeutics Announces First Patients Treated with IDP-023 Allogeneic Natural Killer (NK) Cell Therapy for Cancer (Businesswire) - "Indapta Therapeutics...today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma. The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia...The first patient received a single dose of IDP-023. The second patient has received the first of three planned doses of IDP-023. Subsequent cohorts of patients will receive three doses of IDP-023 with or without interleukin-2....Indapta also announced that it has successfully manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024."

Commercial • Trial status • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers (clinicaltrials.gov) - P1/2 | N=128 | Recruiting | Sponsor: Indapta Therapeutics, INC.

Combination therapy • Metastases • New P1/2 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer (Businesswire) - "Indapta Therapeutics, Inc., a privately held biotechnology company developing a natural killer (NK) cell therapy platform for the treatment of blood and solid tumor cancers, today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application to commence its first-in-human phase 1 trial in patients with multiple myeloma and lymphoma anticipated to begin in the second half of 2023. The University of Texas MD Anderson Cancer Center will serve as the initial clinical site, where Dr. Krina Patel will lead the study."

FcεRIγ-negative NK cells and association with improved outcomes in trastuzumab-treated patients. (ASCO 2023) - "G-NK cells are associated with improved OS and PFS in trastuzumab-treated patients from both clinical trials and real-world datasets, suggesting their presence may serve as a predictive marker for treatment efficacy. Adoptive transfer of g-NK cells is being explored to augment the efficacy of therapeutic monoclonal antibodies. >Datasets used in analyses: CALGB 40601 trial, C1-2 and C5; Finland Herceptin trial, C3-4 and C6-7; Molecular Taxonomy of Breast Cancer International Consortium, C8; Tempus Labs, RWD1-2."

Clinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • HER-2

Indapta Therapeutics Announces U.S. FDA Clearance of IND for IDP-023, an Allogeneic Natural Killer (NK) Cell Therapy for Cancer (Businesswire) - "Indapta Therapeutics, Inc...announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application to commence its first-in-human phase 1 trial in patients with multiple myeloma and lymphoma anticipated to begin in the second half of 2023....This milestone triggers the second $30 million tranche of its $60M Series A financing raised in January 2022 from its lead investors, Leaps by Bayer, Vertex Ventures, RA Capital, and Pontifax....The study will explore three different dose levels of Indapta’s G-NK cells alone and in combination with interleukin-2 and the monoclonal antibodies, rituximab and daratumumab."

Financing • IND • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology