An Exploartory Trial of IMPT-514, An Autologous Anti-CD19/20 CAR T Therapy in Participants With Active, Refractory Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy

This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).

Start Date13 Jun 2024

Sponsor / Collaborator

Nanjing Drum Tower Hospital

NCT06153095 / RecruitingPhase 1/2

A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus.
IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year.
Participants will continue in long-term follow-up for 15 years from treatment.

Start Date15 Feb 2024

Sponsor / Collaborator

ImmPACT Bio USA, Inc.Startup

100 Clinical Results associated with IMPT-514

100 Translational Medicine associated with IMPT-514

100 Patents (Medical) associated with IMPT-514

News (Medical) associated with IMPT-514

03 Dec 2024

·www.prnewswire.com

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IND

21 Aug 2024

·www.prnewswire.com

ImmPACT Bio Announces FDA Clearance of IND Application for CD19/CD20 Bispecific CAR-T Cell Therapy in Multiple Sclerosis

IMPT-514 is the first-and-only known CD19/CD20 CAR T-cell therapy in development for multiple sclerosis Dual CD19/CD20 targeting is designed to enable broad depletion of pathogenic autoimmune cells Initiation of Phase 1 dose exploration trial expected first half of 2025 LOS ANGELES, Aug. 21, 2024 /PRNewswire/ -- ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, today announced the United States Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS). ImmPACT Bio expects to initiate a Phase 1 dose escalation trial that will focus on patients who have suboptimal disease control despite prior treatment with high efficacy disease-modifying therapies in all forms of MS, with the intent to slow or stop the progression of disability accumulation. IMPT-514 is the only known CD19/CD20 CAR T-cell therapy in development for the treatment of MS. "IND clearance for our bispecific CAR T-cell therapy in MS marks an exciting achievement that further expands clinical development of our autoimmune program," said Sumant Ramachandra, M.D., Ph.D., chief executive officer of ImmPACT Bio. "As an intended one-time treatment, IMPT-514 has the potential to reset the immune system by depleting a broad range of autoreactive immune cells implicated in the pathogenesis of MS in patients. We expect to dose the first patient in the first half of 2025." Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio stated, "The dual-targeting nature of IMPT-514 offers a unique opportunity to potentially ablate autoreactive B cells and the likely pathogenic CD20-expressing T-cells. Moreover, the ability of CAR T-cells to cross the blood brain barrier (BBB) could potentially overcome the limitations of current disease-modifying therapies such as anti-CD20 antibodies that are not effective at crossing the BBB, where potentially pathogenic cells reside. We are pleased to receive IND clearance and further evaluate the therapeutic potential of IMPT-514 to deliver long-lasting protection against MS." About IMPT-514 IMPT-514 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT's IMPT-314, which is under development for certain types of non-Hodgkin's lymphoma and manufactured using the same process. In preclinical studies, IMPT-514 was successfully and efficiently manufactured from heavily immunosuppressed patients across multiple autoimmune disease and showed potent elimination of autologous B-cells and a moderate cytokine profile. About ImmPACT Bio ImmPACT Bio USA, Inc., is a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients. The company's logic-gate-based chimeric antigen receptor (CAR) T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to address antigen escape, reduce toxicity, overcome immunosuppression in the tumor microenvironment, and improve cell persistence. The company's technology is based on the work of pioneering scientists, Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. For more information, visit . SOURCE ImmPACT Bio USA Inc.

INDCell TherapyImmunotherapy

21 May 2024

·www.prnewswire.com

ImmPACT Bio to Present New Preclinical Data for CD19/CD20 Bispecific CAR-T Cell Therapy in Multiple Sclerosis

IMPT-514's dual CAR approach is designed to ablate B-cells and pathogenic CD20+ T cells for potential therapeutic benefit in MS LOS ANGELES, May 21, 2024 /PRNewswire/ -- ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, today announced that it will present new preclinical data supporting the potential therapeutic benefit of IMPT-514 for the treatment of multiple sclerosis (MS). IMPT-514 is ImmPACT Bio's CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy product candidate. These new data will be delivered in a poster presentation at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, taking place in Nashville, Tennessee from May 28 – June 1, 2024. "Multiple sclerosis is a chronic autoimmune disorder which affects the central nervous system (CNS) that is driven by autoreactive immune cells. B-cell depletion using an anti-CD20 approach has demonstrated clinical benefit, but poor tissue penetration has limited activity in the CNS," said Sumant Ramachandra, M.D., Ph.D., chief executive officer of ImmPACT Bio. "Recently, a subset of CD20-expressing T-cells was identified as a contributor to the pathogenesis of MS. Here, we are exploring the potential of our CAR T-cell therapy product candidate, IMPT-514, and its unique dual-targeting CAR design to ablate multiple potentially pathogenic autoimmune subsets including antibody secreting B-cells and CD20+ T-cells for potential therapeutic benefit in MS. To our knowledge, IMPT-514 is the first-and-only CD19/CD20 CAR T-cell therapy in autoimmune diseases." Details for the presentation are as follows: Title: Manufacturing of CD19/CD20 Bispecific CAR T-Cell Therapy (IMPT-514) for the Treatment of Multiple Sclerosis Abstract Number: LB04 Presenter: Ethan BenDavid, ImmPACT Bio Poster Session Date/Time: Thursday, May 30, 2024 at 5:15 – 7:15 PM ET Location: Music City Center, Exhibit Hall AB Abstracts and additional details can be found at the CMSC Annual Meeting website. About IMPT-514 IMPT-514 is a CD19/CD20-targeting CAR T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT's IMPT-314, which is under development for aggressive B-cell non-Hodgkin's lymphoma. In preclinical studies, we have shown that we can routinely manufacture, at research scale, IMPT-514 from patients across multiple autoimmune diseases who were heavily treated with immunosuppressive agents and demonstrated elimination of autologous B-cells and a moderate cytokine profile. About ImmPACT Bio ImmPACT Bio USA, Inc., is a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists, Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. For more information, visit . SOURCE ImmPACT Bio USA Inc.

Cell TherapyImmunotherapyAACR

100 Deals associated with IMPT-514

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 2	US	ImmPACT Bio USA, Inc.Startup	15 Feb 2024
Lupus Nephritis	Phase 2	AU	ImmPACT Bio USA, Inc.Startup	15 Feb 2024
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	Phase 1	US	ImmPACT Bio USA, Inc.Startup	-
Idiopathic Inflammatory Myopathies	Phase 1	US	ImmPACT Bio USA, Inc.Startup	-
Multiple Sclerosis	Phase 1	US	ImmPACT Bio USA, Inc.Startup	-

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