A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2

This is a multi-center phase Ib study, which evaluates the safety and efficacy of lacutamab monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma that express KIR3DL2.

开始日期2022-03-17

申办/合作机构

Innate Pharma SA

NCT04984837 / Recruiting临床2期IIT

A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).
The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

开始日期2021-10-05

申办/合作机构

Le LYSARC

[+1]

NCT03902184 / Active, not recruiting临床2期

TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

开始日期2019-05-22

申办/合作机构

Innate Pharma SA

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100 项与拉可妥单抗相关的专利（医药）

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项与拉可妥单抗相关的文献（医药）

2022-09-29·Blood

KIR3DL2 contributes to the typing of acute adult T-cell leukemia and is a potential therapeutic target

Article

作者: Genestier, Laurent ; Bruneau, Julie ; Gaulard, Philippe ; Lhermitte, Ludovic ; Sicard, Hélène ; Pique, Claudine ; Asnafi, Vahid ; Naveau, Louise ; Dussiot, Mickaël ; Bonnafous, Cécile ; Cheminant, Morgane ; Avettand-Fenoel, Véronique ; Lepelletier, Yves ; Waast, Laetitia ; Ortonne, Nicolas ; Palmic, Patricia ; Brouzes, Chantal ; Bourbon, Estelle ; Hermine, Olivier ; Frenzel, Laurent ; Touzart, Aurore ; Bazarbachi, Ali ; Suarez, Felipe ; Marçais, Ambroise

AbstractAdult T-cell leukemia (ATL) is a lymphoid neoplasm caused by human T-cell leukemia virus type 1 (HTLV-1), which encodes the transcriptional activator Tax, which participates in the immortalization of infected T cells. ATL is classified into 4 subtypes: smoldering, chronic, acute, and lymphoma. We determined whether natural killer receptors (NKRs) were expressed in ATL. NKR expression (KIR2DL1/2DS1, KIR2DL2/2DL3/2DS2, KIR3DL2, NKG2A, NKG2C, and NKp46) was assessed in a discovery cohort of 21 ATL, and KIR3DL2 was then assessed in 71 patients with ATL. KIR3DL2 was the only NKR among those studied frequently expressed by acute-type vs lymphoma- and chronic/smoldering-type ATL (36 of 40, 4 of 16, and 1 of 15, respectively; P = .001), although acute- and lymphoma-type ATL had similar mutation profiles by targeted exome sequencing. The correlation of KIR3DL2 expression with promoter demethylation was determined by microarray-based DNA methylation profiling. To explore the role of HTLV-1, KIR3DL2 and TAX messenger RNA (mRNA) expression levels were assessed by PrimeFlow RNA in primary ATL and in CD4+ T cells infected with HTLV-1 in vitro. TAX mRNA and KIR3DL2 protein expressions were correlated on ATL cells. HTLV-1 infection triggered KIR3DL2 by CD4+ cells but Tax alone did not induce KIR3DL2 expression. Ex vivo, autologous, antibody-dependent cell cytotoxicity using lacutamab, a first-in-class anti-KIR3DL2 humanized antibody, selectively killed KIR3DL2+ primary ATL cells ex vivo. To conclude, KIR3DL2 expression is associated with acute-type ATL. Transcription of KIR3DL2 may be triggered by HTLV-1 infection and correlates with hypomethylation of the promoter. The benefit of targeting KIR3DL2 with lacutamab is being further explored in a randomized phase 2 study in peripheral T-cell lymphoma, including ATL (registered on https://clinicaltrials.gov as #NCT04984837).

2022-03-01·La Presse Médicale4区 · 医学

New biotherapies for the treatment of cutaneous T-cell lymphomas

4区 · 医学

Review

作者: de Masson, A

Most cutaneous lymphomas are cutaneous T-cell lymphomas, and the most common form is mycosis fungoides. Sézary syndrome is a leukemic form of cutaneous T-cell lymphoma which is characterized by erythroderma and the presence of blood tumor cells. The only potential cure of cutaneous T-cell lymphomas remains allogeneic stem cell transplantation. However, monoclonal antibodies have led to a substantial progress in the treatment of advanced-stage cutaneous T-cell lymphomas. Some of them, such as mogamulizumab (anti-CCR4 monoclobal antibody) or brentuximab vedotin (anti-CD30 coupled to monomethylauristatin E, antibody drug conjugate) have shown efficacy in international randomized controlled studies. Lacutamab, an anti-KIR3DL2 monoclonal antibody, is currently tested in an international, prospective phase 2 trial in cutaneous T-cell lymphomas and peripheral T-cell lymphomas. Finally, immune checkpoint inhibitors have shown clinical benefit in open-label phase 2 studies in cutaneous T-cell lymphomas. This review focuses on the new biotherapies currently used in cutaneous T-cell lymphomas.

2019-09-02·Expert Opinion on Investigational Drugs2区 · 医学

Investigative drugs for the treatment of cutaneous T-cell lymphomas (CTCL): an update

2区 · 医学

Review

作者: Guenova, Emmanuella ; Ramelyte, Egle ; Dummer, Reinhard

Introduction: Cutaneous T-cell lymphoma (CTCL) is a heterogeneous group of skin-homing T-cell neoplasms, which represent approximately 75% of all primary cutaneous lymphomas. Mycosis fungoides and Sézary syndrome are the most common CTCL. Early stage disease follows a protracted course, carries a 5-year disease specific survival of 97% and can be treated with skin-directed therapies. Widespread, advanced disease has a 5-year OS of less than 25% and necessitates systemic treatment. Allogeneic stem cell transplantation is a potentially curative treatment option for advanced CTCL, however, transplant-related morbidity and mortality must be considered and a risk-benefit assessment performed on individual basis. Areas covered: Herein, we provide a review of investigative drugs in early-stage trials for the treatment of cutaneous CTCL, including topically applied immunomodulators such as replicating herpes virus or toll-like receptor 7/8 agonist resiquimod and systemic therapies with monoclonal antibodies, such as anti-CD47, recombinant cytotoxic interleukin 2 fusion protein anti-KIR3DL2 antibody and anti-miR-155 antibody. Expert Opinion: Among the reviewed drugs, resiquimod shows promising clinical efficacy with good tolerability in early CTCL. In refractory or relapsed disease, intratumoral anti-CD47-, anti-CCR4- and anti-KIR3DL2-antibodies show high response rates, however, latter two also show considerable toxicity. Larger trials are needed to better evaluate the discussed therapies.

项与拉可妥单抗相关的新闻（医药）

2024-11-11

·PRNewswire

NK Cell Therapy Clinical Trial Pipeline Appears Robust With 140+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

NK cell therapy is gaining momentum as a promising solution to unmet medical needs in cancer treatment, offering safer, targeted options for patients unresponsive to traditional therapies. Increased R&D investment, regulatory support, and successful clinical trials have bolstered confidence in these therapies, while technological advances in cell production are set to meet growing demand. Rising cancer rates and heightened public awareness further amplify market potential, making NK cell therapy a pivotal area of growth in oncology. LAS VEGAS, Nov. 11, 2024 /PRNewswire/ -- DelveInsight's ' NK Cell Therapy Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline NK cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the NK cell therapy pipeline domain. Key Takeaways from the NK Cell Therapy Pipeline Report DelveInsight's NK cell therapy pipeline report depicts a robust space with 140+ active players working to develop 160+ pipeline NK cell therapies. Key NK cell therapy companies such as Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others are evaluating new NK cell therapies to improve the treatment landscape. Promising NK cell therapies in the pipeline such as Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others are under different phases of NK cell therapy clinical trials. In October 2024, Immunitybio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). In July 2024, The U.S. Food and Drug Administration (FDA) gave Nkarta the green light to launch a clinical trial testing its cell therapy candidate NKX019 in people with ANCA-associated vasculitis (AAV) and other autoimmune disorders. In May 2024, KGen Biotech announced that its Safety Review Committee had cleared the Company's cryopreserved autologous, expanded, and enhanced SNK01 to progress into Phase II clinical development. In May 2024, Fate Therapeutics announced that a late-breaking abstract featuring preclinical data from its FT522 program for autoimmune diseases will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. In April 2024, Sanofi moved its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial evaluating the drug's use in treating a range of blood cancers. In April 2024, the FDA granted orphan drug designation to the investigational therapy IGNK001 (Gengleucel) for patients with acute myeloid leukemia (AML). In February 2024, Indapta Therapeutics received FDA Fast Track Designation for its natural killer (NK) cell therapy IDP-023 for patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Request a sample and discover the recent advances in the NK cell therapy segment @ NK Cell Therapy Pipeline Report The NK cell therapy pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage NK cell therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the NK cell therapy clinical trial landscape. NK Cell Therapy Overview Natural Killer (NK) cell therapy is an innovative approach in immunotherapy that harnesses the power of NK cells, a vital component of the innate immune system. Unlike T cells, which require prior sensitization to target cancer cells, NK cells can recognize and kill abnormal cells without prior exposure. This unique ability makes NK cell therapy a promising option for treating various cancers, including hematologic malignancies like leukemia and lymphoma, as well as solid tumors. By isolating and activating NK cells from a patient's blood or using engineered NK cells from healthy donors, researchers aim to enhance the immune response against tumors, leading to improved patient outcomes. Recent advancements in genetic engineering, such as the introduction of chimeric antigen receptors (CAR) into NK cells, are further enhancing their specificity and efficacy against cancer cells. The clinical applications of NK cell therapy are expanding rapidly, supported by a growing body of research and early-phase clinical trials. These studies have shown promising results, demonstrating the ability of NK cell therapy to induce durable remissions in patients with refractory cancers. Furthermore, the off-the-shelf nature of certain NK cell therapies allows for quicker treatment deployment compared to traditional CAR-T cell therapies, which require a personalized approach. Challenges remain, including optimizing NK cell expansion, persistence, and overcoming the immunosuppressive tumor microenvironment. However, ongoing research into combination therapies, such as pairing NK cell therapy with checkpoint inhibitors or monoclonal antibodies, is expected to enhance the therapeutic potential of NK cells and provide new hope for cancer patients. Find out more about NK cell therapy @ Novel NK Cell Therapies A snapshot of the Pipeline NK Cell Therapies mentioned in the report: Learn more about the emerging NK cell therapies @ NK Cell Therapy Clinical Trials NK Cell Therapy Therapeutics Assessment The NK cell therapy pipeline report proffers an integral view of the emerging NK cell therapies segmented by stage, product type, molecule type, and route of administration. Scope of the NK Cell Therapy 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: Vaccines, Monoclonal antibody, Peptides, Polymer, Small molecule Key NK Cell Therapy Companies: Amgen, Innate Pharma, Nektar Therapeutics, SMT bio Co., Ltd., Alphageneron Pharmaceuticals, XNK Therapeutics, ImmunityBio, Cellid, Cantargia, Affimed Therapeutics, Takeda, Artiva Biotherapeutics, Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, ImmunityBio, Inc., Allife Medical Science and Technology, Nkarta, Base Therapeutics, GT Biopharma, Athenex, Ambicion, Biohaven Pharmaceuticals, Acepodia, Bright Path Biotherapeutics, Nkarta Therapeutics, Qihan Biotech, Century Therapeutics, Fate Therapeutics, Chimeric Therapeutics, Senti Biosciences, GICELL, Deverra Therapeutics, Medigen Biotechnology Corporation, GlaxoSmithKline, CytoImmune Therapeutics, Nuwacell Biotechnologies Co., Ltd., and others. Key Pipeline NK Cell Therapies: Bemarituzumab, Monalizumab, NKTR-225, SMT-NK, Enkastim, CellProtect, ALT 803, BVAC-C, PD-L1.t-haNK, Nidanilimab, M ceNK, HER2 t-haNK, AFM-13, TAK-007, IPH4102, AB-101, KDS-1001, AB-201, DF9001, INKmune, IPH65, SNK01, IPH6101 (SAR443579), BCMA CAR-NK 92 cells, DF1001, Allogeneic Natural Killer Cell Therapy (oNKord), WU-NK-101, AFM24, CYNK-001, FLYSYN, GDA-201, AGENT-797, CYNK-101, SAR445514, IDP-023, DF6002, CD19.taNK, Anti-PSMA CAR NK cells, DF2001, NKX101, NK510, GTB-3550, KUR-501, RK-pulsed autologous antigen-presenting cells (APCs), BHV-1100, ACE1702, iPS NKT, Anti-CD19/CD22 CAR NK cell therapy, NKX019, KUR-502, BVAC-P, QN-019a, QN-030a, QN-023a, CNTY-101, FT576, CHM 0201, SENTI-202, AFM28, DF8001, FT522, SNK02, GIC-102, DVX201, Magicell®-NK, GSK4381562, CYTO NK-102, NCR300, and others. Dive deep into rich insights for new NK cell therapies, visit @ NK Cell Therapy Drugs Table of Contents For further information on the NK cell therapy pipeline therapeutics, reach out @ NK Cell Therapy Treatment Drugs Related Reports NK Cell Therapy Market NK Cell Therapy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NK cell therapy companies including Sanofi, Dragonfly Therapeutics, INmune Bio, NKGen Biotech, Asclepius Technology Company Group, Glycostem Therapeutics (IPD Therapeutic), Wugen, Celularity, VERAXA, GamidaCell, MiNK Therapeutics, Indapta Therapeutics, among others. Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , 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

细胞疗法孤儿药快速通道免疫疗法临床2期

2024-11-08

·Business Wire

Innate Pharma Highlights Data From Its Innovative Oncology Portfolio Selected for the SITC Annual Meeting 2024

MARSEILLE, France--( BUSINESS WIRE )--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that new preclinical data supporting the clinical development of its proprietary next generation antibody-drug conjugate ( ADC) and innovative tetra-specific ANKET ® will be presented at the SITC Annual Meeting 2024. “We are thrilled to share our latest preclinical data at the SITC Annual Meeting, highlighting the potential of IPH6501, our tetra-specific NK cell engager and IPH4502, our innovative ADC targeting Nectin-4. These findings underscore our commitment to advancing next-generation immunotherapies and reflect significant progress in the development of our drug candidates. We look forward to engaging with the scientific community as we continue to push the boundaries of next generation immunotherapies,” commented Pr. Eric Vivier, Chief Scientific Officer of Innate Pharma. Details of the presentations Society for Immunotherapy of Cancer (SITC) 39 th Annual Meeting | 6-10 November, Houston, Texas and Virtual Harnessing NK Cells in Cancer Therapies Session 107d: NK Cells and Innate Immunity Presentation Type: Oral Presentation Session Date and Time: Friday, Nov. 8, 2024, 3:50-5:25pm CST Presentation Time: 4:35pm CST Speaker: Eric Vivier, Chief Scientific Officer, Innate Pharma (co-chair of the session) Preclinical Characterization of IPH6501: A Novel IL2v-Armed Tetraspecific NK Cell Engager Targeting CD20 in Relapsed or Refractory B cell Non-Hodgkin Lymphoma Subtypes and Post-CAR-T Therapy. Abstract Number: 1083 Presentation Type: Poster Presentation Primary Category: Immuno-Conjugates and Chimeric Molecules Poster Presentation Day : Friday, Nov. 8, 2024 IPH45, a next-generation antibody-drug conjugate (ADC) targeting Nectin-4 Abstract Number: 1056 Presentation Type: Poster Presentation Primary Category: Immuno-Conjugates and Chimeric Molecules Poster Presentation Day: Saturday, Nov. 9, 2024 More information can be found on the JITC website . Protein & Antibody Engineering Summit (PEGS) Europe | November 5-7, Barcelona, Spain and virtual In addition, the presentation entitled « A Next-Generation ADC for Nectin-4 Expressing Tumours: Preclinical Characterisation of IPH45, a Novel and Differentiated Exatecan-Based ADC Targeting Nectin-4 » was presented at the PEGS Europe Summit. The presentation is available on the Company website, in the publications section . About IPH4502 IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. In non-clinical models, IPH4502 is well tolerated and shows anti-tumor efficacy in vitro and in vivo . In September 2024, the U.S Food and Drug Administration cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications. About IPH6501 IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not a subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023). IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC). Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, several ANKET ® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X . Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

免疫疗法临床申请

2024-09-23

·PipelineReview

Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors

MARSEILLE, France I September 23, 2024 I Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502, its novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. Innate expects to initiate the Phase 1 study in the coming months. The Phase 1, open-label, multi-center study, includes a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers. “ We are thrilled to advance the IPH4502 program, and the IND application acceptance is an important milestone for Innate, as this is our first ADC program to enter the clinic ,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma . “ IPH4502 is a novel and differentiated Nectin-4 ADC that has the potential to provide a new therapeutic option for patients with a cancer expressing a wide range of Nectin-4. Through this Phase 1 study we aim to advance the research on our ADC technology for the benefit of patients. ” About IPH4502 IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4. Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. In non-clinical models, IPH45 was well tolerated and shows anti-tumor efficacy in vitro and in vivo . About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET ® ( A ntibody-based NK cell E ngager T herapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on Twitter and LinkedIn . SOURCE: Innate Pharma

免疫疗法临床申请临床1期

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15322

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
外周T细胞淋巴瘤	临床2期	德国	Innate Pharma SA	2021-10-05
外周T细胞淋巴瘤	临床2期	西班牙	Innate Pharma SA	2021-10-05
塞扎里综合征	临床2期	比利时	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	波兰	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	美国	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	奥地利	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	法国	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	德国	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	意大利	Innate Pharma SA	2019-05-22
塞扎里综合征	临床2期	西班牙	Innate Pharma SA	2019-05-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03902184 (TELLOMAK, ASCO2024) 人工标引	临床2期	蕈样真菌病	107	Lacutamab 750 mg	(繭範獵積繭糧餘廠醖憲) = 醖觸積鏇構鏇膚夢鏇淵鹽網遞遞願遞齋鏇鬱積 (範選顧鏇齋遞築糧簾選, 10.9 ~ 25.0) 更多	积极	2024-05-24
NCT03902184 (TELLOMAK, ASCO2024) 人工标引	临床2期	蕈样真菌病	107	Lacutamab 750 mg (KIR3DL2 ≥1%)	(繭範獵積繭糧餘廠醖憲) = 艱簾獵鬱憲遞鹽窪鹽艱鹽網遞遞願遞齋鏇鬱積 (範選顧鏇齋遞築糧簾選, 11.7 ~ 34.3) 更多	积极	2024-05-24
NCT03902184 (Tellomak Phase 2 Trial, ASH2023)	临床2期	塞扎里综合征	56	Lacutamab 750 mg	(鑰築願壓鹽膚艱鬱餘淵) = 窪獵繭廠廠願壓構遞衊繭遞製顧鹹製獵廠願夢 (襯觸顧築簾醖蓋築鏇齋, 26.0 ~ 50.6) 更多	-	2023-12-09
NCT03902184 (TELLOMAK, ICML2023)	临床2期	蕈样真菌病 KIR3DL2	39	Lacutamab	遞鬱壓積觸鹹範鹽醖願(淵夢餘鑰齋製製廠築簾) = 鬱淵餘衊窪願壓願淵簾壓膚餘壓壓廠鏇壓廠糧 (廠齋廠遞遞襯鏇積繭製, 24.5 ~ 63.5)	积极	2023-06-09
NCT03902184 (Tellomak, ASH2022) 人工标引	临床2期	塞扎里综合征	37	lacutamab	(糧糧廠繭糧願顧網網獵) = 憲製網製範遞鬱衊壓襯鹽窪壓範淵衊繭觸艱艱 (觸齋願遞壓構糧鏇衊範, 11.4 ~ 37.2) 更多	积极	2022-11-15
NCT03902184 (TELLOMAK, Corporate Publications) 人工标引	临床2期	蕈样真菌病	36	Lacutamab (KIR3DL2-expressing cohort)	(築簾範觸蓋選淵繭網網) = 1 CR，10 PR 壓夢範獵餘鹹鬱艱壓齋 (壓蓋鏇膚積繭觸醖願鹽 ) 更多	积极	2021-06-22
NCT03902184 (TELLOMAK, Corporate Publications) 人工标引	临床2期	蕈样真菌病	36	Lacutamab	(築簾範觸蓋選淵繭網網) = 1 CR，10 PR 壓夢範獵餘鹹鬱艱壓齋 (壓蓋鏇膚積繭觸醖願鹽 ) 更多	积极	2021-06-22
TELLOMAK (ICML2021)	临床2期	蕈样真菌病 KIR3DL2 expressing	24	Lacutamab 750 mg	(蓋範艱願鹹衊網築襯構) = 艱醖願願構觸壓獵膚製艱鑰壓鏇淵選範鬱淵窪 (淵餘製鹽網築餘範鏇遞 ) 更多	积极	2021-06-17
TELLOMAK (ICML2021)	临床2期	蕈样真菌病 KIR3DL2 expressing	24	Placebo	(選鹹製鑰餘製製醖簾壓) = 窪壓鹹廠醖廠糧鬱鹽憲鏇夢選網遞鏇艱製糧壓 (範鹹範蓋窪鏇憲夢糧壓 )	积极	2021-06-17
NCT02593045 (Pubmed \| Lancet Oncol) 人工标引	临床1期	皮肤T细胞淋巴瘤	44	IPH4102	(築醖醖餘選餘遞憲憲壓) = 淵鹽簾顧鬱糧鹹壓網憲構齋醖積築憲鹹構網繭 (壓襯艱鹹獵獵簾餘糧襯 ) 更多	积极	2019-08-01
TELLOMAK (ICML2019)	临床2期	T细胞淋巴瘤 KIR3DL2	-	IPH4102 alone	(製鹹窪窪衊築網鑰鬱窪) = 夢鬱製膚衊鏇築繭衊衊廠遞襯製餘鬱鑰衊觸齋 (顧鹹廠網艱蓋繭夢遞網 ) 更多	积极	2019-06-12
NCT02593045 (Phase I Study of IPH4102, ICML2017)	临床1期	皮肤T细胞淋巴瘤 KIR3DL2 expression \| minimal residual disease	22	IPH4102	(獵艱夢鹽廠鹽齋積襯窪) = 鬱鏇廠壓蓋鬱廠選醖衊齋餘願繭鏇襯願製艱艱 (醖積憲鹹鬱積鏇壓衊壓 ) 更多	积极	2017-06-07