A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT05181462 / RecruitingPhase 1/2

A Randomized Non-comparative Open-label Phase 1b/2 Study of Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. "TRIFOUR Study"

Triple negative breast cancer (TNBC) represents approximately 15% of all breast cancers (BC) worldwide. The term triple negative means that tumor growth is not stimulated by the hormones estrogen and progesterone, nor by the HER2 protein, so unlike other types of BC, TNBC, which is an aggressive form of BC, does not have specific effective therapies available being the least common form of BC and the most difficult to treat.
Advanced or metastatic TNBC is treated with combinations of platinum-based chemotherapy with taxanes or gemcitabine with a 5-year survival rate of 12%. Recent studies have shown that TNBC expresses Interleukin 1 Receptor Accessory Protein (IL1RAP) at higher levels than other forms of BC.
Nadunolimab is a fully humanized monoclonal antibody that blocks the signals that occur within the cell produced by IL1RAP protein, thereby impairing the cancer cells' ability to secrete tumor stimulating substances, in turn reducing the tumor, inflammation and tumor progression. On the other hand, it is an antibody designed to activate the immune system to fight cancer cells.
This clinical trial is divided into two phases, phase Ib in which it is expected to include up to 15 patients and phase II in which it is expected to include 102 patients. The main purpose of phase Ib is to ensure that the combination of nadunolimab plus chemotherapy (gemcitabine plus carboplatin) is safe and determine the highest dose of nadunolimab that can be given safely without causing serious side effects. If the pre-specified objectives in this part are achieved, the trial will be expanded to a randomized phase II, to evaluate the efficacy of the combination of nadunolimab plus gemcitabine plus carboplatin, compared to a control group that will receive gemcitabine plus carboplatin only.

Start Date11 Jan 2022

Sponsor / Collaborator

Cantargia AB

[+1]

EUCTR2021-001695-42-ES / Unknown statusPhase 1/2

A Phase 1/2 study of CAN04, a fully humanised monoclonal antibody against IL1RAP, in combination with different chemotherapy regimens in subjects with advanced solid tumours

Start Date22 Sep 2021

Sponsor / Collaborator

Cantargia AB

100 Clinical Results associated with Nadunolimab

100 Translational Medicine associated with Nadunolimab

100 Patents (Medical) associated with Nadunolimab

Literatures (Medical) associated with Nadunolimab

01 Mar 2023·Cancer Immunology, Immunotherapy

Blockade of IL-1α and IL-1β signaling by the anti-IL1RAP antibody nadunolimab (CAN04) mediates synergistic anti-tumor efficacy with chemotherapy

Article

Author: Rydberg Millrud, Camilla ; Liberg, David ; Jaensson Gyllenbäck, Elin ; von Wachenfeldt, Karin ; Grönberg, Caitríona ; Deronic, Adnan ; Forsberg, Göran

IL-1α and IL-1β are both involved in several aspects of tumor biology, including tumor initiation, progression, metastasis, and not least in resistance to various therapies. IL-1α can function as an alarmin to signal cellular stress, and acts to induce downstream events, including production of IL-1β, to amplify the signal. Both IL-1α and IL-1β act through the same receptor complex, IL-1R1-IL1RAP, to mediate signal transduction. IL1RAP is expressed on tumor cells and in the tumor microenvironment by for example CAF, macrophages and endothelial cells. The anti-IL1RAP antibody nadunolimab (CAN04) inhibits both IL-1α and IL-1β signaling and induces ADCC of IL1RAP-expressing tumor cells. As both IL-1α and IL-1β mediate chemoresistance, the aim of this study was to explore the potential synergy between nadunolimab and chemotherapy. This was performed using the NSCLC PDX model LU2503 and the syngeneic MC38 model, in addition to in vitro cell line experiments. We show that chemotherapy induces expression and release of IL-1α from tumor cells and production of IL-1β-converting enzyme, ICE, in the tumor stroma. IL-1α is also demonstrated to act on stromal cells to further induce the secretion of IL-1β, an effect disrupted by nadunolimab. Nadunolimab, and its surrogate antibody, synergize with platinum-based as well as non-platinum-based chemotherapy to induce potent anti-tumor effects, while blockade of only IL-1β signaling by anti-IL-1β antibody does not achieve this effect. In conclusion, blockade of IL1RAP with nadunolimab reduces IL-1-induced chemoresistance of tumors.

01 Apr 2022·British Journal of CancerQ1 · MEDICINE

First-in-human phase 1 dose-escalation study of CAN04, a first-in-class interleukin-1 receptor accessory protein (IL1RAP) antibody in patients with solid tumours

Q1 · MEDICINE

Article

Author: Eskens, Ferry ; Spanggaard, Iben ; Awada, Ahmad ; Sorensen, Morten Mau ; Aftimos, Philippe ; Robbrecht, Debbie ; Steeghs, Neeltje ; Liberg, David ; Fretland, Signe Ø ; Guren, Tormod Kyrre ; Thorsson, Lars ; Svedman, Christer ; Jungels, Christiane

BACKGROUNDInterleukin-1 (IL-1) signalling is involved in various protumoural processes including proliferation, immune evasion, metastasis and chemoresistance. CAN04 is a first-in-class monoclonal antibody that binds IL-1 receptor accessory protein (IL1RAP), required for IL-1 signalling. In this first-in-human phase 1 study, we assessed safety, recommended phase 2 dose (RP2D), pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of CAN04 monotherapy.METHODSPatients with advanced solid tumours known to express IL1RAP and refractory to standard treatments were enrolled in a dose-escalation study with 5 dose levels (1.0-10.0 mg/kg) of weekly CAN04.RESULTSTwenty-two patients were enrolled. Most common adverse events were infusion-related reactions (41%), fatigue (32%), constipation (27%), diarrhoea (27%), decreased appetite (23%), nausea (23%) and vomiting (23%). One dose limiting toxicity was reported. No maximum tolerated dose was identified. Pharmacokinetics analyses indicate higher exposures and slower elimination with increasing doses. Decreases in serum IL-6 and CRP were observed in most patients. Twenty-one patients were evaluable for response, 43% had stable disease per immune-related response criteria with no partial/complete responses.CONCLUSIONSThe IL1RAP targeting antibody CAN04 can be safely administered to patients up to 10.0 mg/kg weekly, which was defined as the RP2D. Serum biomarkers supported target engagement and IL-1 pathway inhibition.CLINICAL TRIAL REGISTRATIONNCT03267316.

Clinical Cancer Research

Efficacy and Safety of the Anti-IL1RAP Antibody Nadunolimab (CAN04) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Advanced/Metastatic Pancreatic Cancer

Article

Author: Arnold, Dirk ; Zvirbule, Zanete ; Baltruskeviciene, Edita ; Pfeiffer, Per ; Yachnin, Jeffrey ; Ivanauskas, Audrius ; Rydberg Millrud, Camilla ; Van Cutsem, Eric ; Eefsen, Rikke L. ; Ochsenreither, Sebastian ; Sanfridson, Annika ; Garcia-Ribas, Ignacio ; Awada, Ahmad ; Losic, Nedjad ; Collignon, Joelle ; Tersago, Dominique ; Magnusson, Susanne

AbstractPurpose:IL1 pathway upregulation is implicated in pancreatic ductal adenocarcinoma (PDAC) progression, therapy resistance, and survival. Nadunolimab is an IL1 receptor accessory protein (IL1RAP)–targeting antibody with enhanced antibody-dependent cellular cytotoxicity that blocks IL1α/IL1β signaling. We investigated efficacy and safety of nadunolimab in PDAC, in combination with gemcitabine/nab-paclitaxel (GN).Patients and Methods:Patients with previously untreated locally advanced/metastatic PDAC received nadunolimab (1.0–7.5 mg/kg) every 2 weeks with standard GN. The primary objective was safety; secondary objectives were antitumor response, progression-free survival, and overall survival (OS). Correlations between serum and tumor biomarkers and clinical response were explored.Results:Seventy-six patients were enrolled; the median age was 63 years (range, 43–89), 42% were female, 97% had metastatic disease, and 9% had received adjuvant chemotherapy. The most frequent grade ≥3 adverse event was neutropenia (66%), typically during cycle 1. Infusion-related reactions occurred in 29% (grade 3, 3%). Only 1 of the 76 patients had grade 3 or above peripheral neuropathy. No marked dose-dependent differences in safety or efficacy were observed among the four dose groups. The median OS was 13.2 months (95% confidence interval, 11.0–15.6), and the 1-year survival rate was 58%. The median immune PFS (immune Response Evaluation Criteria in Solid Tumours) was 7.1 months (95% confidence interval, 5.2–7.4). Treatment efficacy was higher in patients with high versus low tumor baseline IL1RAP expression (OS 14.2 vs. 10.6 months; P = 0.012). A reduction in serum IL8 on treatment correlated with prolonged OS.Conclusions:Nadunolimab combined with GN shows promising efficacy and manageable safety in locally advanced/metastatic PDAC. Higher tumor baseline IL1RAP expression correlated with better outcome.

News (Medical) associated with Nadunolimab

11 Nov 2024

·www.prnewswire.com

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

Cell TherapyOrphan DrugFast TrackImmunotherapyPhase 2

28 Aug 2024

·pipelinereview.com

Cantargia reports timelines for nadunolimab clinical trials in leukemia and triple negative breast cancer

August 27, 2024 I Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported currently expected timelines for nadunolimab clinical trials. The US FDA has granted MD Andersson Cancer Center the IND for nadunolimab related to the upcoming phase 1b/2a clinical trial of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an estimate for trial initiation during Q4 2024. The first results on safety and short-term efficacy in the ongoing phase 2 clinical trial in triple negative breast cancer (TNBC), in collaboration with GEICAM, is expected during H1 2025. “The granted IND is an important milestone for the development of nadunolimab in leukemia. The remaining steps, including IRB review, are currently in process before the trial can be initiated” said Göran Forsberg, CEO of Cantargia. “ We are also looking forward to completing the Phase 2 study with nadunolimab in triple negative breast cancer and obtaining the results during H1 2025.” The new phase 1b/2a clinical trial is designed to investigate nadunolimab in up to 20 patients with AML and 20 with MDS. The trial is sponsored by a grant from the US Department of Defense, DOD, to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial. More details on the trial, including estimated timelines will be disclosed once the trial has received full IRB approval, which is expected during Q3 2024, followed by initiation during Q4 2024. Based on the positive phase 1 clinical data previously presented for nadunolimab combination therapy in TNBC, the randomized, controlled phase 2 clinical trial in approximately 100 patients with TNBC is advancing even though recruitment temporarily slowed down during summer. The first results of the trial, including safety and short-term efficacy, are therefore expected during H1 2025. Cantargia will present new clinical results using nadunolimab at the upcoming ESMO conference in Barcelona Sep 13-17, 2024. Details on the presentation will be disclosed when abstracts become public Sep 9, 2024. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia’s oncology program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com . About nadunolimab (CAN04) The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316 , evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462 , also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR, NCT04990037 , and CESTAFOUR, NCT05116891 , and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial, NCT04452214 . SOURCE: Cantargia

Phase 2Clinical ResultPhase 1IND

14 Jun 2024

·www.biospace.com

Cantargia Reports Further Progress in Ongoing Phase 1 Clinical Trial with CAN10

LUND, SE / ACCESSWIRE / June 14, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; NasdaqStockholm:CANTA) today reported progress in the ongoing phase 1 clinical trial of the CAN10 antibody. Seven dose groups have now been concluded without any safety concerns. Furthermore, additional receptor occupancy studies confirm that CAN10 saturates its target molecule, IL1RAP, on immune cells from the study participants. The study follows timelines with the next dose group starting immediately, followed by the first group investigating multiple dosing, planned to start during Q3. "The CAN10 program has passed another important milestone, and the new data strengthen our confidence in the program. With its unique mechanism of action addressing the disease promoting activity of the IL-1 family, CAN10 has huge potential to treat a large number of autoimmune/inflammatory diseases. We look forward to the continued evaluation including upcoming studies in patients," said Göran Forsberg, CEO of Cantargia. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases and has "pipeline in a pill" potential with several possible target indications. The phase 1 clinical trial investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in participants with mild to moderate psoriasis. The primary endpoint relates to safety. Details on the trial can be found at . The first seven dose groups in healthy volunteers have now concluded the treatment period. No safety concerns have been observed and the eighth dose group is about to start in accordance with the protocol. In addition, the important receptor occupancy study continues to follow predictions from preclinical studies and complete target saturation has now been documented on both monocytes and neutrophils. Biomarker samples taken during the study are being analyzed to document a dose dependent inhibition of IL-1 and IL-36 stimulated release of biomarkers from immune cells. Additional biomarker results based on the first seven dose groups are expected mid-2024. Dosing in participants with psoriasis are expected to start Q3 2024 ahead of phase 2 in 2025. This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-06-14 11:05 CEST. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . About CAN10 The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In preclinical in vivo models of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. The CAN10 surrogate also inhibited disease development in models of systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis and peritonitis. A clinical phase I study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Up to 80 subjects may be included in the trial, the first clinical data set shows good safety. Additional data from the trial are expected continuously during 2024. Attachments Cantargia reports further progress in ongoing phase 1 clinical trial with CAN10 SOURCE: Cantargia View the original press release on accesswire.com

Phase 1ADC

100 Deals associated with Nadunolimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 2	DK	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	SE	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	BE	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	EE	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	ES	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	AT	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	NO	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	DE	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	LV	Cantargia AB	19 Sep 2017
Colorectal Cancer	Phase 2	LT	Cantargia AB	19 Sep 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05116891 (CESTAFOUR, Company_Website) Manual	Phase 1/2	Neoplasms \| Non-Small Cell Lung Cancer \| Biliary Tract Neoplasms	-	Nadunolimab in combination with gemcitabine/cisplatin (NSCLC + first arm)	(lwdgeycfsq) = wmtsjudngn kwiqkszbmc (txnfflnwty ) View more	Positive	28 Oct 2024
				Nadunolimab in combination with gemcitabine/cisplatin (biliary tract cancer + first arm)	(lwdgeycfsq) = uyagunhouh kwiqkszbmc (txnfflnwty ) View more
NCT05116891 (CANFOUR, ESMO2024) Manual	Phase 1/2	Non-Small Cell Lung Cancer First line \| Second line	40	Nadunolimab+cisplatin/gemcitabine or carboplatin/pemetrexed	(fijozxpftd) = czejeucbab iclorsbiox (suhjcnusrv ) View more	Positive	14 Sep 2024
				Nadunolimab+cisplatin/gemcitabine or carboplatin/pemetrexed (1L)	(fijozxpftd) = apitnlijnq iclorsbiox (suhjcnusrv ) View more
NCT04452214 (ESMO2024) Manual	Phase 1	Solid tumor \| Squamous Cell Carcinoma of Head and Neck \| Melanoma \| Non-Small Cell Lung Cancer Second line	15	Nadunolimab 5 mg/kg + Pembrolizumab	(crjvpokcbe) = 1(G3 febrile neutropenia) eaxsegsnzm (tzzlptsowp ) View more	Positive	14 Sep 2024
NCT03267316 (CANFOUR, ASCO2024)	Phase 1/2	Pancreatic Cancer	73	Nadunolimab 1 mg/kg	qktcvesdmk(fjlcpxsywh) = zfhuxzqrqh ohdvidckgs (obphwzwuyn ) View more	Positive	24 May 2024
				Nadunolimab 2.5 mg/kg	qktcvesdmk(fjlcpxsywh) = xuddhsecdt ohdvidckgs (obphwzwuyn ) View more
NCT05181462 (TRIFOUR, ESMO2023) Manual	Phase 1/2	Triple Negative Breast Cancer HER2 Negative \| ER Negative \| PR Negative	13	nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 1 mg/kg)	(ounrsehcrs) = aygeymwdqu rzucqnzffz (bfzlnaephy )	Positive	21 Oct 2023
				nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 2.5 mg/kg)	(ounrsehcrs) = vrnbyejwaj rzucqnzffz (bfzlnaephy )
CANFOUR (AACR2023)	Phase 1/2	Pancreatic Ductal Adenocarcinoma	73	Nadunolimab	(griwasdydf) = azsjkthque pczyatjscz (swnjhkgayu, 10.0 - 19.1) View more	-	04 Apr 2023
NCT04452214 (ASCO2022) Manual	Phase 1	Solid tumor	15	Pembrolizumab+Nadunolimab	(prelcpohkf) = mxwfunkdzy phsdfdgxrm (dsctbuusen ) View more	Positive	02 Jun 2022
NCT03267316 (CANFOUR, ASCO2022) Manual	Phase 1/2	Pancreatic adenocarcinoma	76	gemcitabine+nab-paclitaxel+nadunolimab	(oqhqmylkqk) = Infusion-related reactions were reported in 29% (grade 3 in 3%). Peripheral sensory neuropathy was rare (only two grade 2 events). cuduncjwcl (zxmfajliii ) View more	Positive	02 Jun 2022
NCT03267316 (CANFOUR, ASCO2022) Manual	Phase 1/2	Non-Small Cell Lung Cancer	33	gemcitabine+Cisplatin+nadunolimab	(qbtiifulby) = nhwpscwjlq ecbvbcvfwl (xficrdbcmz ) View more	Positive	02 Jun 2022
				gemcitabine+Cisplatin+nadunolimab	(ocldynohgj) = wmqlutxbgk hieisqnzko (ugwoffxdjt )
NCT03267316 (CANFOUR, ESMO2021) Manual	Phase 1/2	Non-Small Cell Lung Cancer \| Pancreatic Cancer	58	Chemotherapy+CAN04 (PDAC)	(yrtrwlqqdz) = G1/2 IRRs were observed in 40% (G3 3%); 61% occurred at the priming dose. xbtjyvwogu (oqchfujfwn ) View more	Positive	16 Sep 2021
				Chemotherapy+CAN04 (NSCLC)

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