A Phase I (First-in-human) Randomized, Double-blind, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CAN10, an Anti-IL1RAP Monoclonal Antibody, in Healthy Subjects and in Subjects With Mild to Moderate Plaque Psoriasis.

This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. In the first part of the study, the single ascending dose (SAD) cohorts, CAN10 will be given as a single intravenous dose to healthy subjects. In the second part of the study, the multiple ascending dose (MAD) cohorts, CAN10 will be given as repeated subcutaneous doses to participants with mild to moderate plaque psoriasis.

Start Date21 Aug 2023

Sponsor / Collaborator

Cantargia AB

100 Clinical Results associated with CAN-10

100 Translational Medicine associated with CAN-10

100 Patents (Medical) associated with CAN-10

Literatures (Medical) associated with CAN-10

01 Sep 2024·Annals of the Rheumatic Diseases

Combined inhibition of IL-1, IL-33 and IL-36 signalling by targeting IL1RAP ameliorates skin and lung fibrosis in preclinical models of systemic sclerosis

Article

Author: Kreuter, Alexander ; Zhu, Honglin ; Tran-Manh, Cuong ; Grönberg, Caitríona ; Distler, Jörg Hw ; Kunz, Meik ; Li, Yi-Nan ; Dickel, Nicholas ; Györfi, Andrea-Hermina ; Liberg, David ; Zhou, Xiang ; Rattik, Sara ; Matei, Emil-Alexandru ; Rius Rigau, Aleix ; Skoog, Petter ; Trinh-Minh, Thuong

BackgroundThe interleukin (IL)-1 receptor accessory protein (IL1RAP) is an essential coreceptor required for signalling through the IL-1, IL-33 and IL-36 receptors. Here, we investigate the antifibrotic potential of the combined inhibition of these cytokines by an anti-IL1RAP antibody to provide a scientific background for clinical development in systemic sclerosis (SSc).MethodsThe expression of IL1RAP-associated signalling molecules was determined by data mining of publicly available RNA sequencing (RNAseq) data as well as by imaging mass cytometry. The efficacy of therapeutic dosing of anti-IL1RAP antibodies was determined in three complementary mouse models: sclerodermatous chronic graft-versus-host disease (cGvHD), bleomycin-induced dermal fibrosis model and topoisomerase-I (topo)-induced fibrosis.ResultsSSc skin showed upregulation of IL1RAP and IL1RAP-related signalling molecules on mRNA and protein level compared with normal skin. IL-1, IL-33 and IL-36 all regulate distinct gene sets related to different pathophysiological processes in SSc. The responses of human fibroblasts and endothelial cells to IL-1, IL-33 and IL-36 were completely blocked by treatment with an anti-IL1RAP antibody in vitro. Moreover, anti-IL1RAP antibody treatment reduced dermal and pulmonary fibrosis in cGvHD-induced, bleomycin-induced and topoisomerase-induced fibrosis. Importantly, RNAseq analyses revealed effects of IL1RAP inhibition on multiple processes related to inflammation and fibrosis that are also deregulated in human SSc skin.ConclusionThis study provides the first evidence for the therapeutic benefits of targeting IL1RAP in SSc. Our findings have high translational potential as the anti-IL1RAP antibody CAN10 has recently entered a phase one clinical trial.

01 May 2024·Cell Reports

Antibodies targeting the shared cytokine receptor IL-1 receptor accessory protein invoke distinct mechanisms to block all cytokine signaling

Article

Author: Gyllenbäck, Elin Jaensson ; Obi, Juliet ; Sjöström, Kjell ; Kihn, Kyle ; Fields, James K ; Grönberg, Caitríona ; Birkedal, Gabriel Svensson ; Flowers, Maria ; Maravillas, Kino ; Huyhn, Chau ; Bogacz, Marek ; Rattik, Sara ; Fioretos, Thoas ; Deredge, Daniel ; Smith, Ally K ; Hansen, Nils ; Liberg, David ; Sundberg, Eric J

Interleukin-1 (IL-1)-family cytokines are potent modulators of inflammation, coordinating a vast array of immunological responses across innate and adaptive immune systems. Dysregulated IL-1-family cytokine signaling, however, is involved in a multitude of adverse health effects, such as chronic inflammatory conditions, autoimmune diseases, and cancer. Within the IL-1 family of cytokines, six-IL-1α, IL-1β, IL-33, IL-36α, IL-36β, and IL-36γ-require the IL-1 receptor accessory protein (IL-1RAcP) as their shared co-receptor. Common features of cytokine signaling include redundancy of signaling pathways, sharing of cytokines and receptors, pleiotropy of the cytokines themselves, and multifaceted immune responses. Accordingly, targeting multiple cytokines simultaneously is an emerging therapeutic strategy and can provide advantages over targeting a single cytokine pathway. Here, we show that two monoclonal antibodies, CAN10 and 3G5, which target IL-1RAcP for broad blockade of all associated cytokines, do so through distinct mechanisms and provide therapeutic opportunities for the treatment of inflammatory diseases.

News (Medical) associated with CAN-10

18 Dec 2024

·www.accesswire.com

Cantargia Publishes Strong Preclinical Effects and Clinical Monotherapy Results on Nadunolimab in Pancreatic Cancer in Journal for Immunotherapy of Cancer

LUND, SE / ACCESSWIRE / December 18, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced the publication of preclinical and clinical results using the IL1RAP targeted antibody nadunolimab (CAN04) in pancreatic cancer (PDAC). Nadunolimab had pronounced effects on PDAC associated fibroblasts and inhibited recruitment of tumor promoting immune cells. These results were linked to monotherapy data in late-stage metastatic PDAC patients showing both clinically meaningful progression free survival and survival in patients with high IL1RAP levels. The studies were performed as a collaboration between Cantargia, Lund University and PanCAN."Nadunolimab's unique mechanism of action is highly relevant for treatment of pancreatic cancer. This important publication in an impactful scientific journal confirms its significance to the medical community" said Göran Forsberg, CEO of Cantargia.PDAC is one of the cancer forms with the highest medical need. The incidence is increasing, and the survival is poor. A major clinical challenge in PDAC is its distinct and protective tumor microenvironment (TME), which shields the tumor from the immune system and facilitates tumor growth, metastasis, and resistance to therapy. The crosstalk between cancer cells and cancer-associated fibroblasts (CAFs) plays a pivotal role in shaping this TME.The IL-1 family, through IL1RAP, helps activate CAFs, which attract myeloid immune cells like monocytes and neutrophils into the tumor. This study reveals that nadunolimab blocks this process by inhibiting IL1RAP, reducing the number of immune cells recruited, which weakens the tumor's defenses. Through its other mechanism of action (ADCC), nadunolimab enhances tumor destruction.The relevance of these preclinical results could be linked to clinical results using nadunolimab monotherapy in the CANFOUR study. In late stage metastatic PDAC patients, high tumor baseline levels of IL1RAP strongly correlate with increased progression free survival (IL1RAP high vs low: 3.5 vs 1.2 months; p=0.0023) and a trend for survival advantage (5.0 vs 2.2 months) with a follow up of 11.5 months. This is in line with previous published results examining nadunolimab with chemotherapies, gemcitabine and nab-paclitaxel, which showed promising efficacy in first line IL1RAP-high PDAC patients.These findings strongly signify the clinical relevance of targeting IL1RAP in PDAC using nadunolimab. This is particularly noteworthy since IL1RAP is considered as a prognostic marker where high IL1RAP expression is linked to shorter survival in PDAC patients."This study reveals how PDAC tumor cells and cancer-associated fibroblasts drive the immunosuppressive microenvironment through IL-1 signaling. It highlights IL1RAP targeting as a promising therapeutic approach for pancreatic cancer patients" said Dr Marcus Järås, corresponding author and Cantargia co-founder, from Lund University.This study used data from the Pancreatic Cancer Action Network's (PanCAN) Know Your Tumor® precision medicine program as a validation dataset, accessed through the PanCAN SPARK health data platform. This dataset was used to study the impact of IL1RAP expression in PDAC and revealed IL1RAP as a prognostic marker."These results underscore the importance of biomarker testing that allows patients to learn about the genetic makeup of their tumor and allow researchers access to treatment and outcomes data. Ongoing research using real-world datasets like from the Know Your Tumor program in the PanCAN SPARK platform brings researchers one step closer to better treatments and improved outcomes for patient with pancreatic cancer," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN.The article, titled "Blocking IL1RAP on cancer associated fibroblasts in pancreatic ductal adenocarcinoma suppresses IL-1 induced neutrophil recruitment", by Hansen et al., is available via Journal for Immunotherapy of Cancer website: https://jitc.bmj.com/ and at Cantargia's website https://cantargia.com. This publication is based on results that, in part, have been presented at scientific conferences during 2022 and 2023.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia 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 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 hidradenitis suppurativa and systemic sclerosis.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-1α and IL-1β 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 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 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; 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.AttachmentsCantargia publishes strong preclinical effects and clinical monotherapy results on nadunolimab in pancreatic cancer in Journal for Immunotherapy of CancerSOURCE: CantargiaRelated Documents:

Clinical ResultImmunotherapy

11 Dec 2024

·www.accesswire.com

Cantargia and GEICAM Present Updated Phase 1 Clinical Data and New Translational Results on Nadunolimab Treatment in Advanced Triple Negative Breast Cancer at San Antonio Breast Cancer Symposium

LUND, SWEDEN / ACCESSWIRE / December 11, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm:CANTA) today reported updated results from the phase 1b study in 15 advanced triple negative breast cancer (aTNBC) patients treated with nadunolimab combined with platinum-based chemotherapy. The results confirm previous positive findings on safety, and promising antitumor activity. The clinical results along with new biomarker studies will be presented in a poster session at the upcoming San Antonio Breast Cancer Symposium (SABCS), 2024."Besides the strong clinical results already reported in pancreatic and lung cancers, we are excited to present these data in triple negative breast cancer. The presentation includes value-adding information around nadunolimab and its potential effects on the immune system's ability to counteract cancer progression," said Göran Forsberg, CEO of Cantargia.The TRIFOUR phase 1b part evaluated nadunolimab at 1 mg/kg (n=3) and 2.5 mg/kg (n=12) combined with gemcitabine and carboplatin (GC) in 15 previously treated aTNBC patients. Initial results were presented in 2023, and the updated results confirm an acceptable safety profile with a promising efficacy of 60% response rate, 6.2 months progression-free survival (PFS), and 12.8 months overall survival (OS).Analysis of patient samples was performed to identify features connected to nadunolimab/GC treatment. A significant reduction in the neutrophil to lymphocyte ratio (NLR) and C-reactive protein (CRP) was detected, both related to the nadunolimab mode of action. Additionally, a significant decrease in IL-8 levels was associated with a trend towards longer OS. These findings suggest that nadunolimab exerts beneficial effects on immune cells involved in tumor-promoting inflammation.Using a larger, separate set of pre-treatment tumor biopsies and blood samples, a characterization of IL1RAP expression was also performed. This analysis showed IL1RAP expression on tumor, stromal and tumor-infiltrating immune cells. Detailed analysis of circulating cells showed IL1RAP expression on myeloid cells, including myeloid-derived suppressor cells highlighting the relevance of IL1RAP as a promising target in aTNBC.The trial is currently enrolling patients for the randomized phase 2 part at the 2.5 mg/kg dose of nadunolimab with GC vs. only GC. Initial results for this part of the study are expected late H1 2025.The study is done in collaboration with GEICAM (Spanish Breast Cancer Research Group) and will be presented in a poster session at the 47th annual San Antonio Breast Cancer symposium (SABCS), Dec 10-13, 2024.More information on the poster session is found below:Poster number: SESS-3615Poster title: Updated safety, efficacy and emerging biomarker data from the Phase Ib part of a Phase Ib/II clinical study of nadunolimab in combination with gemcitabine and carboplatin in patients with advanced triple negative breast cancer (TRIFOUR study)Session date and time: December 11, 2024 (12:30 - 2:00 PM CST)The poster will be presented at the SABCS, 2024 in San-Antonio, Texas on Dec 11 from 12:30 - 2:00 PM local time by Dr Marta Santisteban Eslava, member of the GEICAM working group for triple negative disease, and one of the Chief Investigators of the TRIFOUR study. The poster related to the presentation will be uploaded on Cantargia's webpage www.cantargia.com.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia 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 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 hidradenitis suppurativa and systemic sclerosis.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-1α and IL-1β 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 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 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; 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.About GEICAMGEICAM is the leader group in breast cancer research in Spain with a recognized worldwide prestige. It is formed by more than 900 experts, who work in 200 institutions throughout Spain.Since its establishment in 1995 until now GEICAM has performed more than a hundred of studies in which almost 68,000 women and men have participated.It has a large multidisciplinary team specialized in the management of clinical trials and other studies, which collaborates with clinical researchers in the design and implementation of clinical trials, as well as in their execution and dissemination in forums and high-impact scientific journals.For more information, you can visit the official website http://www.geicam.org or follow GEICAM on Twitter @GEICAM, @GEICAMujer, and on Facebook.com/GEICAM.AttachmentsCantargia and GEICAM present updated phase 1 clinical data and new translational results on nadunolimab treatment in advanced triple negative breast cancer at San Antonio Breast Cancer SymposiumSOURCE: Cantargia

Phase 1Clinical ResultPhase 2

02 Dec 2024

·www.accesswire.com

Extraordinary General Meeting in Cantargia AB (publ)

LUND, SE / ACCESSWIRE / December 02, 2024 / Cantargia (STO:CANTA) Cantargia's extraordinary general meeting on December 2, 2024, resolved to approve the board's resolution from November 6, 2024 to increase the company's share capital through the issuance of new shares with pre-emptive rights for the company's shareholders. Subscription may also be made without pre-emptive rights, as set forth in the complete issue resolution.Through the rights issue, Cantargia's share capital will increase with not more than SEK 7,347,467.36, through the issue of not more than 91,843,342 new shares.The record date for the right to participate in the rights issue is December 4, 2024. Two existing shares held on the record date, entitle to subscription for one new share. The subscription price is SEK 1.85 per share.For further details and information about the background and reasons for the rights issue, see Cantargia's press release on November 6, 2024.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia 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 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 hidradenitis suppurativa and systemic sclerosis.Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com .AttachmentsExtraordinary general meeting in Cantargia AB (publ)SOURCE: Cantargia

ADC

100 Deals associated with CAN-10

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 1	Germany	Cantargia AB	21 Aug 2023
Hidradenitis Suppurativa	Phase 1	Sweden	Cantargia AB	-
Scleroderma, Systemic	Phase 1	Sweden	Cantargia AB	-
Atherosclerosis	Preclinical	United States	Cantargia AB	02 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06143371 (Biospace) Manual	Phase 1	Plaque psoriasis	-	CAN10	(xbveluzjyk) = No safety concerns have been observed and the eighth dose group is about to start in accordance with the protocol. ukpogzoghe (srntcvymlv )	Positive	14 Jun 2024
NCT06143371 (Biospace) Manual	Phase 1	Scleroderma, Systemic	-	CAN10	(cprtbsfcwd) = the first clinical data set shows good safety fdrgipxesu (bxpbwrgbrw ) View more	Positive	14 Mar 2024

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