CAN10 / Cantargia - LARVOL DELTA

Cantargia reports promising CAN10 phase 1 data from first multiple dose cohort, and FDA and Key Opinion Leader feedback (Cantargia Press Release) - P1| N=80 | NCT06143371 | Sponsor: Cantargia AB | "Cantargia...today reported promising pharmacokinetic (PK) data from the first group of subjects receiving multiple dosing (MAD) subcutaneously (sc) in the phase 1 clinical study with CAN10. These data align with data from the single dose phase of the study, further supporting potential 4-weekly dosing. Additionally, feedback from the FDA, through a pre-IND meeting, has been received supporting our proposed phase 2 HS study design...The FDA feedback and SAB endorsement encourage us as we move towards our planned phase 2 study in HS towards the end of this year....Pharmacokinetic results for the 10 SAD cohorts suggest dose proportionality at clinically relevant dose levels. Observed exposures from the SAD cohorts together with modelling results suggest that 4-weekly dosing is feasible....The IND submission is on track for H2 2025."

IND • New P2 trial • P1 data • Hidradenitis Suppurativa

Cantargia Expands the CAN10 Phase 1 Clinical Program Building on Positive Results (ACCESSWIRE) - "Cantargia...reported initiation of an expanded part of CAN10's phase 1 clinical study to investigate higher dose levels of the antibody. The purpose of this expansion is to build on the good safety, potent effects on biomarkers and pharmacokinetic properties of CAN10. Current data indicate durable effects and potential for treatment every 4th week, which will be a competitive advantage. The first participant in this program has now been dosed....The plan is to perform these activities during the upcoming months in line with the plan to start phase 2 during H2 2025."

New P2 trial • P1 data • Immunology • Psoriasis

Cantargia reports new positive results on biomarkers and safety in CAN10 phase 1 clinical study (Cantargia Press Release) - P1| N=80 | NCT06143371 | Sponsor: Cantargia AB | "Cantargia...announced new results from the CAN10 phase 1 clinical study. All nine groups, including 68 participants receiving a single dose of CAN10 or placebo, show good safety and promising biomarker results. Importantly, even 1 week after the infusion, a single dose of CAN10 can completely block IL-1 signaling in the blood of the participants. Thereby, combined with the previous confirmation of complete blockade of IL-36 stimulation, key endpoints have been reached. Thus, the phase 1 single dose study strongly validates the potential and the unique mode of action of CAN10. The second part of the trial investigating multiple dosing is ongoing....The first phase 2 clinical study is planned to start in H2 2025 to investigate CAN10 therapy in e.g. hidradenitis suppurativa or systemic sclerosis."

New P2 trial • P1 data • Trial status • Hidradenitis Suppurativa • Immunology • Psoriasis • Systemic Sclerosis

Combined blockade of IL-1, IL-33 and IL-36 signaling by targeting IL1RAP to treat inflammatory skin diseases (EADV 2024) - "Daily topical administration of imiquimod was used to induce experimental psoriasis in Balb/c mice and an injection of mannan (Saccharomyces cerevisiae) in B6N.Q.Ncf1m1j/m1j mice was used to induce experimental psoriatic arthritis. Taken together, these results suggest that IL1RAP is a central signaling node for the IL-1, IL-33 and IL-36 cytokines, which are active in skin inflammation and can be targeted by CAN10. These data suggests that CAN10 holds promise as a future therapy in inflammatory skin diseases such as psoriasis and HS where a single agent therapy may not provide complete effectiveness."

Dermatitis • Dermatology • Hidradenitis Suppurativa • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CCL11 • CXCL8 • IL17A • IL1R1 • IL1RAP • IL33 • IL5 • IL6

Cantargia Presents New Results at EADV 2024 Highlighting the Potential of CAN10 Treatment in Dermatology (ACCESSWIRE) - "Cantargia...presented data from preclinical experiments showing the high potential of the IL1RAP targeting antibody CAN10 in treatment of dermatological diseases. The results show overexpression of IL1RAP in a number cell types in hidradenitis suppurativa (HS) and psoriasis skin lesions. The treatment effect of CAN10 in models of skin inflammation was potent and superior to IL-1β blockade. The results are presented at the EADV congress Sep 25-28 in Amsterdam....'The broad mechanism of action of CAN10 seem well suited for this huge disease segment and preparations are ongoing for the first phase 2 study in HS planned to start 2025'."

New P2 trial • Preclinical • Hidradenitis Suppurativa

Cantargia reports start of multiple dosing part in CAN10 phase 1 clinical trial (Cantargia Press Release) - "Cantargia...reported that the first participant has started study treatment in the second part of the phase 1 clinical trial using CAN10, an antibody designed for treatment of autoimmune or inflammatory diseases. This part investigates multiple dosing during 6 weeks in participants with mild to moderate plaque psoriasis....The ongoing phase 1 clinical trial initially investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing using subcutaneous administration in participants with psoriasis....Each participant will receive treatment during six weeks and treatment in the two groups are planned to finish end of Q1 2025."

Trial status • Psoriasis

Cantargia Reports Presentation of New Preclinical Data Supporting CAN10 in Fibrotic Lung Diseases (ACCESSWIRE) - "Cantargia...reported presentation of new preclinical data providing support for CAN10 as a potential treatment of fibrotic lung diseases. The new data shows upregulation of the CAN10 target protein IL1RAP in lungs from patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) and idiopathic pulmonary fibrosis (IPF). IL1RAP is expressed on several cell types important for fibrotic lung disease and the number of IL1RAP positive cells were increased in fibrotic lungs compared to healthy. The data will be presented at the European Respiratory Society's annual congress September 7-11, 2024."

Preclinical • Idiopathic Pulmonary Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Antibodies targeting the shared cytokine receptor IL-1 receptor accessory protein invoke distinct mechanisms to block all cytokine signaling. (PubMed, Cell Rep) - "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."

Journal • Immunology • Oncology • IL1B • IL1RAP • IL33

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. (PubMed, Ann Rheum Dis) - "This 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."

Journal • Preclinical • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • IL1RAP • IL33 • TOP1

Cantargia presents new human data further supporting CAN10 in the treatment of systemic sclerosis (Cantargia Press Release) - P1 | N=NA | "Cantargia...reported new data highlighting the potential of the CAN10 antibody, currently in phase I clinical development, as therapy in systemic sclerosis....The data is presented at the Systemic Sclerosis World Congress in Prague 14-16 March 2024....CAN10 is currently in phase I clinical development with transition from healthy volunteers to patients planned for Q3, 2024....The new results demonstrate that both the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients. This disease develops as fibroblasts promote the formation of an excessive buildup of connective tissue in skin and internal organs, so-called fibrosis. The results show that IL-1, IL-33 and IL-36 collagen production on skin fibroblasts from systemic sclerosis patients, leading to fibrosis. These disease-associated mechanisms can be reduced by CAN10."

P1 data • Immunology • Systemic Sclerosis

COMBINED BLOCKADE OF IL-1, IL-33 AND IL-36 SIGNALING BY TARGETING IL1RAP AMELIORATES SKIN AND LUNG FIBROSIS IN PRECLINICAL MODELS OF SYSTEMIC SCLEROSIS (SSWC 2024) - "For efficacy studies, we used three complimentary mouse models of SSc: chronic sclerodermatous graft-versus-host disease (cGvHD), bleomycin- and topoisomerase I-induced fibrosis. This study suggests that IL1RAP blockade by CAN10 may be a promising approach to treat several of the pathophysiological changes in inflammatory and fibrotic diseases such as SSc."

Preclinical • Fibrosis • Graft versus Host Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • IL1RAP • IL33 • TOP1

Cantargia Reports Phase I Clinical Progress in the CAN10 Project (BioSpace) - P1 | N=80 | NCT06143371 | Sponsor: Cantargia AB | "Cantargia...today reported encouraging progress in the ongoing phase I clinical trial of the CAN10 antibody. The study proceeds according to plan, with the four initial dose groups concluded without any safety concerns....The first four dose groups in healthy subjects have now concluded the treatment period. No safety concerns have been observed and the fifth dose group has started in accordance with the protocol. In addition, a receptor occupancy study shows that already at initial dose levels, the majority of IL1RAP molecules on immune cells are binding CAN10 in a dose dependent manner....The first results from such studies are expected during Q2 2024. Studies in patients with psoriasis are expected to start H2 2024."

P1 data • Trial status • Immunology • Psoriasis

Cantargia Reports New Preclinical Data Confirming the Potential of Nadunolimab and CAN10 (BioSpace) - "Cantargia...reported new preclinical data providing further support for its lead assets, the IL1RAP-binding antibodies nadunolimab (CAN04) and CAN10, in both cancer and cardiovascular disease. The data shows that IL1RAP blockade results in reduced vascular inflammation and that levels of IL1RAP correlate with various inflammatory markers in inflamed tissue....The findings demonstrate that antibody blockade of IL1RAP in a cell-based system results in decreased levels of multiple inflammatory markers, including interleukin-6 (IL-6), produced by vascular cells. The data further indicates that these effects may lead to reduced recruitment of inflammatory immune cells. Notably, analyses of human atherosclerotic plaques show that the level of IL1RAP correlated with several of the inflammatory markers reduced by IL1RAP blockade, including IL-6."

Preclinical • Cardiovascular • Immunology • Oncology • Solid Tumor

Third party withdraws appeal related to Cantargia patent (Cantargia Press Release) - "Cantargia...reported that the Notice of Appeal filed with respect to one of Cantargia’s granted European patents, EP3293202, has been withdrawn. Thereby, the patent remains in force with claims encompassing Cantargia’s lead asset nadunolimab and related variant antibodies, as originally decided by the EPO Opposition Division. 'As this appeal has now been withdrawn, we can conclude the broad scope of our patent portfolio and continue our focus on exploring the commercial opportunities of our clinical projects, nadunolimab and CAN10, and the IL1RAP platform'...."

Patent • Oncology

A Phase I Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis. (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Cantargia AB

New P1 trial • Dermatology • Immunology • Psoriasis

Cantargia expands clinical pipeline and starts treatment in second program, CAN10, for autoimmune diseases (Market Screener) - "Cantargia...announced that the first subject has been treated with the IL1RAP-binding antibody CAN10, developed for treatment of autoimmune/inflammatory diseases. The phase I clinical trial, conducted in Germany, investigates the safety, pharmacokinetics and biomarkers of CAN10 in healthy volunteers and psoriasis patients. A total of 80 subjects may be included in the trial. Initial data from the trial are expected in 2024."

P1 data • Trial status • Immunology • Psoriasis

Cantargia: FDA grants Orphan Drug Designation to CAN10 for treatment of systemic sclerosis (Cantargia Press Release) - "Cantargia...announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to CAN10 for the treatment of systemic sclerosis. This designation provides a range of incentives in the continued clinical development of CAN10 in systemic sclerosis."

Orphan drug • Immunology • Systemic Sclerosis

Cantargia receives regulatory approval to start phase I clinical trial for CAN10 (Market Screener) - "Cantargia...announced that the application for a phase I clinical trial with the IL1RAP-binding antibody CAN10 has been approved. The trial will investigate the safety of various single and multiple dose levels of CAN10 given intravenously to healthy volunteers or subcutaneously to psoriasis patients. Up to 80 subjects may be included in the trial, which is expected to start in September 2023."

New P1 trial • Immunology • Psoriasis • Systemic Sclerosis

Cantargia gets regulatory thumbs up for phase 1 study with CAN10 [Google translation] (Realtid) - "The research company Cantargia's application for a clinical phase 1 study with the IL1RAP-binding antibody CAN10 has been approved regulatory. As approval has been obtained from both the regulatory authority and the ethics committee in Germany, the phase 1 study can now begin, the company states. The study will examine the safety of different single and repeated doses of CAN10 given intravenously to healthy volunteers or subcutaneously to psoriasis patients. Up to 80 individuals may be included in the study, which is expected to start in September."

New P1 trial • Trial initiation date • Immunology • Psoriasis

Cantargia has submitted a phase I clinical trial application for its second project, CAN10 (Market Screener) - "Cantargia...today announced that an application has been submitted to start the phase I clinical trial for the IL1RAP-binding antibody CAN10, in development for treatment of systemic sclerosis and myocarditis. The trial will be conducted in Germany and is planned to start mid-2023, pending regulatory approval timelines....The CAN10 phase I clinical trial will initially evaluate single intravenous dosing in healthy subjects to assess safety and pharmacokinetics, as well as immunological biomarkers. The subsequent part of the trial will focus on repeated subcutaneous dosing and is planned in patients with mild to moderate psoriasis to obtain an initial indication of effects on disease-related biomarkers. The study start is dependent on timelines for regulatory review, but treatment could be initiated shortly following approval of the application, mid-2023."

New P1 trial • Cardiovascular • Immunology • Systemic Sclerosis

Cantargia successfully concludes toxicity study with CAN10 antibody ahead of phase I clinical trial application (PRNewswire) - "Cantargia (Cantargia AB)...announced that the Good Laboratory Practice (GLP) toxicity study for its anti-inflammatory IL1RAP-binding antibody CAN10 has been concluded. Data from the study show that CAN10 was well tolerated when administered over six weeks. Cantargia plans to initiate the phase I clinical trial for CAN10 during the first half of 2023....The study start is dependent on timelines for regulatory review, but treatment of healthy volunteers could be initiated shortly following approval of the application, as early as the first half of 2023."

New P1 trial • Preclinical • Immunology • Systemic Sclerosis

Blocking IL-1, IL-33 and IL-36 Signaling with the Anti-IL1RAP Antibody mCAN10 Ameliorates Inflammation and Fibrosis in Preclinical Models of Systemic Sclerosis (ACR Convergence 2022) - "This study suggests that IL1RAP targeting by CAN10 may be a promising approach in treating several of the pathophysiological changes in inflammatory and fibrotic diseases such as SSc"

Preclinical • Allergy • Atherosclerosis • Cardiovascular • Dermatology • Dyslipidemia • Fibrosis • Gout • Graft versus Host Disease • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Rheumatology • Scleroderma • Systemic Sclerosis • CXCL8 • IL1B • IL1RAP • IL33 • IL6

Cantargia's CAN10 demonstrates positive activity in systemic sclerosis models in new data presented at ACR Convergence 2022 [Google translation] - "In skin biopsies from patients, dysregulation of a range of other markers related to inflammation or fibrosis was also detected, and the corresponding markers were normalized by the surrogate antibody CAN10. CAN10 also reduced the release of inflammatory molecules from human skin fibroblasts in response to IL1RAP stimulation. The data was generated in collaboration with the research group led by Prof. Dr. Jorg Distler..."

Cantargia's CAN10 demonstrates positive activity in systemic sclerosis models in new data presented at ACR Convergence 2022 (Yahoo Finance) - "Cantargia...reported new preclinical data demonstrating positive effects of the IL1RAP-binding antibody CAN10 in three different in vivo models of systemic sclerosis, a lead indication for the drug candidate. Across the models, which mimic difficult-to-treat forms of the disease, CAN10 reduced both pathological inflammation and fibrosis in skin and lung tissue, factors associated with clinical severity in humans....The data have been selected for an oral presentation at ACR Convergence 2022, held in Philadelphia, November 10-14, 2022....Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, and plans to start clinical phase I studies in early 2023."

New P1 trial • Preclinical • Immunology • Systemic Sclerosis

"Cantargias CAN10 visar positiva effekter i modeller av systemisk skleros i de nya data som presenteras vid ACR Convergence 2022 https://t.co/oOLUJweE2A" (@CisionNews)