Apr 20, 2023 · Regulatory information

Cantargia has submitted a phase I clinical trial application for its second project, CAN10

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) 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.

“CAN10 diversifies Cantargia’s project portfolio beyond oncology to inflammatory and autoimmune diseases. We are proud of reaching this milestone, which brings us one step closer to the start of clinical studies,” said Göran Forsberg, CEO of Cantargia.

The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of IL-1, IL-33 and IL-36 signaling, which can be of significant value in the treatment of autoimmune or inflammatory diseases. Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, two diseases with high medical need. CAN10 has shown promising efficacy in several models of both these diseases.

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. After the phase I safety part has been concluded, clinical trials in patients with systemic sclerosis or myocarditis can commence.

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. The main 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 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, atherosclerosis, psoriasis, psoriatic arthritis, and peritonitis. CAN10 is currently in late-stage preclinical development and the first clinical trial is expected to begin mid-2023.