Aug 10, 2023 · Regulatory information

Cantargia receives regulatory approval to start phase I clinical trial for CAN10

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today 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.

Following the approval by both the regulatory authority as well as the ethics committee in Germany, the phase I trial will now be initiated.

“Cantargia has reached another significant milestone as CAN10 now becomes our second program in clinical development. CAN10 has shown strong effects in a number of inflammatory and autoimmune disease models and covers a segment that complements nadunolimab, our lead asset in oncology,” said Göran Forsberg, CEO of Cantargia.

The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, two diseases with a high medical need. CAN10 has shown promising effects in several models of these diseases.

The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10 using a standard design involving single ascending doses (SAD), followed by evaluation of multiple ascending doses (MAD). Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers. Initially, single ascending doses will be given intravenously to healthy volunteers. A subsequent part of the trial is designed to generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis who will receive CAN10 subcutaneously at two dose levels. Indication of clinically relevant effects on biomarkers will also be evaluated throughout the study.

Treatment is expected to start in September 2023. Additional details will be disclosed on clinicaltrials.gov. Once this trial has been concluded, subsequent trials intend to focus on patients with systemic sclerosis or myocarditis.

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. Treatment of subjects in a phase I clinical trial for CAN10 is expected to start in September 2023.