Nov 29, 2024 · Regulatory information

Cantargia expands the CAN10 phase 1 clinical program building on positive results

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today 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 accrued CAN10 clinical results underscore the potential for dosing every 4th week. This is a competitive advantage, therefore the ongoing phase 1 clinical trial is expanded to obtain additional results before the planned start of phase 2 during H2 2025”, said Göran Forsberg, CEO of Cantargia.

CAN10 is an antibody against IL1RAP, designed to potently inhibit the activity of the pro-inflammatory and disease promoting cytokines IL-1, IL-33 and IL-36. CAN10 is currently examined in a phase 1 clinical trial with the primary goal to investigate safety. So far, healthy participants have been treated in 9 single ascending dose (SAD) cohorts and the first multiple ascending dose (MAD) cohort in participants with mild to moderate plaque psoriasis is ongoing. No safety concerns have been reported and biomarker studies confirm binding to immune cells like neutrophils and monocytes as well as complete inhibition of IL-1 and IL-36 stimulation.

The results obtained indicate that CAN10 has long-lasting effects that would allow dosing every 4th week, while several other antibodies use more frequent dosing. To further document this potential competitive advantage e.g. leading to improved patient convenience, the clinical protocol has been amended to allow up to two additional SAD cohorts as well as up to two additional MAD cohorts in healthy participants. The first participant in this new part of the trial has 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.

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 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 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: hidradenitis suppurativa (HS) and systemic sclerosis. In preclinical in vivo models of inflammatory diseases, such as systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis, myocarditis and peritonitis, a CAN10 surrogate antibody significantly reduced the development of the disease. A clinical phase 1 study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Good safety is shown at the completed dose levels, and additional data are expected continuously during 2025.