CAN10 Shows Promise in Early Studies, Supporting Planned Clinical Trial

CAN10, — Cantargia’s experimental therapy for scleroderma and myocarditis, or inflammation of the heart muscle — appears safe and effective at reducing inflammation and myocarditis in preclinical studies.

The findings support plans to develop CAN10 for the treatment of these two conditions.

“With preclinical proof of concept in myocarditis and encouraging toxicology results, the CAN10 development is advancing well,” Göran Forsberg, Cantargia’s CEO, said in a press release.

“We look forward to achieve remaining important milestones followed by the initiation of clinical activities of Cantargia’s second product candidate [CAN10],” Forsberg added.

The company plans to present these promising preclinical data at a scientific conference in the upcoming months and to launch a clinical trial of the therapy’s safety in early 2022.

Activities around process development, scale-up, and initial production of CAN10 are going according to plan, according to Cantargia, and in collaboration with BioInvent, which will produce the therapy.

CAN10 is a monoclonal antibody administered directly into the bloodstream and intended to specifically block the activity of the interleukin 1 receptor accessory protein (IL1RAP) as a means to suppress signals from three important pro-inflammatory molecules — IL-1, IL-33, and IL-36.

The IL-1 family, which includes 11 signaling molecules, plays a crucial role in inflammation, and previous studies have highlighted that several of them are involved in immune responses and fibrosis (scarring) seen in scleroderma.

As such, suppressing IL-1, IL-33, and IL-36 signaling “can be of significant value in the treatment of several autoimmune or inflammatory diseases,” the company stated in the release.

Preclinical data indicated that CAN10, selected from more than 100 anti-IL1RAP antibodies developed by Cantargia, promoted a potent and unique anti-inflammatory effect in mice.

The Swedish biotech company is currently focusing CAN10’s development for the treatment of scleroderma and myocarditis, in which inflammation in the heart muscle leads to reduced heart function.

This focus was supported by an independent analysis of the antibody’s potential in treating about 150 autoimmune and inflammatory diseases.

Newly announced preclinical results showed that CAN10 significantly counteracted disease development in an animal model of myocarditis.

The therapy also was found to potently suppress inflammation in several models of inflammatory disease, as assessed by disease development and biomarkers. These studies are expected to help clarify the therapy’s mechanism of action.

Notably, CAN10 showed greater activity compared to other IL-1-suppressing therapies, such as antibodies against IL-1-beta and anakinra, sold as Kineret to treat some autoimmune and inflammatory diseases, including rheumatoid arthritis.

In addition, the company announced that the first toxicology study of CAN10 has been completed. It was designed to evaluate the safety and pharmacokinetics — the therapy’s movement into, through, and out of the body — of a single administration of different doses of CAN10 (up to 50 mg/kg).

Results from this preclinical study showed no toxicity and no safety concerns after CAN10 treatment, and the antibody was found at expected levels in the blood.

CAN10’s safety program is continuing as planned toward a good laboratory practice toxicity study, expected to begin later this year and to support applications to regulatory agencies requesting the initiation of clinical trials. Good laboratory practice toxicology studies are performed to understand the onset, duration, severity, and reversibility of toxic effects, or adverse events, produced by a particular dose of a medicine.

Cantargia’s lead treatment candidate CAN04, also an anti-IL1RAP antibody, is in Phase 2a stage as a potential therapy for different types of cancer.