Cantargia reports positive preclinical safety and efficacy results in the CAN10 project

Cantargia AB today announced new preclinical results strengthening the development plan of the antibody CAN10 for treatment of myocarditis and systemic sclerosis. In preclinical studies of myocarditis, CAN10 significantly counteracted disease development. CAN10 also potently decreased inflammatory disease in other models used to investigate the CAN10 mechanism of action. The first toxicology study, investigating single dose treatment of CAN10 up to 50 mg/kg, did not identify any safety signals.

Cantargia develops antibody-based pharmaceuticals against interleukin-1 receptor accessory protein (IL1RAP). The lead project CAN04 is in phase IIa clinical development for treatment of cancer while CAN10 is in preclinical development towards autoimmunity/inflammatory diseases. The CAN10 antibody binds IL1RAP with high affinity and functions through simultaneous blockade of IL-1, IL-33 and IL-36 signaling. Inhibition of these signals can be of significant value in the treatment of several autoimmune or inflammatory diseases. Cantargia has initially focused the CAN10 development towards treatment of myocarditis and systemic sclerosis. Clinical development is planned to be initiated early 2022.

In a preclinical disease model of myocarditis, where inflammation in the heart muscle leads to decreased heart function, CAN10 had pronounced effects and counteracted this deterioration. CAN10 has also been investigated in various models of inflammatory disease where it potently reduced the inflammation as measured both by disease development and biomarkers. Importantly, CAN10 showed an enhanced activity compared to IL-1 blockade either performed by antibodies against IL-1β or through the IL-1 receptor antagonist anakinra. Results from these studies will be presented at a scientific conference during Q2 2021.

The first toxicology study of CAN10 has now been finalized. It was designed as a single dose study to investigate safety and pharmacokinetics of CAN10 at different dose levels. The highest dose level investigated was 50 mg/kg. No toxicity was observed. The initial pharmacokinetic data showed expected blood levels of the antibody. The safety program continues as planned towards the GLP toxicity study H2 2021.

The CMC activities around process development, scale up and initial production are ongoing according to plan.

“With preclinical proof of concept in myocarditis and encouraging toxicology results, the CAN10 development is advancing well. We look forward to achieve remaining important milestones followed by the initiation of clinical activities of Cantargia’s second product candidate”, says Göran Forsberg, CEO of Cantargia.

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on 19 March 2021.

About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy show a higher response rate than would be expected from chemotherapy alone. Cantargia’s second project, the antibody CAN10, 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 CAN04
The antibody CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in two clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in 31 patients with NSCLC (gemcitabine/cisplatin) and 31 patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP decreased during treatment. Positive interim data from the combination arms was presented during H2 2020 and showed a higher response rate than expected from chemotherapy alone. A phase I study investigating CAN04 in combination with an immune checkpoint inhibitor started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.

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