CAN04 - Cancer
Cantargia has shown that IL1RAP is expressed on tumours from several types of cancer and that CAN04 binds strongly to the target molecule IL1RAP. CAN04 works both by stopping tumour inflammation and by binding to the cancer cells, which the immune system’s killer cells are then stimulated to destroy. Both of these effects are being studied in various cell-based model systems. Effects of CAN04 on tumour development and on the immune system are also being studied in cancer models in which various combination strategies using other drugs are also being tested. Studies are being conducted in order to obtain further documentation of the properties of CAN04 and in order to support the clinical studies. See our latest scientific publications.
CANFOUR, the first clinical study, is a combined phase I/IIa study where the first part included a limited number of patients who were treated with CAN04 in gradually increasing doses in order to study safety profile to identify a suitable dose for the second part. Thanks to positive results that allowed us to demonstrate, among other things, good safety and an effect on biomarkers, we have now proceeded to phase IIa.
CAN04 is being studied both as a single drug (monotherapy) and in combination with the standard treatments for each indication. With non-small cell lung cancer, the combination is with the chemotherapies cisplatin and gemcitabine, while with pancreatic cancer CAN04 is combined with gemcitabine and nab-paclitaxel.
During 2020, Cantargia will start a new study with CAN04 in combination with a check-point inhibitor i.e. immunotherapy which has been established as standard of care for several cancer forms, including NSCLC, urinary bladder cancer, head and neck cancer, and malign melanoma.
Manufacture and quality control
CAN04 is manufactured in biological production systems. A specific cell line has been licensed from BioWa Inc. that enables the production of antibodies with enhanced ADCC (Antibody-Dependent Cellular Cytotoxicity) activity, which means that the antibodies have a greater ability to stimulate the immune system’s killer cells. You can find more information about this technology at www.biowa.com. The process for the industrial production has been developed by Glycotope Biotechnology GmbH (now Celonic AG www.celonic.com) and manufacturing is performed by Patheon Biologics BV, part of Thermo Fischer Scientific.
CAN04 is produced by means of cell culturing followed by repetition in several stages and finally filling into vials that are distributed to hospitals for use in the clinical development work. CAN04 is given to patients via intravenous infusion.
CAN10 – Autoimmune/inflammatory diseases
IL1RAP is an interesting target also for treatment of diseases outside cancer. In the CAN10 project a new monoclonal antibody targeting IL1RAP is being developed which is designed to treat autoimmune and inflammatory diseases. Initially, we focus on two serious diseases, systemic sclerosis and myocarditis.
The new CAN10 project, currently in preclinical development, develops an antibody which binds to IL1RAP and potently block its signalling function. Unlike CAN04, this antibody potently blocks the activity of IL1RAP without inducing cell killing by ADCC. IL1RAP is required for transferring signals from the cytokines IL-1, IL-33 and IL-36. These molecules can trigger inflammation and have roles in several serious autoimmune and inflammatory diseases. Cantargia has developed antibodies that can block all these signalling pathways simultaneously by binding to IL1RAP, which means that CAN10 has great potential for treatment of several diseases and can have a broader and more potent effect than treatments targeted at individual signalling pathways. After conducting an extensive review of a large number of diseases with Cello Health, Cantargia chose initially to target CAN10 at systemic sclerosis and myocarditis. These diseases can be serious and there is a great medical need for new treatments.
The goal is to start the first studies in humans in the beginning of 2022. Initially, the safety profile of the antibody will be studied followed by studies designed to evaluate the mechanisms and treatment effects in patients.
Manufacture and quality control
Since CAN10 is an antibody, like CAN04, a similar program for development of a stable cell-line expressing the antibody and a production process is undertaken.
CANxx – Cantargia’s IL1RAP-based antibody platform
Cantargia was the first company to develop drugs against IL1RAP and has built up a knowledge and technology platform in the area. Within CANxx, Cantargia has developed over 100 unique antibodies that bind to IL1RAP with different properties. The CANxx antibody library enables Cantargia to rapidly develop new antibodies with properties that can be used for treatment of new diseases. The development of new drugs also depends on analysis and diagnostics, and CANxx is a source of antibodies also for these purposes. CANxx consolidates Cantargia’s strong position for the future.