Cantargia gains approval to initiate the CANFOUR clinical trial of immuno-oncology product candidate CAN04
Cantargia AB (“Cantargia”) today announced that the clinical trial application to study the antibody CAN04 in patients with cancer has been approved by the regulatory authorities as well as the ethics committees in Denmark and Norway. The review is ongoing in additional countries.
The regulatory approvals by the Danish Medicines Agency, Norwegian Medicines Agency and by the ethics committees in Copenhagen and Oslo, follows the previously communicated submission of the CANFOUR phase I/IIa clinical trial application May 12, 2017. In this trial, Cantargia’s proprietary antibody CAN04, directed towards the molecular target IL1RAP, will be investigated in patients with cancer. CAN04 works through an immuno-oncology mode of action and stimulates immune cells to eradicate tumor cells as well as counteracts tumor inflammation. The indications of primary focus in this trial are non-small cell lung cancer and pancreatic cancer. The primary endpoint will be safety. Other endpoints include pharmacokinetics, efficacy and biomarkers.
The first part of the trial will be a dose escalation phase, investigating different dose levels of CAN04. This part is expected to take approximately 12 months. After data analysis, a second part is planned to include one monotherapy treatment arm in approximately 20 patients with non-small cell lung cancer or pancreatic cancer, as well as a combination therapy arm investigating CAN04 with standard therapy in one of these forms of cancer. The exact choice of indication and combination therapy will be decided after completion of the first part. The trial is planned to be conducted as a multicentre trial in the BeNeLux and Scandinavia. Approvals in the remaining countries are expected during the summer. Trial information will be found on www.clinicaltrials.gov.
“Cantargia is in the transition from a preclinical stage company to a clinical stage company”, Göran Forsberg, CEO of Cantargia, says. “With the regulatory approval, we have passed a milestone of major importance”.
“CAN04 is an interesting novel compound targeting an important part of the cancer progression pathway” says Prof Ahmad Awada, coordinating investigator for the CANFOUR trial and Head of the Medical Oncology Clinic at Jules Bordet Institute in Brussels, Belgium. “I am very excited to start investigating CAN04 in patients with advanced cancer.”
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 21 July 2017, at 08.30 am.
Cantargia AB (publ), reg.no. 556791-6019, is a biotech company that is developing antibody-based treatments for life threatening diseases. The original discovery by the research team behind Cantargia was the overexpression of a specific target molecule, interleukin 1 receptor accessory protein “IL1RAP”, in leukemia stem cells, later research has also identified IL1RAP in a large number of other forms of cancer. The lead compound, CAN04 directed against IL1RAP, will be investigated in the CANFOUR phase I/IIa clinical trial in with primary focus on non-small lung cancer and pancreatic cancer. CAN04 has a dual mechanism of action, it blocks IL1RAP function and stimulates the immune system to eradicate tumor cells. Cantargia’s second project is in discovery phase with the goal to develop an IL1RAP binding antibody optimized for therapy of autoimmunity and inflammatory diseases.
Cantargia is listed on Nasdaq Stockholm First North (ticker: CANTA). Sedermera Fondkommission is the company’s Certified Adviser. More information about Cantargia is available at http://www.cantargia.com.