Subject: FDA
Cantargia Submits Request for pre-IND Meeting on CAN04 With US FDA
STOCKHOLM, Sept. 4, 2019 /PRNewswire/ -- Cantargia AB today announced that a request for a pre-IND meeting with the US FDA has been submitted. The purpose of the meeting is to discuss the current documentation on the antibody CAN04 and a proposed new phase I clinical combination study with CAN04 and an immune checkpoint inhibitor under a US IND. The plan is to conduct this trial at clinical centers in the US.
Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling. CAN04 is investigated in an European open label three-armed phase I/IIa clinical trial, CANFOUR, examining monotherapy as well as combination with two different standard chemotherapy regimes in patients with non-small cell lung cancer or pancreatic cancer (www.clinicaltrials.gov).
The new proposed clinical trial will investigate CAN04 in combination with an immune checkpoint inhibitor. The design has been developed in collaboration with experts in the field. The purpose of the trial is primarily to investigate safety of the combination therapy in a few selected IL1RAP expressing cancer forms which are currently being treated with immune checkpoint inhibitors. Besides safety, biomarkers and efficacy will also be studied. A more detailed design will be presented after potential input from the US FDA.
"We are excited to advance the development of CAN04 into combination with other immune therapies as well as initiate discussions with the US FDA. These are two important steps forward for Cantargia", Göran Forsberg, Cantargia's CEO says.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
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 15.30 CET on 4 September 2019.
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 (nidanilimab) is being studied in the clinical phase I/IIa CANFOUR with a primary focus on non-small cell lung cancer and pancreatic cancer. The study is conducting both monotherapy and combination therapy. Cantargia's other project, CANxx, is in the research phase and is aiming to develop an IL1RAP binding antibody optimised for the treatment of autoimmune and inflammatory diseases.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at http://www.cantargia.com.
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