STOCKHOLM, April 7, 2020 /PRNewswire/ -- Cantargia AB today announced that the application for a US IND regarding the antibody CAN04 has been submitted to the US FDA. CAN04, an antibody targeting interleukin 1 receptor accessory protein (IL1RAP), is currently being investigated for treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC) in phase IIa clinical development in Europe. The IND application concerns one new phase Ib clinical trial investigating CAN04 in combination with immunotherapy in selected cancer forms overexpressing IL1RAP.
Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and its anti-tumor activity consists both of stimulation of immune cells to eradicate cancer cells as well as blockade of interleukin 1 signaling. CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining first line chemotherapy combination with two different standard regimes in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer (PDAC), as well as monotherapy in late stage patients (www.clinicaltrials.gov).
Cantargia is now in the process of broadening the development activities and the next step is a phase Ib trial investigating CAN04 in combination with pembrolizumab (Keytruda®). The trial is planned to be conducted in patients in selected cancer forms overexpressing IL1RAP i.e. NSCLC, head and neck cancer urothelial cancer or malignant melanoma. These patients should previously have been treated with, and benefitted from, immune checkpoint therapy. An application to start the trial and get a US IND has been submitted to the US FDA for review. The trial is planned to be conducted at three US clinical centres with University of Pennsylvania being the lead centre.
"We are pleased to have reached this development milestone in our efforts to investigate CAN04 in combination with immunotherapy", said Göran Forsberg, CEO of Cantargia.
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 16.00 CET on 7 April 2020.
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 in the clinical phase I/IIa CANFOUR study with a primary focus on non-small cell lung cancer and pancreatic cancer. The study is focused on combination therapies, but also includes a monotherapy arm. Positive interim data from the combination therapies were presented in December 2019. 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 http://www.cantargia.com.
About CAN04
The antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of IL-1α and IL-1β signaling. CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining first line chemotherapy combination with two different standard regimes in 31 patients with NSCLC (gemcitabine/cisplatin) and 31 patients with PDAC (gemcitabine/nab-paclitaxel) as well as monotherapy in late stage patients (www.clinicaltrials.gov). The phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed a good safety with infusion related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP were decreased with treatment and 9/21 patients had stable disease. Positive interim data from the combination therapies were presented in December 2019. A phase I trial investigating CAN04 in combination with an immune checkpoint inhibitor is planned to start H1 2020.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com
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https://news.cision.com/cantargia-ab/r/cantargia-submits-ind-application-for-can04,c3083628
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