STOCKHOLM, June 2, 2019 /PRNewswire/ -- New phase I clinical data on Cantargia´s antibody CAN04 (nidanilimab) were presented today in an oral session at the 2019 ASCO Annual Meeting. Data from 22 patients show that CAN04 treatment has a good safety profile. Most patients treated got a decrease in the biomarkers IL-6 and CRP already after two weeks of therapy. Nine patients had stable disease for at least 8 weeks. One patient with non-small cell lung cancer (NSCLC) progressed after 31 weeks and one patient with pancreatic cancer (PDAC) after 24 weeks. The results can be accessed through Cantargias webpage www.cantargia.com and are also attached to this release. CAN04 development has expanded into the phase IIa part of the trial to further investigate CAN04 as monotherapy and in combination with standard chemotherapy.
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 a phase I/IIa clinical trial, CANFOUR, examining monotherapy as well as combination with two different chemotherapy regimes in patients with NSCLC or PDAC (www.clinicaltrials.gov). Approximately 80 % of patients with NSCLC and 70 % of patients with PDAC overexpress IL1RAP on their cancer cells and in these diseases all patients have IL1RAP containing cells in the tumor microenvironment. The phase I monotherapy part also included patients with colorectal cancer.
The phase I monotherapy data on CAN04 was presented orally in the section Developmental Immunotherapy and Tumor Immunobiology by the coordinating investigator, Professor Ahmad Awada from Institut Jules Bordet in Brussels. In summary, 22 patients (4 NSCLC, 6 PDAC and 12 colorectal cancer) no longer responding to standard therapy, were treated with CAN04. The safety profile was good; only three patients had a treatment related adverse event of grade 3 and no treatment related adverse events higher than grade 3 was observed. The most common side effect was infusion related reaction (IRR) (41%) during the first infusion. Grade 3 adverse events were one IRR, one neutropenia/leukopenia and one hypokalemia. Serum levels of the disease associated biomarkers CRP and IL-6 were reduced after two weeks of treatment in 13/17 evaluable patients and 17/21 patients, respectively. The median value decreased by 22 % for CRP and 18 % for IL-6. Two patients had a rapid increase in these biomarkers over the first two weeks which correlated with disease progression after only a few weeks. Nine patients had stable disease by irRC at eight weeks follow up. Two patients, one with NSCLC and one with PDAC, had stable disease for a longer tperiod of time and progressed at 31 weeks and 24 weeks, respectively.
"CAN04 treatment was associated with good safety, a decrease in biomarkers associated with disease progression and showed stable disease in several patients. The phase I results are encouraging, and I look forward to the continued evaluation in the ongoing phase IIa expansion monotherapy and combination with chemotherapy," says Professor Ahmad Awada at the Institut Jules Bordet and coordinating investigator for the CANFOUR trial.
The presentation also highlighted the rational for the ongoing clinical evaluation of CAN04 combined with chemotherapy based on synergistic effects observed in preclinical models.
"With most new data at ASCO being selected for poster presentations, an oral presentation at ASCO annual meeting is clearly a milestone for Cantargia leading to increased exposure and attention of the CAN04 project," Göran Forsberg, Cantargia's CEO says.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
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 17.00 CET on 02 June 2019.
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 a 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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The following files are available for download:
ASCO2019 CANFOUR Phase I FINAL 01June 2019
SOURCE Cantargia AB