Cantargia AB (STO:CANTA), a biotechnology company that develops antibody-based treatments for life-threatening diseases, announced on Thursday that 20 patients, six with non-small cell lung cancer (NSCLC) and 14 with pancreatic cancer (PDAC), in the phase IIa monotherapy arm have now started treatment with CAN04 at 10 mg/kg (milligrams per kilogram).

The safety profile has been very good and in line with the results from phase I. Tumour biopsies, taken before and during therapy, have been obtained from most patients in the trial. Analysis of these biopsies will provide an opportunity to study the impact of CAN04 in the tumour microenvironment. Also, biomarkers will be analysed in the serum. It is estimated that the results of these analyses will be reported during Q4 2019 together with efficacy results obtained from CT-scans.

Cantargia's antibody CAN04 (nidanilimab) is being investigated in an open label three-armed phase IIa clinical trial, CANFOUR. CAN04 will be examined as monotherapy or in chemotherapy combinations in patients with NSCLC or PDAC. The study is designed for 20 patients in monotherapy and approximately 30 patients in each combination arm.

All 20 patients planned for the monotherapy arm have now started treatment at 10 mg/kg. Overall, the safety has been good and in line with the results from phase I. The monotherapy results including biomarkers and efficacy are estimated to be ready during Q4 2019.

According to the company, recruitment to the monotherapy arm has gone faster than planned. To take advantage of the rapid recruitment and the good safety of CAN04, up to 12 additional patients are planned to be included to investigate safety and biomarkers at a higher dose level, 15 mg/kg. The recommended phase II dose is 10 mg/kg , and documenting safety at higher dose levels provides long-term advantages e.g. regarding safety margins.

In parallel, recruitment is also ongoing in the combination arms of the CANFOUR study. This trial includes a dose escalation strategy in the first group of patients, using a 3+3 design. The dose escalation phase is ongoing and results from the combination arms are estimated to be presented early 2020.