In the December of 2016, Berlin based Noxxon Pharma AG made a deal with Merck & Co. /MSD to assess the synergistic potential of NOXA1/2 and pembrolizumab immune cancer therapy. The companies recently started a Phase I/II test in patients suffering with pancreatic and colorectal cancer.
The study which is carried out at the National Center for Tumor Diseases in Heidelberg (Germany) will test the impact of NOX-A12 (olaptesed pegol) as a monotherapy on immune cell infiltration into tumors. In addition, Noxxon and Merck & Co will assess safety and efficacy of NOX-A12 in combination with Keytruda (pembrolizumab), MSD’s programmed death receptor-1 (PD-1) immune checkpoint-blocking antibody drug.
The trial is an open label based one, meaning (clinical trial in which both the researchers and participants know which treatment is being administered) consisting of two parts. The blueprint of the study was designed by NOXXON and MSD together. Patients will receive NOX-A12 monotherapy for two weeks which will assess immune infiltrate changes within the tumor microenvironment induced by CXCL12 inhibition with NOX-A12 by comparing pre- and post-treatment biopsy specimens as well as the safety and tolerability of NOX-A12 in patients with metastatic (stage IV) colorectal and pancreatic cancer. Followed by combination therapy of NOX-A12 plus combined with Keytruda®, will assess the safety and tolerability of the combination in addition to the efficacy of treatment for up to two years. 20 patients will be enrolled: 10 patients for each metastatic pancreas and colorectal cancer.