Noxxon Pharma, a biotechnology company whose core focus is on improving cancer treatment by targeting the tumour microenvironment, announced that the first patients were treated in its phase 1/2 clinical trial in patients with metastatic colorectal and pancreatic cancer at the National Center for Tumor Diseases in Heidelberg, Germany. The goal of the trial is to evaluate safety and the effects of NOX-A12 (olaptesed pegol) as a monotherapy on immune cell infiltration into tumours in addition to safety and efficacy of NOX-A12 in combination with Keytruda (pembrolizumab), a programmed death receptor- 1 (PD-1) immune checkpoint-inhibiting antibody marketed by Merck & Co./MSD.
Noxxon and Merck & Co./MSD collaborated closely in the two-arm clinical trial design (ClinicalTrials.gov; Identifier: NCT03168139) that is composed of two parts: patients will receive NOX-A12 monotherapy for two weeks, followed by combination therapy of NOX-A12 plus Keytruda for up to two years. The open-label trial is designed to include 20 patients, 10 patients for each metastatic pancreas and colorectal cancer.
Two patients have now completed part 1 of the trial in which they received NOX-A12 monotherapy for two weeks. Data from this stage will be used to analyze safety and, through tumour biopsies taken before and after NOX-A12 treatment, the ability of NOX-A12 to modulate the tumour microenvironment including the number of T-cells present in the tumours. Part 1 could, as such, provide clinical data to support the broad potential applicability for combinations of NOX-A12 not only with checkpoint inhibitors but also other T-cell based therapeutics such as CAR-T approaches. If successful, this avenue of therapeutic intervention could potentially become game-changing for a wide range of cancers. Both patients that completed part 1 have now progressed into part 2, receiving NOX-A-12 in combination with Keytruda. Top-line data for all 20 patients from part 1 is targeted to be available in Q2 2018, and initial response-rate data in Q4 2018.
“We believe that our lead product NOX-A12 has the potential to transform cancer types that are resistant to checkpoint inhibitor therapy into checkpoint inhibitor sensitive tumours. We would like to thank the team at the National Center for Tumor Diseases in Heidelberg (Germany) for the excellent start to this trial, which will provide us with the first human data to test this hypothesis,” said Jarl Ulf Jungnelius, chief medical officer of Noxxon Pharma. “Our interactions with the Merck team and the strong preclinical data we have generated underscore NOX-A12’s potential as a future component of innovative treatment for patients suffering from colorectal and pancreatic cancers.”