Noxxon Pharma N.V., a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced that patient recruitment is almost complete in its ongoing clinical trial (NCT03168139) testing NOX-A12 alone (part 1) and subsequently in combination with Merck & Co./MSD’s Keytruda (part 2) in metastatic, microsatellite stable pancreatic and colorectal cancer patients.
Top-line data for part 1 of the ongoing clinical trial of examining the effects of NOX-A12 monotherapy on the tumor microenvironment is now expected to be available in the third quarter of 2018. Timing for top-line data from all patients in part 2 remains unchanged at Q4 2018.
Part 1 of the study compares tumor biopsies taken at baseline and after two weeks of NOX-A12 monotherapy in order to obtain data on the NOX-A12 mode of action in the tumor microenvironment. Interim data released in May 2018 showed markers consistent with Th1 type immune responses in a number of patients treated with NOX-A12 therapy alone. Additionally, changed levels of CXCL12 in tumors confirmed penetration of NOX-A12 into tumor tissue.
“The team at the National Center for Tumor Diseases in Heidelberg recently had several potential patients that were finally not eligible for our clinical trial,” said Aram Mangasarian, CEO of Noxxon. “As a result, we will need more time to complete recruitment. We will then analyze the data as per the trial design to extend the results already announced before the ASCO Annual Meeting in June 2018. We remain confident that we will be able to provide top-line data from part 2 of the trial on schedule in the fourth quarter of 2018.” Noxxon’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier, blocking tumor repair and exposing hidden tumor cells.