BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today 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. Through neutralizing chemokines in the tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 will deliver top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in 2018. The company plans to initiate further studies with NOX-A12 in brain cancer in combination with radiotherapy, for which an orphan drug status has been granted in the US and EU. The company’s second asset, NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX-E36 in pancreatic cancer patients both as a monotherapy and in combination. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
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