NOXXON announces key finding that NOX-A12 plus KEYTRUDA® induces an immune response and results in clinical benefit for patients

• Findings include stable disease and prolonged time on treatment vs. prior therapy in heavily pretreated metastatic pancreatic and colorectal cancer patients
• Data supports best-in-class pharmacology for NOX-A12

Berlin, Germany, December 14, 2018, 12.30 p.m. CET – NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), publishes top-line efficacy data from the second part of its ongoing open label Phase I clinical trial (NCT03168139). The trial in 20 patients is testing NOX-A12 (olaptesed pegol) in combination with Merck & Co./MSD’s PD-1 inhibitor Keytruda® in metastatic, microsatellite stable pancreatic (PaC) and colorectal cancer (CRC) patients. Data will be presented at the ESMO Immuno-Oncology Congress taking place in Geneva, Switzerland, December 13-16, 2018.
Patients enrolled in the study had a mean number of 3 (PaC) or 5 (CRC) lines of prior treatment. Of the patients who were still alive after three months, as targeted in the inclusion criteria and to allow sufficient time for treatment to have an effect, 70% were still alive at 24 weeks and 50% at 36 weeks. This unexpectedly high number of patients with extended time on study relative to prior therapy and stable disease included mostly patients who progressed rapidly on their prior therapy and whose best response to prior therapy was progressive disease. Five of the patients, representing 25% in the study achieved stable disease according to the RECIST criteria used (22% PaC, 27% CRC).

Dr. Jarl Ulf Jungnelius, CMO of NOXXON, said: “Normally when patients move from one line of therapy to the next, we expect they will do less well, however what we saw repeatedly in this study was that patients who progressed very rapidly to their last therapy were able to stay on the NOX-A12/Keytruda® combination therapy for longer – in fact, up to ten times longer. This combination appears to bend the tumor growth curve downward and could benefit patients even if they do not achieve stable disease.”

“These results are very encouraging for these two difficult to treat cancers. When we look at the results obtained with only one dose of NOX-A12 per 3-week Keytruda® cycle, we believe that NOX-A12 has best-in-class pharmacology. We believe that further studies with NOX-A12 are needed in these indications and we are currently refining the design of the next trials,” said Aram Mangasarian, CEO of NOXXON.

The study confirmed the mechanism of action of NOX-A12 in these tumor types where both proteomic and immunohistochemical analyses confirmed abundant expression of the CXCL12 chemokine drug target in both tumor types. The extent of neutralization of the target by NOX-A12 correlated with a “hotter” immune response and clear clinical benefit for patients.

The poster is available on the NOXXON website.