BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that Aram Mangasarian, Ph.D., Chief Executive Officer, will present a clinical trial update at Bio€quity Europe 2018 in Ghent, Belgium, on May 16, 2018 at 12:00 noon CEST.
The presentation will include new results from NOXXON’s clinical trial (NCT03168139) testing NOX-A12 alone (part 1) and subsequently in combination with Keytruda® (part 2) in metastatic, microsatellite stable pancreatic and colorectal cancer patients. The company will provide an update on patient recruitment for the clinical trial and data from part 1 of the trial, which studies the effects of the NOX-A12 monotherapy. Patient recruitment of the trial and tumor biopsy analysis from part 1 is expected to be completed in the second quarter of 2018, as planned. It is expected to publish top-line efficacy data from the NOX-A12 plus Keytruda® combination in the fourth quarter of 2018.
“Based on encouraging data emerging from the monotherapy part of our ongoing clinical trial testing NOX-A12 alone and in combination with Keytruda®, we are taking the opportunity to provide an overview to investors. As more patients are analyzed comparing baseline tumor biopsies to those taken after two weeks of NOX-A12 monotherapy, we are starting to see patterns emerge. As an example, one particularly clear set of changes was seen in a pancreatic cancer patient where NOX-A12 monotherapy led to increases in interferon gamma, IL-2 and TNF-beta amongst other relevant cytokines consistent with a Th1 type immune response,” said Aram Mangasarian, Ph.D., Chief Executive Officer of NOXXON.
Jarl Ulf Jungnelius, Ph.D., Chief Medical Officer of NOXXON, added: “It is very interesting to see a change in the tumor microenvironment of one specific patient who was heavily pre-treated and who had already progressed on three prior lines of therapy. This patient has a typical profile for our study, where, as of April 2018, pancreatic cancer patients have a mean of three prior lines of therapy and the colorectal cancer patients a mean of five prior lines of therapy.”
The presentation will also include information on a non-interventional study of non-small-lung cancer (NSCLC) patient samples, which suggests that the target of NOX-A12 is also a factor for immune cell exclusion in this cancer and that NOX-A12 may be of interest to treat NSCLC patients whose tumor is progressing on anti-PD-(L)1 immune checkpoint therapy.
The presentation is available on NOXXON’s website.
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.
Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.