NOXXON announces completion of patient recruitment in ongoing NOX-A12 pancreatic and colorectal cander trial

  • Part 1 top-line data of the NOX-A12 trial to be presented at the September ‘Fourth International Cancer Immunotherapy Conference’
  • Part 2 top-line efficacy data available at year end 2018

Berlin, Germany, September 3, 2018, 08.00 a.m. CEST - NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today that patient recruitment has been completed in the ongoing clinical trial (NCT03168139) testing NOX-A12 (olaptesed pegol) alone (part 1) and subsequently in combination with Merck & Co./MSD’s PD-1 inhibitor Keytruda® (part 2) in metastatic, microsatellite stable pancreatic and colorectal cancer patients.

Part 1 of the ongoing clinical trial compares tumor biopsies taken at baseline and after two weeks of NOX-A12 monotherapy to assess the effects of NOX-A12 on the tumor microenvironment. Top-line data for the NOX-A12 part 1 trial is planned to be published and presented at the Fourth CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference taking place from September 30 to October 3, 2018 in New York, NY, USA.

We are happy to announce that recruitment is complete and can confirm that there are 11 colorectal and 9 pancreatic cancer patients enrolled in the study. Depending on the timing of patient data analysis, we now expect top-line efficacy data from part 2 of the trial to be available at year end 2018,” said Jarl Ulf Jungnelius, CMO of NOXXON.

Completing recruitment of the NOX-A12 clinical trial is an important milestone for NOXXON and brings clarity to our upcoming clinical events and corporate news flow,” said Aram Mangasarian, CEO of NOXXON. “Targeting the tumor microenvironment is an important approach to treating cancer as it plays a critical role in all aspects of cancer biology, thus making this approach ideal for developing new anti-cancer therapies. Another exciting aspect of our approach is that it is designed to complement, not compete, with other cancer treatments.

NOX-A12 can modulate the tumor microenvironment including the type, number and distribution of immune cells as well as chemokine and cytokine signatures in the tumor tissue. Interim data from the NOX-A12 trial were released in May 2018 and 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.

First patients in the Phase 1/2 clinical trial were treated at the National Center for Tumor Diseases in Heidelberg, Germany, in June 2017. All patients completing part 1 will move to part 2, in which they receive NOX-A12 in combination with Keytruda®. Part 2 is designed to explore the safety, tolerability and efficacy of NOX-A12 in combination with Keytruda® and results are expected to be published at year end 2018.

For more information, please contact:

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
Tel. +49 (0) 30 726 247 0
amangasarian@noxxon.com

MC Services AG
Raimund Gabriel
Managing Partner
Tel. +49 (0) 89 210228 0
noxxon@mc-services.eu

Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 172 861 8540
schweitzer@trophic.eu

NewCap
Alexia Faure
Tel. +33 (0) 1 44 71 98 51
afaure@newcap.fr

About NOXXON
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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