NOXXON Pharma N.V. announced that it has filed the clinical trial application (CTA) with the Federal Institute for Drugs and Medical Devices, to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
Company aims to be ready to launch the trial in Q2-2019
Berlin, Germany, February 27, 2019, 06.00 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), announced today that it has filed the clinical trial application (CTA) with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
NOXXON plans to conduct the trial in collaboration with investigators at three hospitals in Germany: Mannheim, Essen and Bonn. The primary endpoint of this dose escalation study, which will assess up to three doses of NOX-A12, is the safety and tolerability of NOX-A12 combined with radiotherapy. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.
“Provided we can rapidly address any regulatory questions from the independent ethics committee, we should be ready to initiate the trial in mid-2019. The combination of NOX-A12 with radiation is the second therapeutic approach that we have developed for solid tumors and we believe that it can be applicable to many tumor types. We are encouraged by the strong support of clinical experts in both, the US and Europe,” said Dr. Jarl Ulf Jungnelius, Chief Medical Officer of NOXXON Pharma.
For more information, please contact:
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726247 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) 176 2103 7191
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 and blocking tumor repair. By 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 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in December 2018 and further studies are being planned in these indications. The company initiated preparations for an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX-E36 in patients with solid tumors 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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