Berlin, Germany, July 4, 2017 – NOXXON Pharma N. V. (Euronext Growth Paris : ALNOX), a biopharmaceutical company developing mainly cancer treatments targeting the tumor microenvironment, today announced that the first patients have been treated in its clinical study Phase 1/2 study in patients with metastatic colorectal cancer or metastatic pancreatic cancer, at the National Center of Tumor Diseases (NCT) Heidelberg in Germany. The purpose of this study is to evaluate the safety and the effects of NOX-A12 (olaptesed pegol as a single agent on the infiltration of immune cells into the tumors, as well as the safety and efficacy of NOX-A12 in combination with Keytruda® (pembrolizumab), an antibody inhibitor of the checkpoint that blocks the receptor 1 programmed cell death (PD-1) marketed by Merck & Co./MSD.
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NOXXON and Merck & Co./MSD have jointly prepared the plan of the clinical study in both arms (ClinicalTrials.gov Identify: NCT03168139), composed of two parts : first, NOX-A12 administered as a single agent to patients for two weeks, which then receive the combination of NOX-A12 and Keytruda® (pembrolizumab) for a period of up to two years. The protocol of this study phase 1/2 open plans to recruit 20 patients in total, including 10 with cancer of the pancreas metastatic disease and 10 patients with metastatic colorectal cancer.
Two patients have now completed the first part of the study during which they received NOX-A12 as monotherapy for two weeks for the evaluation of its safety. Tumor biopsies were performed in these patients before and after treatment with NOX-A12 to analyze the ability of NOX-A12 to modulate the tumor microenvironment, including the number of T lymphocytes present in tumors. Thus, this first part could provide clinical data to support the potential application of combination therapy with NOX-A12, not only with inhibitors of the checkpoint, but also with other treatments using T-cells (e.g. cells carrying a chimeric receptor CAR-T). In case of positive results, this intervention could potentially become a therapy disruptive applicable to a wide range of cancers. The two patients who completed the first part of the study have now moved on to the second part (treatment of NOX-A12 in combination with Keytruda®).
The intermediate data of the 20 patients included in the first part are expected for the 2nd quarter 2018, and the first data on the response rate in the 4th quarter of 2018.
“We believe that our flagship product, NOX-A12 has the potential to transform the cancers today that are resistant to inhibitors of checkpoint cancers receptive to these treatments.
We would like to thank the National Center of Tumor Diseases (NCT) Heidelberg in Germany for the excellent start of the study, which we will provide the first data testing this hypothesis in humans, ” says Jarl Ulf Jungnelius, medical Director at NOXXON Pharma. “Our interactions with the team from Merck and preclinical data solid we have collected attest to the potential of NOX-A12 as a component in the future of an innovative treatment for patients with colorectal cancers and pancreatic cancers. ”
About NOXXON
NOXXON Pharma N. V. is a biopharmaceutical company developing mainly in treatments against cancer. The goal of NOXXON is to significantly improve the effectiveness of cancer treatments, including the approaches to immuno-oncology (inhibitors of checkpoint immune) and current treatment the most common management (chemotherapy and radiotherapy). The platform of Spiegelmers of NOXXON has enabled the development of a select portfolio of product candidates at the clinical stage, in which its candidate anticancer drug lighthouse, NOX-A12 (olaptesed pégol) is the subject of a collaboration in immuno-oncology with Merck & Co. Inc / MSD (NYSE:MRK) to conduct a clinical study of NOX-A12 is associated with the inhibitory antibody point-of-control anti-PD-1, Merck & Co.s, Keytruda® (pembrolizumab), in pancreatic cancer and colorectal cancer. The clinical study evaluating NOX-A12 alone and in combination with Keytruda® is underway in one of the leading centers specialized in the research and treatment of cancer, the National Center for Tumor Diseases (NCT) Heidelberg in Germany. NOXXON is backed by international investors of repute, including TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB, NGN and Seventure. Its headquarters are located in Amsterdam, the netherlands and its offices in Berlin, Germany. More information can be found on www.noxxon.com.
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