Type of information: Clinical research agreement
Compound: NOX-A12 (olaptesed pegol) and Keytruda® (pembrolizumab)
Company: Noxxon Pharma (Germany) National Center for Tumor Diseases (NCT) in Heidelberg (Germany)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
- spiegelmer/monoclonal antibody/immune checkpoint inhibitor. Olaptesed pegol/NOX-A12 specifically antagonizes CXCL12/SDF-1 (CXC Chemokine Ligand 12 / Stromal Cell-Derived Factor-1), a chemokine which attracts and activates immune and non-immune cells including stem cells from the bone marrow. CXCL12 binds with high affinity to two chemokine receptors, CXCR4 and CXCR7. The CXCL12 / CXCR4 / CXCR7 axis has been shown to play a role in stem cell mobilization, vasculogenesis, tumor growth and metastasis. CXCL12 signaling has been shown to play an important role in the pathophysiology of CLL, especially in the interaction of leukemic cells with the tissue microenvironment. The therapeutic concept of NOX-A12 is to inhibit such tumor-supporting interactions and thereby sensitize CLL cells to chemotherapy.
- Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
Disease: metastatic pancreatic cancer, metastatic colorectal cancer
Details: • On May 16, 2017 , Noxxon announced the signing of an agreement with the National Center for Tumor Diseases (NCT) in Heidelberg under which the NCT will conduct a trial evaluating Noxxon’s lead product candidate NOX-A12 in combination with Keytruda® (pembrolizumab) in metastatic pancreatic and colorectal cancer. In some preclinical studies, NOX-A12 has shown an ability to make the immediate area surrounding a model tumor, the so-called tumor microenvironment, more accessible to the immune system. The ability of many tumors to use the tumor microenvironment to hide from the immune system is believed to contribute to the insensitivity of some tumors towards checkpoint inhibitors, such as Keytruda®.
The NCT investigators leading the clinical trial include Prof. Dr. Dirk Jäger, Managing Director, head of the clinical and tumor immunology research groups, and Dr. Niels Halama, Group Leader.
- • On July 4, 2017, Noxxon Pharma announced that the first patients were treated in its Phase 1/2 clinical trial in patients with metastatic colorectal and pancreatic cancer at the National Center for Tumor Diseases in Heidelberg, Germany. The goal of the trial is to evaluate safety and the effects of NOX-A12 (olaptesed pegol) as a monotherapy on immune cell infiltration into tumors in addition to safety and efficacy of NOX-A12 in combination with Keytruda® (pembrolizumab), a programmed death receptor-1 (PD-1) immune checkpoint-inhibiting antibody marketed by Merck&Co.