Last December, Noxxon Pharma AG signed an agreement with Merck & Co./MSD to evaluate the synergistic potential of NOXA1/2 and pembrolizumab immune cancer therapy. Now, the companies have kicked off a Phase I/II study in patients with pancreatic and colorectal cancer.

The study conducted at the National Center for Tumor Diseases in Heidelberg (Germany) will investigate the impact of NOX-A12 (olaptesed pegol) as a monotherapy on immune cell infiltration into tumors. In addition, Noxxon and Merck & Co will assess safety and efficacy of NOX-A12 in combination with Keytruda (pembrolizumab), Merck & Co./MSDs programmed death receptor-1 (PD-1) immune checkpoint-blocking antibody drug.

The open-label trial (NCT03168139) is composed of two parts: patients will receive NOX-A12 monotherapy for two weeks, followed by combination therapy of NOX-A12 plus pembrolizumab for up to two years. 20 patients will be enroled: 10 patients for each metastatic pancreas and colorectal cancer.

The design of the clinical trial was a collaborative effort between NOXXON and MSD. Part 1 of the study, in which patients will receive NOX-A12 monotherapy for up to two weeks, will evaluate immune infiltrate changes within the tumor microenvironment induced by CXCL12 inhibition with NOX-A12 by comparing pre- and post-treatment biopsy specimens as well as the safety and tolerability of NOX-A12 in patients with metastatic (stage IV) colorectal and pancreatic cancer. Part 2 of the study, in which NOX-A12 is to be combined with Keytruda, will assess the safety and tolerability of the combination in addition to the efficacy of treatment. Top-line data for all 20 patients from part 1 is expected to be available in Q2/2018, and initial response-rate data in Q4/2018.

NOX-A12 inhibits CXCL12, a key tumor microenvironment chemokine and a stem cell migration factor. The chemokine that acts by binding to to CXCR4 and CXCR7 may be a key partner for a wide range of IO (immuno-oncology) agents. Noxxon has generated promising pre-clinical and clinical data, including animal data showing synergy with a checkpoint inhibitor, as well as recent phase 2a trials in multiple myeloma and a second hematological cancer that showed a safety profile that supports further development and first signs of efficacy. The company said that its study will position the drug to be combined with multiple classes of IO approaches including those acting on or through T cells and/or NK cells.

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Noxxon/MSD start testing of immunoncologic combo - European Biotechnology