NOXXON Pharma N.V. has announced a collaboration with Merck & Co. (MSD), Inc, under which the two companies will collaborate in a phase 1/2 clinical trial of NOXXON’s anti-CXCL12 agent, NOX-A12, and MSD’s anti-PD-1 inhibitor, Keytruda (pembrolizumab), in patients with metastatic solid tumors that do not usually respond to checkpoint inhibitor monotherapy.
The goal of the two-part, open-label phase 1/2 study is to evaluate pharmacodynamic effects and safety of NOX-A12 as a monotherapy in addition to safety and efficacy of NOX-A12 in combination with Keytruda in patients with metastatic colorectal and pancreatic cancer. A total of twenty patients will be recruited, ten of each cancer type. NOXXON will be the sponsor of the study, which will be conducted in Europe, the company said in its press release.
NOXXON explained that 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.
NOX-A12, which inhibits the key tumor microenvironment chemokine CXCL12, may be a key partner for a wide range of IO (immuno-oncology) agents. NOXXON has generated promising pre-clinical and clinical data, including recent 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. NOXXON believes that its planned clinical 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.
Under the collaboration agreement, MSD will provide Keytruda to NOXXON for the conduct of the trial and has approved the trial design. Multiple paths for further development of the combination in pivotal clinical trials are envisioned in this agreement, although the agreement grants no commercial rights to either party for the other party’s compound. Additional details were not disclosed.
Aram Mangasarian, PhD, Chief Executive Officer of NOXXON commented: “This collaboration with MSD allows us to initiate a clinical trial of NOX-A12 in patients with metastatic solid tumors with the advice and support of one of the key players in the immuno-oncology space. We are pleased that MSD shares our interest in the potential of the CXCL12 pathway to modulate the tumor microenvironment to increase the efficacy of checkpoint therapy.”