German clinical-stage biopharmaceutical company Noxxon has signed a collaboration agreement with Merck to conduct a Phase I/II clinical trial of NOX-A12 and Keytruda to treat solid tumours unresponsive to checkpoint inhibitor monotherapy.

NOX-A12 (olaptesed pegol) is Noxxon’s Spiegelmer drug candidate that targets C-X-C Chemokine Ligand 12 (CXCL12), a chemokine (signalling) protein considered responsible for tumour growth, new blood vessel formation and metastasis and subsequently hinders tumour apoptosis.

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Merck’s Keytruda has been developed as a humanised monoclonal antibody that strengthens the immune system to detect and fight tumour cells.

It resists PD-1 from interacting with its ligands, PD-L1 and PD-L2, subsequently activating T-lymphocytes, which may affect both tumour and healthy cells.

Under the agreement, trial sponsor Noxxon will be provided Keytruda by Merck who has also given approval to the design of the trial.

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Part I of the open-label phase I/II study will be conducted to determine pharmacodynamic effects and safety of NOX-A12 as a monotherapy that will be administered to patients for two weeks.

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"We are pleased that MSD shares our interest in the potential of the CXCL12 pathway to modulate the tumour microenvironment to increase the efficacy of checkpoint therapy."

It will compare pre-treatment and post-treatment biopsy specimens to examine the immune infiltrate changes within the tumour microenvironment, which resulted in CXCL12 inhibition with NOX-A12.

Additionally, the study will test the safety and tolerability of NOX-A12 in patients with metastatic (stage IV) colorectal and pancreatic cancer.

Part II of the study will evaluate the safety and tolerability of NOX-A12 in combination with Keytruda.

The trial is expected to enrol 20 patients with ten different cancer types.

Noxxon CEO Aram Mangasarian said: “This collaboration with MSD allows us to initiate a clinical trial of NOX-A12 in patients with metastatic solid tumours 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 tumour microenvironment to increase the efficacy of checkpoint therapy.”

The agreement explores further ways to develop the combination in pivotal clinical trials.

Noxxon expects that the clinical trial will validate its drug to be combined with multiple classes of IO approaches with those acting on or through T-cells and / or NK cells.