Californian biotech Apexigen has agreed to pair up its immuno-oncology drug APX005M with Bristol-Myers Squibb’s Opdivo in solid tumours, including non-small cell lung cancer (NSCLC).
Apexigen’s drug is a monoclonal antibody designed to activate CD40, a cellular receptor – which is suppressed in tumours – that regulates the activation of immune system cells
The two companies hope that combining APX005M with PD-1 inhibitor Opdivo (nivolumab) will remove two ‘brakes’ holding back the actions of antigen-presenting cells in the tumour microenvironment, and thereby restore an immune reaction against the cancer cells.
“Targeting the tumour microenvironment through activation of antigen-presenting cells is a novel approach that we are excited to add to our immuno-oncology strategy as we continue to advance research for cancers with limited treatment options,” said BMS’ head of oncology development Fouad Namouni.
The two companies are planning two studies, one that will recruit second-line metastatic NSCLC patients who have failed prior chemotherapy, and a second in metastatic melanoma patients who have failed prior immuno-oncology therapy.
The agreement is the second for San Carlos-based Apexigen in many months, having agreed to combine APX005M with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in a phase I/II study involving patients with metastatic melanoma. It started clinical trials of APX005M as a monotherapy in 2015.
Checkpoint inhibitors such as Opdivo and Keytruda have already started to revolutionise the way cancer is treated, but some patients do not respond and it is widely thought that the real potential of these cancer immunotherapies will be seen when they are used in combination, both with each other and with chemotherapy or targeted cancer drugs.
Furthermore, drug developers are forging alliances on all sides to test their drugs in tandem and with so many trials on the go it could be years before the optimal cocktails for individual cancer types are worked out.
BMS already has a swathe of such alliances in place, most recently signing a wide-ranging alliance with Incyte to combine Opdivo with its IDO1 inhibitor epacadostat in clinical trials, including phase III studies in first-line NSCLC and head and neck cancer.