As part of the global strategic alliance between Merck and Pfizer to jointly develop and commercialise avelumab, an investigational immune checkpoint inhibitor, the companies on September 24, 2015 announced that they have a collaboration agreement in place with Dako, an Agilent Technologies company, for the development of a potential companion diagnostic test (CDx).
The three-party agreement, signed recently, enables Dako, Merck and Pfizer to work to develop the CDx to assess programmed death-ligand 1 (PD-L1) protein expression levels in tumor tissue, and its microenvironment, including tumor-associated immune cells. The investigational CDx is part of the protocols in ongoing clinical trials of avelumab, some of which will be reported at upcoming scientific congresses.
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to potentially enable the activation of T cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialise avelumab.
The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialise avelumab, and advance Pfizer’s PD-1 antibody. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.