Friday, September 25, 2015
As part of the global strategic alliance between Merck KGaA, and Pfizer Inc. to jointly develop and commercialize avelumab, an investigational immune checkpoint inhibitor, the companies have announced that they have a collaboration agreement in place with Dako, an Agilent Technologies ( A ) company, for the development of a potential companion diagnostic test or CDx. The financial terms of the agreement were not disclosed.
The three-party agreement, signed recently, enables Dako, Merck KGaA, Darmstadt, Germany, 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 the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C).
Avelumab is currently under clinical investigation and has not been approved for use in the U.S., E.U., Canada, or elsewhere. All investigational products have not yet been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.
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