On April 8, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported that its Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio) has been accepted by the U.S. Food and Drug Administration (FDA) (Press release, 4SC, APR 8, 2020, View Source [SID1234556210]). The MERKLIN 2 study is a Phase II clinical study evaluating domatinostat in combination with avelumab in patients with advanced MCC whose disease has progressed on anti-PD-(L)1 antibody therapy. Avelumab is an anti-PD-L1 antibody co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer.

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MCC is a relatively rare, but highly aggressive and immunogenic type of non-melanoma skin cancer. In 2017, avelumab was the first anti-PD-(L)1 antibody approved in both the EU and US for treatment of metastatic MCC. Since 2017, anti-PD-(L)1 antibodies have become the standard of care in metastatic MCC globally. However, a majority of patients may become refractory or relapse on this treatment, and currently do not have access to effective subsequent therapeutic options, which is reflected by a high mortality rate. The MERKLIN 2 study seeks to address this high unmet medical need.

Jason Loveridge, Ph.D., CEO of 4SC: "We are delighted to be working with Merck KGaA, Darmstadt, Germany and Pfizer as pioneers of immune checkpoint blockade to address the high unmet medical need in patients with advanced MCC disease and now that our IND is open, we can go forward with this study in the US as soon as practically possible".