On May 4, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that patient dosing was initiated in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod (CMP-001) in combination with nivolumab for the treatment of patients with anti-PD-1 refractory advanced melanoma. Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. Checkmate previously announced initiation of dosing in patients in an additional trial which is evaluating the efficacy and safety of vidutolimod in combination with nivolumab compared to nivolumab monotherapy in patients with first-line metastatic or unresectable melanoma (Press release, Checkmate Pharmaceuticals, MAY 4, 2021, View Source [SID1234579122]). The data from these two trials are intended to support a biologics license application for the treatment of patients with anti-PD-1 refractory advanced melanoma.
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"Initiation of dosing in this pivotal trial is an important milestone as we move towards potential registration of vidutolimod in melanoma," said Barry Labinger, President and Chief Executive Officer of Checkmate. "Melanoma is estimated to be the fifth most diagnosed cancer in the United States, with more than 100,000 new cases and 7,000 deaths per year. There is a significant unmet medical need for patients who have progressed following treatment with anti-PD-1 therapy since there is no well-established standard of care."
Checkmate previously announced initiation of patient dosing in a Phase 2 trial of vidutolimod in combination with pembrolizumab to evaluate safety and efficacy in patients with first-line head and neck cancer.
Additional information about the Phase 2 anti-PD-1 refractory melanoma trial and the Phase 2/3 melanoma study, including participating investigative sites, can be found here: View Source
Information about Checkmate’s HNSCC trial can be found here: View Source