MKC1106-MT is an active immunotherapeutic treatment consisting of three components, a DNA plasmid encoding select portions of Melan A and tyrosinase (two tumor-specific antigens that are highly expressed by melanoma tumor cells) and two synthetic peptides with sequences analogous to the targeted portion of Melan A and tyrosinase.
In a previous Phase 1 study, repeat intranodal administration of the treatment regimen was well-tolerated and generated immune responses meeting the primary endpoints of the study.
MannKind’s Phase 1 study also generated objective responses in a subset of patients with disease localised to the lymphatic system.
MannKind’s Phase 2 study is an open-label, multicenter, nonrandomised, Simon Optimum 2-stage design with up to 19 subjects with metastatic melanoma primarily confined to the lymph nodes treated with MKC1106-MT in the first stage and a potential total of 44 subjects overall.
The primary objective of the study is objective response per Recist 1.1 where response is defined as complete response, partial response and stable disease for 12 weeks or longer, while the secondary objectives include time to progression, progression-free survival and overall survival measured at six months and one year.
MannKind corporate vice president and chief scientific officer Peter Richardson said that following the results of their Phase 1 trial, the initiation of this Phase 2 study of MKC1106-MT marks an important step forward for MannKind’s oncology portfolio.