MannKind Corporation (NASDAQ:MNKD) today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind’s cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma. 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. The phase 1 study also generated encouraging objective responses in a subset of patients with disease localized to the lymphatic system. Final results of the phase 1 study were presented as a poster at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2010.
“Following the promising results of our phase 1 trial, the initiation of this phase 2 study of MKC1106-MT marks an important step forward for MannKind’s oncology portfolio,” said Dr. Peter Richardson, MRCP, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. “Given the lack of treatments available for individuals suffering from advanced melanoma, we are pleased to continue our evaluation of this innovative, targeted therapy, which has already shown early evidence of clinical response and tolerability.”
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. The treatment is administered in a plasmid-prime/peptide-boost approach by intranodal injection to superficial lymph nodes in order to maximize antigen exposure to T-cells.