MannKind is best known in the industry for its ongoing attempts to win approval of it's inhaled insulin drug Afrezza. The developer is waiting for a final FDA decision on the drug later this year, but in the meantime it's advancing its oncology portfolio with the initiation of a Phase II melanoma vaccine study.
The Phase II study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma. The drug was well-tolerated in a Phase I study, and generated immune responses. MannKind adds that it saw encouraging data from a subset of patients with disease localized to the lymphatic system. MannKind expects to complete the study in June 2012.
The company has a second vaccine--MKC1106-PP--in development. It's completed Phase I trials for treatment of solid tumor malignancies where the PRAME and PSMA tumor associated antigens are frequently expressed. In an interview with Seeking Alpha earlier this year, CEO Alfred Mann said that his company's vaccines have potential advantages over Dendereon's Provenge (for prostate cancer), noting that MannKind's vaccines are less expensive. He added that both MKC1106-MT and MKC1106-PP are at least three years from approval
- check out MannKind's release
- read the Seeking Alpha interview