Production of Image Guided Metastatic Melanoma Therapy Radiopharmaceuticals

DESCRIPTION provided by applicant Melanoma the fastest growing cancer incidence in the world today and the American Cancer Society reports that death rates for melanoma continue to rise Alarmingly melanoma is the most common cancer in young adults under One characteristic of metastatic melanoma cells that is recognized as a potential target for new therapies is upregulation of cell surface receptor melanocortin subtype I MCR However there are no agents currently available that exploit this identifiable difference between melanoma and normal cells This proposal is focused on development validation and commercialization of an automated system for the preparation of Pb labeled peptides that bind with high affinity and specificity to MCR for targeted imaging and therapy of metastatic melanoma Our innovative approach enlists matched pair isotopes Pb Pb to enable quantitative dosimetry based on Pb SPECT imaging for Pb alpha particle therapy Viewpoint Molecular Targeting LLC has developed a strong strategic business partnerships that are driving our commercialization of diagnostic therapeutic agents Pb DOTA VMT MCR Pb DOTA VMT MCR Matched pair isotopes Pb Pb is also attractive due to a relatively long half life h of Pb which is favorable for centralied manufacturing of radiotracers for their direct shipment to imaging facilities Our overall objectie is to develop effective image guided therapy for metastatic melanoma that will improve outcomes for melanoma patients with fewer milder side effects than current therapies To achieve these objectives we propose the following specific aims Determine the feasibility of an automated cassette based fluid handling system for clinical manufacturing of Pb labeled chelator modified VMT MCR and Determine the feasibility of Pb TCMC VMT MCR and Pb C N VMT MCR for molecular imaging and radionuclide therapy for metastatic melanoma With success in our Aims we expect to determine the feasibility of an automated system to produce high specific activity Pb VMT MCR under Aim We further expect to have determined the feasibility of three VMT MCR compositions to advance to clinical imaging trials via an eIND under Aim We expect these successes to have the positive impact of advancing VMT MCR through initial commercial risk mitigating milestones to a first in humans imaging trial with Pb VMT MCR We expect this to lead to Pb VMT MCR therapy which has the potential to circumvent drug resistance that limits the effectiveness of current treatments for metastatic melanoma PUBLIC HEALTH RELEVANCE This proposal is aimed to establish the feasibility of a novel automated system for the preparation of Pb and Pb labeled peptide conjugates for clinical imaging and image guided therapy of metastatic melanoma No other agents are available that are based on this approach for metastatic melanoma imaging and therapy