VIEWPOINT MOLECULAR TARGETING, INC. — Department of Health and Human Services SBIR Phase I: 102

Description

DESCRIPTION provided by applicant Melanoma incidence is growing faster than any other cancer and the American Cancer Society reports that death rates for melanoma have been rising in the United States for the past years 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 melanocortin receptor subtype I MCR However there are no agents currently available that can be used to exploit this identifiable difference between melanoma cells and normal cells This proposal is focused on development validation and commercialization of novel class of theranostic Pb labeled peptides that bind with high affinity and specificity to MCR for targeted imaging and image guided therapy of metastatic melanoma Our innovative approach enlists matched pair isotopes Pb Pb to enable unambiguous dosimetry based on Pb SPECT imaging for Pb alpha particle therapy Viewpoint Molecular Targeting LLC has developed a strong business partnership with Radiomedix that is driving our development and commercialization of diagnostic SPECT radiotracer Pb DOTA VMT MCR which will be followed by radiotherapeutic agent Pb DOTA VMT MCR in future Randamp D Matched pair isotopes Pb Pb is also attractive due to a relatively long half life h of Pb which is favorable for centralized manufacturing of radiotracers for their direct shipment to imaging facilities and a h half life of Pb which can be commercialized through regional therapy centers Our overall objective is to develop effective theranostic approach for metastatic melanoma that improve diagnosis and therapy of melanoma and provide improved clinical outcomes with fewer milder side effects than current therapies To achieve these objectives we propose the following specific aims Scale up and perform IND enabling validation preparations of Pb DOTA VMT MCR for inclusion in an IND submission to the FDA for first in humans clinical imaging and Determine the feasibility of centralized manufacturing distribution of Pb DOTA VMT MCR for molecular imaging of metastatic melanoma Upon successful completion of our Aims we expect to have validated a manufacturing process for production of ultra high specific activity Pb DOTA VMT MCR and to have collected required CMC data for submission of our clinical imaging IND We further expect to have demonstrated the feasibility of centralized commercial manufacturing and distribution of Pb DOTA VMT MCR These successes are expected to advance VMT MCR through initial commercial risk mitigating milestones to a first in humans clinical trial with Pb DOTA VMT MCR for imaging melanoma of metastatic melanoma patients These studies are the foundation to advance our Pb DOTA 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 radiolabeled Pb labeled peptide conjugate for targeted imaging and future Pb based image guided therapy of metastatic melanoma No other agents are available that are based on this theranostic approach for metastatic melanoma cancer imaging and therapy