On Target Laboratories, Inc. — Department of Health and Human Services SBIR Phase II: 102

Description

Project Summary Abstract Lung cancer remains the leading cause of cancer related deaths worldwideSurgical removal of the tumor is the best therapeutic options for patients with non small cell lung canceryet up toof patients still leave the operating room with deposits of cancer left behindAdvances in CAT and PET scans have provided surgeons with helpful radiographic imaging information prior to surgerybut have limited specificity for nodules less thanmm in diameterSubsequent pathological analysis confirms refutes what a surgeon has resectedHoweverboth of these procedures require additional time and occur outside of the operating roomproviding little real time support during the surgeryThe applicant has developed a novel cocktailOTLthat combines two ligands targeted specifically to lung tumor tissue tagged with a near infraredNIRdyeOTLOTLThe fluorescent cocktail containing ligands targeted to both folate and the CA IX receptors will essentially identify tumor populations that overexpress either or both of these cell surface receptorsReal time visualization not only of the complete tumor margins but also potentially other malignant sites outside the primary tumor area will enable complete surgical removal of primary and other tumor tissuesMoreoverfluorescence imaging could aid in the surgical decision to conserve lung function by removing only the diseased tumor tissue rather than lobectomy or pneumonectomyDuring Phase IIOTL will perform a critical proof of concept study that will extend prior studies using components of the cocktailalone and in combinationand validate continued development toward an Investigational New DrugINDapplicationFirstOTL will optimize the manufacturing of OTLPrepharmacological studies will then be conducted in small animals to determine the optimum doseimaging timetumor to background ratioetcof OTLto be used in the IND enabling studiesOTL will manufacture OTLnon GMPC OTLandC OTLin house for the IND enabling safety and pharmacology toxicity studies that will be conducted at Charles River LaboratoriesCRLSimilarlyfollowing the optimization of formulation and drug drug interaction and pre pharmacological studies of the cocktailOTLIND enabling bridging toxicity studies for the cocktail will be conducted in rodent and non rodent species at CRLThe ultimate goal will be to finish non GMP manufacturing and IND enabling studies to file the IND application for the Phasefirst in human study of the cocktailCommercialization efforts will be aimed at the development of the cocktail for intraoperative use in lung cancer resection surgery that will enable more complete tumor removal and a reduction in the recurrence rate of pulmonary cancer and its associated morbiditymortalityand expense