Five Eleven Pharma Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

AbstractThe objective of this Fast Track proposal is to support the development and commercialization of a proprietary positron emission tomographyPETimaging agentGa Pthat specifically targets prostate specific membrane antigenPSMAin patients with prostate cancerProstate cancer is the second leading cause of death from cancer in U SmenThere are no commercially availableGa PSMA inhibitors on the marketwhich is preventing the widespread use of this clinically useful class of diagnostic drugsThe advantage of targeting PSMA using radiolabeled PSMA inhibitors is the combination ofxx fold expression levels of PSMA on the epithelium of prostate adenocarcinomaswhich in combination with nM affinity constants results in uptake ratios of andgtwhereas other radiotracers proposed for PCa exhibit much lower uptake ratios of the order ofenabling detection of much smaller lesionsOurGa Pagent utilizes a proprietary chelator linker pharmacophore combination and has performed well in pre clinical evaluationFive Eleven Pharma is self funding two Phase I clinical trials under INDto determine human dosimetry and pharmacokinetics in cancer patients usingGa PPreliminary data from these trials has shown a good safety profilefavorable dosimetry and accumulation ofGa Pin PSMA expressing tissue and prostate cancer lesionsDuring this early phase developmentthe FDA has suggested further investigations into the drug substance chemistry to support the longer term development ofGa Pand eventual NDA filingThe Phasestudy of the Fast Track proposal is designed to validate the manufacturing process ofGa Pthrough targetedstresstestingtaking into account comments by the FDA addressing the identityquantitation and stability of isomers in the final drug productAfter successful completion of Fast Track Phase Iwill have sufficient data to fully characterize the isomer content of the drug substanceGa Pincluding how isomer content may impact its biological activityIn Phaseof the Fast Track SBIR we proposes a Phase IIa clinical study that will focus on PSMA imaging in PCa patients presenting with biochemical recurrenceBCRrising serum PSA after primary treatmentThe endpoint of the Phase IIa clinical trial is to detect achange in management care in BCR patients when comparing treatment plans usingGa Pimaging information those based on standard of care imaging aloneThis pilot efficacy data will help Five Eleven Pharma to design Phase IIb III studies thatafter consulting with the FDAwill lead to NDA enabling clinical protocols NarrativeProstate cancer is the second leading cause of death in U Smen and is often associated with an overexpression of prostate specific membrane antigenPSMAa specific biomarker for both primary and metastatic prostate cancerFive Eleven Pharma Incis developing a proprietary PSMA targeted imaging agentGa Pto more clearly detect both primary and metastatic prostate cancerusing a generator based radionuclideGaand positron emission tomographyPETOnce obtaining FDA approvalthis proprietary agent should provide greater patient access to better detection and quantitation of prostate cancerand should lead to improved outcomes in patients with prostate cancerand broad adoption by the medical community