Shuttle Pharmaceuticals Holdings Inc 2024年度报告

Pursuing a Curefor Cancerure We are developing novel therapiesdesigned to increase cancer curerates, prolong patient survival, andimprove quality of life.erapiesr cureal, and It is with great excitement that I write to review the key milestones that have beenreached over the past year and those that remain in focus to advance Shuttle Pharma’smission to improve outcomes for cancer patients receiving radiation therapy (RT).Itrem L E A D P R O G R A M L A U N C H E D W I T H E N R O L L M E N TM E E T I N G A L L E X P E C T A T I O N SLMLM The biggest milestone achievedthis past year was the successful launch of our Phase 2 trial ofRopidoxuridine and RT for treatment of patients with glioblastoma. We officially reached that milestonein November 2024 when the first patients had been enrolled and treated at three of the six cancercenter affiliates: UVA Cancer Center, Miami Cancer Institute, part of Baptist Health South Florida, and thehn Theurer Cancer Center at Hackensack University Medical Center.ThRoinceJJoo Sincethefirstpatientsweredosed,enrollmentintotheclinicaltrialhasbeenrobustandhasmetallexpectations.Asofwritingthisletter,wehaveachieved43%enrollmentintheinitialrandomizedphaseoftheclinicaltrialwithatotalenrollmentof17oftheinitial40patients.Further,11ofthe40patientshavecompletedallsevencycles.Ourobjectiveistofinalizeenrollmentlaterthisyearwithfollowupanddatareadoutin2026. Leadinguptotrialcommencement,wesuccessfullyonboardedallsixnationallyrecognized,EastCoastcancercenters.Thesixcenterswerechosenfortheirrecognizedstate-of-the-artcancercareandtheavailabilityofpatientspresentingwiththemostaggressiveformofbraintumors–IDHwild-type,methylationnegativeglioblastoma,thetargetoftheclinicaltrial. Asareminder,thePhase2clinicaltrialdesigninitiallyrandomizes40patientsintotwodifferentdoselevelsofdrug,with20patientsreceiving1,200mg/dayand20patientsreceiving960mg/day,todetermineanoptimaldoseforuseinglioblastomapatientsincombinationwithRT.Aftertheoptimaldoseisidentified,14additionalpatientswillbeenrolledattheoptimaldosetoreachstatisticalsignificancewiththeend-pointdemonstratingincreasedsurvivalascomparedtohistoricalcontrols. Thisclinicaltrialiscriticaltothebroaderradiationtherapyindustryaswelooktoleverageradiationsensitizerstoincreasecancercurerates,prolongpatientsurvivalandimprovequalityoflifeforpatientssufferingfromglioblastoma.Ilookforwardtocontinuedtrialexecutionasweaimtoimprovethelivesofmillionsofpatientsimpactedbycancerandtobringhopetopatientsandfamiliesaroundtheworld. A D V A N C E M E N T O F A R O B U S T D E V E L O P M E N TP O R T F O L I O Our primary focus is on our lead therapeutic Ropidoxuridine program. However, it remainsimportant to understand the depth of development stage assets across both cancerTherapeuticsandDiagnostics. THERAPEUTICS Within Therapeutics, after Ropidoxuridine, the second priority has been focused on our HDAC6 selectiveinhibitor SP-2-225. During the past year, we have contracted with Dr. Alejandro Villagra’s laboratory atGeorgetown University to perform in vivo studies of HDAC6 inhibition in 4T1 syngeneic mouse breastcancers.Tumor growth delayhas been observed, andvalidation experimentshave been completed.SP- 2-225 is ready for IND-enabling studies followed by Phase I clinical testing.S Development of other preclinical assets, including our next generation radiation sensitizer formulationof Ropidoxuridine / Tipiracil and our Class I selective HDAC inhibitor forER+ breast cancer, will beprioritized as funds become available. In addition, we plan to submit applications for NIH funding andseek collaborations or joint ventures to support further development of selected preclinical assets.Dops DIAGNOSTICSD Our Shuttle Diagnostics subsidiaryaims to develop pretreatment diagnostic blood tests and imagingagents for prostate cancer patients. The PC-Rad test was developed for predicting outcomes followingradiation therapy for localized prostate cancer and the PSMA-B ligand is a theranostic moleculesoffering diagnosis and therapeutics capability for metastatic prostate cancer.Oarao The intellectual property underlying thePC-Rad Test predictive biomarkertechnology was developedby a collaboration of Shuttle Pharma and Georgetown University scientists through analytical validationand is ready for clinical validation to seek FDA approval as a medical device. Current plans focus oninitiation of the clinical trial for clinical validation of the PC-Rad Test by an investigator-initiated clinicaltrial, working with colleagues at MedStar-Georgetown University Hospital, and expanding to a multi-institutional clinical trial as resources become available. For ourPSMA-B development program, we have entered into a sponsored research agreement withthe University of California, San Francisco (UCSF) to advance pre-clinical development as a potentialdiagnostic and therapeutic, or theranostic, molecule. In a discovery project to develop a novel, boron-containing PSMA ligand to enhance proton radiat