{"id":"aglatimagene-besadenovec-valacyclovir","safety":{"commonSideEffects":[{"rate":null,"effect":"Flu-like symptoms"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL3544993","moleculeType":"Gene"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Aglatimagene besadenovec is a conditionally replicating adenovirus engineered to express interleukin-12 (IL-12), which enhances anti-tumor immune responses by promoting T-cell activation and infiltration into the tumor microenvironment. Valacyclovir, a nucleoside analog antiviral, is co-administered to fine-tune viral replication dynamics and potentially optimize the immunogenic window. Together, this combination aims to leverage oncolytic virotherapy with immunostimulation for enhanced anti-tumor efficacy.","oneSentence":"Aglatimagene besadenovec is an oncolytic adenovirus expressing IL-12 that replicates in tumor cells and triggers immune activation, combined with valacyclovir (an antiviral) to modulate viral replication kinetics.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:00:10.395Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic pancreatic cancer"},{"name":"Ovarian cancer"}]},"trialDetails":[{"nctId":"NCT07332000","phase":"PHASE2","title":"A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec","status":"RECRUITING","sponsor":"Candel Therapeutics, Inc.","startDate":"2025-10-30","conditions":"Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer (Adenocarcinoma)","enrollment":45},{"nctId":"NCT04495153","phase":"PHASE2","title":"CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Candel Therapeutics, Inc.","startDate":"2020-10-13","conditions":"Non Small Cell Lung Cancer","enrollment":90},{"nctId":"NCT02768363","phase":"PHASE2","title":"Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Candel Therapeutics, Inc.","startDate":"2016-05","conditions":"Prostate Cancer","enrollment":187},{"nctId":"NCT01436968","phase":"PHASE3","title":"Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Candel Therapeutics, Inc.","startDate":"2011-09","conditions":"Prostate Cancer","enrollment":711},{"nctId":"NCT03131037","phase":"PHASE1","title":"Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2017-05-04","conditions":"Lung Cancer","enrollment":12},{"nctId":"NCT03576612","phase":"PHASE1","title":"GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2018-02-27","conditions":"Glioma, Malignant","enrollment":41},{"nctId":"NCT00589875","phase":"PHASE2","title":"Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2007-03","conditions":"Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma","enrollment":52},{"nctId":"NCT01997190","phase":"PHASE1","title":"Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2013-10","conditions":"Malignant Pleural Effusion, Lung Cancer, Mesothelioma","enrollment":19},{"nctId":"NCT00634231","phase":"PHASE1","title":"A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2010-10","conditions":"Malignant Glioma, Recurrent Ependymoma","enrollment":8},{"nctId":"NCT00638612","phase":"PHASE1","title":"AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2008-08","conditions":"Pancreatic Adenocarcinoma, Pancreatic Cancer","enrollment":27},{"nctId":"NCT00751270","phase":"PHASE1","title":"Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas","status":"COMPLETED","sponsor":"Candel Therapeutics, Inc.","startDate":"2005-11","conditions":"Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma","enrollment":15},{"nctId":"NCT03541928","phase":"PHASE2","title":"Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery","status":"UNKNOWN","sponsor":"The Methodist Hospital Research Institute","startDate":"2018-08-02","conditions":"High-risk Prostate Cancer, Prostate Cancer","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CAN-2409 plus prodrug","AdV-tk","CAN-2409"],"phase":"phase_3","status":"active","brandName":"aglatimagene besadenovec + valacyclovir","genericName":"aglatimagene besadenovec + valacyclovir","companyName":"Candel Therapeutics, Inc.","companyId":"candel-therapeutics-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Aglatimagene besadenovec is an oncolytic adenovirus expressing IL-12 that replicates in tumor cells and triggers immune activation, combined with valacyclovir (an antiviral) to modulate viral replication kinetics. Used for Metastatic pancreatic cancer, Ovarian cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}