etoposide toniribate (CAP7.1) / CellAct Pharma, Mundipharma - LARVOL DELTA

CAP7.1 is associated with prolonged survival in CES2+ Biliary Tract Cancer patients (CCF 2023) - No abstract available

Clinical • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Randomized phase II trial of the carboxylesterase (CES)-converted novel drug EDO-S7.1 in patients (pts) with advanced biliary tract cancers (BTC). (ASCO-GI 2019) - P2; "NCT02094560; Background: The novel drug EDO-S7.1 (CAP7.1) is converted to active etoposide by CES allowing administration of higher doses, reducing resistance, and permitting treatment of advanced tumors... EDO-S7.1 demonstrated efficacy in pts with advanced BTC and may provide a new biomarker-guided therapeutic option with stratification by intra-tumor CES assessment. These findings will be explored in a larger patient cohort."

Clinical • P2 data

Co-delivery of Paclitaxel and Etoposide Prodrug by Human Serum Albumin and PLGA nanoparticles: synergistic cytotoxicity in brain tumor cells. (PubMed, J Microencapsul) - "These nanodelivery systems may be useful to improve combination chemotherapy for brain tumor treatment. To our knowledge, this is the first report describing the non-cross-linked HSA-based co-delivery nanosuspension which was prepared using nab™ technology."

Journal • Tumor cell • Brain Cancer • CNS Tumor • Glioma • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Dual-Drug Nanosystem: Etoposide Prodrug and Cisplatin Coloaded Nanostructured Lipid Carriers for Lung Cancer Therapy. (PubMed, Drug Des Devel Ther) - "EtpP-CDDP NLCs exhibited more sustained plasma retention, the highest drug distribution in tumors, and the highest tumor-inhibition rates in lung tumor-bearing mice. EtpP-CDDP NLCs improved tumor-cell uptake, cytotoxicity, and tumor-inhibition efficiency, and could be used as a promising drug-delivery system for lung cancer combination therapy."

Journal • Lung Cancer • Oncology • Solid Tumor

Post-hoc analyses of a subgroup of patients with advanced biliary tract cancer (BTC) who crossed over to treatment with etoposide toniribate (EDO-S7.1) in a randomized phase II study (ESMO 2019) - P2; "Background: Etoposide toniribate (also known as EDO-S7.1, and previously known as CAP7.1), a novel topoisomerase II inhibitor, is activated in the presence of carboxylesterases. This post-hoc analysis provides further evidence for the efficacy of etoposide toniribate and suggests that early initiation in pts with advanced BTC may offer a potential survival benefit. The efficacy of etoposide toniribate will be further investigated in a planned phase III study. Funding: CellAct Pharm GmbH and Mundipharma EDO GmbH."

Clinical • P2 data • Retrospective data

Randomized phase II trial of the carboxylesterase (CES)-converted novel drug EDO-S7.1 in patients (pts) with advanced biliary tract cancers (BTC). (ASCO-GI 2019) - P2; "NCT02094560; Background: The novel drug EDO-S7.1 (CAP7.1) is converted to active etoposide by CES allowing administration of higher doses, reducing resistance, and permitting treatment of advanced tumors... EDO-S7.1 demonstrated efficacy in pts with advanced BTC and may provide a new biomarker-guided therapeutic option with stratification by intra-tumor CES assessment. These findings will be explored in a larger patient cohort."

Clinical • P2 data

Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study. (PubMed, Cancers (Basel)) - "Adverse events were predictable, dose-dependent and consistent with those previously observed with etoposide. These efficacy and safety findings in second-line BTC warrant further clinical investigation of CAP7.1."

Clinical • Journal • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Real-time monitoring of etoposide prodrug activated by hydrogen peroxide with improved safety. (PubMed, J Mater Chem B) - "The prodrug 6YT was also verified with comparable activity and improved safety with etoposide both in cells and in a mouse model. As a safe and effective prodrug, 6YT is expected to be one of the promising candidates in chemotherapy against cancer."

Clinical • Journal • Oncology

Imbrium Therapeutics announces U.S. FDA Orphan Drug Designation for etoposide toniribate for the treatment of relapsed refractory biliary tract cancer (Businesswire) - "Imbrium Therapeutics...in conjunction with Mundipharma EDO GmbH, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug etoposide toniribate, a novel topoisomerase II inhibitor, for the treatment of relapsed refractory biliary tract cancer."

Orphan drug