On June 15, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that the US Food and Drug Administration (FDA), after reviewing the comprehensive submission, has approved the company’s Investigational New Drug (IND) application to evaluate the company’s lead asset NOX-A12 in a Phase 2 study in pancreatic cancer (OPTIMUS) in the United States (Press release, TME Pharma, JUN 15, 2023, View Source [SID1234632767]).
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OPTIMUS is an open-label Phase 2 study designed to evaluate the safety and efficacy of NOX-A12 combined with anti-PD-1 pembrolizumab (Keytruda from Merck) and two different chemotherapy regimens (nanoliposomal irinotecan/5-FU/Leucovorin or gemcitabine/nab-paclitaxel) in second-line pancreatic cancer. The study is expected to enroll approximately 70 patients in clinical sites in the US, as well as France and Spain, where the study has been previously approved.
"The US Food and Drug Administration’s approval of our IND application is an important milestone for TME Pharma, as it represents the first review and approval of NOX-A12 – and more broadly the first review of our class of compounds – by the FDA. Now we will be able to test NOX-A12 in clinical trials in the US, and this is a very positive piece of news for the future development of NOX-A12. We have thus delivered on our promise to the market to bring the OPTIMUS IND application with the FDA to successful completion, allowing rapid resumption of the pancreatic cancer program once financing is available," said Aram Mangasarian, CEO of TME Pharma.
As announced in June 2022, TME Pharma is currently focusing its capabilities on the development of NOX-A12 in glioblastoma. Therefore, the OPTIMUS Phase 2 trial in second-line pancreatic cancer will be initiated once appropriate funding becomes available.
NOX-A12 is currently being developed in GLORIA, a Phase 1/2 study evaluating NOX-A12 in combination with radiotherapy and with or without bevacizumab in first-line glioblastoma brain cancer (glioblastoma) patients with tumors resistant to standard chemotherapy (with unmethylated MGMT promoter). Interim data reported to date from GLORIA demonstrate that NOX-A12 has an excellent safety profile with extremely encouraging signs of efficacy showing an 83% rate of survival at 14 months in patients with detectable chemotherapy refractory tumor remaining after surgery.