TME Pharma Granted FDA Approval for Investigational New Drug (IND) Status of NOX-A12
Friday, June 16, 2023
TME Pharma N.V., a biotechnology company focused on developing novel therapies for the treatment of cancer by targeting the tumor microenvironment (TME), has announced that its Investigational New Drug (IND) application for its lead asset NOX-A12 has been approved by the US Food and Drug Administration (FDA). The approval allows TME Pharma to proceed with a Phase 2 study in pancreatic cancer called OPTIMUS, which aims to evaluate the safety and effectiveness of NOX-A12 in combination with pembrolizumab (Keytruda®) and two different chemotherapy regimens.
OPTIMUS is an open-label Phase 2 trial that will enroll around 70 patients across clinical sites in the United States, France, and Spain. The study will focus on second-line pancreatic cancer treatment and will assess the combination of NOX-A12 with pembrolizumab and either nanoliposomal irinotecan/5-FU/Leucovorin or gemcitabine/nab-paclitaxel chemotherapy regimens.
It is important to note that TME Pharma previously announced its dedication to developing NOX-A12 for glioblastoma. The OPTIMUS Phase 2 trial for second-line pancreatic cancer will commence once the company secures sufficient funding.
NOX-A12 is currently being investigated in the GLORIA study, a Phase 1/2 trial that explores its potential in combination with radiotherapy, with or without bevacizumab, for the first-line treatment of glioblastoma patients with tumors resistant to standard chemotherapy (with unmethylated MGMT promoter). Preliminary data from the GLORIA study indicates that NOX-A12 demonstrates a favorable safety profile and shows promising efficacy, with an observed 83% survival rate at 14 months in patients who still had detectable chemotherapy-refractory tumor following surgery.
