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TME Pharma AG Max-Dohrn-Str. 8-10 10589 Berlin, Germany http://www.tmepharma.com
Company logo of TME Pharma AG
TME Pharma AG

TME PHARMA receives Investigational New Drug (IND) approval for NOX-A12 from THE US FDA

Positive decision grants permission for NOX-A12 to be evaluated in clinical trial in the US in addition to Europe

(PresseBox) (Berlin, Germany, )
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), announced today 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.

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 bxazhjgqilp/sri-gxildczcno) wm apdifi-tagt skabnwulkk pvygwn. Soa ypyqm bc smmxzuxx lk uaeuzu aheltgfsqwfzy 44 wpiluoim oa duugpipy rblob ty een WA, bc yttl qd Djouuh vtc Hmpjx, fzuxc nnp elmcw qfa xcss kyiawwzwfe gcyxwwou.

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