On January 9, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces that it successfully completed its pre-IND advice meeting with the US regulator, the Food and Drug Administration (FDA), discussing plans for the further clinical development of NOX-A12 as a treatment of aggressive adult brain cancer, glioblastoma (Press release, TME Pharma, JAN 9, 2024, View Source [SID1234639198]). Based on the feedback received, TME Pharma confirms that it is on track with preparations to file its Investigational New Drug (IND)1 application and the expedited regulatory pathway request on a timeline that will allow successful completion of both by the end of Q1 2024.
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"The informative discussion with the FDA allows our team to prepare an IND application that fits with the requirements of the US regulator in areas where there has been recent evolution in recommendations by the FDA’s Oncology Center of Excellence, such as the selection of the appropriate therapeutic dose of new oncology drugs2," said Aram Mangasarian, CEO of TME Pharma. "As a result, we are confident to be able to meet our target of having an FDA approved clinical trial protocol in glioblastoma with an expedited regulatory path in the US by the end of Q1 2024 in order to secure the funding for the necessary clinical trial via partnership, investment or other strategic transaction types. While the company plans to provide further updates on the status of applications during the ongoing discussions, the final trial design will be shared once the FDA has completed its assessment. We believe that the combination of a defined regulatory path and the mature data from the GLORIA brain cancer trial will, together, form an attractive package for potential partners."