Polymeric Paclitaxel-loaded micelles for the treatment of Triple Negative Breast Cancer



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The overall goal of the BMBF-funded PP-TNBC project is to promote the development and clinical translation of paclitaxel-loaded π–π stacking stabilized polymeric micelles (Picelles) for the treatment of triple-negative breast cancer (TNBC). This will be achieved by putting together a comprehensive data package encompassing optimization and GMP-compliant scale-up of polymer synthesis, development of GMP-ready protocols for formulating paclitaxel in Picelles, and preclinical evaluation of the biodistribution, therapeutic efficacy and safety of paclitaxel-loaded Picelles. With regard to the latter, we anticipate that paclitaxel-loaded Picelles will outperform the clinical products Taxol® and Abraxane® in advanced TNBC mouse models, both in monotherapy regimens and in combination with immunotherapy. We will also compile documentation for interaction with regulatory authorities and stakeholders for guidance on further clinical development. Collectively, the outcomes of the above efforts will put us in a strong position to secure follow-up funding to proceed to phase 1/2a clinical trials immediately after the end of the PP-TNBC project. Within this project, we closely collaborate with the Fraunhofer Pilot Plant Center for Polymer Synthesis and Processing PAZ in Schkopau, the Experimental Pharmacology & Oncology Berlin-Buch in Berlin, the Clinic for Nuclear Medicine, the Clinic for Gynaecology and Obstetrics, and the Center of Translational & Clinical Research of the Uniklinik RWTH Aachen. At ExMI, we mainly contribute with the synthesis of monomers and polymers for the formulation of paclitaxel-loaded micelles, the development of an upscaling of the production and the preclinical evaluation to facilitate the translation into the clinic.