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AU-007 + aldesleukin + avelumab is an investigational combination therapy being studied primarily for the treatment of advanced or metastatic PD-L1+ non-small cell lung cancer (NSCLC) that has progressed after first-line checkpoint inhibitor therapy. - **AU-007** is a human IgG1 monoclonal antibody targeting interleukin-2 (IL-2), designed to enable selective activation of immune effector cells (like CD8+ T cells and NK cells) while minimizing activation of immunosuppressive regulatory T cells. - **Aldesleukin** is recombinant human interleukin-2, a cytokine therapy that stimulates the proliferation and activation of T cells and NK cells. - **Avelumab** is a fully human IgG1 monoclonal antibody that binds programmed death-ligand 1 (PD-L1), inhibiting its interaction with the PD-1 receptor, thus promoting anti-tumor immune responses by reversing the tumor’s immune evasion. Avelumab is also capable of mediating antibody-dependent cellular cytotoxicity (ADCC). The combination leverages multi-pronged immunotherapy: modulating the activity of IL-2 with the AU-007 antibody, boosting effector immune cell response with aldesleukin, and removing tumor immune suppression via PD-L1 blockade with avelumab. This combination is under development by Aulos Bioscience in collaboration with Merck KGaA (Darmstadt, Germany) for advanced or metastatic PD-L1+ NSCLC. Clinical investigations are currently in phase 2[1][3][5].
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