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The aim of this Article is to showcase the emerging AI licensing solutions pioneered by RROs and to explore how these frameworks address the challenges posed by AI’s reliance on copyrighted works. The discussion begins with a primer on the structure and operation of collective management frameworks, highlighting their effectiveness in managing rights for secondary uses. Following this, the Article examines the necessity of licensing in the AI context, emphasizing why exceptions and limitations under current copyright regimes are insufficient to adequately address the complexities of AI training. This section underscores the limitations of existing legal frameworks and the potential harm to rightsholders if AI systems continue to use copyrighted works without appropriate permissions or compensation. Finally, the Article presents an analysis of the emerging licensing solutions tailored to AI, illustrating how these initiatives by RROs are not only meeting the demands of the AI market but are also paving the way for sustainable and equitable practices at the intersection of copyright and technology.

BackgroundProstate cancer (PC) is the most frequently diagnosed cancer in men worldwide, making up 21% of all cancer cases. Although generally slow-growing, 370,000 men die from PC yearly. Immune checkpoint inhibitors (ICIs) are currently only indicated for the rare cases of microsatellite instability high or tumor mutation burden high disease. Combination therapy strategies that induce immune responses may expand the utility of ICIs. Here, we investigated the safety and efficacy of PROSTVAC, a therapeutic cancer vaccine that targets prostate-specific antigen (PSA), in combination with the programmed cell death protein-1 inhibitor nivolumab (NCT02933255).MethodsWe enrolled two cohorts in this trial (phase 1 and 2), both treated with PROSTVAC vaccine and nivolumab. The lead-in cohort had 12 patients with metastatic castration-resistant PC (mCRPC); the neoadjuvant cohort included 12 patients with localized PC who were candidates for radical prostatectomy (RP). We assessed tumor-infiltrating lymphocytes and programmed death-ligand 1 expression in matched formalin-fixed paraffin-embedded samples from baseline biopsies and RP samples. We measured changes in peripheral blood serum analytes, immune cell subsets and antigen-specific T cells targeting PSA, brachyury, and MUC-1 in both cohorts.ResultsIn the lead-in cohort, two patients had a prolonged complete radiographic response by Response Evaluation Criteria in Solid Tumors V.1.1. In the neoadjuvant cohort, CD4+ T helper cell and CD8+ T-cell densities were increased by >2-fold in RP samples compared with baseline in most patients (91% and 83% of patients, respectively). Proliferation of CD4+ and CD8+ T cells also increased in RP samples compared with baseline. Most patients from both cohorts (lead-in and neoadjuvant) had a >2-fold increase in PSA-specific (82% and 58%), MUC-1-specific (64% and 73%), and brachyury-specific (70% and 82%) T cells after therapy. In peripheral blood, we detected increases in proliferative CD4+ and CD8+ T cells but reductions in total CD4+ and CD8+ T cells.ConclusionNeoadjuvant PROSTVAC in combination with nivolumab is associated with increased intratumoral T-cell infiltrates, increased circulating tumor-associated antigen-specific T cells, and with radiographic and biochemical responses in the mCRPC setting. Our findings support the idea that the addition of a vaccine to a tumor-associated antigen might improve the clinical activity of immune checkpoint inhibition.Trial registration number NCT02933255.