AMUN-003

The “Triplet” combination of AMUN-003, anti-PD1 and anti-CTLA-4 antibodies was associated with decrease of poor prognosis biomarkers in serum: TGF-β1: Triplet p< 0.001, ICIs p<0.01, AMUN-003 p< 0.05; IL-27p28/IL-30: Triplet and ICIs p< 0.05; IL-1β: Triplet, AMUN-003, ICIs, and AMUN-003+anti-CTLA-4 p< 0.05; TNF-α: Triplet p< 0.01, ICIs p<0.05, and increase of immune stimulatory IFN-γ: Triplet p<0.01 (all compared to the buffer). In lung tissue, no significant changes in cytokine/chemokine expression were detected, however Granzyme B levels were significantly increased in Triplet: p< 0.05. In spleen, we detected increased cytokine expression (IL-2: Triplet, anti-CTLA-4, AMUN-003+anti-PD-1 p< 0.05; IL-4: Triplet p< 0.001, AMUN-003+anti-PD-1, AMUN-003+anti-CTLA-4: p< 0.01).

In syngeneic immune competent animals harboring an aggressive TNBC tumor, single agent Amun-003 appeared safe and was more effective at controlling tumor progression following an intratumoral injection when compared to other tested adenovirus constructs. In the same model, combinations of ICI with Amun-003 resulted in delayed tumor growth and control of metastatic spread. These results with Amun- 003 support advancement to human clinical testing.