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anti-PD-1 mAb + ERNA-101 is an experimental combination immunotherapy regimen consisting of an anti-PD-1 monoclonal antibody (checkpoint inhibitor) and ERNA-101, an allogeneic, off-the-shelf, induced pluripotent stem cell-derived mesenchymal stromal cell (iMSC) therapy engineered to express an interleukin-7 (IL-7) and interleukin-15 (IL-15) fusion cytokine. Developed by Ernexa Therapeutics (formerly Eterna Therapeutics) in collaboration with MD Anderson Cancer Center, ERNA-101 leverages the intrinsic tumor-homing capabilities of mesenchymal stem cells to deliver the pro-inflammatory cytokine payload directly to the tumor microenvironment. This localized delivery converts immunologically 'cold' tumors into 'hot' tumors by promoting T-cell and natural killer (NK) cell infiltration and activation, while the co-administered anti-PD-1 antibody blocks the PD-1/PD-L1 pathway to prevent tumor-mediated immune evasion. In preclinical models of platinum-resistant ovarian cancer, the combination of ERNA-101 and PD-1 blockade demonstrated synergistic anti-tumor activity, leading to complete tumor clearance and durable survival.
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