Portage Biotech Inc. announced updated interim data from the Phase 1 portion of the trial evaluating its lead invariant natural killer T cell (iNKT) engager, PORT-2 (IMM60), alone and in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma and metastatic non-small cell lung cancer (NSCLC) presented in a poster presentation at the 2023 ASCO Annual Meeting. Based on the favorable safety and tolerability data for PORT-2 shown to date with early evidence of single agent activity, the Company is expanding the Phase 1 portion of its Phase 1/2 trial to evaluate higher dose levels. Results of the expanded Phase 1 trial are anticipated by end of 2023 and will be used to confirm the recommended Phase 2 dose of PORT-2 and clinical trial strategy for the Phase 2 portion of the trial.

PORT-2 is a liposomal formulation of IMM60, an invariant natural killer T cell (iNKT) small molecule engager developed by the University of Oxford. iNKT cells are a distinct class of T lymphocytes which play an important role in anti-tumor immune responses by recognizing lipid antigens on the surface of the tumor. Portage's synthetic iNKT engagers are designed to optimally engage the T cell receptor on the iNKT and facilitate its binding to dendritic cells, resulting in the secretion of a large amount of pro-inflammatory cytokines.

This leads to the activation and expansion of important immune system components and primes and boosts an adaptive immune attack against cancer. The liposome provides improved pharmacokinetic profile and selective delivery to immune cells in the tumor. Monotherapy treatment with PORT-2 (IMM60) has demonstrated a heightened immune response and cancer control in animal models that are resistant to PD-1 antibody treatment.

Additionally, combination therapy with PD-1 antibodies is synergistic with PORT-2 and restores sensitivity to PD-1 blockade in PD-1 resistant animals.