Despite significant advances in cancer therapies, many malignancies remain resistant to current treatments due to immunosuppressive mechanisms, limited neoantigen expression and dynamic tumor adaptations. Furthermore, multiple life-threatening infectious &/or inflammatory conditions threaten many patients, underscoring the need for innovative therapeutic widely-usable strategies. iNKT cells have inherent anti-tumor, anti-pathogen and immunomodulatory properties.  Unlike classical T cells, human iNKT can proliferate logarithmically without exhaustion.  They can also be transduced with CARs and rTCRs to enhance targeting. 

We have produced a hghly-pure allogeneic iNKT cell therapy called agent-797.  We have an in-house, scalable, closed automated process to produce functional iNKT at >100 billions of cells/donor and relatively low cost-of-goods.  agent-797 has been used to effectively and safely treat patients with acute respiratory distress trial with various causes in an ongoing clinical (n > 40).  agent-797 has also been used in promising clinical trials in cancer patients, alone and in combination with checkpoint antibodies (n > 45).  Combination of agenT-797 with other therapies induced tumor infiltration by T cells and antigen-presenting cells, activation of central and effector memory T cells and elevated levels of circulating IFN-γ. Additional biomarker analyses are in process, including TCR sequencing of tissue and matched peripheral blood.  Latest data will be presented.  In addition, cancer stromal FAP-targeted CAR was expressed in IL15-armored iNKT (MiNK-215) and a PRAME-HLA-A02-targeted recombinant TCR also expressed in iNKT.  Both specifically enhanced relevant anti-tumor activities of iNKT cells in vitro and in vivo and are being developed for further trials.  Functional data will also be shown.