The patient case report shows that a heavily pre-treated patient with metastatic appendix carcinoma achieved stable disease over the course of 27 weeks of treatment with invIOs’s Cbl‑b silenced cell therapy.
The poster, “APN401, a novel EpiC-based anti-cancer cell therapy, case report: Cbl-b silenced, autologous PBMCs induced stable disease in an appendix carcinoma patient”, presents the case of a patient who was initially diagnosed with appendix carcinoma that had metastasized into the peritoneum and liver.
Following tumor resection and 11 lines of prior systemic therapy, the patient was enrolled in the ongoing Phase 1b trial presenting with progressive disease. Multiple infusions of APN401 were administered through intravenous delivery route every three weeks respectively followed by safety evaluation. Within a timeframe of 44 weeks, the patient received six cycles of APN401 at dose level 1 (5 x 106 PBMCs/kg) followed by six cycles of APN401 at dose level 2 (1.5 x 107 PBMCs/kg). Treatment with APN401 was well tolerated and the patient presented with stable disease for 27 weeks, suggesting immunological anti-tumor activity resulting from treatment with APN401.
Analysis of the patient’s Cbl-b-silenced PBMCs (peripheral blood mononuclear cells) showed increased cytotoxicity, indicated by an elevated CD8+/CD4+ ratio, and increased potency, as evidenced by elevated IL-2 levels. Further, biomarker analysis of the patient’s T cells before each infusion cycle revealed an accumulation of three T cell clonotypes during the treatment period, as well as improved immunity and anti-tumor reactivity, as determined via a surrogate marker. This supports the potency of APN401 and its potential as an effective therapeutic for malignancies, which is being further investigated in the ongoing clinical trial.