ONCOS-102 showed encouraging Phase I efficacy data in a challenging patient population. In its Phase I clinical trial in heavily-pretreated patients with multiple types of solid tumors, ONCOS-102 demonstrated a stable disease (SD) rate of 40% in 10 evaluable patients.
- Patient-level data demonstrate multiple immunotherapeutic mechanisms. The Phase I data showed a dramatic increase in tumor-infiltrating cytotoxic CD8+ T-cells, innate immune system activation, and cancer specific CD8+ T-cells in blood indicating systemic activation of the immune system. Both the increase of innate immune cell infiltration and the increase of CD8+ T-cells were correlated with overall survival.
- Clean safety database in over 100 patients. A five-year compassionate use program has demonstrated an encouraging safety profile in 115 ONCOS-102 treated patients. Adverse events were mostly of grade 1 or 2. The ONCOS-102 Phase I study did not identify a dose-limiting toxicity.
- Synergistic potential in combination usage. Preclinical data has shown synergistic effects between ONCOS-102 and chemotherapy (doxorubicin/ifosfamide). There is also compelling mechanistic rationale for combining ONCOS-102 with immune checkpoint inhibitors, which would benefit from ONCOS-102’s innate immune system activation, co-stimulatory effects and T-cell activation, yielding a complete immunotherapeutic arsenal.