On behalf of the OncoSec team, we’re thrilled to announce the first patient enrolled in the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the safety and efficacy of the combination of our investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma.
This trial is an important milestone for OncoSec as we seek to address one of oncology’s greatest challenges: the majority of patients with solid tumors who have been treated with anti-PD-1/PD-L1 therapies do not respond to treatment. We believe our technology, ImmunoPulse™ IL-12, can address this unmet medical need by increasing the proportion of patients who will respond to anti-PD-1 and other checkpoint therapies.
Patients who possess “switched-off” anti-tumor CD8+ T-cells in their tumors (i.e. increased tumor-infiltrating lymphocytes, or TILs) are most likely to respond to therapy with anti-PD1 or anti-PD-L1 drugs. However, studies show that these TILs – the target cell for T-cell checkpoint agents – are lacking in the majority of patients.
Preclinical data indicates that local delivery and expression of ImmunoPulse™ IL-12 promotes tumor immunogenicity and increases TILs. As a pro-inflammatory cytokine, IL-12 can promote the recruitment of T-cells to the tumor. By driving T-cells or TILs into the tumor microenvironment, ImmunoPulse™ IL-12 may enhance response to anti-PD-1 and convert anti-PD-1 non-responders to responders.
This collaboration allows us to test our hypothesis and serves as a critical and positive step in the development of our immunotherapy. We believe the combination of OncoSec’s ImmunoPulse IL-12 and checkpoint inhibitors has the potential to be a powerful approach in the fight against cancer, and we look forward to sharing updates on this trial with our constituents.