RE:RE:G12D/G12V KRAS mutation in PC & CRC patients respond to PelaPelareorep's switching off KRAS G12D induces expression of the Fas pathway, reversing early tumor growth, increasing CD8+ T cell infiltration, decreasing myeloid infiltration, the reprogramming of the tumor microenvironment in both early- and late-stage tumors and the elimination of established tumors upon the activation of CD8+ T cells.
Combining various immune checkpoint inhibitors (i.e. Keytruda and Tecentriq) with pelareorep led to sustained tumor regression, enhanced cancer cell clearance and improved survival outcomes with the remodeling of the TME and the leveraging of the activation of the innate and adaptive immune systems.
ONCY's GOBLET-1 study involving the pancreatic cancer cohort combining pelareorep + paclitaxel + the checkpoint inhibitor Tecentriq has already demonstrated an ORR of 69%.
With the above understanding of pelareorep 's ability to switch off KRAS G12D and synergistically enhance checkpoint inhibitors, the PanCan network unequivocally decided to advance this combination into a Phase 3 registration study where an early Accelerated Approval could be granted on the Phase 2 GOBLET-1 data, as had happened with Mirati Therapeutics' KRAS 12C inhibitor in NSCLC, and whose Phase 3 confirmatory is currently on going.
And while the world has been focused on Mirati’s pre-clinical MRTX1133 , ONCY has been delivering on its late stage clinical development plans with pelareorep in combination with CPIs in breast, pancreatic and colorectal cancers.
https://www.cell.com/trends/cancer/fulltext/S2405-8033(23)00137-1