RE:RE:RE:RE:Adlai NortyeAdlai Nortrye's 3 cohort bridging trial investigated pelareorep dosing in combination with paclitaxel. The first 2 cohorts investigated pelareorep + paclitaxel in doses that were equivalent to the IND-213 trial, with the final cohort dosing regimen being equivalent to ONCY's Phase 2 Bracelet - 1 trial.
In March 2022 Adlai Nortye reported that it had advanced to the third and final dose escalation cohort of the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer.
Adlai Nortye's pelareorep + paclitaxel dose escalation study were in Chinese patients to demonstrated safety, tolerability and preliminary effectiveness in an Asian patient populations as opposed to ONCY's IND-213 and Bracelet-1 Phase 2 clinical trial, which were primarily conducted on European derived of African-American patients.
Consequently, the Adlai Nortye dosing results would likely be included in ONCY's (or acquirer) accelerated approval FDA biological license application package, as part of the phamacology/pharmacokinetics section demonstrating the performance of pelareorep in genetically diverse / hetergeneous populations, as opposed to historical BLAs which presented results only on homogeneous European derived populations.
Since Merck KGaA and Pfizer had requested that the results of the Bracelet-1 study remain confidential and that a 3 month stand-still period be imposed from the Bracelet-1 trial end-date (October 2022) for Merck/Pfizer to evaluate the results and move on theri intent - it is likely that Adlai Nortye's results have been enbargoed at Merck/Pfizer's request so that the BLA's filing would remain robust.