Oncolytics Biotech Inc T.ONC

RE:RE:RE:Accelerated Approval after Bracelet-1

[Lesalpes29]

SundayMovies wrote: Yes, a guess but an educated one nonetheless. We do know that Adlai got something spectacular from a boring dosing escalation confirmation trial where they did add a check point inhibitor on 10 patients:

Results published in the SABCS abstract indicate that pelareorep in combination with paclitaxel was safe, well tolerated, and showed anti-tumor activity in Adlai Nortye's single-arm bridging clinical trial in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. As of the abstract's data cut-off date (June 2, 2022), ten patients had been treated in the trial, with four achieving a partial response (two confirmed, two unconfirmed) and five showing stable disease (SD). Eight of the nine patients achieving a partial response (PR) or SD remained on study and continued to receive treatment as of the cut-off date. Updated and additional data from the trial will be presented in the poster corresponding to the abstract in accordance with the SABCS embargo policies.

The bridging trial is designed to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. Results from IND-213 showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel monotherapy. BRACELET-1 remains ongoing, with a readout on overall response rate, progression-free survival, and evolving overall survival data from the randomized phase 2 trial expected in the first half of 2023.

We can expect lotz of PR (partial responses) maybe even a few CR (completed responses because of Goblet-1) when Bracelet-1 data will be available... If so, accelerated approval for Breast Cancer (1st fast-tracked designation). 

By the way I love your guess!