https://www.sec.gov/Archives/edgar/data/1129928/000112992822000073/oncyq22022earningspr.htm
(August 11, 2022) - BRACELET-1’s data to occur at a major oncology meeting in the first half of 2023. The change in the expected timing of the trial’s first data announcement will allow Oncolytics and its partners and collaborators to showcase not only top-line data on overall response rate, but also mature progression-free survival data, evolving overall survival data, and translational data. Oncolytics believes presenting this dataset as a whole will aid in its efforts to advance pelareorep towards registration as efficiently as possible. Oncolytics remains engaged with regulators and partners as it plans its registration program.
https://ir.oncolyticsbiotech.com/all-sec-filings/content/0001129928-22-000085/0001129928-22-000085.pdf (Novermber 07, 2022) - Co-development Agreement with Pfizer Inc. and Merck KGaA, Darmstadt, Germany: BRACELET-1 study
In 2019, we entered into a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to co-develop pelareorep in combination with paclitaxel and avelumab (Bavencio ), a human anti-PD-L1 antibody, for the treatment of HR+/HER2- mBC. This phase 2 clinical trial is jointly funded by Oncolytics and Pfizer. The study, known as BRACELET-1, is a randomised open-label study that enrolled 48 patients into three cohorts: paclitaxel alone, paclitaxel in combination with pelareorep, and paclitaxel in combination with both pelareorep and avelumab. PrECOG LLC, a leading cancer research network, is managing the BRACELET-1 study. We completed patient enrollment in the second quarter of 2022.
The study is examining the expression of immune-related biomarkers to identify changes in T cell population between pretreatment and on-therapy biopsies and seeks to confirm our previously identified biomarker. It is designed to assess efficacy in terms of overall response rate at week 16 per RECIST 1.1. The safety of the combination is also being evaluated.
The results of this study may provide an opportunity to add an arm to our proposed registration study that includes a checkpoint inhibitor in addition to the chemotherapy-pelareorep combination.
Furthermore, the results of the BRACELET-1 study may provide important confirmatory data in the same patient population as our IND.213 study, for which we presented a statistically significant near doubling of overall survival with pelareorep treatment in HR+/HER2- mBC.
These endpoints, including the biomarker data, are expected to further de-risk our contemplated registration study, permitting for a smaller study with a higher likelihood of clinical success.
In the third quarter of 2022, we continued re-treating patients still on-study, monitored those patients who came off treatment due to progression, and assisted with follow-up activities. These activities included analyzing data on the study's primary endpoint on week 16 overall response rate and secondary endpoints of progression free survival and overall survival.
https://ir.oncolyticsbiotech.com/all-sec-filings/content/0001129928-23-000006/0001129928-23-000006.pdf
(March 03, 2023) - BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer with cohorts evaluating: (1) paclitaxel alone; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the checkpoint inhibitor avelumab. Oncolytics expects to announce overall response rate and progression-free survival data from BRACELET-1 at a major medical meeting in the second quarter of 2023.
https://ir.oncolyticsbiotech.com/all-sec-filings/content/0001129928-23-000008/0001129928-23-000008.pdf