RE:ONCY Corporate Investor PresentationAs pertinent as March 07, 2024 and beginning with the January 2024 Investor Presentation ....
January 2024 ... Latest Corporate Investor Presentation
https://oncolyticsbiotech.com/wp-content/uploads/2024/01/Oncolytics.Deck_.January.pdf
March 07, 2024 - ONCY Q4 2023 & full year financial results
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-reports-fourth-quarter-and-full-year-2023-financial-results-and-operational-highlights/
"New translational data in breast and pancreatic cancer reported in the fourth quarter continued to highlight pelareorep’s role in stimulating tumor-directed immune responses and shaping the tumor microenvironment, affirming its immunotherapeutic mechanism of action (MOA).
These [ Bracelet & Goblet] studies also point to the potential use of tumor-infiltrating lymphocytes, or TILs, as a clinical biomarker for future studies and patient care based on a positive association with tumor responses.
We are optimistic about the potential for pelareorep to provide improved outcomes for cancer patients and look forward to updating investors and our key stakeholders on our registrational readiness and progress as the year unfolds,” concluded Dr. Coffey.
** Comments on Phase 3 Breast Cancer Registrational Study
“Positive 2023 data further de-risked pelareorep and re-defined Oncolytics as a late-stage cancer company. Data from the randomized BRACELET-1 breast cancer trial in HR+/HER2- metastatic patients, reported in June using a March 3, 2023 cut-off date, nearly tripled response rates in the test arm compared to the control arm. Additionally, median progression-free survival was 50% higher in the test arm, and the hazard ratio was 0.29. In the coming months, we expect to report overall survival results from the BRACELET-1 study and define a registrational path that will focus on patients with metastatic HR+/HER2- disease and utilize a pelareorep/paclitaxel combination. Productive, ongoing discussions with our clinical collaborators and potential strategic partners have sharpened and enriched our thinking on the design of this study,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.
** Results of Goblet 1/2 Trial in first line pancreatic cohort presented at ESMO 2023:
https://oncolyticsbiotech.com/wp-content/uploads/2023/10/ESMO_2023_PDAC_poster-FINAL1a.pdf
With these results in hand, we have expanded enrollment in the anal cancer cohort, and, in pancreatic cancer, we intend to initiate an adaptive trial in first-line patients this year. This registration-enabled study will be a landmark achievement for Oncolytics and evaluate the GOBLET pancreatic cohort treatment regimen that was granted Fast Track designation by the FDA.
** Third-line metastatic colorectal cancer patients receiving pelareorep, atezolizumab, and trifluridine/tipiracil (Cohort 3) recorded a 40% disease control rate and met the pre-specified success criteria according to the Simon two-stage methodology.
These findings are encouraging given that exhaustion of tumor-infiltrating lymphocytes, resulting from late stage of disease and extensive prior chemotherapy, may have limited their ability to expand in response to treatment. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep’s ability to synergize with atezolizumab. These data also support pelareorep’s immunologic mechanism of action and will inform our plans for further development.”
https://oncolyticsbiotech.com/press_releases/oncolytics-achieves-success-criteria-for-efficacy-in-the-third-line-colorectal-cancer-cohort-of-the-goblet-study/
https://oncolyticsbiotech.com/wp-content/uploads/2023/10/ESMO_2023_CRC-FINAL.pdf