Oncolytics Biotech Releases a Letter to Shareholders - 2021 Review and 2022 Outlook
SAN DIEGO, Calif. and CALGARY, AB, Jan. 11, 2022 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is providing a letter to shareholders, included below.
To the Shareholders of Oncolytics Biotech,
2021 generated ground-breaking data that creates the foundation for continued success in 2022 as we build our clinical opportunities and the data required to embark on our registrational study in metastatic breast cancer. This critical data encompasses data requested by the FDA and our global pharma collaborators, data that de-risks both our registrational program and clinical studies going forward. I would like to provide a summary of our 2021 accomplishments, an update on the final pieces of our metastatic HR+/HER2- breast cancer program, and provide some commentary on several of our promising programs in other indications.
Most importantly, the AWARE-1 study results presented this past year exceeded our expectations and provided us with additional confidence in our overall clinical development program. We are well on our way to completing enrollment in BRACELET-1, expected to occur in early 2022. The combination of clinical data from BRACELET-1 along with data from AWARE-1 will provide the final elements necessary to develop and launch a registrational study in metastatic breast cancer.
HR+/HER2- Breast Cancer Program: Our Primary Focus
If you have been following the Company, you're likely aware that we saw a near doubling of overall survival (OS) in metastatic HR+/HER2- breast cancer patients treated with pelareorep in IND-213, a randomized phase 2 study (link to the PR). After analyzing these data, we focused on achieving three key objectives set forth by regulators and our pharma partners, which represent important steps on the path to a registrational study. These objectives are to:
- confirm that pelareorep works through an immunotherapeutic mechanism of action. Our enhanced understanding demonstrates pelareorep acts as an immunotherapeutic agent, part of an emerging drug class that provides much longer-lasting anti-cancer effects. This understanding allows us to better design clinical studies that are more likely to be successful;
- determine whether pelareorep synergizes with immune checkpoint inhibitors (ICIs). Enhancing ICI activity exposes the Company to an oncology market expected to exceed $55 billion by 2025;
- identify a biomarker to select patients who are likely to have better clinical outcomes. Biomarkers allow us to identify patients who are likely to respond to treatment, streamlining our registration program.
I am pleased to report that we are well on our way to achieving these three objectives. In April, at AACR (link to the PR), we presented data from cohort 1 and cohort 2 (both cohorts exclusively enrolled HR+/HER2- breast cancer patients) of our AWARE-1 study, which is being conducted in collaboration with Roche. Importantly, these data showed we had achieved the first two objectives referenced above. Specifically, we demonstrated that pelareorep treatment reverses immunosuppressive tumor microenvironments, generates and expands T cell clones, upregulates PD-L1 expression, promotes tumor infiltration of CD8+ T cells, and increases CelTIL score, a metric known to correlate with improved clinical outcomes. These effects were even more notable when pelareorep was combined with Roche's ICI atezolizumab, which demonstrates synergy between the two agents. This finding could be a significant advance, not only in breast cancer but in multiple other indications. Finally, in Q4 2021, after completing further analyses of samples from AWARE-1, we reported that changes in peripheral blood T cell populations acts as a putative predictive biomarker. This robust engagement of anti-tumor activity in AWARE-1 supports the hypothesis that the near doubling of overall survival seen in IND-213 was the result of the engagement of innate and adaptive immunity.