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Oncolytics Biotech Inc (NASDAQ: ONCY), together with SOLTI, has announced new clinical data from the AWARE-1 window-of-opportunity breast cancer study evaluating pelareorep plus checkpoint blockade therapy.
These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2021.
Data from 20 HR+/HER2- early-stage breast cancer patients included in AWARE-1's first two cohorts are presented.
These patients were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) Roche's PD-L1 inhibitor atezolizumab (Tecentriq) before surgery.
Pelareorep treatment in cohort 1 induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes.
Data from cohort 2 patients demonstrated that pelareorep and atezolizumab generated an anti-cancer immune response in the tumor and peripheral blood.
Notably, cohort 2 met the pre-specified success criteria for the study's primary endpoint (50% of patients with over 30% increase in CelTIL score)—six of ten patients achieved at least a 30% increase in CelTIL score following treatment.
Pelareorep reversed immunosuppressive tumor microenvironments and promoted immune effector cell infiltration into solid tumors.
Tumor-cell-specific pelareorep replication was observed in all evaluated patients following intravenous pelareorep administration.
70% of all cohort 1 and 2 patients (n=20) saw an increase in CelTIL from baseline to surgery.
Compared to cohort 1, cohort 2 patients had a higher ratio of CD8+ T cells to regulatory T cells, suggesting pelareorep and checkpoint inhibition enhance inflammation within the tumor microenvironment.
Oncolytics will host a Key Opinion Leader event today at 2:00 pm E.T.
Price Action: ONCY shares are down 8.9% at $3.65 on the last check Monday.
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