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Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. González Convention Center in San Antonio, Texas from December 6 – 10, 2022.
One poster will feature interim results from a bridging clinical trial being conducted by Oncolytics' partner, Adlai Nortye, to evaluate pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. The second poster, in collaboration with SOLTI-Innovative Cancer Research, will include data from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.
Additional details on the upcoming posters and corresponding abstracts are shown below. Full texts of the abstracts are available on the SABCS website here.
Title: A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced / Metastatic Breast Cancer (REO 026-1)
Program Number: P3-07-04
Session Title: Poster Session 3
Session Date: December 7, 2022
Session Time: 5 p.m. CT
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.
Title: Pelareorep Primes the Tumor for Checkpoint Inhibition Therapy by Activating the Interferon-Gamma Signaling Pathway and Tumor Inflammation Signature in Early Breast Cancer Patients - Results of the AWARE-1 Trial
Program Number: PD4-03
Session Title: Spotlight Poster Discussion 4
Session Date: December 7, 2022
Session Time: 7 a.m. CT
Described in this abstract are the results of gene expression analyses from cohorts 1 and 2 of AWARE-1, a collaborative window-of-opportunity study in patients with early-stage breast cancer that was conducted by Oncolytics Biotech and SOLTI-Innovative Cancer Research. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with the HR+/HER2- breast cancer subtype who were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Results published in the abstract showed that the studied combinations altered tumor microenvironments to induce and enhance anti-tumor immunity. Additional details on the analyses and results described in the abstract will be provided during the SABCS poster presentation in accordance with symposium embargo policies.
