On March 9, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported phase 1b data demonstrating clinical proof-of-concept for pelareorep-proteasome inhibitor combination therapy in multiple myeloma (Press release, Oncolytics Biotech, MAR 9, 2022, View Source [SID1234609764]). The data are featured in an abstract accepted for a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is taking place both virtually and in-person April 8-13, 2022, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The abstract is also posted on the AACR (Free AACR Whitepaper) meeting website.

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The AACR (Free AACR Whitepaper) data are from a completed phase 1b trial evaluating the combination of pelareorep and the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma patients. Results from the trial showed that the combination was well-tolerated and led to prolonged progression-free survival (PFS) of over three years in a subset of patients. Additionally, biomarker data demonstrated increased infiltration of T and NK cells in the tumor immune microenvironment post-treatment. These post-treatment increases in anti-cancer immune cells correlated with both clinical response and changes in T cell clonality, which has previously been identified as a potential predictive biomarker that could increase the likelihood of success in future trials of pelareorep by informing patient selection.

"To see patients resistant to prior therapies achieve multi-year PFS is a remarkable finding that speaks to pelareorep’s potential to synergistically combine with anti-cancer agents and provide sustained clinical benefit," said Kevin Kelly, M.D., Ph.D., Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Principal Investigator of the trial. "The observed correlation between clinical response and increases in anti-cancer immune cells in the tumor immune microenvironment is also an important result, as it suggests the studied combination’s activity is being driven by pelareorep’s immunologic mechanism of action. I look forward to discussing these findings with the clinical community and presenting additional data from the trial at the upcoming AACR (Free AACR Whitepaper) meeting."

Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc., added, "These are exciting results that we believe bode well for successful outcomes in our two ongoing multiple myeloma studies that are evaluating pelareorep in combination with a next-generation proteasome inhibitor. We are also very pleased that this study further supports the potential of T cell clonality to predict patient responses to therapy, and we look forward to continuing the development of this biomarker as a potential tool to improve our ability to select patients most likely to respond to pelareorep-based therapies in future trials across multiple indications."

Oncolytics continues to build on data from the completed multiple myeloma trial through the advancement of two ongoing phase 1 trials of pelareorep in this indication. The first of these trials, NCI-9603, is being conducted in collaboration with the United States National Cancer Institute and is evaluating pelareorep in combination with the proteasome inhibitor carfilzomib (Kyprolis). The second, WINSHIP 4398-18, is a collaboration with Bristol Myers Squibb and is evaluating the combination of pelareorep, carfilzomib, and the checkpoint inhibitor nivolumab (Opdivo). For more information on these trials, see Clinicaltrials.gov identifiers NCT02101944 (NCI-9603) and NCT03605719 (WINSHIP 4398-18).

Additional details on the AACR (Free AACR Whitepaper) abstract titled, Using imaging mass cytometry to visualize the multiple myeloma tumor microenvironment post immune priming, and its corresponding poster are shown below.

Session Category: Tumor Biology
Session Title: Models and Technical Approaches to Analyze and Examine the Tumor Microenvironment
Session Date and Time: Wednesday April 13, 2022, 9:00 AM – 12:30 PM Central Daylight Time
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 14
Poster Board Number: 25
Abstract Number: 3880