On March 3, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the quarter and year ended December 31, 2021 (Press release, Oncolytics Biotech, MAR 3, 2022, View Source [SID1234609454]). All dollar amounts are expressed in Canadian currency unless otherwise noted.
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"We begin 2022 with a strong foundational dataset and potential value-inflection points expected across our pipeline throughout the year," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Chief among these potential inflection points is the expected fourth quarter top-line data announcement for BRACELET-1, our randomized phase 2 trial in HR+/HER2- metastatic breast cancer. This trial builds upon prior clinical data demonstrating pelareorep’s ability to deliver statistically significant survival benefits and synergize with checkpoint inhibition in breast cancer. Importantly, its completion represents the last major clinical step on our path to a registrational study."
Dr. Coffey continued, "Our efforts to advance towards our 2022 milestones are built upon the progress we made in 2021. Analyses from the AWARE-1 breast cancer trial highlight changes in peripheral blood T cell populations as a potential predictive biomarker that could markedly identify patients most likely to respond to pelareorep. The use of such a biomarker could improve our chances of success in subsequent trials and we are working to further its development as part of BRACELET-1. We are employing a similar strategy in our triple-negative breast and gastrointestinal cancer trials, which are showing positive progress following recent updates confirming the favorable safety profile of pelareorep-checkpoint inhibitor combinations. Looking ahead, we will continue to leverage partnerships with industry leaders and academia to advance pelareorep across a spectrum of indications while remaining primarily focused on completing the steps needed to begin a registrational breast cancer study."
Fourth Quarter and Subsequent Highlights
Breast Cancer Program
AWARE-1 data indicate that changes in peripheral blood T cell populations may be a predictive biomarker of pelareorep therapy
Recently announced analyses from AWARE-1’s first two cohorts focused on changes in T cell populations from the peripheral blood and tumors of early-stage HR+/HER2- breast cancer patients following treatment with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab. These changes were compared to the CelTIL score (a measure of tumor cellularity and inflammation) and tumor-infiltrating CD8+ T cells, two metrics that are associated with favorable clinical outcomes. Collectively, the analyses reinforced pelareorep’s immunotherapeutic mechanism of action and its ability to synergize with checkpoint inhibitors such as atezolizumab. They also indicated that changes in peripheral blood T cell populations may predict responses to pelareorep therapy and could
potentially serve as a blood-based biomarker to inform the selection of patients in future studies. This has the potential to significantly de-risk a phase 3 registrational trial and supports expansion into indications that have historically not responded to checkpoint blockade therapies.
Reported a positive interim safety update from the phase 2 IRENE trial at the 2021 San Antonio Breast Cancer Symposium
IRENE is an investigator-sponsored, phase 2 trial designed to evaluate the safety and efficacy of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC) who failed prior chemotherapy. Safety data from the trial show that the combination has been well-tolerated, as no safety concerns were noted in any of the five patients enrolled in the trial at the time of reporting (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future trials by allowing for the early identification of patients most likely to respond to therapy.
Partner Adlai Nortye advanced to the second dose escalation cohort of the Chinese bridging trial evaluating pelareorep-paclitaxel combination treatment in breast cancer
The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in China, which comprises the world’s second-largest pharmaceutical market. Advancement into the trial’s second cohort followed the completion of dosing in the first cohort without any safety issues. The dose being evaluated in the second dose escalation cohort is equivalent to the dose administered in the IND-213 study, which reported a statistically significant near doubling of median survival in HR+/HER2- metastatic breast cancer patients. Results from the bridging trial are expected to allow Adlai Nortye to include data from IND-213 and Oncolytics’ ongoing North American metastatic breast cancer trial, BRACELET-1, in future submissions to regulators in China and its territories.
Gastrointestinal Cancers Program
Reported positive interim safety and enrollment updates from phase 1/2 GOBLET trial
The GOBLET trial is being conducted by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with advanced or metastatic pancreatic, colorectal, and anal cancers. The study design was featured in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (link to PR, link to poster) and included three-patient safety run-ins for two of its four cohorts (first-line advanced pancreatic cancer and third-line metastatic colorectal cancer). The pancreatic cancer cohort’s safety run-in is fully enrolled and has been evaluated by the study’s Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns and recommended the study proceed as planned. The safety run-in for the metastatic colorectal cancer cohort is fully enrolled and is awaiting DSMB review.
In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to assess the potential of CEACAM6 and T cell clonality as predictive biomarkers. An effective predictive biomarker could increase the likelihood of success of future registrational studies by allowing the selection of the most appropriate patients.
The trial builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster).
Corporate Highlights
Promoted Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer
Dr. Heineman has over two decades of experience successfully leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations. Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma and Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman’s experience further extends to big pharma and academia as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.
Financial Highlights
•As of December 31, 2021, the Company reported $41.3 million in cash and cash equivalents.
•Operating expense was $3.8 million for the fourth quarter of 2021 and $13.3 million for the full year 2021, compared to $4.0 million in the fourth quarter of 2020 and $12.5 million for the full year 2020.
•R&D expense was $3.7 million for the fourth quarter of 2021 and $12.9 million for the full year 2021, compared to $4.1 million in the fourth quarter of 2020 and $12.9 million for the full year 2020.
•The net loss for the fourth quarter of 2021 was $7.8 million, compared to a net loss of $9.3 million in the fourth quarter of 2020. The basic and diluted loss per share was $0.14 in the fourth quarter of 2021, compared to a basic and diluted loss per share of $0.21 in the fourth quarter of 2020. The net loss for the full year 2021 was $26.3 million, compared to a net loss of $22.5 million for the full year 2020. The basic and diluted loss per share was $0.49 for the full year 2021, compared to a basic and diluted loss per share of $0.56 for the full year 2020.
•Net cash used in operating activities was $22.4 million for the full year 2021, compared to $22.1 million for the full year 2020.
Anticipated Milestones and Catalysts
•Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q1/Q2 2022
•Glioblastoma study update: H1 2022
•Multiple myeloma study data: H1 2022
•GOBLET 3rd-line metastatic colorectal cohort update: H1 2022
•GOBLET pancreatic cohort update: Q3 2022
•Top-line data from phase 2 BRACELET-1 metastatic breast cancer study: Q4 2022
Oncolytics expects to provide updates on the timing of the following milestones:
•Interim safety update from BRACELET-1 metastatic breast cancer study
Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 5:00 p.m. ET today, March 3, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4650-7590. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 507-590.