On November 5, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and development highlights for the quarter ended September 30, 2021 (Press release, Oncolytics Biotech, NOV 5, 2021, View Source [SID1234594604]). All dollar amounts are expressed in Canadian currency unless otherwise noted.
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"Over the past few months, we achieved key milestones that have advanced pelareorep’s development programs and further highlighted the advantages of its broadly applicable mechanism of action," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "These milestones include the reporting of new clinical biomarker data from our AWARE-1 breast cancer study, which we are pleased to be announcing today. These data further demonstrate pelareorep’s immunotherapeutic effects and its ability to synergize with checkpoint inhibition. It also indicates that changes in peripheral blood T cell populations may be predictive of patient response. This exciting finding could improve our chances of success in subsequent studies by allowing for early identification of patients most likely to benefit from pelareorep therapy. We are evaluating this hypothesis as part of our BRACELET-1 breast cancer trial, which is assessing the safety, efficacy, and pharmacodynamic effects of pelareorep with and without checkpoint inhibition to support the advancement of our lead program to a registrational study."
Dr. Coffey continued, "Beyond our lead program, we also advanced our collaboration with Roche and AIO with the initiation of dosing in our phase 1/2 GOBLET trial. This trial addresses a pressing unmet need in gastrointestinal cancer by leveraging pelareorep’s immunotherapeutic effects to overcome checkpoint inhibitor resistance and then increase the proportion of patients responding to checkpoint inhibition therapies. Looking forward, we will continue to strategically leverage collaborations and partnerships to drive pelareorep’s development as an enabling technology for various immuno-oncology agents across multiple indications with high unmet needs. We believe this will allow us to maximally benefit from pelareorep’s value-creating potential while maintaining focus on our lead breast cancer program."
Third 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
Additional analyses from AWARE-1’s first two cohorts being announced today focus on changes in the peripheral blood and tumors’ T cell populations of HR+/HER2- early-stage 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 assessments of CelTIL score (a measure of tumor cellularity and inflammation) and tumor-infiltrating CD8+ T cells, two metrics that are associated with favorable clinical outcomes. Highlights from the analyses using Spearman’s Rank-Order Correlation not adjusted for multiplicity are shown below:
Pooled analysis across cohorts showed:
A statistically significant decrease in peripheral blood T cell diversity post-treatment, explained by the expansion and generation of new middle frequency anti-viral and anti-tumor T cell clones.
A statistically significant association between pre- vs. post-treatment decreases in peripheral blood T cell diversity and increased post-treatment CelTIL score.
A statistically significant association between increased peripheral blood T cell fraction pre-treatment and tumor-infiltrating CD8+ T cells post-treatment.
Comparative analysis of cohort 1 vs. cohort 2 showed:
The addition of atezolizumab enhanced pelareorep’s ability to generate and expand new anti-viral and anti-tumor T cell clones.
A greater decrease in pre- vs. post-treatment changes in peripheral blood T cell diversity in cohort 2 compared to cohort 1.
A numerical association between decreased post-treatment T cell diversity in the peripheral blood and pre- vs. post-treatment increases in tumor-infiltrating CD8+ T cells in cohort 1. This association reached statistical significance in cohort 2 with the addition of atezolizumab.
Collectively, these analyses further demonstrate pelareorep’s immunotherapeutic mechanism of action and its ability to synergize with checkpoint inhibitors such as atezolizumab. They also suggest that changes in peripheral blood T cell populations are predictive of response to pelareorep therapy and could potentially serve as the basis for a blood-based biomarker to inform the design of subsequent studies.
Oncolytics has completed its planned analyses of AWARE-1’s first two cohorts, which enrolled patients with HR+/HER2- breast cancer. Evaluation of these cohorts was the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study. Following the completion of these cohorts, Oncolytics amended the protocol of the trial so that all remaining cohorts focus exclusively on patients with the HER2+ breast cancer subtype. Together with AWARE-1’s first two cohorts and the ongoing IRENE trial in triple-negative breast cancer, these cohorts will facilitate the evaluation of pelareorep in all breast cancer subtypes.
Partner Adlai Nortye dosed first patient in Chinese bridging trial evaluating pelareorep-paclitaxel combination treatment in breast cancer
The bridging clinical trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Results are expected to allow Adlai Nortye to include data from Oncolytics’ North American IND-213 and BRACELET-1 trials in a future submission to Chinese regulators. This may accelerate pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second largest in the world.
Gastrointestinal Cancers Program
Dosed first patient in the phase 1/2 GOBLET trial in collaboration with Roche and AIO
GOBLET is a phase 1/2 multi-center trial designed to evaluate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial builds off previously reported phase 2 data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster), as well as prior early clinical data showing that pelareorep-based combinations 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).
Additional Immunotherapeutic Combinations and Opportunities
Announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy
Preclinical data presented in a poster at The International Conference on Immunotherapy Radiotherapy Combinations showed that combination treatment with pelareorep and radiotherapy promoted the tumor infiltration of anti-cancer T cells and prolonged survival in a murine cancer model. Increased infiltration of anti-cancer T cells was observed both in tumors exposed to local treatment with radiation and pelareorep, and in tumors located away from the treatment site. Collectively, these data are indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination (link to PR, link to poster).
Financial Highlights
As of September 30, 2021, the Company reported $48.1 million in cash and cash equivalents.
Operating expense for the third quarter of 2021 was $2.9 million, compared to $2.5 million in the third quarter of 2020.
R&D expense for the third quarter of 2021 was $3.3 million, compared to $3.9 million in the third quarter of 2020.
Net cash used in operating activities for the third quarter of 2021 was $3.7 million, compared to $6.1 million for the third quarter of 2020.
The net loss for the third quarter of 2021 was $4.9 million, compared to a net loss of $6.7 million in the third quarter of 2020. The basic and diluted loss per share was $0.09 in the third quarter of 2021, compared to a basic and diluted loss per share of $0.16 in the third quarter of 2020.
Anticipated Milestones and Catalysts
Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q4 2021/Q1 2022
Interim safety update from phase 2 IRENE study in triple-negative breast cancer: Q4 2021
Multiple myeloma study data: Q4 2021
Oncolytics expects to provide updates on the timing of the following milestones:
Interim safety update from BRACELET-1 metastatic breast cancer study
Phase 2 BRACELET-1 metastatic breast cancer study: final data
Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 8:00 a.m. ET today, November 5, 2021. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 7285-9440. 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: 859-440#.