SAN DIEGO, Calif and CALGARY, AB, May 5, 2022 (Canada NewsWire via COMTEX) -- Anticipated Q4 2022 data readout from randomized phase 2 study in breast cancer is on track and expected to inform the design of a registrational trial
Clinical biomarker data demonstrates pelareorep's induced improvement in the prognosis of HR+/HER2- breast cancer patients by decreasing their risk of recurrence
Preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with CAR T cell therapy in solid tumors published in Science Translational Medicine
$39.5 million in cash and cash equivalents expected to provide runway through key catalysts and into 2023
Management hosting conference call and webcast today at 5:00 p.m. ET
SAN DIEGO, Calif and CALGARY, AB, May 5, 2022 /CNW/ -- Oncolytics Biotech(®) Inc. /zigman2/quotes/204741333/composite ONCY +0.35% /zigman2/quotes/203812837/delayed CA:ONC 0.00% today announced recent operational highlights and financial results for the first quarter ended March 31, 2022. All dollar amounts are expressed in Canadian currency unless otherwise noted.
"Recent updates from multiple clinical trials have showcased pelareorep's wide-ranging therapeutic potential as well as the advantages of our corporate strategy," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Our latest data in HR+/HER2- breast cancer show pelareorep driving changes in the tumor microenvironment that are known to be associated with improved patient outcomes and a decreased risk of recurrence. These results increase our understanding of pelareorep's mechanism of action and build upon our prior phase 2 data that showed pelareorep delivering a clinically meaningful and statistically significant survival benefit to HR+/HER2- breast cancer patients. They also further de-risk our lead program's upcoming randomized phase 2 data readout, which is expected to confirm and expand upon these prior findings and move us forward into a registrational study."
Dr. Coffey continued, "Recent clinical and preclinical data also showed pelareorep safely combined with a range of drug classes and demonstrated its potential to enable the success of CAR T cell therapies against solid tumors. We believe our strategy has positioned us for sustained success, as its execution allowed us to generate proof-of-concept data in multiple indications while maintaining a strong balance sheet and a clear focus on our lead breast cancer program."
First Quarter and Subsequent Highlights
Breast Cancer Program
AWARE-1 data demonstrate pelareorep's ability to improve the prognosis of HR+/HER2- breast cancer patients and decrease their risk of recurrence
New clinical biomarker analyses from AWARE-1's first two cohorts presented at the European Society for Medical Oncology (ESMO) Breast Cancer Meeting evaluated changes in the tumor microenvironment (TME) following treatment with pelareorep and letrozole with (cohort 2) or without (cohort 1) the checkpoint inhibitor atezolizumab (link to PR). Gene expression analyses showed 100% of evaluable patients with a Risk of Recurrence Score (ROR-S) classified as "low" 21-days post-treatment vs. 55% with a "low" ROR-S prior to treatment. In both cohorts, the treatment regimen caused tumors to convert from the more aggressive luminal B classification to luminal A classification, which is associated with improved clinical outcomes. Collectively across both cohorts, the percentage of evaluable patients with a luminal A classification increased from 55% before treatment to 85% 21 days after treatment. Statistically significant increases in markers of tumor cell death and T cell activation were also observed with treatment. Altogether, these results reaffirm pelareorep's ability to improve the prognosis of breast cancer patients and decrease their risk of recurrence by remodeling the TME and stimulating anti-tumor immunity.
Partner Adlai Nortye advanced Chinese bridging trial of pelareorep-paclitaxel combination to final dosing cohort
The ongoing bridging trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Initiation of the trial's final cohort followed the completion of the dose escalation evaluation periods of the first two cohorts, which indicated that the studied combination was well tolerated with no new safety signals observed. The dosing regimen for the trial's second cohort is equivalent to that administered in IND-213, while the regimen for the third cohort is equivalent to the regimen being administered in BRACELET-1, an ongoing phase 2 trial in HR+/HER2- breast cancer that is evaluating pelareorep plus paclitaxel with and without a checkpoint inhibitor. Completion of the bridging trial is expected to accelerate pelareorep's development in China, the world's second largest oncology market.
Gastrointestinal Cancers Program
Successfully completed safety run-ins for the phase 1/2 GOBLET trial
The GOBLET trial is evaluating 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 three-patient safety run-ins for the trial's pancreatic cancer and third-line metastatic colorectal cancer (mCRC) cohorts have each been successfully completed following an independent review by the study's Data Safety Monitoring Board (DSMB), which noted no safety concerns. Following the DSMB reviews and authorization from the Paul Ehrlich Institute (PEI; Germany's medical regulatory body), all of the trial's four cohorts are now cleared for full enrollment.
In addition to providing data on the safety and efficacy of pelareorep-atezolizumab combinations, the GOBLET trial is designed to evaluate CEACAM6 and T cell clonality as predictive biomarkers of treatment response. Use of a predictive biomarker in future studies may increase their likelihood of success by ensuring selection of the most appropriate patients.
Additional Immunotherapeutic Opportunity
Preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors published in Science Translational Medicine
Though CAR T cells have generated long-term cures in patients with hematological malignancies(1), they have thus far had limited success against solid tumors due primarily to challenges posed by short-lived perseverance, immunosuppressive TMEs, and antigen escape. A peer-reviewed preclinical study published recently in Science Translational Medicine showed the persistence and anti-cancer activity of CAR T cells improved dramatically when these cells were loaded with pelareorep (link to PR, link to publication). Compared to either treatment alone, treatment with pelareorep-loaded CAR T cells led to statistically significant survival benefits in murine models of skin and brain cancer. In addition, boosting mice treated with pelareorep-loaded CAR T cells with a subsequent intravenous dose of pelareorep led to a further enhancement in efficacy and tumor cures in >80% of mice treated in each model. Mechanistic analyses indicated that the enhanced efficacy of this combination was due to pelareorep's ability to increase CAR T cell perseverance, reverse immunosuppressive TMEs, and reduce antigen escape. The reduction in antigen escape was linked to the creation of dual-specific CAR T cells that target both the tumor directly and pelareorep proteins within the tumor. Given that solid tumors represent the vast majority of cancer cases, these results demonstrate pelareorep's potential to significantly expand the commercial opportunity offered by CAR T cell therapies.
-- As of March 31, 2022, the Company reported $39.5 million in cash and cash equivalents. -- Operating expense for the first quarter of 2022 was $2.6 million, compared to $3.1 million for the first quarter of 2021. -- R&D expense for the first quarter of 2022 was $3.7 million, compared to $2.8 million for the first quarter of 2021. -- The net loss for the first quarter of 2022 was $6.8 million, compared to a net loss of $6.4 million in the first quarter of 2021. The basic and diluted loss per share was $0.12 in the first quarter of 2022, compared to a basic and diluted loss per share of $0.13 in the first quarter of 2021. -- Net cash used in operating activities for the first quarter of 2022 was $6.3 million, compared to $5.6 million for the first quarter of 2021.
Anticipated Milestones and Catalysts
-- Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q2 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