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Oncolytics Biotech Inc. (NASDAQ:ONCY) Q1 2024 Earnings Call Transcript May 9, 2024 Oncolytics Biotech Inc.
Matt Coffey: " I'll start with a brief note on what makes [pelareorep] such a compelling immunotherapy candidate. In a nutshell, it's all about results, how it is delivered, intravenously and work systemically. It is able to selectively replicate in tumors and introduce double-stranded RNA into these cancer cells.
This results in generating recruiting and training the immune cells to begin identifying cancer cells to enable cancer cell killing in addition to remodeling the tumor microenvironment to activate immune cells.
This has been highly unique because the responses [pella] generates have lead to synergies with multiple cancer treatments, including chemotherapy, immune checkpoint inhibitors, CAR T cell therapy and others. These synergies come from two randomized breast cancer studies. Multiple studies in pancreatic cancer and recently, there's been an intriguing efficacy signal in the anal cancer cohort of our GOBLET study, which included a complete response even in the absence of standard cytotoxic chemotherapies. In these clinical trials, elements used in combination with chemotherapy drugs like nab-paclitaxel for immune checkpoint inhibitors like atezolizumab, compelling data from these studies showed that treatment with pela produced meaningful clinical responses with favorable comparisons to historical controls."
" As in the case of GOBLET from randomized controlled trials demonstrated in breast cancer. It's demonstrated a positive association between increases in tumor infiltrating lymphocytes or TILs and tumor responses, and those [indiscernible] by patients. Taken together these data form the basis of our enthusiasm for pela as a novel differentiated immunotherapeutic agent and supports our plans to study with registration track studies. 2024 is off to a promising start. We're building on our compelling pela clinical databases and continuing our transition to become a late-stage oncology company. A few notable milestones marked our year to date progress. We've been granted a Type C meeting with the FDA for a Q2 2024 meeting to discuss our planned registrational enabling study in breast cancer.
Defining this registration pelareorep in breast cancer as a pivotal cohort clinical goal for the year. We expanded enrollment for the cancer cohort of the GOBLET study to strengthen the already promising signal of efficacy. This is important because could open the door to a new registrational indication, an accelerated approval for pathway. We received regulatory clearance to begin enrolling patients in the new pancreatic cancer cohort and GOBLET study. This cohort will evaluate pela in combination with a widely used chemotherapy regimen called modified FOLFIRINOX with and without atezolizumab. The study is supported by a US $5 million grant from the Pancreatic Cancer Action Network of known PanCAN, which provides additional positive validation for pela.
We affirm plans to report overall survival data from the Phase 2 BRACELET breast cancer study and H2 2024. While we have reported overall survival response data for pela paclitaxel, that is three times paclitaxel monotherapy, overall survival data continues to mature. This has the potential to be a major catalyst as we have already had another metastatic breast cancer study called IND-213 for overall survival integrations. We announced that two abstracts related to clinical and translational data were selected for presentation at the annual meeting of the American Society for Clinical Oncology or ASCO 2024, which we'll be able to discuss in more detail later this month. We continue to maintain an active dialogue with our clinical collaborators and potential strategic partners.
These discussions provide valuable perspectives that have shaped and enriched our registrational study plans. Looking ahead, we remain laser focused on our critical objectives for 2024. In H1 2024, we intend to provide guidance on the registration path for pela and breast cancer. Over the coming months, we expect to enroll the first patient in Cohort five of the GOBLET study, which is evaluating pela plus modified FOLFIRINOX with and without atezolizumab in pancreatic cancer patients. Also in H2 2024, we expect to report overall survival data from the BRACELET-1 breast cancer study. Now before I turn the call over to Tom to provide you with an update on our clinical programs. I'd like to thank everyone in the Oncolytics organization and our collaborators for the dedication that you bring to our mission every day to improve the care of patients with cancer."