Welcome to our dedicated page for Oncolytics Biotech news (Ticker: ONCY), a resource for investors and traders seeking the latest updates and insights on Oncolytics Biotech stock.
Oncolytics Biotech Inc (ONCY) is a clinical-stage biotech company advancing pelareorep, an innovative oncolytic virus immunotherapy targeting multiple cancer types. This dedicated news hub provides investors and researchers with centralized access to corporate developments and scientific progress updates.
Track critical updates including clinical trial results, regulatory milestones, and strategic partnerships. Our curated collection features press releases spanning Phase 2 breast cancer studies, pancreatic cancer research advancements, and manufacturing capacity expansions. Regular updates ensure timely awareness of key developments in HR+/HER2- metastatic breast cancer trials and other high-priority programs.
Discover verified information on pelareorep's mechanism of action, trial design specifics, and intellectual property developments. The resource eliminates the need by aggregating essential updates from randomized controlled studies to manufacturing quality initiatives. Bookmark this page for efficient monitoring of Oncolytics' progress in transforming cancer treatment through viral immunotherapy approaches.
Oncolytics Biotech (NASDAQ: ONCY) has announced significant developments in their pelareorep-based cancer treatments, to be presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The company reported compelling results in two key areas:
In anal cancer, the combination of pelareorep with checkpoint inhibitor atezolizumab showed a 33% objective response rate in twelve evaluable patients, significantly outperforming historical checkpoint inhibitor monotherapy rates of 10-24%. Notably, one patient maintained a complete response for over 15 months.
In pancreatic cancer, following previous positive results with gemcitabine and nab-paclitaxel combination, new safety data supports pelareorep's compatibility with modified FOLFIRINOX treatment. This expansion was supported by a $5 million PanCAN grant, and the Data Safety Monitoring Board has approved continued patient enrollment without modifications.
The GOBLET study's anal cancer cohort has met its Stage 1 efficacy criteria and is proceeding to Stage 2, enrolling 18 additional patients. The treatment shows promising tumor-infiltrating lymphocyte expansion in responding patients.
Oncolytics Biotech (NASDAQ: ONCY) has received approval from Germany's Paul-Ehrlich-Institute to continue enrollment in Cohort 5 of the GOBLET study, which evaluates pelareorep combined with mFOLFIRINOX, with or without atezolizumab, for newly diagnosed pancreatic ductal adenocarcinoma patients.
The approval follows a positive safety review by the independent Data Safety Monitoring Board and allows for full enrollment of 30 patients in Stage 1. Early safety data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium, with initial efficacy results expected in H2 2025.
The company reports encouraging tumor response rates from an earlier GOBLET cohort, suggesting pelareorep's potential to improve outcomes for metastatic pancreatic cancer patients. The current cohort explores a different chemotherapy combination to potentially benefit a broader patient population.
Oncolytics Biotech (NASDAQ: ONCY) highlights significant achievements from 2024 and outlines key milestones for 2025. The company reported promising results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer, showing an estimated median overall survival benefit exceeding one year and nearly doubled two-year survival rates compared to paclitaxel monotherapy.
Key developments include a productive FDA meeting regarding breast cancer program elements, collaboration with GCAR on a registration-enabling pancreatic cancer study, and progress in the PanCAN-supported GOBLET study. The company completed safety run-in enrollment for a new pancreatic cancer cohort and expanded enrollment in anal cancer trials showing promising response rates.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced the upcoming presentation of two significant data sets at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. The presentations will showcase pelareorep's potential in treating gastrointestinal cancers, specifically focusing on pancreatic and anal cancers.
The first abstract (#6) will present preliminary safety and tumor response results for relapsed anal carcinoma patients treated with pelareorep and atezolizumab. The second abstract (#730) will discuss results from the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, and atezolizumab.
According to Dr. Tom Heineman, Chief Medical Officer, pelareorep works by engaging patients' immune systems to enhance the effectiveness of chemotherapies and checkpoint inhibitors, potentially improving survival rates in these challenging cancers.
Oncolytics Biotech (NASDAQ: ONCY) announced the completion of initial safety phase enrollment for Cohort 5 of the GOBLET trial in pancreatic cancer. The Data Safety Monitoring Board recommended continued enrollment following review of safety data from six randomized patients. The study will evaluate pelareorep combined with modified FOLFIRINOX, with or without atezolizumab, in newly diagnosed pancreatic ductal adenocarcinoma patients.
The cohort, funded by a $5 million PanCAN Therapeutic Accelerator Award, will initially enroll 30 patients with potential expansion to 64 participants. Safety data is expected in H1 2025, with initial efficacy results in H2 2025.
Oncolytics Biotech (NASDAQ: ONCY) reported Q3 2024 financial results and operational highlights. The company's BRACELET-1 trial showed impressive results in HR+/HER2- metastatic breast cancer, with pelareorep + paclitaxel demonstrating 12.1 months progression-free survival versus 6.4 months for paclitaxel alone. The company reported $19.6 million in cash and cash equivalents, with a net loss of $9.5 million ($0.12 per share) compared to $9.9 million ($0.14 per share) in Q3 2023. R&D expenses increased to $6.8 million from $5.8 million year-over-year, while G&A expenses decreased to $3.1 million from $5.2 million.
Oncolytics Biotech will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss its third-quarter 2024 financial results and recent operational highlights. The event will be accessible via North American toll-free number (888) 510-2154 and international number (437) 900-0527. Participants can also join through RapidConnect or access the webcast on the Investor Relations page of Oncolytics' website. The webcast will be archived for three months, with a dial-in replay available for one week at (888) 660-6345 (North America) or (289) 819-1450 (International) using replay code 68336#.
Oncolytics Biotech (NASDAQ: ONCY) announced significant progress in breast and pancreatic cancer treatments. The BRACELET-1 trial in HR+/HER2- breast cancer showed a median progression-free survival (PFS) benefit of 5.7 months for the pelareorep + paclitaxel arm compared to chemotherapy alone. This paves the way for a Phase 2 study aimed at FDA accelerated approval, set to begin in H1 2025, targeting 180 patients with advanced/metastatic breast cancer. Additionally, Oncolytics is advancing gastrointestinal cancer studies, with key milestones expected in 2025. Collaborations with GCAR and PanCAN will support further research in pancreatic cancer, with initial efficacy results from the GOBLET study expected in H2 2025.
Oncolytics Biotech Inc. (NASDAQ: ONCY) reported positive results from its BRACELET-1 Phase 2 study evaluating pelareorep in HR+/HER2- advanced or metastatic breast cancer patients. Key findings include:
1. Median overall survival (OS) not reached in the pelareorep + paclitaxel arm, with over half of patients alive at study end.
2. Estimated median OS of at least 32 months for pelareorep + paclitaxel vs 18 months for paclitaxel alone.
3. Two-year survival rate of 64% for pelareorep + paclitaxel vs 33% for paclitaxel alone.
4. Median progression-free survival (PFS) of 12.1 months for pelareorep + paclitaxel vs 6.4 months for paclitaxel alone.
These results, along with the previous IND-213 study, support the potential of pelareorep-based combination therapy in advanced breast cancer. Oncolytics Biotech is now seeking funding for a registration-enabling study.
Oncolytics Biotech Inc. (NASDAQ: ONCY), a clinical-stage immunotherapy company, has announced its participation in two upcoming investment conferences in September 2024. Chief Financial Officer Kirk Look will attend the H.C. Wainwright 26th Annual Global Investment Conference on September 11, while Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in the 2024 Cantor Global Healthcare Conference on September 19.
Both executives will engage in fireside chats at their respective events in New York City. The company will also conduct one-on-one investor meetings during these conferences. Webcasts of the presentations will be available on Oncolytics' Investor Relations page and archived for three months.
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