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 develops pelareorep, an investigational systemically delivered immunotherapy for cancer that has been shown to activate innate immune-sensing pathways. Company news centers on pelareorep clinical and translational data, FDA interactions, and study activity across gastrointestinal and other solid tumor indications, including metastatic colorectal cancer, squamous cell anal carcinoma, pancreatic cancer, and breast cancer.
Recurring updates also cover the company's registration-focused development priorities, Fast Track Designation for pelareorep-based treatment in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, scientific meeting presentations, financing arrangements, and its completed change of jurisdiction to Nevada while ONCY common stock continues to trade on Nasdaq.
Oncolytics Biotech announced progress in its clinical trials and a strong financial position with approximately $41.3 million in cash. The BRACELET-1 trial for metastatic breast cancer is on track for top-line data in Q4 2022. Changes in T cell populations may serve as a predictive biomarker for therapy response, potentially reducing risk for further trials. Interim safety updates from ongoing trials indicate a favorable safety profile for pelareorep combinations. The net loss for 2021 was $26.3 million, showing improvement compared to $22.5 million in 2020.
Oncolytics Biotech (NASDAQ: ONCY) has scheduled a conference call and webcast for March 3, 2022, at 5:00 p.m. ET to review its fourth quarter and full year 2021 financial results. The company is advancing pelareorep, an immunotherapeutic agent aimed at treating various cancers by inducing anti-cancer immune responses. Ongoing and planned clinical trials are underway, including studies evaluating pelareorep in combination with checkpoint inhibitors. The investor relations page will host the webcast, available for three months.
Oncolytics Biotech announced the successful completion of the safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study, with no toxicity concerns reported by the Data Safety Monitoring Board. The study explores the efficacy of pelareorep in combination with Roche's checkpoint inhibitor, atezolizumab, for treating metastatic pancreatic, colorectal, and anal cancers. This evaluation adds to previous data showcasing pelareorep's potential to improve clinical responses by reversing immunosuppressive environments. The study is set to enroll patients at 14 sites in Germany.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the completion of enrollment in the first dose escalation of a clinical trial evaluating pelareorep combined with paclitaxel for advanced breast cancer in China. There have been no reported safety issues, and the trial is progressing to its second cohort, which mirrors an earlier study showing improved survival rates. Results from this trial could facilitate future regulatory submissions in China, enhancing pelareorep's market potential in one of the largest pharmaceutical markets.
Oncolytics Biotech (NASDAQ: ONCY) updated on the phase 1/2 GOBLET study for pelareorep presented at the 2022 ASCO-GI symposium. The study evaluates pelareorep combined with Roche's atezolizumab in treating metastatic pancreatic, colorectal, and anal cancers. Enrollment for safety run-ins is complete at 14 sites in Germany. Prior studies suggest pelareorep may enhance responses to immune checkpoint inhibitors in GI cancers. The study aims to validate pelareorep's efficacy and identify potential biomarkers for patient selection.
Oncolytics Biotech (NASDAQ: ONCY) released a letter to shareholders reviewing 2021 achievements and outlining goals for 2022, particularly in developing pelareorep for metastatic breast cancer. The company highlighted a near doubling of overall survival in HR+/HER2- breast cancer patients and progress in clinical trials. Key objectives include confirming pelareorep's mechanisms, assessing synergy with immune checkpoint inhibitors, and identifying biomarkers for patient selection. Upcoming milestones include full enrollment in BRACELET-1 and top-line data release expected in Q4 2022.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the promotion of Dr. Thomas C. Heineman to Chief Medical Officer. Dr. Heineman brings over two decades of clinical development experience, having previously served as Global Head of Clinical Development at Oncolytics. His role will focus on the advancement of the company's lead program for metastatic breast cancer and the ongoing development of pelareorep, an immunotherapeutic agent. This compound aims to induce immune responses against cancer and is currently being evaluated in combination with other therapies.
Oncolytics Biotech has announced promising preclinical results showing that the combination of pelareorep and azacitidine significantly reduces tumor burden in acute myeloid leukemia (AML) cells. Data presented at the 2021 American Society of Hematology Annual Meeting indicates a p reduction in tumor burden and a p enhancement of anti-leukemic activity compared to individual treatments. The combination also upregulated genes driving immune responses, highlighting pelareorep's potential across various blood cancers. The company aims to expand research into leukemia and other malignancies.
Oncolytics Biotech presented a positive interim safety update from the investigator-sponsored Phase 2 IRENE trial at the 2021 San Antonio Breast Cancer Symposium. This trial evaluates the combination of pelareorep and Incyte's retifanlimab for treating metastatic triple-negative breast cancer (TNBC). No safety concerns were reported among the five enrolled patients. The study aims to assess both safety and efficacy, focusing on PD-L1 expression changes, which might identify patients likely to respond to therapy. The trial continues at key cancer institutes.
Oncolytics Biotech will present updates on the Phase 2 IRENE trial for treating metastatic triple-negative breast cancer (TNBC) at the 2021 San Antonio Breast Cancer Symposium from December 7-10, 2021. The study evaluates the combination of pelareorep and Incyte's anti-PD-1 inhibitor, retifanlimab, on 25 patients. This open-label trial focuses on safety and response rates, with secondary endpoints including progression-free survival and overall survival. The IRENE trial is crucial in advancing pelareorep as a potential treatment option in oncology.