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Oncolytics Biotech Inc. (symbol: ONCY) is a pioneering biotechnology company dedicated to the development of oncolytic viruses as innovative cancer therapeutics. Their flagship product, pelareorep, is a unique immunotherapeutic agent designed to harness the power of the human reovirus to enhance the body's immune response against cancer. Pelareorep has shown promising potential in making tumors more responsive to a variety of oncology treatments by promoting an inflamed tumor phenotype.
The company's robust clinical development pipeline includes multiple human trials targeting some of the most prevalent cancers, such as breast, gastrointestinal, and pancreatic cancers. Notably, Oncolytics is conducting a Phase III trial for head and neck cancers and has several ongoing trials in advanced stages, including the GOBLET study, which explores the efficacy of pelareorep in combination with different chemotherapy regimens.
In breast cancer, Oncolytics is advancing towards registration-enabling studies for HR+/HER2- metastatic breast cancer, supported by compelling data from the BRACELET-1 and IND-213 randomized studies. The company is also making significant strides in pancreatic cancer research, recently receiving a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN) for a new Phase 1/2 cohort in the GOBLET study, assessing pelareorep in combination with modified FOLFIRINOX and atezolizumab (Tecentriq®).
Financially, Oncolytics is well-positioned with a strong balance sheet and ongoing support from strategic partnerships and grants. The company’s collaborations with leading research institutions and oncology networks enhance its clinical programs and accelerate the development of pelareorep as a versatile cancer therapy. Oncolytics continues to innovate and push the boundaries of cancer treatment, aiming to bring new hope to patients worldwide.
Oncolytics Biotech announced the successful completion of a three-patient safety run-in for the third-line metastatic colorectal cancer cohort in its phase 1/2 GOBLET study. An independent review identified no safety concerns, allowing the trial to proceed to full enrollment with regulatory clearance from Germany's Paul Ehrlich Institute. The study, in collaboration with Roche, evaluates the efficacy of pelareorep combined with atezolizumab in several gastrointestinal cancer cohorts, including pancreatic and anal cancers. Previous data show a 90% clinical benefit rate in KRAS-mutated mCRC patients.
Oncolytics Biotech has announced that its partner, Adlai Nortye, has reached the third and final dose escalation cohort in the Chinese bridging trial for pelareorep in combination with paclitaxel, aimed at advanced breast cancer. The first two cohorts showed good tolerability with no new safety signals. This trial aligns with Oncolytics' North American studies and aims to facilitate regulatory submissions in key Asian markets, including China and Hong Kong. Significant survival benefits were noted from previous trials, furthering the potential for pelareorep's approval.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the publication of preclinical and patient data on pelareorep in Immunology. The study highlights pelareorep's effects on Natural Killer (NK) cells and their activation, which is crucial for anti-cancer immunity. Results showed enhanced NK cell activity in patients with colorectal liver metastases after pelareorep treatment, mediated by type 1 interferon signaling. Going forward, Oncolytics aims to leverage these findings to further develop pelareorep in oncology, particularly for breast cancer and other indications.
Oncolytics Biotech announced promising phase 1b trial results for pelareorep combined with a proteasome inhibitor, achieving over three years of progression-free survival in relapsed/refractory multiple myeloma patients. Notable findings include increased tumor-infiltrating immune cells correlating with better clinical outcomes. The results will be presented at the AACR Annual Meeting on April 13, 2022. The company is advancing two ongoing phase 1 trials of pelareorep, collaborating with the National Cancer Institute and Bristol Myers Squibb for further evaluations.
Oncolytics Biotech (NASDAQ: ONCY) announced a poster presentation featuring long-term follow-up results from the ReoGlio phase 1b trial. This trial evaluates the combination of pelareorep and GM-CSF alongside standard chemoradiotherapy and temozolomide for glioblastoma multiforme (GBM) treatment. The presentation will occur at the AACR Annual Meeting 2022 in New Orleans, from April 8-13. The company is focusing on the efficacy of pelareorep as an immunotherapeutic agent and its potential synergies with other oncology treatments.
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.
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