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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 (NASDAQ: ONCY) will have its Chief Medical Officer, Thomas Heineman, participate in a fireside chat at the Canaccord Genuity Horizons in Oncology Virtual Conference.
Date: April 14, 2022
Time: 10:00 a.m. ET
Webcast: click here
Additionally, the company will engage in one-on-one investor meetings, highlighting its focus on developing pelareorep, an immunotherapeutic agent aimed at treating various cancers.
Oncolytics Biotech announced positive long-term results from the ReoGlio phase 1b trial, demonstrating pelareorep's potential in treating glioblastoma multiforme (GBM). A higher dose led to a median overall survival (mOS) of 50% at 24 months, with one patient alive at 42 months. The trial confirmed the treatment's favorable safety profile, supporting further studies. These findings suggest pelareorep may extend survival benefits beyond breast cancer to other challenging cancers. The results will be presented at the AACR Annual Meeting.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced new clinical data from a phase 1b trial of pelareorep in relapsed/refractory multiple myeloma patients. Notably, some patients achieved progression-free survival (PFS) exceeding three years despite prior treatment failures. This study illustrates pelareorep's ability to facilitate immune cell recruitment into the tumor microenvironment. The results increase understanding of pelareorep's mechanism and safety profile, paving the way for further clinical development in multiple cancers, including ongoing breast cancer trials.
Oncolytics Biotech (NASDAQ: ONCY) released a letter to shareholders detailing significant progress in its development pipeline during Q1 2022. The company remains on track to announce top-line data for its BRACELET-1 trial in Q4 2022, aimed at advanced HR+/HER2- breast cancer. Their collaboration with Roche in gastrointestinal cancers is on schedule, and they are advancing trials in China for pelareorep. The safety profile of pelareorep is highlighted as a key factor for business development, enhancing its potential in various cancer treatments.
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.