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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 successful results from the AWARE-1 breast cancer study, achieving its primary endpoint. The study demonstrated that pelareorep, combined with the PD-L1 inhibitor atezolizumab, significantly enhances anti-cancer immune responses in HR+/HER2- patients. Key findings include a 60% increase in CelTIL score in cohort 2, indicating improved tumor immune activity. Management highlights the results as validation of their clinical strategy, paving the way for future registrational studies. The data underscores pelareorep's potential to boost checkpoint inhibitor efficacy in breast cancer treatments.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced promising preclinical data demonstrating that pelareorep can enhance the effectiveness of established anti-cancer agents, talazoparib and palbociclib. These findings were showcased at the AACR Annual Meeting 2021, where both combinations showed increased cancer cell apoptosis and improved tumor responses in murine models. Pelareorep exhibited synergy through immunological pathways, suggesting potential for broader therapeutic applications. The company aims to advance pelareorep in combination studies and is preparing for a pivotal phase 3 trial in metastatic breast cancer.
Oncolytics Biotech (NASDAQ: ONCY) announced that CEO Dr. Matt Coffey will participate in a panel discussion titled "Off-the-Shelf CAR T - solid tumors, myeloma, lymphoma" at the Canaccord Genuity Horizons in Oncology Virtual Conference.
Date: April 15, 2021, Time: 8:15 am ET.
Oncolytics is advancing its immuno-oncolytic virus, pelareorep, targeting various cancers. They are preparing for a Phase 3 registration study in metastatic breast cancer, exploring synergies with approved immuno-oncology therapies.
On April 5, 2021, Oncolytics Biotech announced a Key Opinion Leader (KOL) webinar for April 12, 2021, at 2:00 pm ET, focusing on AWARE-1 data concerning the immunotherapeutic effects of pelareorep in breast cancer and its synergy with CAR T cells. Key speakers include Dr. Aleix Prat from Hospital Clínic Barcelona and Dr. Richard Vile from the Mayo Clinic. The AWARE-1 study involves 38 patients and aims to evaluate pelareorep's efficacy. The company's management will also provide an update and be available for questions during the event.
Oncolytics Biotech (NASDAQ: ONCY) announced updated clinical data presentations from its AWARE-1 study on early-stage breast cancer and preclinical findings on pelareorep-based therapies. These will be shared at the AACR Annual Meeting on April 10-15, 2021. Key presentations include the AWARE-1 study's findings on pelareorep with atezolizumab and preclinical studies showing synergy with CDK4/6 inhibitors and talazoparib. The study's primary endpoint is CelTIL measurement, with 38 patients across five cohorts. Further details will be released post-abstract publication.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has initiated an at-the-market (ATM) equity offering agreement with Canaccord Genuity LLC, allowing the company to issue common shares up to US$80 million at prevailing market prices. This strategic move aims to enhance financial flexibility, facilitating ongoing business operations and clinical trials, while strengthening negotiation positions for potential agreements. Additionally, a Prospectus Supplement has been filed with relevant securities commissions to govern the offering, which will only take place in the U.S. through NASDAQ.
Oncolytics Biotech reported a financial overview and operational highlights for 2020, revealing a robust cash position with approximately $50 million on hand. Clinical data for pelareorep demonstrated significant potential in enhancing the efficacy of checkpoint inhibitors, particularly for HR+/HER2- breast cancer patients, evidenced by AWARE-1 trial results showing tumor PD-L1 expression increased by 105-fold. The company also advanced its BRACELET-1 and IRENE studies and plans to report further data in 2021, underpinning its strategy to address unmet medical needs.
Oncolytics Biotech Inc. (NASDAQ: ONCY) will host a conference call on March 5, 2021, at 8:30 am ET, to discuss its fourth quarter and full year 2020 financial results and corporate updates. Investors can access the call via dial-in and webcast, with a replay available post-call. The company focuses on the development of pelareorep, an immuno-oncolytic virus targeted at treating various cancers. Oncolytics is preparing for a phase 3 registration study in metastatic breast cancer and exploring additional studies in combination with other therapies.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced promising results from a preclinical study showcasing the enhanced effectiveness of pelareorep in combination with CAR T cell therapy for solid tumors. Conducted in collaboration with the Mayo Clinic, the study demonstrated a survival rate of 100% in mice treated with CAR T cells and pelareorep boosts. This combination overcame major limitations faced by CAR T therapies in solid tumors, leading to potential broadened applications in cancer treatment. The findings were presented at the CAR-TCR Summit Europe 2021.
Oncolytics Biotech announced significant findings from the AWARE-1 study at the San Antonio Breast Cancer Symposium, showing that pelareorep substantially increases the CelTIL score and PD-L1 expression in patients with early-stage breast cancer. Seventy-two percent of patients experienced increased CelTIL, while PD-L1 expression rose over 105-fold, enhancing the potential for immunotherapy. The study's results suggest pelareorep can synergize with checkpoint inhibitors, potentially improving treatment outcomes and expanding patient eligibility for these therapies.
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