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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) reported positive results from the ReoGlio phase 1b trial, assessing the combination of pelareorep and GM-CSF with standard chemoradiotherapy for glioblastoma multiforme patients. This trial demonstrated promising efficacy signals and confirmed safety with a median progression-free survival of approximately 8 months. The results were presented at the 2020 Society of Neuro-Oncology Annual Meeting, showing a median PFS of 9.4 months at a higher pelareorep dose. Oncolytics aims to advance pelareorep across various cancer indications while acknowledging the contributions of key partners.
Oncolytics Biotech (NASDAQ: ONCY) announced the presentation of three abstracts at the virtual 2020 San Antonio Breast Cancer Symposium from December 8-11, 2020. The abstracts include studies on the oncolytic virus pelareorep combined with other therapies for breast cancer treatment. Notable studies are the window-of-opportunity study (REO-027, AWARE-1) and the Bracelet-1 trial assessing response rates with metastatic breast cancer treatments. Pelareorep is designed to induce tumor lysis and enhance immune responses, highlighting its role in ongoing cancer therapy developments.
Oncolytics Biotech (NASDAQ: ONCY) reported its Q3 2020 financial results, showing a net loss of $6.7 million, compared to $3.5 million in Q3 2019. The company held $26.7 million in cash and cash equivalents. Notable clinical advancements include positive AWARE-1 trial results demonstrating a 14-fold increase in CD8 T cells, with 70% of patients showing an increase in CelTIL. The company is also advancing trials for pelareorep in breast cancer and gastrointestinal cancers, with upcoming data releases expected in Q4 2020 and H1 2021.
Oncolytics Biotech (NASDAQ: ONCY) and SOLTI presented data from the AWARE-1 breast cancer study at the SITC 35th Annual Meeting. Findings revealed that 70% of cohort-1 patients experienced an increase in CelTIL, a measure linked to favorable outcomes, following treatment with pelareorep. The data underlines pelareorep's ability to generate anti-tumor T cell clones, which may enhance immune responses against breast cancer. Pelareorep demonstrated a 14-fold increase in CD8+ T cells, emphasizing its potential as an effective immunotherapy. The AWARE-1 study aims to confirm pelareorep's efficacy in early-stage breast cancer.
Oncolytics Biotech (NASDAQ: ONCY) announced the publication of an abstract for an oral presentation at the 2020 Society of Neuro-Oncology Annual Meeting, detailing clinical data from the ReoGlio phase 1b trial. This study evaluated the combination of pelareorep and GM-CSF with standard therapies in treating newly diagnosed glioblastoma multiforme. The trial included 15 patients, primarily aimed at determining dosage and assessing treatment activity. The findings will be presented by Professor Susan Short, with the abstract accessible on the SNO website.
Oncolytics Biotech (NASDAQ: ONCY) will host a conference call on November 11, 2020, at 5:00 pm ET to discuss its third-quarter financial results and corporate updates. The call can be accessed via North American toll-free number (888) 231-8191 or internationally at (647) 427-7450. Oncolytics is developing pelareorep, an immuno-oncolytic virus aimed at enhancing cancer treatments. The company is advancing studies, including a phase 3 trial in metastatic breast cancer, while navigating challenges posed by COVID-19.
Oncolytics Biotech announced a new multi-center phase 1/2 clinical trial, GOBLET, to evaluate pelareorep in combination with Roche's atezolizumab for gastrointestinal cancers, targeting the nearly 4.8 million global cases annually. The trial aims to improve treatment responses in patients—especially since about 80% do not respond to current therapies. Previous studies showed promising results, including over 90% clinical benefit in colorectal and 80% progression-free survival in pancreatic cancer patients. The trial will enroll about 55 patients across four cohorts, focusing on safety and biomarkers.
Oncolytics Biotech has appointed Richard Vile, Ph.D., to its Scientific Advisory Board. A prominent expert in oncolytic viruses and adoptive T cell therapies, Dr. Vile joins to strengthen the team focused on advancing pelareorep, an innovative immuno-oncolytic virus. His insights are expected to enhance pelareorep's synergy with immunotherapeutic agents, aimed at treating cancers like metastatic breast cancer. This move highlights Oncolytics' commitment to addressing unmet medical needs and advancing clinical studies.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the appointment of Dr. Richard Vile to its Scientific Advisory Board. Dr. Vile, a Professor at Mayo Clinic, specializes in oncolytic viruses and immunotherapy. His expertise is expected to enhance Oncolytics' strategic direction as the company advances its lead candidate, pelareorep, which targets immunosuppressive tumor environments and shows promise in treating breast cancer. Positive clinical data supports pelareorep's potential advantages in regulatory approval and efficacy against challenging cancers.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced its participation in the BIO Investor Forum Digital from October 13-15, 2020. Attendees can access an on-demand corporate overview by CEO Dr. Matt Coffey and schedule one-on-one investor meetings through the event website. The company is developing pelareorep, an immuno-oncolytic virus that targets various cancers by inducing tumor lysis. Pelareorep shows potential synergies with immune checkpoint inhibitors and is preparing for a phase 3 study in metastatic breast cancer.
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