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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 operational highlights and financial results for Q4 and full year 2022, emphasizing progress in its pancreatic and breast cancer programs. Notably, the phase 1/2 GOBLET trial showed a 69% objective response rate in advanced pancreatic cancer, leading to FDA Fast Track designation. The BRACELET-1 trial in metastatic breast cancer is on track for data readout in Q2 2023. As of December 31, 2022, the company reported $32.1 million in cash, providing a runway through anticipated milestones. The net loss for Q4 2022 was $8.6 million, and for the full year, it was $24.8 million, reflecting a decrease in losses compared to 2021.
Oncolytics Biotech (NASDAQ: ONCY) announced a conference call and webcast to discuss its fourth quarter and full year 2022 financial results, scheduled for March 3, 2023, at 8:30 a.m. ET. The call will cover corporate updates and financial insights regarding the company’s lead immunotherapeutic agent, pelareorep, which is in trials for treating various cancers. The company is advancing towards registration studies in metastatic breast cancer and pancreatic cancer while evaluating pelareorep in combination with immune checkpoint inhibitors.
Oncolytics Biotech's partner Adlai Nortye presented interim results from a bridging clinical trial evaluating pelareorep-paclitaxel therapy for advanced HR+/HER2- breast cancer in Chinese patients. Out of 14 evaluable patients, 93% achieved disease control, with 86% showing tumor shrinkage. The median progression-free survival (PFS) was reported at 9.1 months. The combination therapy was well tolerated with no serious adverse events. Upcoming data from the ongoing BRACELET-1 trial are anticipated to further support pelareorep's development towards regulatory approval.
Oncolytics Biotech (NASDAQ: ONCY) announced FDA Fast Track designation for pelareorep combined with atezolizumab, gemcitabine, and nab-paclitaxel to treat advanced pancreatic ductal adenocarcinoma (PDAC). This designation follows a reported 69% objective response rate from their phase 1/2 GOBLET study, significantly higher than the historical average of ~25%. Fast Track status enables more frequent communication with the FDA, potentially leading to Accelerated Approval and Priority Review. Oncolytics is focused on pivotal trials for its core programs in breast and pancreatic cancer.
Oncolytics Biotech announced promising results from the phase 1/2 GOBLET study, demonstrating a 69% objective response rate (ORR) for first-line treatment of advanced pancreatic cancer, significantly outperforming the historical average of 25%. In total, 85% of patients showed a clinical benefit, with plans to advance to a pivotal study. The interim findings will be discussed in a key opinion leader webinar on November 14, 2022. The GOBLET study highlights the potential of pelareorep when combined with atezolizumab and chemotherapy, showing encouraging results for pancreatic cancer treatment.
Oncolytics Biotech reported significant interim data from its GOBLET trial, revealing a 70% objective response rate (ORR) for pancreatic cancer, nearly triple the historical average of 25%. The company holds $32.4 million in cash, projected to fund operations through 2023. They plan further studies for both pancreatic and breast cancer treatments, aiming for pivotal trials, with impactful results expected from their BRACELET-1 trial in early 2023. Despite a net loss of $4.4 million for Q3 2022, losses are down from $4.9 million during the same period last year.
Oncolytics Biotech reported interim results from the phase 1/2 GOBLET study for advanced pancreatic ductal adenocarcinoma, showing a 70% objective response rate (ORR), nearly three times higher than the average 25% from historical trials. The data indicates that pelareorep enhances the efficacy of PD-(L)1 inhibitors combined with standard chemotherapy. The company plans to engage regulators regarding expedited approval and will further discuss these findings in their upcoming earnings call.
Oncolytics Biotech announced a conference call on November 7, 2022, at 8:30 a.m. ET, to discuss its third-quarter financial results and corporate updates. The call will focus on the performance of pelareorep, an immunotherapeutic agent in development for various cancers, including its upcoming registration study in metastatic breast cancer. Interested parties can participate via a dial-in number or a webcast available on the company's Investor Relations page.
Further details and a replay option are provided in the press release.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has appointed Jonathan Rigby to its Board of Directors. Rigby, with over 30 years in the pharmaceutical sector, previously served as CEO of Revolo Biotherapeutics and led SteadyMed through its NASDAQ listing. His experience is expected to aid Oncolytics in advancing its cancer therapeutic, pelareorep, which has shown potential in late-stage trials for breast and pancreatic cancers. The company anticipates valuable data readouts that may propel pelareorep towards registration, enhancing its partnerships within the biopharmaceutical industry.
Oncolytics Biotech announced key developments in their clinical trials, notably the full enrollment of the Phase 2 BRACELET-1 trial focused on HR+/HER2- breast cancer and success in the pancreatic cancer cohort of the GOBLET trial, achieving partial responses in all Phase 1b patients.
They reported $33.7 million in cash as of June 30, 2022, providing a financial runway into late 2023. The management highlighted pelareorep's potential to enhance cancer treatment outcomes. A conference call is scheduled today for further details.
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