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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 Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapy company focused on oncology, has announced a conference call and webcast scheduled for Thursday, August 1, 2024, at 4:30 p.m. ET. The event will provide a corporate update and discuss financial results for the second quarter of 2024. Investors and interested parties can join via North American toll-free number (800) 836-8184 or international number (646) 357-8785, using conference ID 34386. A webcast will also be available on the company's Investor Relations page and archived for three months. A dial-in replay will be accessible for one week after the call.
Oncolytics Biotech announced productive feedback from the U.S. FDA on its Type C meeting, supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA endorsed progression-free survival as the primary endpoint and overall survival as a key secondary endpoint. The study will include patients who have failed hormonal therapy and have received no more than one line of ADC therapy. This step builds on promising data from previous studies (BRACELET-1, IND-213, and AWARE-1) showcasing pelareorep's efficacy and immunotherapeutic action. Oncolytics is on track to report overall survival data from the BRACELET-1 trial in H2 2024, advancing their mission to offer better treatment options for breast cancer patients.
Oncolytics Biotech announced that Dr. Matt Coffey, President and CEO, will take a medical leave of absence effective immediately. Wayne Pisano, Chair of the Board, will assume the role of interim CEO during Dr. Coffey's absence. Despite this leadership change, Oncolytics remains optimistic about its ongoing clinical trials and strategic priorities.
The company highlighted its key developments, such as the expected overall survival data from the BRACELET-1 breast cancer study in H2 2024 and the advancement of their pelareorep combination therapy towards a registration-enabling study for pancreatic cancer.
Wayne Pisano, who has extensive experience in the pharmaceutical and biotech industries, will lead the company during this transitional period. He has previously held significant positions, including President of VaxInnate and CEO of Sanofi Pasteur.
Oncolytics Biotech has dosed the first patient in the GOBLET study cohort, which assesses the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The study, funded by a US$5 million grant from PanCAN’s Therapeutic Accelerator Award, aims to evaluate the objective response rate (ORR) and safety of this combination therapy. This collaboration involves AIO-Studien-gGmbH and is part of a larger Phase 1/2 multiple indication study for gastrointestinal cancers. The outcomes could potentially lead to the development of new pancreatic cancer treatment regimens.
Oncolytics Biotech presented two abstracts at the 2024 ASCO Annual Meeting that highlight the potential of pelareorep in treating metastatic pancreatic ductal adenocarcinoma (PDAC) and its immunotherapeutic mechanism of action.
The first abstract discusses a new cohort in the GOBLET study, which will test pelareorep combined with mFOLFIRINOX, with and without atezolizumab. This cohort is funded by a $5 million grant, expecting enrollment to start this quarter.
The second abstract highlights pelareorep's ability to induce tumor-infiltrating lymphocytes (TILs) expansion, correlating with improved tumor response across multiple cancers, providing further support for its use as a backbone immunotherapy.
On May 16, 2024, Oncolytics Biotech announced the voting results from its Annual General Meeting held on May 15, 2024. Representing 41.34% of outstanding shares, shareholders elected eight directors with the following votes: Patricia Andrews (84.78%), Deborah M. Brown (74.81%), Matthew C. Coffey (70.97%), Angela Holtham (77.53%), James T. Parsons (74.81%), Wayne Pisano (72.88%), Jonathan Rigby (76.81%), and Bernd R. Seizinger (81.49%).
Additionally, shareholders approved the number of directors at eight and reappointed the auditors for the coming year. For more details, refer to the management information circular at SEDAR.
Oncolytics Biotech (NASDAQ: ONCY) announced a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR) to include pelareorep in a planned pancreatic cancer trial. The trial will use a combination therapy of checkpoint inhibition and chemotherapy, and aims to accelerate the development timeline while reducing costs. The adaptive Phase 2/3 design will assess multiple investigational therapies for metastatic pancreatic cancer, providing a potential registration pathway. Updated data from the GOBLET study showed a 62% objective response rate with pelareorep, nearly triple the historical control trials. This strategic collaboration is expected to advance the development of pelareorep to address urgent patient needs.
Oncolytics Biotech® reported first-quarter 2024 financial results and operational highlights including advancing pelareorep to registration-enabling studies, obtaining FDA Type C meeting for HR+/HER2- metastatic breast cancer, and anticipated milestones like overall survival data in H2 2024. The company has a cash position of $29.6 million providing runway into 2025.
Oncolytics Biotech Inc. has received regulatory clearance to evaluate pelareorep in combination with modified FOLFIRINOX and an anti-PD-L1 inhibitor in pancreatic cancer. The company will start enrollment in a new GOBLET study cohort, supported by a $5M grant from PanCAN, with the first patient expected to be enrolled in Q2 2024. The study aims to enhance pelareorep's potential in addressing pancreatic cancer and expand its role in providing benefits to patients.
Oncolytics Biotech® Inc. (NASDAQ: ONCY) will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference. Dr. Matt Coffey, the CEO, will be speaking at the event taking place on May 14-15, 2024, in New York. The company will also hold one-on-one investor meetings and provide a live webcast of the presentation on its website.
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