Welcome to our dedicated page for Oncolytics Biotech news (Ticker: ONCY), a resource for investors and traders seeking the latest updates and insights on Oncolytics Biotech stock.
Oncolytics Biotech, Inc. (Nasdaq: ONCY) is a clinical-stage biotechnology company whose news flow centers on the development of pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Company updates frequently highlight clinical data in metastatic pancreatic cancer, metastatic breast cancer, and gastrointestinal tumors such as anal and colorectal cancers, where pelareorep is being evaluated in combination with chemotherapy and checkpoint inhibitors.
News releases from Oncolytics often cover clinical trial milestones, including results from the GOBLET study in squamous cell anal carcinoma and colorectal cancer, as well as alignment with the U.S. Food and Drug Administration on pivotal trial designs in first-line metastatic pancreatic ductal adenocarcinoma. Investors can also expect announcements about planned registration-directed studies, accelerated approval strategies in indications with no FDA-approved therapies, and translational findings such as tumor-specific T-cell responses in KRAS-mutant metastatic colorectal cancer.
Oncolytics’ news also addresses corporate and regulatory developments, including its proposal to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada, its transition to domestic issuer status under SEC rules, and capital markets activities such as at-the-market equity programs. Additional updates describe expansions of the company’s Gastrointestinal Tumor Scientific Advisory Board and appointments of senior leaders in strategy, operations, and biostatistics to support late-stage clinical execution.
This ONCY news page aggregates these press releases and related coverage so readers can follow key developments in pelareorep’s clinical progress, regulatory interactions, intellectual property initiatives, and corporate strategy. It is a useful resource for tracking how new data, advisory board input, and structural changes may influence the company’s oncology pipeline over time.
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.
Oncolytics Biotech® announced a conference call and webcast to discuss corporate updates and financial results for the first quarter of 2024. The event will take place on May 9, 2024, at 4:30 p.m. ET.
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