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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) announced significant progress in breast and pancreatic cancer treatments. The BRACELET-1 trial in HR+/HER2- breast cancer showed a median progression-free survival (PFS) benefit of 5.7 months for the pelareorep + paclitaxel arm compared to chemotherapy alone. This paves the way for a Phase 2 study aimed at FDA accelerated approval, set to begin in H1 2025, targeting 180 patients with advanced/metastatic breast cancer. Additionally, Oncolytics is advancing gastrointestinal cancer studies, with key milestones expected in 2025. Collaborations with GCAR and PanCAN will support further research in pancreatic cancer, with initial efficacy results from the GOBLET study expected in H2 2025.
Oncolytics Biotech Inc. (NASDAQ: ONCY) reported positive results from its BRACELET-1 Phase 2 study evaluating pelareorep in HR+/HER2- advanced or metastatic breast cancer patients. Key findings include:
1. Median overall survival (OS) not reached in the pelareorep + paclitaxel arm, with over half of patients alive at study end.
2. Estimated median OS of at least 32 months for pelareorep + paclitaxel vs 18 months for paclitaxel alone.
3. Two-year survival rate of 64% for pelareorep + paclitaxel vs 33% for paclitaxel alone.
4. Median progression-free survival (PFS) of 12.1 months for pelareorep + paclitaxel vs 6.4 months for paclitaxel alone.
These results, along with the previous IND-213 study, support the potential of pelareorep-based combination therapy in advanced breast cancer. Oncolytics Biotech is now seeking funding for a registration-enabling study.
Oncolytics Biotech Inc. (NASDAQ: ONCY), a clinical-stage immunotherapy company, has announced its participation in two upcoming investment conferences in September 2024. Chief Financial Officer Kirk Look will attend the H.C. Wainwright 26th Annual Global Investment Conference on September 11, while Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in the 2024 Cantor Global Healthcare Conference on September 19.
Both executives will engage in fireside chats at their respective events in New York City. The company will also conduct one-on-one investor meetings during these conferences. Webcasts of the presentations will be available on Oncolytics' Investor Relations page and archived for three months.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapy company focused on oncology, has announced its participation in Canaccord Genuity's 44th Annual Growth Conference. The event will take place from August 13-15, 2024 at the InterContinental Boston Hotel.
Chief Medical Officer Dr. Thomas Heineman will engage in a fireside chat on Tuesday, August 13, 2024, at 8:30 a.m. ET in the Hutchinson Room. The presentation will be accessible via webcast on the company's Investor Relations page.
Additionally, Oncolytics' management team will be available for one-on-one investor meetings during the conference. Interested parties can schedule meetings through the conference website, Canaccord representatives, or by emailing jpatton@oncolytics.ca.
Oncolytics Biotech reported Q2 2024 financial results and operational highlights for its pelareorep immunotherapy program. Key updates include:
- Productive FDA feedback on planned registration trial for HR+/HER2- metastatic breast cancer
- On track to report overall survival results from BRACELET-1 breast cancer study in H2 2024
- Dosed first patient in new GOBLET pancreatic cancer cohort supported by PanCAN funding
- Collaboration with GCAR for adaptive registration-enabling pancreatic cancer trial
Financial highlights:
- Cash position of $24.9 million, providing runway into 2025
- Q2 2024 net loss of $7.3 million vs $7.4 million in Q2 2023
- R&D expenses increased to $4.6 million in Q2 2024 vs $3.7 million in Q2 2023
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.
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