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Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
Globenewswire· 2026-02-04 13:50
Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026 Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ( ...
Oncolytics Biotech® Announces Results of Special Meeting of Shareholders
Globenewswire· 2026-01-15 21:01
Core Viewpoint - Oncolytics Biotech Inc. announced the results of its Special Meeting of Shareholders, where all proposed resolutions were approved, facilitating the company's transition and incentive plan [1][2]. Group 1: Voting Results - The Continuance Resolution was approved with 14,994,075 votes (85.21%) in favor and 2,602,405 votes (14.79%) against [3]. - The Domestication Resolution received 15,304,574 votes (86.98%) for and 2,291,905 votes (13.02%) against [3]. - The 2026 Incentive Award Plan Resolution was supported by 13,508,657 votes (76.77%) while 4,087,822 votes (23.23%) were against [3]. Group 2: Company Developments - The approval of the resolutions allows Oncolytics to transition from Alberta to British Columbia and then to Nevada, with the 2026 Incentive Award Plan expected to take effect by the end of Q1 2026 [4]. - Oncolytics is focused on developing pelareorep, an investigational immunotherapeutic agent, which has shown promising results in various cancer studies [5]. - The company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors for metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA [6].
Oncolytics Biotech® Appoints John McAdory as EVP of Strategy and Operations and Yujun Wu to Lead Biostatistics
Globenewswire· 2026-01-14 14:00
Appointments strengthen late-stage clinical execution and statistical leadership as the Company advances multiple registration-directed programs in gastrointestinal cancersSAN DIEGO, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced the appointment of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics. Th ...
Oncolytics Biotech (NasdaqCM:ONCY) Earnings Call Presentation
2026-01-14 12:00
Oncolytics Biotech PELAREOREP a transformative dsRNA immunotherapy platform for gastrointestinal tumors January 2026 Forward-Looking Statements Oncolytics Biotech Confidential This presentation is strictly confidential. Neither the Securities and Exchange Commission nor any state or foreign securities commission or regulatory authority has passed upon the adequacy or accuracy of this presentation. Any representation to the contrary is a criminal offense. This presentation does not constitute an offer to sel ...
Oncolytics Biotech® Announces Updated Clinical Data from GOBLET Cohort 4 Demonstrating Activity of Pelareorep Plus Atezolizumab in Third-Line Anal Cancer
Globenewswire· 2026-01-12 14:00
Core Insights - The combination of pelareorep and atezolizumab has shown a nearly tripled objective response rate (ORR) compared to historical benchmarks, achieving an ORR of approximately 29% in a heavily pretreated population of third-line metastatic squamous cell anal carcinoma (SCAC) patients [1][3][5] - The median duration of response (DOR) for this combination therapy is approximately 17 months, indicating significant clinical benefit in a setting with no FDA-approved therapies [1][3][5] Clinical Data Summary - In the updated GOBLET Cohort 4, four out of 14 evaluable patients achieved objective responses, including two complete responses and two partial responses [3][4] - Historical studies in third-line SCAC typically report an ORR of around 10% or less, highlighting the potential of pelareorep plus atezolizumab in addressing unmet medical needs [4][5] Development Strategy - Oncolytics plans to pursue a registration study based on the promising data from GOBLET Cohort 4, aiming for accelerated approval from the FDA [7] - The company has received initial positive feedback from key opinion leaders (KOLs) and the FDA, with a Type C meeting scheduled for Q1 2026 to discuss the development plan [7]
Oncolytics Biotech (ONCY) Leadership Strengthens As Pelareorep Advances
Yahoo Finance· 2026-01-12 09:23
Group 1: Leadership and Strategic Developments - Oncolytics Biotech Inc. has strengthened its leadership by appointing Dr. Eileen O'Reilly, Dr. Neil Segal, and Dr. Van Morris to its Gastrointestinal Tumor Scientific Advisory Board, enhancing clinical and strategic oversight as the company advances pelareorep toward registration-enabling trials in pancreatic, colorectal, and anal cancers [2] - The expanded advisory board is expected to sharpen the late-stage development strategy for a GI-focused immunotherapy platform, which targets large addressable markets [2] Group 2: Clinical and Translational Momentum - Recent data from trials in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer showed a 33% objective response rate, significantly higher than the historical rate of 6-11% [3] - The trials also indicated more than double the progression-free and overall survival compared to standard therapy, highlighting the potential effectiveness of pelareorep [3] - Increased KRAS-specific T-cell responses were reported in translational analyses, reinforcing the mechanistic differentiation of pelareorep [3] Group 3: Company Focus and Technology - Oncolytics Biotech Inc. is focused on developing pelareorep, an immune-oncolytic virus platform that targets solid tumors and hematologic malignancies [4] - The technology leverages tumor-selective viral replication to stimulate both innate and adaptive anti-cancer immune responses [4]
Oncolytics Biotech (ONCY) Leadership Strengthens As Pelareorep Advances
Yahoo Finance· 2026-01-12 09:23
Group 1: Leadership and Strategic Developments - Oncolytics Biotech Inc. has strengthened its leadership by appointing Dr. Eileen O'Reilly, Dr. Neil Segal, and Dr. Van Morris to its Gastrointestinal Tumor Scientific Advisory Board, enhancing clinical and strategic oversight as the company advances pelareorep toward registration-enabling trials in pancreatic, colorectal, and anal cancers [2] - The expanded advisory board is expected to sharpen the late-stage development strategy for a GI-focused immunotherapy platform, which targets large addressable markets [2] Group 2: Clinical and Translational Momentum - Recent data from clinical trials in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer showed a 33% objective response rate, significantly higher than the historical rate of 6-11% [3] - The trials also demonstrated more than double the progression-free and overall survival compared to standard therapy, indicating strong efficacy of pelareorep [3] - Translational analysis revealed increased KRAS-specific T-cell responses, reinforcing the mechanistic differentiation of pelareorep [3] Group 3: Company Focus and Technology - Oncolytics Biotech is focused on developing pelareorep, an immune-oncolytic virus platform that targets solid tumors and hematologic malignancies, utilizing tumor-selective viral replication to stimulate both innate and adaptive anti-cancer immune responses [4]
Oncolytics Biotech® Outlines Strategic Rationale for Proposal to Change Jurisdiction of Incorporation to Nevada
Globenewswire· 2026-01-09 14:00
SAN DIEGO, Jan. 09, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today provided additional context regarding its previously announced proposal to change the Company’s jurisdiction of incorporation from Alberta, Canada, to the State of Nevada in the United States. The Company believes it is important to clearly communicate the strategic and operational reasons underlying this proposal as Oncolyt ...
Oncolytics Biotech® Reschedules Special Meeting of Shareholders to Change Jurisdiction of Incorporation to Nevada
Businesswire· 2025-12-09 23:00
Core Viewpoint - Oncolytics Biotech Inc. has filed an amended registration statement on Form F-4 with the SEC, which includes a management circular/prospectus and other relevant documents related to various proposals [1] Group 1 - The registration statement has been declared effective by the SEC [1]
THE EFFICIENCY PARADOX: 5 Market Anomalies Trading Below Reality
Markets.Businessinsider.Com· 2025-12-06 18:51
Core Insights - The market is experiencing inefficiencies, with certain subsectors lagging behind despite overall momentum in the S&P 500 [1] - Specific undervalued companies have been identified, particularly in late-stage biotech and defense infrastructure, which are poised for growth due to improved fundamentals [2] Oncolytics Biotech - Oncolytics Biotech has developed pelareorep, a treatment that converts "cold" tumors into "hot" ones, enhancing the effectiveness of existing cancer therapies [3] - The company is addressing a significant patent cliff in the pharmaceutical industry, with over $250 billion in annual sales at risk, making its solutions attractive to Big Pharma [4] - A pivotal Phase 3 trial for pancreatic cancer is set to begin, with a focus on overall survival as the primary endpoint [4] - Previous Phase 2 data indicated a near-doubling of median overall survival compared to historical controls, leading to partnerships with major pharmaceutical companies [5] - The current market capitalization is below $150 million, significantly undervalued compared to comparable oncology assets [6] Avant Technologies - Avant Technologies is addressing the critical issue of data security in pharmaceutical AI by creating private compute grids for biotech firms [7][8] - The company has shifted its business model to focus on partnerships with biotech firms that require secure computational resources for cell-based therapies [9] - Avant is misclassified as a generic microcap tech stock, while it actually provides specialized infrastructure for data-sensitive sectors [11] VisionWave Holdings - VisionWave Holdings develops AI-powered detection systems for autonomous drone swarms, addressing the evolving needs of modern defense networks [12] - The company recently launched Argus, a space-enabled counter-drone system that utilizes satellite-based sensors for enhanced threat detection [14] - VisionWave is positioned to benefit from the Pentagon's increased focus on counter-drone technology and autonomous systems [15] - The current market valuation does not reflect the company's technological capabilities, which are expected to improve as their systems move from development to deployment [16] GoldHaven Resources - GoldHaven Resources is advancing a high-grade gold project in Brazil, capitalizing on increasing demand for gold amid geopolitical tensions and inflation [17][18] - The company is drilling high-priority targets, with the potential to define significant resources in a prolific gold belt [19] - GoldHaven is trading at a discount compared to peers, with the market pricing in exploration risks without recognizing its jurisdictional advantages [20] VentriPoint Diagnostics - VentriPoint Diagnostics offers a cost-effective solution for cardiac imaging by transforming standard 2D ultrasound images into 3D reconstructions [21][22] - The company's VMS+ software allows hospitals to upgrade existing ultrasound machines, avoiding the high costs associated with MRI installations [23] - VentriPoint is positioned to benefit from the shift in healthcare systems towards software-driven efficiency, with a significant addressable market for cardiac imaging software [26]