Latest news with #OncolyticsBiotech
Globe and Mail
11 hours ago
- Business
- Globe and Mail
With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology
USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC , June 20, 2025 /CNW/ -- USA News Group News Commentary – The costs of cancer drugs is skyrocketing, according to a recent report from Bloomberg. Analysts at Nova One Advisor estimate that the global oncology drugs market will grow at a 7.4% CAGR through to US$366.24 billion by 2034. Help doesn't appear to be coming from the public sector, as reports state that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors to note, plenty of oncology innovators have provided recent developments, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Immuneering Corporation (NASDAQ: IMRX), GRAIL, Inc. (NASDAQ: GRAL), Intensity Therapeutics, Inc. (NASDAQ: INTS), and Relay Therapeutics, Inc. (NASDAQ: RLAY). The global oncology market is expected to see strong growth over the next decade, with ResearchAndMarkets forecasting it to reach US$866.1 billion by 2034 at a 10.8% CAGR. A separate estimate from Vision Research Reports projects the market will surpass US$903.81 billion by the same year, growing at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has entered a new phase of leadership with the appointment of Jared Kelly as Chief Executive Officer and member of the Board. Kelly brings a background in high-stakes biotech transactions and strategic immuno-oncology development, positioning him to guide the company through its next stage of clinical and business evolution. Before joining Oncolytics, Kelly served as General Counsel at Ambrx Biopharma, where he played a key role in its $2 billion acquisition by Johnson & Johnson. His earlier work includes advising life sciences firms on licensing, partnerships, and M&A while at Kirkland & Ellis LLP and Lowenstein Sandler LLP. Now leading Oncolytics, he steps into a company advancing pelareorep, a virus-based immunotherapeutic designed to work synergistically with checkpoint inhibitors and other agents across a range of solid and blood cancers. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly , CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear strategic focus: advancing pelareorep toward key late-stage milestones through a capital-conscious approach that remains open to strategic collaboration. Pelareorep currently holds FDA Fast Track designation for both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —a rare dual recognition that underscores its regulatory momentum. Across multiple studies, the virus-based therapy has demonstrated consistent immune activation, broad combinability with checkpoint inhibitors and chemotherapies, and encouraging response rates in challenging cancer types. In mPDAC, pelareorep has achieved over 60% objective response rates in tumor-evaluable patients across Phase 1 and 2 trials—more than double what's typically seen in historical benchmarks. Separate analyses also reported two-year survival rates four to six times higher than control arms or prior studies. In HR+/HER2- mBC, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed survival benefits supportive of further investigation. Meanwhile, a Phase 2 cohort in anal cancer pairing pelareorep with a checkpoint inhibitor reported partial or complete responses in nearly half of evaluable patients—substantially higher than historical norms for monotherapy in this setting. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano , Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Kelly's compensation package includes equity grants and milestone-linked incentives tied to future financings and potential strategic transactions—aligning leadership priorities with long-term shareholder interests. The structure signals a commitment to advancing both clinical and corporate goals while preserving balance sheet discipline and maintaining appeal for potential partners. With multiple cohorts progressing in the GOBLET study—including those in pancreatic and anal cancer supported by external funding and regulatory engagement— Oncolytics is positioned to move forward with a combination of scientific momentum, financial agility, and renewed strategic focus. In other recent industry developments and happenings in the market include: Immuneering Corporation (NASDAQ: IMRX) reported positive Phase 2a data for atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. At six months, the study showed 94% overall survival and 72% progression-free survival in 34 patients, with no median OS or PFS reached yet. "These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind , Ph.D., Co-founder and CEO of Immuneering. "Our ultimate goal is to help cancer patients outlive their disease, and today's announcement represents an important milestone on that journey." The combination also demonstrated a 39% overall response rate, an 81% disease control rate, and a notably favorable tolerability profile. Many patients experienced deep, durable tumor regressions, including lesions rendered undetectable. The regimen was well tolerated, with an adverse event profile suggesting potential best-in-class positioning among MEK inhibitors. GRAIL, Inc. (NASDAQ: GRAL), recently announced strong top-line results from the PATHFINDER 2 registrational study evaluating its Galleri® multi-cancer early detection test in over 25,000 adults. "We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round," said Josh Ofman , MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward." The study showed a substantially higher positive predictive value (PPV) compared to the original PATHFINDER trial, with consistent specificity and cancer signal origin accuracy, and no serious safety concerns reported. GRAIL plans to submit these results to the FDA as part of its ongoing premarket approval process under Breakthrough Device Designation. Intensity Therapeutics, Inc. (NASDAQ: INTS) announced that the first patients in its ongoing Phase 2 INVINCIBLE-4 trial achieved high levels of tumor necrosis within eight days of receiving two doses of INT230-6, before starting standard-of-care immunochemotherapy for triple-negative breast cancer (TNBC). "We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation," said Lewis H. Bender , President and CEO of Intensity. "TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result." MRI scans showed substantial tumor destruction and inflammation, suggesting immune activation following direct intratumoral injection. The randomized study compares INT230-6 followed by standard treatment versus standard treatment alone, with pathological complete response (pCR) as the primary endpoint. Relay Therapeutics, Inc. (NASDAQ: RLAY) reported updated interim data from its Phase 1/2 study of RLY-2608 plus fulvestrant, showing a median progression-free survival (PFS) of 11.0 months in second-line patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer. "We are encouraged by the consistency of these updated RLY-2608 + fulvestrant data, which continue to show the potential benefit of a mutant-selective PI3Kα inhibitor for improving both the tolerability profile and progression free survival compared to standard of care," said Don Bergstrom , M.D., Ph.D., President of R&D at Relay Therapeutics. "We look forward to starting the first mutant-selective PI3Kα Phase 3 trial, ReDiscover-2, in the middle of this year." Among patients at the recommended Phase 3 dose, the clinical benefit rate reached 67%, and 39% had confirmed partial responses, with notably higher response rates in those with kinase mutations. The combination maintained a favorable tolerability profile, with low rates of high-grade adverse events and minimal treatment discontinuations. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
The Market Online
11-06-2025
- Business
- The Market Online
Oncolytics Biotech stock takes off after naming new CEO
Oncolytics Biotech (TSX:ONC), a clinical-stage oncology immunotherapy stock, is up by more than 20 per cent after onboarding new chief executive officer and director Jared Kelly Kelly brings a strong track record as a biotech executive, including ample experience with large-scale deals The company is currently developing immunotherapies against breast, anal and pancreatic cancer Oncolytics Biotech stock has given back 50 per cent year-over-year and 74.27 per cent since 2020 Oncolytics Biotech (TSX:ONC), a clinical-stage oncology immunotherapy stock, is up by more than 20 per cent after onboarding new chief executive officer and director Jared Kelly. Kelly brings a strong track record as a biotech executive, including ample experience with large-scale deals, such as the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. He has also advised leading-edge biotech companies on M&A and licensing as part of law firms Lowenstein Sandler LLP and Kirkland & Ellis LLP. The appointment bodes well for the advancement of pelareorep, Oncolytics' flagship intravenously-administered immunotherapeutic agent, which has been granted Fast-Track Designation by the U.S. Food and Drug Administration in metastatic breast cancer (mBC) and metastatic pancreatic ductal adenocarcinoma (mPDAC). In phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep delivered a more than 60 per cent objective response rate, more than double compared to historical control trials, as well as two-year survival rates 4-6 times those of control patients or prior benchmark studies. In mBC, pelareorep achieved a meaningful survival benefit in two randomized phase 2 studies, in addition to improvements in a separate phase 2 study upon historical data for treatment with a checkpoint inhibitor in second-line or later unresectable squamous cell carcinoma of the anal canal. According to Oncolytics' investor presentation for March 2025, the company sees multi-billion-dollar upside for pelareorep across a growing number of cancer variants. Leadership insights 'Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date,' Wayne Pisano, Oncolytics' chair and outgoing interim CEO, said in a statement. 'We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors.' 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications,' Kelly added. 'Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders.' Oncolytics Biotech is a clinical-stage biotechnology company developing immunotherapies against breast, anal and pancreatic cancer. Oncolytics Biotech stock (TSX:ONC) is up by 23.68 per cent trading at C$0.70 per share as of 10:53 am ET. The stock has given back 50 per cent year-over-year and 74.27 per cent since 2020. Join the discussion: Find out what everybody's saying about this cancer immunotherapy stock on the Oncolytics Biotech Inc. Bullboard and check out Stockhouse's stock forums and message boards. The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.
Globe and Mail
23-05-2025
- Business
- Globe and Mail
Oncolytics Biotech® to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities
Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responses New analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumors Pre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancer SAN DIEGO and CALGARY, AB , May 23, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation highlights pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC), offering new insights into how this immunotherapy stimulates multiple arms of the immune system and primes tumors for treatment. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman , M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL clones in the blood. These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size. Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." Abstract Number: 2562 Title: Role of pelareorep in activating anti-tumor immunity in PDAC. Presentation Type: Poster Session Title: Developmental Therapeutics – Immunotherapy Session Date and Time: June 2, 2025 , 1:30 - 4:30 p.m. CT A copy of the ASCO presentation will be available on the Media page of Oncolytics' website ( LINK) following the conclusion of the meeting. Highlights from the poster and abstract include: Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24 Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq ®) in first-line metastatic PDAC patients, showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate About GOBLET The GOBLET ( G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1 st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1 st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3 rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2 nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. Tecentriq ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@ Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@ Media Contact for Oncolytics Michael Rubenstein LifeSci Communications mrubenstein@
