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Cision Canada
9 hours ago
- Business
- Cision Canada
With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology
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.
Cision Canada
12-06-2025
- Business
- Cision Canada
As Public Cancer Funding Wavers, Oncology's Brightest Breakthroughs Are Coming From Industry
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /CNW/ -- Equity Insider News Commentary – The 2025 ASCO Annual Meeting has wrapped, leaving behind a wave of cautious optimism across the oncology landscape. From advances in immunotherapy and CAR T-cell strategies to new applications in AI, diagnostics, and even exercise-based interventions, this year's gathering spotlighted a broad array of promising approaches. However, looming over the scientific excitement are concerns about proposed U.S. budget cuts, including a potential 40% reduction in funding for the National Cancer Institute (NCI). As public investment comes under pressure, many are turning to the private sector to carry the load — with recent moves by companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Anixa Biosciences, Inc. (NASDAQ: ANIX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and ImmunityBio, Inc. (NASDAQ: IBRX). The rising global burden of cancer is driving urgent demand for next-generation therapies. By 2030, annual case counts are expected to climb 20%, with projections pointing to a 75% surge by 2050, according to Statista. Market researchers anticipate oncology spending will scale to match: ResearchAndMarkets forecasts the sector hitting US$866.1 billion by 2034, growing at a 10.8% CAGR, while Vision Research Reports places the market for cancer treatments even higher — surpassing US$903.81 billion at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "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 priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls — and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "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." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. In other recent industry developments and happenings in the market include: Anixa Biosciences, Inc. (NASDAQ: ANIX) is advancing two novel programs at the frontlines of cancer immunotherapy. The company will present new data from its first-in-human ovarian cancer CAR-T clinical trial later this month at the ESMO Gynaecological Cancers Congress, showcasing a unique chimeric endocrine receptor T-cell (CER-T) platform targeting the follicle stimulating hormone receptor (FSHR). Separately, Anixa is also working with Cleveland Clinic to develop a preventative breast cancer vaccine designed to train the immune system to recognize "retired" proteins reactivated in early malignancies. "While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need. Our vaccine may offer a unique, immunologic pathway for both prevention and treatment." Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has published the final five-year analysis from its Phase 2 C-144-01 trial evaluating Amtagvi® (lifileucel), the first FDA -approved T cell therapy for solid tumors in patients with advanced melanoma. "Amtagvi has demonstrated long-term benefit and meaningful overall survival in a difficult-to-treat melanoma patient population resistant to immune checkpoint inhibitor therapy," said Theresa Medina, M.D., medical oncologist at the University of Colorado Cancer Center on the Anschutz Medical Campus. "Five years following one-time Amtagvi treatment, responses persisted or deepened during an extended treatment-free interval for some patients. Amtagvi offers a new standard of care for the advanced melanoma community and sets a new bar for one-time cell therapies with curative intent in solid tumors." The results, featured in the Journal of Clinical Oncology and presented at ASCO 2025, highlight durable responses in heavily pretreated patients—with nearly one-third of responders maintaining benefit five years after a single treatment. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently reported compelling Phase 3 results for Libtayo® (cemiplimab) as an adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. The trial showed a 68% reduction in disease recurrence or death and strong secondary endpoint performance, including 80% and 65% reductions in locoregional and distant recurrence, respectively. "The Phase 3 C-POST trial demonstrates that cemiplimab is a highly active therapy in high-risk CSCC, with clinically meaningful outcomes across primary and secondary endpoints and exceptionally low rates of locoregional and distant recurrence," said Danny Rischin, M.D., Head of Head and Neck Cancer and Cutaneous SCC at Peter MacCallum Cancer Centre. "While surgery and radiotherapy remain the cornerstones of treatment, there is a critical unmet need for systemic therapies to help prevent relapse and metastasis." Regulatory filings have already been submitted in the U.S. and EU, and experts say these findings could reshape treatment standards. ImmunityBio, Inc. (NASDAQ: IBRX) is advancing what may be the first true therapy for lymphopenia—a condition long associated with poor outcomes in cancer but never directly treated until now. "Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. " Backed by FDA Expanded Access authorization, the company's Cancer BioShield™ platform centers on ANKTIVA®, an IL-15 superagonist approved in bladder cancer and now being deployed to help restore immune function in patients with solid tumors who've exhausted first-line therapies. "This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA," said Soon-Shiong. "The survival benefit we observed at ASCO 2025 in 3 rd to 6 th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease." At ASCO 2025, ImmunityBio presented landmark data showing that reversing lymphopenia with ANKTIVA and CAR-NK cells significantly extended survival in late-stage pancreatic cancer patients, especially when intervention occurred at a lower tumor burden. The results represent a potential paradigm shift: treating immune collapse itself—not just the tumor—may drive better long-term outcomes. Based on this mechanism, the platform could open doors to broader applications in oncology, infectious disease, and immune senescence. CONTACT: Equity Insider [email protected] (604) 265-2873 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. Equity Insider 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.
Business Insider
02-06-2025
- Business
- Business Insider
BeOne Medicines to present new data from Phase 3 SEQUOIA trial of BRUKINSA
BeOne Medicines (ONC) will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago, IL. Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. The best undetectable minimal residual disease rate in peripheral blood at a sensitivity level 10-4 was 59%. These efficacy responses observed in Arm D, despite the high proportion of high-risk patients enrolled, are in line with recent fixed-duration studies in fitter, healthier patient populations. Additionally, 11 patients in Arm D were able to discontinue treatment early due to meeting uMRD-guided stopping criteria, and 9 patients remain in ongoing clinical remission with sustained uMRD, allowing them to remain treatment-free. In patients without del(17p) and TP53 mutations, 43% achieved uMRD by cycle 16 and 60% by cycle 28. These data were published today in the Journal of Clinical Oncology. Confident Investing Starts Here:
Associated Press
23-05-2025
- Business
- Associated Press
New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs
Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /PRNewswire/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically 'cold' tumors into 'hot,' inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. '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. 'It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood.' According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. 'These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size,' Heineman added. '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.' The abstract, titled 'Role of pelareorep in activating anti-tumor immunity in PDAC,' (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help 'turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. 'Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients,' said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. 'This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile.' As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. 'We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders,' said Brian McKelligon, CEO of Akoya Biosciences. 'We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability.' Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. 'The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns,' said Masoud Toloue, PhD, CEO of Quanterix. 'The combined company will provide a significant value creation opportunity for shareholders.' The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. 'This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies,' said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. 'We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year.' Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. 'These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,' said Rami Elghandour, CEO of Arcellx. 'There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible.' The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. 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