Pembrolizumab

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 10, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer rates are rising everywhere, but more dramatically in some places. According to a new analysis of CDC data, Maine currently has the highest rates among US states, while Utah has the lowest. However, another study found that survival rates for cancer patients on immunotherapy depend on their insurance coverage, whether it be through private, Medicaid, or those who are uninsured. With cases for several types of cancers, such as breast cancer, there is plenty of new tech innovation for diagnosis and treatments coming from the private sector. With public resources under pressure, and the cancer research budget for the National Cancer Institute set to be slashed by up to 40%, the oncology landscape is looking towards a new generation of biotechs to step up—including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Kazia Therapeutics Limited (NASDAQ: KZIA), Immuneering Corporation (NASDAQ: IMRX), Nuvation Bio Inc. (NYSE: NUVB), and Calidi Biotherapeutics Inc. (NYSE-American: CLDI). Continue Reading Cancer Innovation Accelerates as Funding Cuts Loom and Biotechs Step Up While U.S. cancer death rates continue to decline, global cancer cases are expected to rise sharply. As well, early-onset diagnoses in younger patients are climbing at a troubling pace. Now, industry analysts are estimating the global oncology drug market could surpass US$900 billion in revenue by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently highlighted survival data and an upcoming KOL webinar that together underscore growing expert and clinical support for its virus-based immunotherapy, pelareorep, in hard-to-treat cancers like metastatic pancreatic and breast cancer. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), pelareorep-based treatment regimens have shown a two-year overall survival rate of 21.9% across pooled data from more than 100 patients—more than double the historical benchmark of 9.2%. In a separate single-arm study combining pelareorep with chemotherapy and a checkpoint inhibitor, the objective response rate reached 62% in evaluable patients. No immunotherapy is currently approved in this indication. "We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, newly-appointed CEO of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology." HR+/HER2- metastatic breast cancer (mBC) has also shown strong survival numbers. In HR+/HER2- mBC, pelareorep extended median overall survival by more than 10 months across two randomized trials. The BRACELET-1 trial also showed median progression-free survival of 12.1 months, nearly double the 6.4 months in the control arm. The company recently reinforced its leadership bench with two high-profile appointments—naming Jared Kelly as Chief Executive Officer and Andrew Aromando as Chief Business Officer—as it sharpens its focus on late-stage development and strategic transactions. Both Kelly and Aromando played instrumental roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson, and bring deep experience in value creation, partnerships, and registration pathways in oncology. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "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." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. Across more than 1,100 patients treated to date, pelareorep has maintained a favorable safety profile, with most adverse events limited to flu-like symptoms. The drug has shown broad synergy with checkpoint inhibitors and chemotherapies and continues to generate immune responses in multiple solid tumor types. Oncolytics is advancing toward registration-enabling trials and partnership opportunities with a disciplined, investor-aligned approach to growth. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Kazia Therapeutics Limited (NASDAQ: KZIA) shared encouraging early data from its Phase 1b trial evaluating paxalisib alongside Keytruda and chemotherapy in triple-negative breast cancer. The first patient, a 61-year-old woman with lung metastases, experienced a greater than 50% reduction in circulating tumor cells (CTCs) after just one treatment cycle. "The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial," said Dr. John Friend, MD, CEO of Kazia Therapeutics. "CTC clusters are emerging as key drivers of metastatic spread—they're 20–100X more efficient at seeding than single CTCs—and the sharp decline we're seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression." Notably, both single CTCs and clusters—key drivers of metastasis—were sharply reduced, along with the mesenchymal phenotype often linked to aggressive disease. These initial results echo Kazia's preclinical findings and hint at the potential for meaningful anti-metastatic activity early in treatment. Immuneering Corporation (NASDAQ: IMRX) has been granted a U.S. composition of matter patent for atebimetinib, a once-daily oral cancer drug designed to overcome resistance and deliver longer-lasting benefits. In an ongoing Phase 2a study, the drug showed a 94% six-month survival rate in first-line pancreatic cancer—compared to 67% with standard care—while maintaining a strong safety profile. "Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives," said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneering. "We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer." The patent provides exclusivity into 2042, with potential extension, supporting Immuneering's broader strategy to advance this "deep cyclic" MEK inhibitor across multiple tumor types. Nuvation Bio Inc. (NYSE: NUVB) has announced that IBTROZI (taletrectinib)—its newly FDA-approved targeted therapy for advanced ROS1+ non-small cell lung cancer (NSCLC)—has now been added as a Preferred Agent in the latest National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines. This designation applies to both first-line and follow-up treatment, and specifically highlights IBTROZI's benefit for patients with brain metastases and resistance mutations. "We are very pleased the NCCN acted with such urgency to review and update the NCCN Guidelines to include taletrectinib (IBTROZI) as a preferred option for advanced ROS1-positive NSCLC across treatment lines, with particular recognition of benefit for patients with brain metastases and those with acquired resistance after first-line therapy," said David Hung, M.D., Founder, President and CEO of Nuvation Bio. "These updates address critical needs for patients across their treatment journeys, especially with the prevalence of CNS involvement for those living with ROS1+ NSCLC. Additionally, this version builds further upon a previous guideline update that importantly highlights preferred utilization of ROS1-targeted agents instead of immunotherapy and chemotherapy for these patients." The update strengthens IBTROZI's position as a next-generation treatment in a rare, aggressive lung cancer that often spreads to the brain. Calidi Biotherapeutics Inc. (NYSE-American: CLDI) is gaining traction as it advances CLD-401, a next-generation systemic virotherapy armed with CD55-enhanced shielding and an IL-15 superagonist payload to improve immune activation and tumor penetration. Preclinical data presented at ASCO 2025 showed the platform's potential to evade immune clearance, target metastatic tumors, and stimulate both NK and CD8+ T cell responses—supporting its promise as an off-the-shelf immunotherapy for difficult-to-treat cancers. The company recently secured $4.6 million in funding through warrant exercises and reaffirmed its IND submission timeline and partnering goals in a shareholder update. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Eric Poma, PhD, CEO of Calidi in a shareholder letter. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an aggressive dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of Redtail in patients with metastatic disease." With clinical readiness targeted for 2026, Calidi appears well-positioned at the intersection of innovation, execution, and immuno-oncology momentum. Source: CONTACT: USA NEWS GROUP [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. 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. Video - Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

In eight tumors where patients failed immune checkpoint inhibitor (ICI) treatment, Plinabulin + radiation + PD-1 inhibitors demonstrated an overall response rate (ORR) of 23% and a disease control rate (DCR) of 54% in non-irradiated lesions. Biomarker analysis linked Plinabulin’s mechanism to GEF-H1–dependent dendritic cell maturation, offering the potential to pre-select patients at baseline and predict clinical response. July 07, 2025 -- BeyondSpring Inc. (NASDAQ: BYSI) today announced publication of a human clinical study in Med (Cell Press) demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell (DC) maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy. The study also identified a potential biomarker—baseline GEF-H1 immune signature—that may enable patient pre-selection and clinical response prediction. “These results offer early but important signals that Plinabulin’s dendritic cell maturation mechanism could play a pivotal role in reversing ICI-acquired resistance,” said Dr. Steven Lin, M.D., Ph.D., corresponding author and Professor of Radiation Oncology at The University of Texas MD Anderson Cancer Center. “The ability of Plinabulin to activate the immune system in this setting is both scientifically intriguing and clinically promising—particularly given the durability of responses in some heavily pretreated patients.” Dr. Lin added, “It is especially noteworthy that Plinabulin combination demonstrated the best responses in non-small cell lung cancer, head and neck squamous cell carcinoma, and Hodgkin lymphoma.” “This study builds upon the seminal work of Nobel Laureate Dr. Ralph Steinman and Dr. Ira Mellman, who helped define the essential role of dendritic cells in immune activation,” said Lan Huang, Ph.D., Co-Founder, Chairman, and CEO of BeyondSpring. “Plinabulin’s ability to drive dendritic cell maturation and induce immune responsiveness offers a potential breakthrough strategy for patients who are refractory or relapsed on checkpoint inhibitors. We are committed to advancing Plinabulin’s development in partnership with pioneering cancer research institutions like MD Anderson.” This investigator-initiated, Phase 1 translational trial (NCT04902040) evaluated a triple immunotherapy approach combining Plinabulin, radiation (RT), and anti-PD-1 checkpoint inhibitors in patients with eight cancer types who are refractory or relapsed on prior ICI therapy. RT was administered only during the first cycle. The primary endpoint was tumor response in non-irradiated lesions. Lin S.H., Subbiah V., Cohen E.N. et al. “Plinabulin following radiation enhances dendritic cell maturation and checkpoint inhibitor retreatment of relapsed/refractory cancers.” Med. Published June 27, 2025. This open-label, single-arm Phase 1 basket study (NCT04902040) at MD Anderson Cancer Center investigates safety and efficacy of Plinabulin plus radiation and PD-1 inhibitor in patients refractory or relapsed after prior immunotherapy. The primary endpoint is investigator-assessed ORR (RECIST 1.1) in non-irradiated lesions; secondary endpoints include DCR. – Radiation (Cycle 1 and optional Cycle 2): Local consolidative RT (8 Gy × 3; 12.5 Gy × 4; or 4 Gy × 5) on Day 1. Optional sequential RT in Cycle 2 at investigator discretion. – Plinabulin: 30 mg/m² on Days 1 and 4 of Cycle 1 (3–6 hours post-RT); Day 1 of Cycle 2 onward; Additional Day 4 in Cycle 2 if RT is given in Cycle 2. – PD-1 inhibitor: Pembrolizumab 200 mg on Day 1 every 21 days or nivolumab 240 mg on Day 1 every 14 days × 2 doses per cycle. Plinabulin is a first-in-class dendritic cell maturation agent that binds reversibly to a unique site on tubulin, destabilizing microtubules in a controlled manner to release GEF-H1 (Chem 2019; Cell Reports 2019). Immune protein GEF-H1 activates the RhoA/ROCK signaling pathway, promoting dendritic cell maturation and anti-tumor T-cell immunity. This mechanism is distinct from traditional tubulin agents and does not interfere with tubulin stabilizers like docetaxel. Across multiple clinical studies and approximately 800 patients, Plinabulin has shown durable anti-cancer activity and a favorable safety profile, and has significantly reduced chemotherapy-induced neutropenia, potentially enhancing docetaxel tolerability. – In the Dublin-3 Phase 3 second and third line (2/3L) NSCLC, EGFR wild-type trial (n=559), Plinabulin + docetaxel demonstrated a significant overall survival benefit over standard-of-care docetaxel (Lancet Respiratory Medicine 2024 - Press Release Link). – In a Phase 2 study of Plinabulin + pembrolizumab + docetaxel in 2/3L NSCLC who progressed on PD-1/L1 inhibitors (n=47), median PFS was 6.8 months, and 15-month OS rate was 78% (ASCO 2025 - Press Release Link). BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and a range of cancer indications. Plinabulin’s novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors to prior failure or progression to checkpoint inhibitors. In addition, BeyondSpring is the founding equity holder of SEED Therapeutics, a biotechnology company pioneering targeted protein degradation (TPD) through the discovery of novel molecular glues and bifunctional degraders. Powered by its proprietary RITE3™ platform, SEED is advancing a pipeline of first-in-class degraders to address traditionally undruggable targets across oncology, neurodegeneration, immunology, and virology. SEED’s strategic collaborations with Eli Lilly and Company and Eisai Co., Ltd. support its mission to develop transformational therapies. Learn more at beyondspringpharma.com. The content above comes from the network. if any infringement, please contact us to modify.