Regorafenib

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 8, 2025 /PRNewswire/ -- Equity Insider News Commentary – As cancer rates climb and drug costs continue to soar, pressure is mounting on the private sector to drive innovation. Now, cancer experts are alarmed over a "gut wrenching" plan from the U.S. government to cut nearly 40% of National Cancer Institute funding, even as the price of oncology treatments pushes new limits—raising urgent concerns about access and affordability. In this shifting landscape, investors are turning their attention to a new wave of biotechs and specialty care providers developing breakthrough therapies and smarter care models, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Citius Oncology, Inc. (NASDQ: CTOR), Exelixis, Inc. (NASAQ: EXEL), and The Oncology Institute, Inc. (NASDAQ: TOI). Continue Reading Amid NCI Budget Fears, Emerging Oncology Stocks Gain Attention Market forecasts suggest oncology could be one of the decade's fastest-growing sectors. Nova One Advisor projects the global oncology drug market will reach US$366.24 billion by 2034, with a 7.4% CAGR. Other firms are even more bullish— ResearchAndMarkets sees the market hitting US$866.1 billion, while Vision Research Reports expects revenue in 2034 to surpass US$903.81 billion, fueled by rising demand for advanced diagnostics and targeted therapies. For emerging cancer stocks, the timing couldn't be better. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has highlighted survival data that may redefine expectations for immunotherapy in cold tumors, especially in metastatic pancreatic and breast cancers, where treatment options remain limited. In first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), Oncolytics's flagship pelareorep, an intravenously delivered immunotherapeutic agent, has 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%. "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." In a 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 first-line metastatic pancreatic ductal adenocarcinoma. Breast cancer results are also very impressive. In HR+/HER2- metastatic breast cancer (mBC), pelareorep extended median overall survival by more than 10 months across two randomized trials compared to standard chemotherapy. In the BRACELET-1 trial, pelareorep plus paclitaxel delivered median progression-free survival of 12.1 months—nearly doubling the 6.4 months observed in the control arm. "Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies." With over 1,100 patients studied to date, pelareorep continues to demonstrate a favorable safety profile, with most side effects limited to transient, flu-like symptoms. The company says it is now preparing for registration-enabling trials, leveraging its existing Fast Track designations in both mPDAC and HR+/HER2- mBC, as well as Orphan Drug status for pancreatic cancer in both the U.S. and Europe. 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 the company sharpens its focus on late-stage development and strategic transactions. Both men previously played key roles in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson and bring a track record of value creation in oncology-focused biotechs. Their arrival signals a deliberate pivot toward unlocking the value of pelareorep, Oncolytics' virus-based immunotherapy currently in multiple mid-to-late-stage studies. "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 CEO Jared 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." Pelareorep holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC), and has shown encouraging synergy with checkpoint inhibitors and chemotherapy. In mPDAC, Phase 2 data showed objective response rates above 60% in tumor-evaluable patients, exceeding historical benchmarks, with survival at two years also outperforming expectations. Meanwhile, in HR+/HER2- mBC, two randomized phase 2 trials (IND-213 and BRACELET-1) demonstrated overall survival trends that support continued development. The drug's potential may extend even further. A Phase 2 anal cancer cohort combining pelareorep with a checkpoint inhibitor produced responses that surpassed historical checkpoint monotherapy outcomes, suggesting broader utility. Most recently, new data from the GOBLET trial presented at ASCO 2025 highlighted pelareorep's ability to activate both innate and adaptive immune responses in metastatic pancreatic cancer—reinforcing its potential as a backbone immunotherapy. With experienced leadership now in place and a growing clinical footprint, Oncolytics is advancing toward potential partnership, planning registration-enabling trials, and commercialization readiness—all while maintaining a disciplined, investor-aligned approach to capital and growth. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Celcuity Inc. (NASDAQ: CELC) has reported encouraging early-phase data from two separate clinical trials evaluating gedatolisib in prostate and breast cancer. In metastatic castration-resistant prostate cancer, a Phase 1 trial combining gedatolisib with darolutamide showed a 66% six-month radiographic progression-free survival rate. "We are very encouraged by this preliminary efficacy and safety data," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "The 66% six-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib." In HER2+ metastatic breast cancer, a Phase 2 trial of gedatolisib plus standard doses of trastuzumab-pkrb showed a 43% objective response rate in patients who had received at least three prior lines of therapy. Citius Oncology, Inc. (NASDQ: CTOR) is preparing to launch LYMPHIR, an FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma, in the second half of 2025. "We've made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "With our supply chain secured, market access supported, and no anticipated impediments to reimbursement, we are encouraged by the momentum we've built. These efforts are pivotal as we transition into a commercial-stage company and believe the planned 2025 launch of LYMPHIR has the potential to be an important inflection point for both the company and the CTCL community." The company has completed commercial-scale manufacturing, secured distribution partnerships, and built a launch strategy with AI-enhanced targeting of key oncology centers. With regulatory infrastructure in place and early clinical interest, Citius is positioned to transition into full commercial operations this year. Exelixis, Inc. (NASAQ: EXEL) reported positive Phase 3 results from its STELLAR-303 trial, showing that zanzalintinib combined with atezolizumab significantly improved overall survival versus regorafenib in patients with metastatic colorectal cancer. "The STELLAR-303 results, which showed a survival benefit with the combination of zanzalintinib and atezolizumab versus regorafenib across all randomized patients with previously treated metastatic colorectal cancer, marks an important first milestone for our zanzalintinib pivotal development program," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference." The combination met one of the trial's dual primary endpoints, and a final analysis for the second—overall survival in patients without liver metastases—is still pending. No new safety signals were observed, and full results are expected at an upcoming medical conference. The Oncology Institute, Inc. (NASDAQ: TOI) has entered into a major partnership with SilverSummit Healthplan to provide oncology care to over 80,000 Medicaid members across Nevada. "We couldn't be more excited about the opportunity to expand our partnership with SilverSummit and help create improved access and quality of cancer care to their Medicaid patient population," said Daniel Virnich, MD, CEO of The Oncology Institute. "We have a longstanding track record of providing outstanding care to Medicaid patients in other markets, and we look forward to broadening these efforts within the Las Vegas community." Effective July 1, TOI is now the exclusive provider of cancer services for SilverSummit's patient base, with dedicated clinics already open in Las Vegas, Henderson, and Spring Valley. The expansion reflects TOI's ongoing growth in value-based oncology, particularly among underserved populations. Both organizations emphasized the importance of delivering high-quality, community-based cancer care tailored to the needs of Medicaid patients. Source: 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. 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ESMO GI 2025微专辑扫描二维码可查看更多内容编者按在2025年欧洲肿瘤内科学会（ESMO）胃肠癌大会（7月2~5日，巴塞罗那）上展示的PARERE和OrigAMI-1试验数据表明，通过不同抑制方法进行的ctDNA指导的抗EGFR再挑战策略，在RAS/BRAF野生型转移性结直肠癌（mCRC）中是一种有效的策略。在Ⅱ期PARERE试验中，对213例难治性肿瘤患者（这些患者对一线抗EGFR治疗有反应）而言，使用帕尼单抗进行抗EGFR治疗后在疾病进展时改用瑞戈非尼的治疗方案，比相反的治疗顺序效果更好（摘要4O）。与瑞戈非尼相比，帕尼单抗的客观缓解率（ORR）更高（16% vs. 2%；P<0.001），疾病控制率（DCR）也更高（59% vs. 32%；P<0.001）。帕尼单抗的无进展生存期1（PFS1）为4.1个月，而瑞戈非尼为2.4个月（P=0.116）。在精选的ctDNA RAS/BRAF野生型患者中，帕尼单抗的无进展生存期优势更为明显；在19例至少有1种抗EGFR耐药突变的患者中，帕尼单抗和瑞戈非尼之间没有差异。图1. 在PARERE试验中，难治性ctDNA RAS/BRAF野生型mCRC患者疾病进展时使用帕尼单抗后改用瑞戈非尼与相反治疗顺序的疗效对比来自Ib/II期OrigAMI-1试验的更新结果显示，在54例左侧ctDNA RAS/BRAF野生型mCRC患者中（摘要6MO），在更长的时间间隔（>8.8个月vs.≤8.8个月）后再次使用EGFR-MET双特异性抗体amivantamab单抗进行再挑战，可使客观缓解率（32% vs. 7%）和中位无进展生存期（7.0个月vs. 2.8个月；P=0.0081）得到改善，并且总体生存期（OS）有延长的趋势（16.1个月vs.10.4个月；P=0.088），基线ctDNA突变分析不能预测治疗反应。英国利兹大学的珍妮·塞利格曼教授说：“这两项试验中取得的缓解率在经过多线预处理的情况下是有意义的，PARERE试验中的疾病控制率非常令人鼓舞。这些结果在更大型、随机的试验环境中证实了之前报道的小型单臂CHRONOS研究的结果。”在大会上还展示了一项来自西班牙的回顾性研究，研究对象为134例RAS/BRAF野生型mCRC患者，结果表明，较长的既往抗EGFR无进展生存期（>20个月）和抗EGFR治疗间歇期（>10.4个月）分别与更好的疾病控制率（P=0.04和P<0.01）、无进展生存期（P=0.01和P<0.01）相关。EGFR治疗间歇期还与总生存期相关（P<0.01），相比之下，较短的间隔则没有这些效果（摘要42P）。塞利格曼认为，研究治疗之间的理想间隔很重要，令她感到欣慰的是，再挑战的效果延伸到了临床治疗的患者身上，尽管该队列是在高度专业化的专家中心接受治疗的。目前这是一个非常活跃的研究领域，新的数据“推动抗EGFR再挑战方法向标准治疗迈进”。不过，她强调还需要更多的研究和考虑：“未来的挑战包括正式确定抗EGFR再挑战在治疗路径中的时间安排，以及ctDNA指导再挑战的时间安排。此外，尽管这些数据令人兴奋，但我们应该记住，液体活检指导的治疗对患者的可及性可能比较有限，因为许多中心无法获得必要的ctDNA技术。”参考来源Ciracì P, et al. Liquid biopsy-guided selection for anti-EGFR re-treatment in RAS/BRAF wild-type (wt) chemorefractory metastatic colorectal cancer patients (mCRC pts): Results from the phase II randomized PARERE trial. ESMO Gastrointestinal Cancers Congress 2025, Abstract 4OProffered Paper Session 2, 04.07.2025, h. 16:30 – 18:00, Room MadridArnold D, et al. Rechallenge with amivantamab, an EGFR-MET bispecific antibody, after disease progression on prior EGFR inhibitor in left-sided RAS/BRAF wild-type metastatic colorectal cancer: Updated results from OrigAMI-1. ESMO Gastrointestinal Cancers Congress 2025, Abstract 6MOMini Oral Session – Innovation in Gl Cancers, 02.07.2025, h. 16:15 – 17:35, Room BarcelonaMascaró Baselga P, et al. Real-world outcomes of anti-EGFR rechallenge in RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC). ESMO Gastrointestinal Cancers Congress 2025, Abstract 42PPoster Display Session 2, 04.07.2025, h. 15:30 – 16:30, Foyer（来源：肿瘤瞭望消化时讯）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。