Cretostimogene Grenadenorepvec

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 18, 2025 /PRNewswire/ -- USA News Group News Commentary – According to a recent report in Newsweek, more Americans younger than 50 are getting cancer. In fact, the report cites a recent study from the National Institutes of Health (NIH), which found that between 2010 and 2019, more than 2 million Americans aged 15 to 49 were diagnosed with cancer, with early-onset cases rising significantly in 14 different cancer types, including breast, colorectal, and kidney cancers. The dire statistics from the study come at a time where Bloomberg has recently reported on the skyrocketing costs of cancer drugs, and their lack of life-extension successes. That said, with the recent close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers remain optimistic. For investors to note, oncology innovators have provided recent developments to pay attention to, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Galectin Therapeutics, Inc. (NASDAQ: GALT), ProPhase Labs, Inc. (NASDAQ: PRPH), CG Oncology, Inc. (NASDAQ: CGON), and Perspective Therapeutics, Inc. (NYSE-American: CATX). Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) With reports coming out 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. According to analysts at ResearchAndMarkets, the global oncology market is projected to reach US$866.1 billion by 2034, rising at a 10.8% CAGR, while Vision Research Reports projects the global oncology market to surpass US$903.81 billion by 2034, 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. Photo - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Galectin Therapeutics, Inc. (NASDAQ: GALT) is advancing belapectin, a galectin-3 inhibitor with applications in both MASH cirrhosis and oncology, including combination immunotherapy for head and neck cancers. The company recently presented updated data at the 2025 EASL Congress highlighting statistically significant improvements in liver stiffness and reduced varices progression. "This quarter, we remained laser-focused on advancing additional analyses for belapectin," said Joel Lewis, CEO and President of Galectin Therapeutics. "We look forward to sharing more biomarker data as it becomes available." With Fast Track Designation in place, Galectin continues to evaluate expansion into cancer indications pending a development partner. ProPhase Labs, Inc. (NASDAQ: PRPH) has recently reported successful validation of its BE-Smart™ molecular test in detecting esophageal cancer using brush cytology samples, showing a technical success rate above 95%. "The ability to run BE-Smart on brush biopsy samples opens the door to much broader clinical use," said Ted Karkus, CEO of ProPhase Labs. "BE-Smart now stands apart as the only advanced molecular test designed to work with both forceps biopsies and brush-based tissue collection." The company is positioning BE-Smart for near-term commercialization, targeting the $10 billion esophageal disease testing market. With dual compatibility across standard biopsy methods, BE-Smart is designed to improve early detection and risk stratification for deadly cancers like EAC. CG Oncology, Inc. (NASDAQ: CGON) continues to progress its lead candidate cretostimogene, an oncolytic immunotherapy aimed at non-muscle invasive bladder cancer (NMIBC). "With best-in-disease durability and tolerability data from the BOND-003 Cohort C registrational trial recently presented at AUA, we are well positioned to initiate our BLA submission in the second half of the year for the treatment of patients with HR NMIBC unresponsive to BCG," said Arthur Kuan, Chairman and CEO of CG Oncology. "If approved, I'm confident that cretostimogene is well positioned to become backbone therapy in NMIBC, potentially addressing more than 70% of the market opportunity in need of a new and innovative therapy." At the 2025 AUA Annual Meeting, the company reported a 42.3% complete response at 24 months in its BOND-003 Cohort C, with nearly all patients avoiding progression to invasive disease. CG plans to initiate its BLA submission in the second half of 2025 while advancing multiple cohorts across BCG-unresponsive and intermediate-risk populations. Backed by over $688 million in cash and marketable securities, CG Oncology is positioned to reach multiple late-stage milestones over the next 12 months. Perspective Therapeutics, Inc. (NYSE-American: CATX) announced updated Phase 1/2a trial results for [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting, with promising signs of durability and safety in patients with progressive SSTR2-positive neuroendocrine tumors. "[212Pb]VMT-α-NET is emerging as an exciting potential treatment option for patients with progressive NETs, with continued durability of anti-tumor activity at the dose level used in Cohort 2 and a favorable tolerability profile seen so far," said Vikas Prasad, MD, Associate Professor of Radiology at the Mallinckrodt Institute of Radiology, Siteman Cancer Center. "I am eager to find more treatments to help my patients fight hard against their disease and return to their normal lives." Among nine early patients in Cohorts 1 and 2, seven remained progression-free after a year, with multiple confirmed objective responses now observed. Safety data from 42 total treated patients showed no dose-limiting toxicities, no Grade 4/5 adverse events, and no treatment-related discontinuations. The company is now in discussions with the FDA to finalize dose selection and continue advancement of this alpha-emitting radiotherapeutic platform. 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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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▎Armstrong2025年4月28日，CG Oncology在美国泌尿外科学会（AUA）年会上公布了溶瘤病毒疗法Cretostimogene（CG0070）单药治疗非肌层浸润性膀胱癌（NMIBC）三期临床BOND-3的最新数据。受此消息影响，CG Oncology当天股价大涨25%，目前市值达到21亿美元。Cretostimogene为一款工程化5型腺病毒溶瘤病毒，嵌入了两种编码基因-肿瘤选择性启动子E2F-1和GM-CSF基因，可以选择性地在Rb调控缺陷的肿瘤细胞内复制，最终裂解肿瘤细胞，进而释放肿瘤抗原以及GM-CSF，通过双重杀瘤作用可以将抗肿瘤活性最大化。Cretostimogene围绕NMIBC进行了全方位布局，覆盖70%以上的NMIBC患者，此次更新的是三期临床BOND-3的数据，包括Cohort C和Cohort P。Cohort C针对高危、卡介苗不响应的伴原位癌（CIS）患者，Cohort P针对高危、卡介苗不响应Ta/T1患者，Cohort C取得NMIBC历史最佳的持久性疗效数据，同时没有发生3级及以上副作用，Cohort P则表现出有潜力的初步疗效信号。BOND-03的临床方案设计如下，Cohort C共入组112例对BCG无应答的高危NMIBC CIS患者，主要终点为任何时间的CR率，次要终点包括12个月CR率、DoR、PFS等。Cohort P入组75例BCG无应答的高危NMIBC Ta/T1患者，主要终点为任何时间的CR率，次要终点包括RFS、PFS等。Cohort C入组的多为经过多线治疗的患者，41.1%的患者接受过化疗。主要终点任何时间CR率为75.5%，12个月CR率为50.7%，24个月CR率为42.3%。24个月时，97.3%的患者没有进展到MIBC，响应患者中91.3%的患者避免了根治性膀胱切除术。24个月持续响应率达到58.3%，Cretostimogene的mDoR尚未达到，超过28个月，这也是NMIBC的历史最佳数据。在获得优异疗效的情况下，Cretostimogene的安全性表现十分出色，没有3级及以上副作用，没有停药事件。Cretostimogene获得了NMIBC疾病历史最佳疗效数据，同时也获得了最好的安全性数据，奠定了NMIBC基石疗法的地位。对于NMIBC Ta/T1患者，Cohort P同样表现出有潜力的疗效信号，3个月、6个月、9个月的RFS率均为90.5%。CG Oncology同时也在推进Cretostimogene的联合疗法，包括与PD-1抗体联用治疗卡介苗不响应的NMIBC患者，初步数据表明可以进一步提升疗效，以及与化疗联用治疗使用过卡介苗的NMIBC患者。总结CG0070的大中华区权益由乐普生物引入，CG Oncology在国外不断取得临床突破的同时，乐普生物也在同步积极推进国内的临床进展。乐普生物同时手握已上市的PD-1抗体普特利单抗可以形成互补，联合治疗NMIBC进一步提升疗效。乐普生物PD-1抗体已经获批上市，全球首创EGFR ADC已经处于上市审评阶段，引进的溶瘤病毒疗法CG0070也在三期临床中证实BIC地位，研发管线的全面开花，不断夯实乐普生物在大分子创新药领域的优势地位。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。