Cretostimogene Grenadenorepvec

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 8, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's unprecedented wave of Breakthrough Therapy Designations through August has accelerated development timelines for life-saving cancer treatments[1], while major pharmaceutical companies deployed several multi-billion-dollar strategic partnerhips (with one topping $11 billion) to secure next-generation immunotherapies[2]. These recent designations are creating momentum for companies advancing breakthrough oncology platforms including Oncolytics Biotech Inc. (NASDAQ: ONCY), HUTCHMED (China) Limited (NASDAQ: HCM), CG Oncology, Inc. (NASDAQ: CGON), C4 Therapeutics, Inc. (NASDAQ: CCCC), and IDEAYA Biosciences, Inc. (NASDAQ: IDYA). Industry analysts expect the antibody-drug conjugate market to reach $50 billion by 2030[3], driven by 16 approved therapies and accelerating clinical pipelines. Immuno-oncology revenues jumped from $94 billion to $109.39 billion in 2025 alone[4], as leading institutions recognize the transformative potential of precision-targeted therapies and combination treatment approaches for previously untreatable cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space." The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: HUTCHMED (China) Limited (NASDAQ: HCM) highlighted clinical data from multiple oncology studies at the 2025 World Conference on Lung Cancer and CSCO Annual Meeting, showcasing updated analysis from savolitinib's SACHI, SAVANNAH and Phase IIIb confirmatory studies in non-small cell lung cancer patients. The company will present first-time clinical data of HMPL-653, a novel CSF-1R inhibitor, from a Phase I study in patients with tenosynovial giant cell tumor. Savolitinib, an oral and highly selective MET tyrosine kinase inhibitor being jointly developed with AstraZeneca, continues advancing through multiple clinical programs targeting various lung cancer indications. According to Hutchmed's announcement, updated analysis from savolitinib's SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer patients will be presented at WCLC 2025. The comprehensive clinical program spans investigator-initiated studies of fruquintinib and surufatinib across multiple cancer types, with HUTCHMED positioning itself as an innovative commercial-stage biopharmaceutical company committed to bringing targeted therapies from in-house discovery to patients worldwide. The company has successfully marketed its first three medicines in China, with its lead compound also approved globally, including in the US, Europe and Japan. CG Oncology, Inc. (NASDAQ: CGON) continues to demonstrate best-in-disease durability with its cretostimogene immunotherapy, reporting an additional 12 patients achieving complete response at 24 months in the BOND-003 Cohort C study. The robust 24-month complete response rate of 41.8% observed in 46 out of 110 patients with high-risk non-muscle invasive bladder cancer unresponsive to BCG treatment represents unprecedented durability in this heavily pretreated patient population. Notably, 90% of 12-month responders remained disease-free at 24 months, while 96.6% of patients were free from progression to muscle-invasive disease at 24 months. "Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results." The company is preparing to initiate its BLA submission for cretostimogene in the fourth quarter of 2025, with the Phase 3 BOND-003 Cohort C representing the largest study in this patient population to date. Cretostimogene's safety profile remains consistent with no Grade 3 or greater treatment-related adverse events or deaths reported, supporting its potential as a breakthrough backbone treatment for bladder cancer patients. C4 Therapeutics, Inc. (NASDAQ: CCCC) completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, with the investigational MonoDAC degrader continuing to demonstrate a well-tolerated safety profile and compelling response rates. The company will present comprehensive data from all safety and efficacy evaluable multiple myeloma patients across all dose levels studied in the cemsidomide with dexamethasone cohort at the International Myeloma Society Annual Meeting on September 20, 2025. Cemsidomide is designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas, with unique pharmacokinetic properties and demonstrated anti-myeloma activity and immunomodulatory effects. C4 Therapeutics will host an investor webcast on September 20, 2025, at 3 PM ET to highlight the data presentation and provide additional detail on the planned next steps of clinical development. The company is progressing its TORPEDO platform to efficiently design and optimize small-molecule degrader medicines targeting difficult-to-treat diseases, with cemsidomide representing a key advancement in harnessing the body's natural protein recycling system. IDEAYA Biosciences, Inc. (NASDAQ: IDYA) enrolled their first patient with non-small cell lung cancer in the ongoing Phase 1/2 combination trial of IDE397 and Trodelvy® in patients with MTAP-deletion solid tumors, expanding beyond the initial focus on MTAP-deletion urothelial cancer. IDE397, a potential first-in-class small molecule MAT2a inhibitor, is being combined with Gilead's Trop2-directed antibody-drug conjugate Trodelvy under a clinical study collaboration and supply agreement. MTAP-deletion is found in up to 20% of non-small cell lung cancer cases and represents an area with no approved targeted therapies, creating a significant opportunity for this novel therapeutic approach. "We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion." IDEAYA retains commercial rights to IDE397 while Gilead provides Trodelvy supply, with the precision medicine oncology company building a deep pipeline focused on synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications. The expansion into NSCLC represents a significant milestone in the company's mission to develop tailored, potentially first-in-class targeted therapies aligned to genetic drivers of disease. 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. SOURCES CITED: 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

近日，乐普生物发布了2025年上半年业绩预告，公司预计上半年将取得利润不少于2400万元，实现同比扭亏为盈。 这是公司成立以来首次实现盈利。据乐普表示，能实现转亏为盈，主要得益于公司收入的大幅成长，其中主要包括与ArriVent BioPharma就MRG007开展的许可合作收入，以及普佑恒®（普特利单抗注射液）的销售收入增长。 PD-1销售增长强势 普特利单抗（普佑恒）仍是乐普唯一的的商业化产品，于2022年7月获药监局批准上市，已获批黑色素瘤、高微卫星不稳定性或错配修复缺陷(MSI-H/dMMR)实体瘤两项适应症。 虽然普佑恒在销售收入上难以与百济、信达、君实、恒瑞等相比，但其销售增势上一众PD-1十分突出。 上市后，普佑恒的首个完整销售年度（2023年）销售额便破亿，同比增长551%，2024年进一步跃升至3亿元，同比增长约200%。 目前，乐普开展了普佑恒与其ADC管线MRG003、MRG002等的联用临床开发，以进一步拓展其他适应症。 将迎来首款上市ADC 虽然乐普在抗体、双特异性抗体、溶瘤病毒等多种形式的药物上都有涉足，但是ADC还是乐普生物最核心、进展最快的领域。 目前，乐普有7条ADC管线在研，最快的ADC管线已经到上市申报阶段，还有三款ADC管线也推到了Ⅲ期。 其中，CMG901和MRG007相继实现了对外授权，其中与ArriVent达成的授权合作（MRG007）也是公司这次能实现转亏为盈的重要原因之一。 最受期待的管线无疑是MRG003，目前全球进展最快的一款EGFR ADC，已在国内提交用于治疗复发性/转移性鼻咽癌(R/MNPC)的新药上市申请，并被纳入优先审评，有望成为国内首个批准上市的EGFR-ADC。 目前MRG003针对局部晚期头颈鳞癌（HNSCC）的III期临床正在进行中。 MRG003所处的EGFR ADC赛道竞争格局相对较好，全球范围内目前仅有一款EGFR ADC获批上市—为日本厚生省批准的光敏ADC药物Akalux，用于二线头颈鳞癌治疗。 CMG901、MRG002以及MRG004也都已经进入临床III期阶段。 双抗领域，目前还处于早期开发阶段，最新的消息是与Excalipoint达成的授权合作，两款TCE管线CTM012和CTM013被授权给了该公司，其中CTM012已申报IND。 溶瘤病毒方面，目前主要推进为引进管线CG0070，此前，其原研公司CG Oncology公布的其III期最新临床积极数据也间接利好了乐普，带动了其股价上涨。 CG0070在国内进展稍慢，目前尚处于临床Ⅰ期阶段。今年1月，CG0070还被CDE授予了突破性疗法认定，用于治疗对卡介苗（BCG）无应答的高危非肌层浸润性膀胱癌（NMIBC）患者。 总结 乐普这次实现盈利，其中合作收入做出了重要贡献，如果未来普佑恒持续保持其销售增势，加上后续有望获批的ADC产品，相信很快乐普通过产品收入实现年度盈亏平衡，迎来真正盈利。