Lunresertib

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 23, 2024 /PRNewswire/ -- USA News Group News Commentary – Recent advancements in cancer treatment continue to underscore the transformative potential of innovative therapies to improve patient outcomes. A stage 4 breast cancer patient in the United States reportedly achieved complete remission within six weeks through a novel immunotherapy approach, as highlighted by the New York Post. Meanwhile, in Europe, a Scottish woman became the first recipient of a personalized mRNA cancer vaccine, training her immune system to target cancer cells and marking a significant step toward more precise, less toxic treatments. These breakthroughs emphasize the dynamic nature of oncology research and the commitment to delivering groundbreaking therapies to patients worldwide. Key players driving these advancements include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cargo Therapeutics, Inc. (NASDAQ: CRGX), Immuneering Corporation (NASDAQ: IMRX), RenovoRx, Inc. (NASDAQ: RNXT), and Repare Therapeutics Inc. (NASDAQ: RPTX). The article continued: Additionally, the oncology sector has attracted significant investment, with companies like Ottimo Pharma raising $140 million to develop more effective cancer treatments with fewer side effects—highlighting the industry's commitment to addressing the global cancer burden. Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across its clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities. "This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of Oncolytics Biotech's Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep's potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy—and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO GI Symposium—an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert 'cold' tumors to 'hot,' pelareorep's unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients' immune responses—making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey." Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, highlight pelareorep's promise as a groundbreaking treatment option. With FDA alignment on a planned registration-enabling study, Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually. Significant progress has also been made in pancreatic cancer. Collaborations with the Global Coalition for Adaptive Research (GCAR) and Roche have set the stage for a registration-enabling study. This builds on the GOBLET study's outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the PanCAN-funded GOBLET cohort, evaluating pelareorep plus mFOLFIRINOX with or without atezolizumab, recently completed safety run-in enrollment and received positive feedback from the Data Safety Monitoring Board. Looking ahead, Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cargo Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next-generation, potentially curative cell therapies for cancer patients, recently reported financial results and key program updates. In the Phase 2 FIRCE-1 study, 57 LBCL patients relapsed or refractory to CD19 CAR T-cell therapy have been dosed, with the IDMC recommending the study continue without modification. Interim results are expected in the first half of 2025. For CRG-023, the company plans to submit an IND application for Non-Hodgkin's lymphoma in Q1 2025 and dose the first patient later that year. Preclinical data demonstrating CRG-023's durable anti-tumor activity across multiple antigens will be presented at the 66th ASH Annual Meeting. "We are pleased to report another quarter of strong execution underscored by continued progress in our FIRCE-1, Phase 2 study of firi-cel in addition to meaningful pipeline advancements," said Gina Chapman, President and CEO of CARGO. "With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025. We also anticipate a clear path forward to advancing CRG-023, our innovative tri-specific CAR T product candidate, into the clinic following our successful pre-IND meeting with the FDA and we are excited to share more at the upcoming ASH meeting." Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company developing universal-RAS/RAF medicines for broad cancer patient populations, recently announced plans to host a virtual Investor Event in early January 2025 to discuss data from its Phase 2a trial of IMM-1-104. The event will feature additional data on IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data on IMM-1-104 combined with mFFX in first-line pancreatic cancer, and monotherapy results in second-line pancreatic cancer. Initial PK, PD, and safety data from the Phase 1 portion of the Phase 1/2a trial of IMM-6-415 will also be presented. Access details for the event will be shared closer to the date. "We are excited to soon share additional data from our Phase 2a study of IMM-1-104 in patients with pancreatic cancer," said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. "Pancreatic cancer patients urgently need new options that enable them to live longer and feel better. The FDA has recently granted IMM-1-104 Orphan Drug designation in pancreatic cancer, along with Fast Track designations in first and second-line pancreatic cancer, and advanced melanoma. We look forward to building on our September update with additional data from the Phase 2a study of IMM-1-104." RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared local drug-delivery platform, recently announced that SCRI Oncology Partners in Nashville, TN, has begun enrolling patients with locally advanced pancreatic cancer (LAPC) in the pivotal Phase III TIGeR-PaC clinical trial. This study leverages RenovoRx's TAMPTM (Trans-Arterial Micro-Perfusion) therapy platform, which delivers gemcitabine directly to tumors via the RenovoCath system using pressure-mediated delivery. The trial is comparing this innovative drug-device combination to the current standard-of-care systemic intravenous chemotherapy, with the goal of improving outcomes for LAPC patients. "On an annual basis, SCRI and its affiliated sites reach one in five patients with cancer and is responsible for enrolling thousands of patients on clinical trials," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "We believe this collaboration will assist the Company in both accelerating patient enrollment in our pivotal Phase III TIGeR-PaC clinical trial and driving the study towards its expected enrollment completion in the first half of 2025." Repare Therapeutics Inc. (NASDAQ: RPTX), a leading clinical-stage precision oncology company, recently reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib (a first-in-class precision oncology small molecule PKMYT1 inhibitor) and camonsertib (Lunre+Camo) (a potential best-in-class oral small molecule inhibitor of ATR) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers. "We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial," said Lloyd M. Segal, President and CEO of Repare. "These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025." 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. 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▎药明康德内容团队编辑 Repare Therapeutics宣布其MYTHIC临床1期妇科癌症扩展试验取得积极成果。该试验评估了在推荐2期剂量（RP2D）下，lunresertib和camonsertib（lunre+camo）联合疗法在携带lunre敏感性生物标志物的子宫内膜癌和铂耐药性卵巢癌（PROC）患者中的疗效。数据显示，近一半妇科癌症患者在24周时保持无疾病进展，效果优于当前的标准治疗。公司计划于2025年下半年启动lunre+camo治疗子宫内膜癌患者的注册性3期试验。 MYTHIC是一项全球性、“first-in-human”的开放标签1期剂量递增试验，旨在评估lunre+camo在晚期实体瘤患者中的安全性、药代动力学、药效动力学及初步抗肿瘤活性。截至2024年11月14日，妇科癌症扩展队列共有51名可评估患者。分析显示，在接受RP2D剂量的患者中，有73%患者的肿瘤缩小，31%患者达成缓解（16/51）。 ▲MYTHIC试验疗效结果（图片来源：参考资料[2]） 子宫内膜癌患者中共有27名可评估患者，关键疗效结果如下： 患者的总缓解率（ORR）达25.9%（7名患者中5名确认缓解）。 48.1%患者观察到临床获益，患者的缓解通常在12周或更晚发生。 在24周时，几乎一半的患者获得持久的临床益处，患者24周时的无进展生存率（PFS24w）为43%（95% CI：21%-63%）。 铂耐药卵巢癌患者中共有24名可评估患者，关键疗效结果如下： 患者的ORR达37.5%（9名患者中4名确认缓解）。 79%患者观察到临床获益。 患者24周时的无进展生存率达45%（95% CI：22%-66%）。 在接受RP2D优化剂量治疗的所有患者（n=67）中，lunre+camo显示出良好且具差异化的耐受性，与现有及新兴疗法相比表现出明显优势。最常见的不良事件为贫血（26.9%，3级）。 Lunresertib是一种潜在“first-in-class”的精准肿瘤学小分子PKMYT1抑制剂，通过调控细胞周期发挥抗癌作用。Camonsertib则是一款潜在“best-in-class”的ATR口服小分子抑制剂，ATR是DNA损伤应答通路的关键组成部分。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Repare Therapeutics Announces Positive Results of the Lunresertib and Camonsertib Combination from the MYTHIC Phase 1 Gynecologic Expansion Clinical Trial. Retrieved December 13, 2024 from https://ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-announces-positive-results-lunresertib-and [2] MYTHIC Lunresertib and Camonsertib Clinical Data Update. Retrieved December 13, 2024 from https://ir.reparerx.com/static-files/92c4a8df-f6db-41f4-9505-bfa866768880 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新