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USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 19, 2024 /PRNewswire/ -- USA News Group – This year's 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) has now come and gone, but not without increasing hope for cancer patients around the world. This year's ASCO 2024 theme was 'The Art and Science of Cancer Care: From comfort to cure,' with attendees hearing presentations from experts and receiving a wide range of important clinical results for the first time. According to analysts at Spherical Insights, the Global Oncology Drugs Market is projected to be worth $564.5 billion by 2033, growing at a CAGR of 11.5%. Because a new drug typically might take 10-15 years to complete all 3 phases of clinical trials, the developments of today directly impact the results of tomorrow. This is why retail investors are wise to pay attention to the milestones and data shared by this year's ASCO attendees, which included O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), AbbVie Inc. (NYSE: ABBV), AstraZeneca PLC (NASDAQ: AZN), Pfizer Inc. (NYSE: PFE), and Bristol-Myers Squibb Company (NYSE: BMY). Updating the audience for its flagship novel immunotherapy, pelareorep, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts demonstrating further potential for the intravenously delivered immunotherapeutic agent in pancreatic cancer and its immunotherapeutic mechanism of action across multiple cancer indications. Oncolytics' first abstract presented was for a trial-in-progress of cohort 5 of the company's GOBLET study, evaluating the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without Roche's atezolizumab (Tecentriq®) in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). "The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy." Funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN), Oncolytics Biotech plans to start enrolling patients this quarter following regulatory clearance received in May. The GOBLET cohort 5 abstract and poster detail a study assessing innovative treatments for patients newly diagnosed with metastatic PDAC. Utilizing a Simon two-stage design, the study aims to determine if the treatments are promising enough for further investigation. Initially, 15 patients per treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab. The study's primary goals include evaluating the effectiveness and safety of these treatments. Researchers will measure progression-free survival (the length of time patients live without the cancer worsening), overall survival (the total length of time patients live), and biomarkers (biological indicators of treatment response). Should the first stage yield positive results, one or both treatment groups may progress to the second stage, which will involve an additional 17 patients per arm. Throughout the study, blood and tumor samples will be collected for in-depth analysis. This approach aims to provide a comprehensive understanding of how the treatments impact patient outcomes and pave the way for potential future advancements in PDAC therapy. Among the big pharma contenders that presented at ASCO 2024 was AbbVie Inc. (NYSE: ABBV), which took the opportunity at the meeting to showcase its robust solid tumor pipeline, with new data from its innovative antibody-drug conjugate (ADC) platform. AbbVie's ADCs are designed to target unique protein biomarkers such as c-Met (MET protein) and SEZ6 (seizure-related homolog 6 protein), which are over-expressed across various tumor types. The biotech giant states that by utilizing these biomarkers as targets, ADCs are designed to deliver potent cancer cell death-inducing agents called 'payloads' to the tumor. "Building upon our strong commitment to patients and existing leadership in hematological malignancies, we are rapidly advancing a differentiated pipeline in solid tumors," said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors, Oncology Development, for AbbVie. "Our ADC platform allows us to utilize selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death by delivering potent anti-cancer agents." At the meeting, Abbvie presented positive Phase I and II trial data for three ADC therapies, Teliso-V, ABBV-400 and ABBV-706, in solid tumour patients—with Teliso-V being the company's most advanced c-Met targeted ADC in development. The LUMINOSITY study enrolled 172 patients with c-Met protein overexpression and epidermal growth factor receptor wild type, advanced/metastatic non-squamous NSCLC. The Teliso-V results showed a mean overall response rate (ORR) of 28.6%, with ORRs of 34.6% in c-Met high patients and 22.9% in c-Met intermediate patients. The therapy demonstrated a median duration of response (DOR) of 9 months in c-Met high patients and 7.2 months in c-Met intermediate patients. Another ADC gaining attention was Enhertu, developed by British multinational AstraZeneca PLC (NASDAQ: AZN) and Japanese multinational Daiichi Sankyo. In a clinical trial, Enhertu reduced the risk of breast cancer progression by 37% compared to chemotherapy in patients who are HER2-positive, HER2-low, and HER2-ultralow. "DESTINY-Breast06 represents another potential paradigm shift in how we treat patients across the spectrum of HR-positive metastatic breast cancer," said Susan Galbraith, Executive Vice President, Oncology R&D, of AstraZeneca. "The results reinforce the potential for Enhertu to improve outcomes earlier in the treatment landscape and in a broader population of patients with HER2-expressing breast cancer who have never before been eligible for a HER2-directed therapy." AstraZeneca achieved multiple successes at ASCO this year. Among the highlights was the impressive performance of Tagrisso in a phase 3 lung cancer trial. The kinase inhibitor significantly reduced the risk of disease progression by 84% compared to the placebo. "Tagrisso extended progression-free survival by more than three years in this potentially curative setting, reinforcing the need to test and diagnose patients early," said Galbraith. "These practice-changing data cement the powerful impact Tagrisso can make as backbone therapy in EGFR-mutated lung cancer, especially in the lives of these patients who have historically experienced early progression following chemoradiotherapy." Another highlight at ASCO 2024 came from Pfizer Inc.'s (NYSE: PFE) phase 3 clinical trial results for Lorbrena, a drug approved by the U.S. Food and Drug Administration (FDA) for non-small cell lung cancer (NSCLC) in 2021. The five-year follow-up of patients with the ALK mutation showed that Lorbrena reduced the risk of disease progression by 81% compared to Xalkori, a recognized first-line treatment for NSCLC. Lorbrena's readout was among the most impressive at ASCO as 60% of the patients showed a five-year progression-free survival. "These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "These results are an excellent example of Pfizer's long-standing commitment to discovering and developing scientific breakthroughs for patients, and support LORBRENA as a standard of care for the first-line treatment of people with ALK-positive advanced NSCLC." Another class of drugs that garnered attention at ASCO 2024 was KRAS inhibitors. However, the trial results from Bristol-Myers Squibb Company (BMS) (NYSE: BMY) and Amgen each experienced challenges. Although KRAS mutations are common in non-small cell lung cancer (NSCLC), and despite the drug being granted accelerated approval by the FDA in 2022, BMS's Krazati underperformed when looking at median progression-free survival, even though it reduced tumor progression risk by 42%. Krazati's median progression-free survival (PFS) – the period during which a patient's condition remains stable after treatment – extended beyond chemotherapy by 1.7 months in a confirmatory study. "The accelerated approval of KRAZATI from the FDA in 2022 was welcome news for patients with KRASG12C-mutated locally advanced or metastatic NSCLC," said Abderrahim Oukessou, M.D., Vice President, Global Program Lead, KRAZATI, Bristol Myers Squibb. "These confirmatory results further support KRAZATI as an efficacious, targeted treatment option for these patients. We look forward to further sharing these results, while also continuing to evaluate KRAZATI in other advanced KRASG12C-mutated solid tumors." Article Source: 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. SOURCE USA News Group

▎药明康德内容团队报道 根据中国国家药监局药品审评中心（CDE）官网及公开资料，在刚刚过去的5月，有近50款1类新药首次在中国获得临床试验默示许可（IND）。按照新注册分类，“1类新药”是指尚未在全球任何国家和地区获批上市的药物，它们也往往代表了药物研发领域的前沿方向。本月在中国获批临床的新药有哪些亮点，本文将带大家一起了解下。 通过梳理发现，从药品申请人角度来看，这些新药中有约40款来自中国公司，包括恒瑞医药、荃信生物、石药集团、信达生物等；其余近10款来自国际医药公司，包括诺华（Novartis）、罗氏（Roche）、艾伯维（AbbVie）、阿斯利康（AstraZeneca）等。 从分子类型角度来看，这些新药中占比最多的是小分子药物，有近20款，靶点涵盖MAT2A、MyD88、IDH1/2、XOI等等。其次是抗体类药物、抗体偶联药物（ADC），各有5款获批临床。抗体类药物的靶点包括Aβ、c-kit、Beta Klotho、OSMRβ、PD-1等，ADC疗法的靶点则包括c-Met、NaPi2b、B7-H3等。另外，细胞与基因疗法（CGT）、核药、多肽类药物、核酸类药物领域均有新药获批开展临床研究。 从疾病类型来看，5月首次在中国获批IND的新药中，以抗癌药居多，有20余款，它们拟用于治疗乳腺癌、多发性骨髓瘤、脑胶质瘤、结直肠癌、肝细胞癌等；其次是罕见病，有6款新药获批临床，拟用于治疗肌萎缩侧索硬化（ALS）、特发性肺纤维化、肺动脉高压、神经营养性角膜炎等。此外，感染类疾病、中枢神经系统（CNS）疾病、自身免疫性疾病等领域也分别迎来多款新药获批IND。 以下将分享5月在中国获批临床的ADC疗法基本信息，供读者参阅。扫描下方二维码，即可获得“2024年5月首次在中国获批IND的1类新药”完整PDF文件。 艾伯维（AbbVie）：ABBV-400注射用粉末 作用机制：靶向c-Met的ADC 适应症：结直肠癌 ABBV-400是一种靶向c-Met的ADC，有效载荷为TOP1i，用于治疗c-Met阳性实体瘤。该产品本次在中国获批临床，拟用于不可切除的局部晚期/转移性结直肠癌。在临床前研究中，ABBV-400在非小细胞肺癌、胃食管癌和结直肠癌的异体移植模型中表现出良好的药代动力学、体外抗增殖活性和令人信服的疗效。 在刚刚过去的2024年美国临床肿瘤学会（ASCO）年会上，研究人员以口头报告的形式公布了ABBV-400首次人体研究的结直肠癌队列结果。初步疗效结果显示，在c-Met表达较高的患者中，有效剂量（≥2.4 mg/kg）下观察到ORR增加> 30%。在c-Met表达水平较低的患者中也观察到活性。研究认为，患者接受每三周一次（Q3W）2.4mg/kg和3.0 mg/kg ABBV-400治疗具有可耐受和可管理的安全性，以及良好的抗肿瘤活性。 宜联生物：注射用YL211、注射用YL205 作用机制：靶向c-Met的ADC、靶向NaPi2b的ADC 适应症：晚期实体瘤、晚期实体瘤 根据宜联生物公开资料，YL211是特异性靶向c-MET的新型ADC，采用了宜联生物的新一代、肿瘤微环境可激活的新型毒素连接子平台技术。今年1月，宜联生物已经与罗氏（Roche）达成一项超10亿美元的合作，后者获得YL211项目在全球范围内的开发、制造和商业化的独家权益。该药本次在中国获批临床，拟开发治疗晚期实体瘤。 YL205是特异性靶向NaPi2b的下一代抗体偶联药物（ADC），以新型拓扑异构酶I抑制剂为有效载荷。NaPi2b是一种细胞表面钠依赖性磷酸盐转运蛋白，在高级别浆液上皮性卵巢癌、输卵管癌和原发性腹膜癌等多种癌症中表达，而在正常组织中表达有限，因此其有望作为癌症治疗的靶点。 英诺湖医药：ILB-3101 作用机制：靶向B7-H3的ADC 适应症：晚期恶性肿瘤 根据英诺湖医药新闻稿介绍，ILB-3101为抗B7H3偶联艾立布林ADC。公开资料显示，B7-H3是近年来颇受关注的抗癌新靶点。靶向B7-H3的抑制剂包括抗体、ADC、放射免疫疗法等，是一类新的抗肿瘤药物。艾立布林则是当前全球ADC管线开发的有效载荷选择之一。它通过干扰微管的动态平衡防止细胞分裂，从而起到杀伤癌细胞的作用。此外，以艾立布林为有效载荷的ADC具有较强的“旁观者效应”，临床效果较好。 百利药业：注射用BL-B16D1 作用机制：一款双抗ADC 适应症：实体瘤 根据百利药业公告介绍，BL-B16D1是该公司自主研发的一款双抗ADC疗法，偶连了新一代毒素，拟开发适应症为晚期实体瘤。 双抗ADC相较于双抗或单抗ADC，具有肿瘤特异性更强、副作用更小、临床效果更好等潜力，已经成为当前的研究热点。根据百利天恒药业官网管线信息，该公司已经开发了涵盖双特异性抗体、四特异性抗体、多特异性抗体、双抗ADC等在内的20余条研发管线。其中在双抗ADC领域，今年4月，百利天恒一款EGFR×HER3双抗ADC产品注射用BL-B01D1已经被CDE纳入突破性治疗品种，百时美施贵宝公司还以一项总金额达84亿美元的合作，获得BL-B01D1在中国大陆地区以外的全球其他地区开发和商业化的权利。 除了上述药物，5月还有其它类型药物首次在中国获批临床，限于篇幅，本文不再一一介绍。希望这些新药后续临床研究顺利进行，早日造福患者！ 扫描下方二维码，您将可以获取“2024年5月首次在中国获批IND的1类新药”完整PDF文件。 参考资料： [1]中国国家药监局药品审评中心（CDE）官网. From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c [2] 各公司官网及新闻稿 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「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。 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。