Ir CPI

Topline data expected in second half of 2024THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment CHICAGO, IL, Feb. 22, 2024 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that enrollment is now complete in its Phase 2 THIO-101 go-to-market clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC). The trial reached the enrollment target of 41 patients for the 180mg/dose on February 19, 2024. As of the latest data available for the trial, 79 patients had received either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to 182 patients, including all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule. “Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months. As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC.” The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. About THIO THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. About THIO-101, a Phase 2 Clinical Trial THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944. About MAIA Biotechnology, Inc. MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com. Forward Looking Statements MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries. Investor Relations Contact +1 (872) 270-3518ir@maiabiotech.com

「  本文共：16条资讯，阅读时长约：3分钟 」今日头条新元素急性痛风新药获批Ⅰ期临床。新元素医药抗炎症领域小分子创新药ABP-745获FDA批准开展I期临床，拟评估用于治疗急性痛风的安全性与初步疗效。该新药目前已在国内报IND。值得一提的是，该公司也正在开发一种口服小分子URAT1抑制剂ABP-671用于治疗慢性痛风，该药物旨在降低患者的血尿酸水平，目前正在全球范围内开展关键性多中心临床试验。国内药讯1.阿斯利康RSV长效单抗中国获批上市。阿斯利康长效呼吸道合胞病毒（RSV）抗体Nirsevimab注射液获国家药监局批准上市，用于预防新生儿和婴儿由呼吸道合胞病毒（RSV）引起的下呼吸道感染（LRTI）。这是全球唯一、可广泛应用于婴幼儿群体的单剂次被动免疫制剂。在临床试验中，nirsevimab可降低79.5%（p<0.0001）的婴幼儿因RSV感染导致的LRTI风险。2.百济神州PD-1单抗获批一线治疗肝癌。百济神州PD-1抑制剂替雷利珠单抗注射液（商品名：百泽安）获国家药监局批准用于治疗一线不可切除或转移性肝细胞癌患者。在全球III期RATIONALE 301研究（NCT03412773）中，替雷利珠单抗与索拉非尼对照组相比达到总生存期（OS）非劣效性的治疗效果（中位OS：15.9个月vs14.1个月）。3.君实PD-1单抗新适应症获批上市。君实生物PD-1抑制剂特瑞普利单抗获国家药监局批准新适应症，联合化疗用于可切除III期非小细胞肺癌（NSCLC）的围手术期治疗和单药用于辅助治疗后巩固治疗。在III期临床（Neotorch）中，与单纯化疗相比，特瑞普利单抗的治疗方案可显著延长患者无事件生存期，使疾病复发、进展或死亡风险降低达60%（HR=0.40，95%CI：0.277-0.565，双侧P<0.0001）。4.恒瑞HER3-ADC获肺癌快速通道资格。恒瑞医药靶向HER3的抗体偶联药物（ADC）SHR-A2009获FDA授予快速通道资格，用于治疗经三代EGFR酪氨酸激酶抑制剂和含铂化疗后疾病进展的EGFR突变的转移性非小细胞肺癌。SHR-A2009可特异性结合肿瘤细胞表面上的HER3，进而被内吞至细胞内水解释放游离毒素，杀伤肿瘤细胞。在国际I期临床中，SHR-A2009已显示出具有良好的抗肿瘤活性和安全性。5.信达GLP-1R/GCGR激动剂上肥胖III期临床。信达生物GLP-1R/GCGR双重激动剂玛仕度肽9mg (IBI362) 用于中国肥胖受试者减重的III期临床（GLORY-2）完成首例受试者给药。Ⅱ期临床48周治疗数据显示，玛仕度肽（9mg）治疗较安慰剂使患者体重降幅达到18.6%（减重17.8公斤）；该组减重超过5%和10%的患者比例分别达到83.7%和69.8%。这也是玛仕度肽开展的第四项III期临床研究。6.江苏瑞科带状疱疹疫苗早期临床积极。瑞科生物自主研发的新佐剂重组带状疱疹疫苗REC610在菲律宾首次人体（FIH）试验中获积极结果。REC610组接种后可诱导较强的gE特异性体液免疫和细胞免疫应答，免疫应答在两剂接种后30天达到高峰，其水平与Shingrix®（葛兰素史克）组相当，且在数值上高于Shingrix®组；REC610在老年及成年人群均可诱导较好的体液免疫和细胞免疫应答。此外，疫苗总体安全性良好。7.宜联生物c-Met靶向ADC授权罗氏。宜联生物宣布已与罗氏就其临床前期靶向间质表皮转化因子（c-Met）的下一代抗体偶联药物（ADC）YL211达成合作和许可协议，授予后者在全球范围内的开发、制造和商业化的独家权益。根据协议，宜联生物将获得首付款及近期里程碑付款5000万美元，约10亿美元的开发、注册和商业化潜在里程碑付款，以及产品销售净额的梯度特许权使用费。国际药讯1.FDA发布细胞和基因治疗产品的效力保证指南草案。FDA日前发布“细胞和基因治疗产品的效力保证”的指南草案，就制定基于科学和风险的策略以帮助确保人用细胞和基因治疗（CGT）产品的效力提供建议。FDA建议企业在产品生命周期的所有阶段使用质量风险管理来评估产品效力的风险，并将这些风险降低到可接受的水平。FDA 建议企业在为产品设计效力保证策略时考虑下述概念：质量目标产品概况（QTPP）、控制策略、关键质量属性（CQA）、关键过程参数（CPP），以及风险评估和风险降低。2.现货型细胞免疫疗法乳癌临床积极。BriaCell公司现货型细胞免疫疗法Bria-IMT（SV-BR-1-GM）治疗晚期转移性乳腺癌的临床试验结果积极。该项研究评估Bria-IMT单药以及与免疫检查点抑制剂（CPI）联合用药的治疗效果。数据显示，Bria-IMT治疗使71%患者（n=5/7）CNS病变显著缓解；所有乳腺癌亚型患者均观察到CNS转移肿瘤消退。此前，Bria-IMT已获FDA授予快速通道资格。3.JAK抑制剂治疗1型糖尿病Ⅱb期临床积极。礼来与Incyte开发的JAK抑制剂巴瑞替尼（Olumiant）一线治疗具有临床C肽分泌功能的1型糖尿病者的Ⅱb期临床积极结果发表在NEJM上。干预48周后，巴瑞替尼组混合餐刺激的C肽平均水平中位数0.65 nmol/(L·min)，显著高于安慰剂组0.43 nmol/(L·min)；校正后的平均组间差异为0.13（P=0.001）；两组日均胰岛素用量分别为0.41 U/(kg·d)和0.52 U/(kg·d)，两组均未发生严重不良事件。4.O药联合LAG-3抗体结直肠癌Ⅲ期临床失败。百时美施贵宝宣布将终止PD-1抑制剂纳武利尤单抗Opdivo联合LAG-3抗体relatlimab（Opdualag）治疗转移微卫星稳定（MSS）结直肠癌（CRC）的III期RELATIVITY-123临床。与瑞戈非尼或曲氟尿苷替匹嘧啶相比，O药和relatlimab组合未达到主要研究终点。该组合治疗其它类型肿瘤的试验仍继续进行。Relatlimab是首款获FDA批准的LAG-3抗体。5.可可提取物补充剂或对老人认知有好处。由布莱根妇女医院开展、评估每天服用可可提取物或普通复合维生素补充剂是否会降低患心脏病、中风、癌症和其他重要健康问题的风险的临床COSMOS研究成果在线发表在The American Journal of Clinical Nutrition期刊上。为期两年的针对认知能力的评估结果显示，服用每天含有500毫克可可黄烷醇的可可提取物补充剂对习惯性饮食质量较低的老年人的认知能力有好处。6.AI模型加速发现新型候选抗生素。麻省理工学院James Collins教授团队日前在国际期刊Nature上发表"Discovery of a structural class of antibiotics with explainable deep learning"研究论文。该研究利用人工智能（AI）和可解释的深度学习模型，从超过1200万种化合物中识别出一种革命性的新型抗生素类型，可以杀死临床上常见的超级细菌——耐甲氧西林金黄色葡萄球菌（MRSA）。而且，这些化合物对人类细胞的毒性很低。医药热点1.上海首批32家社区标准化口腔诊室建成。近日，上海首批32家社区标准化口腔诊室建成，旨在提升社区口腔服务能级，满足更多居民“家门口”多层次社区口腔诊疗和保健服务需求。下一步，在继续巩固社区口腔诊室建设成效的基础上，上海市将继续推进社区标准化口腔的建设，至2030年末，基本实现社区标准化口腔诊室功能全覆盖，社区口腔诊疗、保健服务全面提升能级。2.复旦附属眼耳鼻喉科医院浦江院区二期项目启动。12月27日，复旦大学附属眼耳鼻喉科医院浦江院区二期项目正式启动。浦江院区二期工程位于闵行区江月路2600号，占地100亩。在一期350张住院床位基础上，新增住院床位150张，进一步改善医疗就医环境与条件。此外，项目在设计中引入纵贯南北的“医疗街”，将整个院区有机整合，各功能区结构明确、流程清晰、独立成区，又互相紧密联系。评审动态  1. CDE新药受理情况（12月30日) 2. FDA新药获批情况（北美12月27日）股市资讯上个交易日 A 股医药板块 +0.42%涨幅前三     跌幅前三生 物 谷 +8.56%  博瑞医药-7.03%诺思兰德+7.51%  迈威生物-5.29%济川药业+5.95%  昊海生科-4.89%【普利制药]收到美国食品药品监督管理局(以下简称“FDA”)签发的创新药注射用PLAT001的药物临床试验批件。产品为注射用PLAT001，拟用于治疗胰腺癌等晚期或转移性实体瘤患者，IND号为156926。【君实生物]特瑞普利单抗注射液(商品名:拓益®，产品代号:JS001)，用于可切除IIIA-IIB期非小细胞肺癌的成人患者的新适应症上市申请获得批准，是我国首个、全球第二个获批的肺癌围手术期疗法。【益方生物]于近日收到国家药品监督管理局核准签发的《受理通知书》，公司产品格舒瑞昔片用于既往经一线系统治疗后疾病进展或不可耐受的、并且经检测确认存在KRAS G12C突变的局部晚期或转移性非小细胞肺癌的治疗的新药上市申请获得受理。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。