Ateganosine

CHICAGO--( BUSINESS WIRE )-- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has amended the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo ® ). The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo ® (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy. The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process. The THIO-101 trial has been amended and expanded to further evaluate efficacy at the target dose and target third line patient population. "In keeping with our clinical strategy for THIO, we look forward to continuing our collaboration with Regeneron to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. So far, THIO-101 has demonstrated favorable disease control, progression free survival, overall response rates, and we remain on track to achieve our overall survival goals,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. Under terms of the amended clinical supply agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo® for the treatment of all patients in the trial including the additional patients in the THIO 101 expansion. MAIA holds an exclusive worldwide patent license to develop and commercialize THIO. MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future. The company continues to evaluate its regulatory strategy and believes that there could be an opportunity for an accelerated approval in the United States based on the ultimate outcome of the ongoing THIO 101 trial. 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 THIO followed by cemiplimab (Libtayo®) 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.

点击蓝字 关注我们 SITC微专辑 扫描二维码 可查看更多内容 根据2024癌症免疫治疗学会（SITC）年会上公布的II期THIO-101试验（NCT05208944）的结果，首创的端粒靶向药物THIO与cemiplimab联合使用在检查点抑制剂耐药的晚期非小细胞肺癌（NSCLC）患者中显示出持久活性，较高的疾病控制率（DCR）和生存获益。采用180 mg THIO剂量治疗实现了38%的客观缓解率（ORR），超过了接受过大量治疗的人群中的标准疗法[1]。 THIO于2022年4月获得FDA授予的孤儿药资格，用于治疗肝细胞癌患者[2]。2022年8月，该药还获得FDA授予的小细胞肺癌孤儿药资格[3]。THIO-101是一项开放标签、多中心研究，招募了接受免疫检查点抑制剂治疗后病情进展或复发的晚期NSCLC成年患者[4]。入组要求患者患III期或IV期疾病，根据RECIST1.1至少有1个可测量病灶，预期寿命超过12周，ECOG体能状态评分为0或1。研究的A部分采用了改良的3+3设计，患者每3周一次在第1~3天接受THIO 120 mg（每周期共360 mg），第5天接受cemiplimab 350 mg[1,4]。然后将患者随机分配，每3周一次在第1~3天接受THIO 60 mg（n=24）、180 mg（n=41）或360 mg（n=14），第5天联合cemiplimab 350 mg。共同主要终点是安全性、ORR和DCR[1]。 在2024年9月16日的数据截止时，在完成至少1次基线后评估的可评估患者（n=69）中，9名患者根据RECIST1.1达到部分缓解（PR），7名患者根据研究者评估通过第二次扫描获得确认PR。19名患者的生存随访超过12个月；二线治疗的所有9名患者均在持续随访中，三线治疗的10名患者中有8名在持续随访中，1名患者已接受25个周期的治疗。 三线治疗的患者（n=20）的DCR达到85%。在11.5个月的中位生存期随访中，70%的患者超过了5.8个月的总生存期（OS）阈值，85%的患者超过了2.5个月的无进展生存期（PFS）阈值。 三线治疗接受180mg剂量THIO+cemiplimab治疗的患者（n=8）的ORR为38%（远超标准疗法的ORR）。在11.4个月的中位生存期随访中，中位PFS为5.5个月，75%的患者超过了5.8个月的OS阈值，88%的患者超过了2.5个月的PFS阈值。6个月OS率为75%。 接受THIO+cemiplimab治疗会诱导循环肿瘤细胞中出现端粒功能障碍诱导灶（TIF）。研究作者指出，这表明TIF阳性与更有利的结果之间存在潜在联系。TIF水平升高与患者结局改善相关，TIF水平稳定可能表明疾病进展。TIF是实现个性化癌症治疗和改进治疗策略的宝贵生物标志物。 在安全性方面，THIO+cemiplimab治疗通常耐受性良好，大多数不良反应（AE）为1级或2级；在安全性导入期间未报告剂量限制性毒性。在总体人群中，至少有2名患者发生的任何级别的治疗期间出现的不良反应（TEAE），包括天冬氨酸氨基转移酶（AST；26.6%）升高、丙氨酸氨基转移酶（ALT；22.8%）升高、恶心（12.7%）和中性粒细胞减少症（5.1%）。≥3级TEAE包括ALT升高（11.4%）、AST升高（11.4%）和中性粒细胞减少症（3.8%）。在出现4级肝功能检查结果升高后，360 mg组的招募暂停。 2023年11月，THIO 180 mg被选为最佳剂量，目前正在研究的B部分评估，并于2024年2月完成招募。 参考文献 （上下滑动可查看） 1.Csoszi T, Jankowski T, Urban L, et al. Telomere-targeting agent THIO in sequential combination with cemiplimab demonstrates long term therapeutic benefits beyond treatment cessation. A phase 2 trial in advanced immune checkpoint inhibitor resistant non-small cell lung cancer patients. Presented at: 2024 SITC Annual Meeting; November 6-10, 2024; Houston, TX. Abstract 1492. 2.MAIA Biotechnology, Inc. announces FDA orphan drug designation for THIO for the treatment of hepatocellular carcinoma (HCC). News release. MAIA Biotechnology. April 26, 2022. Accessed November 8, 2024.https://ir.maiabiotech.com/news-events/press-releases/detail/35/maia-biotechnology-inc-announces-fda-orphan-drug 3.MAIA Biotechnology receives FDA orphan drug designation for THIO for the treatment of small-cell lung cancer (SCLC). News release. MAIA Biotechnology. August 2, 2022. Accessed November 8, 2024. https://ir.maiabiotech.com/news-events/press-releases/detail/41/maia-biotechnology-receives-fda-orphan-drug-designation-for 4.THIO sequenced with cemiplimab in advanced NSCLC. ClinicalTrials.gov. Updated August 31, 2023. Accessed November 8, 2024. https://clinicaltrials.gov/study/NCT05208944 （来源：《肿瘤瞭望》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。