CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces favorable interim survival benefit from its lead clinical candidate THIO, a telomere-targeting treatment for patients with advanced non-small cell lung cancer (NSCLC).

芝加哥--（商业新闻短讯）--MAIA Biotechnology，Inc.（纽约证券交易所美国证券交易所代码：MAIA）（“MAIA”，以下简称“公司”）是一家临床阶段的生物制药公司，开发针对癌症的靶向免疫疗法，今天宣布其主要临床候选药物THIO（一种针对晚期非小细胞肺癌（NSCLC）患者的端粒靶向治疗）将带来有利的中期生存益处。

A Phase 2 clinical trial, THIO-101, is evaluating THIO sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced NSCLC who failed two or more standard-of-care therapy regimens..

一项2期临床试验THIO-101正在评估使用Regeneron免疫检查点抑制剂（CPI）cemiplimab（Libtayo®）对两种或两种以上标准治疗方案失败的晚期非小细胞肺癌患者进行THIO测序。。

Published available results suggest that overall survival (OS) in third-line patients is 5.8 months.1

公布的现有结果表明，三线患者的总生存期（OS）为5.8个月。1

As of August 01, 2024, 16 patients had survival follow-up surpassing 12 months, including 9 in third line treatment (3L). Interim median survival follow-up in 3L was 10.6 months.

截至2024年8月1日，16例患者的生存随访超过12个月，其中9例在三线治疗（3L）中。3L的中期中位生存期随访为10.6个月。

“THIO is showing a survival benefit for patients with advanced NSCLC. As our follow-up continues, we have noted that three of the earliest patients enrolled are approaching 17-month survival. We’re on track to achieve our survival goals in third-line therapy,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA.

MAIA主席兼首席执行官弗拉德·维托克（VladVitoc）医学博士说：“THIO对晚期非小细胞肺癌患者的生存有好处。随着我们的随访继续，我们注意到最早入选的三名患者中有三名接近17个月的生存期。我们正在按计划实现三线治疗的生存目标。”。

“THIO’s outperformance to date supports our thesis that our telomere targeting agent could become a treatment option for people suffering from advanced NSCLC.”.

“THIO迄今为止的表现支持了我们的论点，即我们的端粒靶向剂可能成为晚期非小细胞肺癌患者的治疗选择。”。

The 12-month survival data corresponds to the Company’s most recent data from THIO-101 demonstrating favorable disease control and overall response rates. As announced in April 2024, THIO 180mg + CPI in third-line treatment showed, in part, overall response rate (ORR) of 38%, disease control rate (DCR) of 88% and median progression-free survival (PFS) of 5.5 months..

12个月的生存数据与该公司来自THIO-101的最新数据相对应，显示出良好的疾病控制和总体缓解率。正如2024年4月宣布的那样，三线治疗中的THIO 180mg+CPI部分显示总有效率（ORR）为38%，疾病控制率（DCR）为88%，中位无进展生存期（PFS）为5.5个月。。

MAIA expects to release full efficacy results of THIO-101 this year.

MAIA预计今年将公布THIO-101的全部疗效结果。

About THIO

关于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.

THIO（6-硫代-dG或6-硫代-2'-脱氧鸟苷）是目前临床开发中用于评估其在非小细胞肺癌（NSCLC）中活性的一流研究性端粒靶向剂。端粒与端粒酶一起，在癌细胞的存活及其对当前疗法的抵抗力中起着至关重要的作用。

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.

修饰的核苷酸6-硫代-2'-脱氧鸟苷（thio）诱导端粒酶依赖性端粒DNA修饰，DNA损伤反应和选择性癌细胞死亡。THIO损伤的端粒片段在胞质微核中积累，并激活先天性（cGAS/STING）和适应性（T细胞）免疫应答。

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..

通过诱导癌症类型特异性免疫记忆，用THIO和PD-（L）1抑制剂序贯治疗可在晚期体内癌症模型中导致深刻而持久的肿瘤消退。THIO目前被开发为非小细胞肺癌的第二或更高治疗方案，用于进展超过现有检查点抑制剂标准治疗方案的患者。。

About THIO-101, a Phase 2 Clinical Trial

关于THIO-101，一项2期临床试验

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.

THIO-101是一项多中心，开放标签，剂量发现的2期临床试验。这是第一个旨在评估THIO在PD-（L）1抑制后的抗肿瘤活性的试验。该试验正在检验一个假设，即在cemiplimab（Libtayo®）之前给予低剂量的THIO将增强和延长晚期NSCLC患者的免疫反应，这些患者以前没有反应或产生耐药性，并且在含有另一种检查点抑制剂的一线治疗方案后进展。

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 Regeneron’s cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population.

该试验设计有两个主要目标：（1）评估THIO作为抗癌化合物和引发免疫激活剂的安全性和耐受性（2）使用总有效率（ORR）评估THIO的临床疗效作为主要临床终点。迄今为止，在经过大量预处理的人群中，用THIO治疗，然后用Regeneron的cemiplimab（Libtayo®）治疗，通常耐受性良好。

For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944..

。。

About MAIA Biotechnology, Inc.

关于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.

MAIA是一家靶向治疗的免疫肿瘤学公司，专注于开发和商业化具有新型作用机制的潜在一流药物，旨在有意义地改善和延长癌症患者的寿命。我们的主要项目是THIO，它是临床开发中潜在的一流癌症端粒靶向剂，用于治疗端粒酶阳性癌细胞的NSCLC患者。

For more information, please visit www.maiabiotech.com..

有关更多信息，请访问www.maiabiotech.com。。

Forward Looking Statements

前瞻性声明

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.

MAIA警告说，除本新闻稿中包含的历史事实声明外，所有声明均为前瞻性声明。前瞻性陈述受到已知和未知风险、不确定性和其他因素的影响，这些风险、不确定性和其他因素可能导致我们或我们行业的实际结果、水平或活动、绩效或成就与此类陈述所预期的大不相同。

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.

使用“可能”、“可能”、“将”、“应该”、“可能”、“预期”、“计划”、“预期”、“相信”、“估计”、“项目”、“打算”、“未来”、“潜力”或“继续”等词语以及其他类似表达旨在识别前瞻性陈述。然而，没有这些词语并不意味着声明不具有前瞻性。

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.

例如，我们就（i）临床前和临床研究以及我们的研究和开发计划的启动、时间、成本、进展和结果，（ii）我们将候选产品推进并成功完成临床研究的能力，（iii）监管备案和批准的时间或可能性，（iv）我们开发、制造和商业化候选产品以及改进制造过程的能力，（v）候选产品的市场接受率和程度，（vi）候选产品市场的规模和增长潜力以及我们服务这些市场的能力，以及（vii）我们对候选产品获得和维持知识产权保护能力的期望，都是前瞻性的。

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 expr.

所有前瞻性陈述均基于我们管理层的当前估计、假设和期望，尽管我们认为这些估计、假设和期望是合理的，但本质上是不确定的。任何前瞻性声明。

1 Girard N, et al. J Thorac Onc 2009;12:1544-1549.

1 Girard N等人，《美国胸科杂志》，2009年；12:1544-1549.