CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens.

芝加哥--（商业新闻短讯）--MAIA生物技术公司（纽约证券交易所美国代码：MAIA）（“MAIA”，以下简称“公司”）是一家开发针对癌症的靶向免疫疗法的临床阶段生物制药公司，今天宣布了其2期THIO-101临床试验的新疗效数据，该试验评估了用免疫检查点抑制剂（CPI）cemiplimab（Libtayo®）测序的THIO对2种或更多标准治疗方案失败的晚期非小细胞肺癌（NSCLC）患者的疗效。

Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024..

最新结果显示，三线治疗中THIO+CPI的总体缓解率（ORR）为38%，疾病控制率（DCR）为85%。新数据于2024年6月3日在美国临床肿瘤学会（ASCO）2024年会的海报会议上发布。。

The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment..

THIO-101 2期试验的主要目标是检查THIO作为抗癌药物和免疫系统引物的安全性和耐受性，并检查THIO以ORR形式的临床疗效。在最近的数据截止时（2024年4月30日），所有可评估患者均完成了≥1次基线后评估。。

Results from third-line treatment:

三线治疗结果：

Disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy1

THIO的疾病控制率（DCR）为85%，而化疗的标准治疗DCR为25-35%1

65% of patients crossed the 5.8-month overall survival (OS) threshold2

65%的患者超过了5.8个月的总生存期（OS）阈值2

85% of patients crossed the 2.5-month progression-free survival (PFS) threshold3-4

85%的患者超过了2.5个月的无进展生存期（PFS）阈值3-4

Median survival follow-up time is currently 9.1 months (n=20)

中位生存随访时间目前为9.1个月（n=20）

Results from third-line treatment with THIO 180mg (optimal dose selection)

THIO 180mg三线治疗结果（最佳剂量选择）

Median PFS of 5.5 months (24.1 weeks)

中位PFS为5.5个月（24.1周）

78% OS rate at 6 months

6个月时OS率为78%

38% ORR vs. standard of care 6–10% for chemotherapy2

化疗的ORR为38%，而标准治疗为6-10%2

75% of patients crossed the 5.8-month OS threshold2

75%的患者超过了5.8个月的OS阈值2

88% of patients crossed the 2.5-month PFS threshold3-4

88%的患者超过了2.5个月的PFS阈值3-4

Median survival follow-up time is currently 9.1 months (n=8)

中位生存随访时间目前为9.1个月（n=8）

1 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89.

1 Matsumoto H等人，Transl Lung癌症研究2021；10:2278–89.

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

2 Girard N等人，《胸科杂志》2009；12:1544-1549.

3 Shepherd F, et al. N Engl J Med 2005;353:123-132.

3 Shepherd F等人《英国医学杂志》2005；353:123-132.

4 Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

Fossella F等人，J Clin Oncol 2000；18（12）：2354-62。

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments.

MAIA主席兼首席执行官弗拉德·维托克（VladVitoc）医学博士说：“迄今为止，我们试验中所有异常的疗效指标都超出了我们自己的预期，优于护理标准。”。“ASCO提供的数据提高了THIO的出色临床表现，对于化疗和其他可用治疗后进展的患者来说，它是一种强大，安全且高效的替代方案。

We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”.

我们热切期待今年下半年来自THIO-101的全面疗效数据。”。

To date, treatment with THIO + cemiplimab has been generally well tolerated in a heavily pre-treated patient population. Full enrollment in THIO-101 was completed on February 19, 2024, earlier than expected as per trial design. The Company expects that THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment..

迄今为止，在经过严重预处理的患者群体中，使用THIO+cemiplimab治疗通常具有良好的耐受性。THIO-101的全部注册于2024年2月19日完成，比试验设计预期的要早。该公司预计THIO-101将是端粒靶向剂在癌症药物发现和治疗领域的首次完成临床研究。。

The poster and updated Company presentations can be accessed on the company’s website.

海报和更新的公司演示文稿可以在公司网站上访问。

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 cemiplimab (Libtayo®) followed by THIO 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cemiplimab（Libtayo®）和THIO进行治疗通常具有良好的耐受性。

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

有关此II期试验的更多信息，请使用标识符NCT05208944访问ClinicalTrials.gov。。

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存在重大差异。

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管理层当前的估计、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。