CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, THIO, in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC)..

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”或“公司”），一家临床阶段的生物制药公司，开发针对癌症的端粒靶向免疫疗法，今天宣布了THIO-101的剂量选择，这是一项评估其主要资产THIO的2期临床试验，与Regeneron的抗PD-1 cemiplimab（Libtayo®）序贯联合治疗晚期非小细胞肺癌（NSCLC）患者。。

During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo®). The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials.

在THIO-101的剂量发现阶段，患者每个周期服用60mg，180mg或360mg THIO，然后服用350mg cemiplimab（Libtayo®）。所选剂量为180mg/周期，具有更好的安全性，并且在NSCLC试验的关键疗效指标中优于其他剂量。

Subsequently, all future trial participants will be treated with THIO 180mg/cycle..

随后，所有未来的试验参与者将接受THIO 180mg/周期的治疗。。

“All THIO dose levels tested exceeded the disease control rate (DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, beating our goal of disease control in 8 out of 19 patients per arm. Among the three studied doses, the 180mg dose showed stronger DCR and preliminary response rates compared to other doses,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer..

“所有测试的硫代剂量水平都超过了疾病控制率（DCR）THIO-101第二阶段试验第一阶段的阈值。我们在前8至9名患者中观察到疾病控制，每只手臂进行基线后扫描，每只手臂19名患者中有8名超过了我们的疾病控制目标。在研究的三种剂量中，与其他剂量相比，180mg剂量显示出更强的DCR和初步缓解率，”MAIA主席兼首席执行官Vlad Vitoc医学博士说。。

“These results are particularly impressive in this pool of patients who were heavily pre-treated and resistant to prior treatments with immune checkpoint inhibitors, a group that does not yet have standard of care treatment. We are highly encouraged by the unprecedented clinical data generated thus far in our Phase 2 trial, and as we move forward, we plan to pursue accelerated approval for THIO in the U.S.

“这些结果特别令人印象深刻的是，这些患者经过了大量的预处理，并且对免疫检查点抑制剂的先前治疗产生了耐药性，而免疫检查点抑制剂是一个尚未获得标准护理治疗的群体。我们对2期试验迄今为止产生的前所未有的临床数据感到鼓舞，随着我们的进展，我们计划加速批准THIO在美国。

for the treatment of patients with advanced NSCLC. We believe THIO’s DCRs and ORRs in second line treatment suggest the drug’s potential to define the standard of care for this NSCLC patient population.”.

用于治疗晚期非小细胞肺癌患者。我们相信THIO在二线治疗中的DCR和ORR表明该药物有可能确定该NSCLC患者人群的护理标准。”。

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

THIO是目前在癌症药物发现和治疗领域正在进行临床开发的唯一直接端粒靶向剂。

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）我们的开发能力，制造和商业化我们的候选产品，并改进制造过程，（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，（vii）我们对我们获得和维护候选产品知识产权保护的能力的期望是前瞻性的。

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。