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MAIA Biotechnology, Inc., (NYSE American: MAIA)

MAIA生物技术公司（纽约证券交易所美国证券交易所：MAIA）

(“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo.

（“MAIA”，即“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THIO-101关键性2期临床试验的积极更新数据，该试验评估了其主要临床候选物THIO，并用Regeneron的免疫检查点抑制剂（CPI）cemiplimab（Libtayo）测序。

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) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

)晚期非小细胞肺癌（NSCLC）患者未能通过两种或两种以上标准治疗方案。

As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months.

截至2025年1月15日，第三行（3L）数据显示，在试验的A部分和B部分，接受至少一剂THIO（意向治疗人群）的22名NSCLC患者的中位总生存期（OS）为16.9个月。分析显示95%置信区间（CI）下限为12.5个月，99%置信区间下限为10.8个月。

The treatment has been generally well-tolerated to date in this heavily pre-treated population.

迄今为止，在这个经过严重预处理的人群中，这种治疗通常具有良好的耐受性。

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. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.

。在类似情况下对NSCLC的标准治疗（SOC）化疗治疗的研究显示OS为5至6个月。

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“Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin,” said Vlad Vitoc, M.D., CEO of MAIA. “THIO’s efficacy in advanced stages of NSCLC continues to exceed our expectations, especially in third-line treatment where the cancer is typically even more resistant to therapy.

MAIA首席执行官弗拉德·维托克（VladVitoc）医学博士说：“现在用THIO治疗显示，总生存率将大大超过化疗指标的概率为99%。”。“THIO在晚期非小细胞肺癌中的疗效继续超过我们的预期，特别是在三线治疗中，癌症通常对治疗更具抵抗力。

Our findings suggest great benefits to patients with unmet medical needs who see little hope for the future..

我们的研究结果表明，对于那些对未来几乎没有希望的医疗需求未得到满足的患者来说，这有很大的好处。。

“With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,” Dr. Vitoc concluded.

维托克博士总结道：“根据我们最新的总体生存结果，我们对潜在的FDA商业批准THIO的前景比以往任何时候都要乐观。”。

Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.

根据其监管策略，MAIA认为，根据正在进行的THIO-101试验扩展的最终结果，可能有机会加速FDA对THIO的批准。

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

THIO-101是一项多中心，开放标签，剂量发现的2期临床试验。。该试验正在检验以下假设：在cemiplimab（Libtayo）之前服用低剂量的THIO

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) 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.

)将增强和延长晚期非小细胞肺癌患者的免疫反应，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。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。

Treatment with THIO followed by cemiplimab (Libtayo.

用THIO治疗，然后用cemiplimab（Libtayo。

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) 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.

)迄今为止，在经过严重预处理的人群中，人们的耐受性普遍良好。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 .

有关更多信息，请访问。

www.maiabiotech.com

www.maiabiotech.com

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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。

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Details on safety can be found on the previously announced SITC 2024 presentation available on

有关安全的详细信息，请参阅先前发布的SITC 2024演示文稿

MAIA’s website

MAIA网站

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

Girard N等人，J Thorac Onc，2009年；12:1544-1549。