-- On track to provide update from ongoing Phase 1 clinical trial in mid-2024; additional data expected in 1H 2025 --

--有望在2024年年中提供正在进行的1期临床试验的最新信息；预计2025年上半年的其他数据--

BOSTON, Feb. 22, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that it has expanded its ongoing Phase 1 clinical trial of EO-3021 outside the United States, dosing the first patient in Japan.

波士顿，2024年2月22日/PRNewswire/--Elevation Oncology，Inc.（纳斯达克：ELEV），一家创新的肿瘤学公司，专注于发现和开发选择性癌症疗法，以治疗一系列严重未满足医疗需求的实体瘤患者，今天宣布将其正在美国境外进行的EO-3021第一阶段临床试验扩大，给日本第一位患者服用药物。

This trial is evaluating the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers..

该试验正在评估EO-3021在可能表达Claudin 18.2的晚期，不可切除或转移性实体瘤患者中的安全性，耐受性和初步抗肿瘤活性，包括胃癌，胃食管癌，胰腺癌或食管癌。。

'We are pleased to expand our clinical development efforts outside of the United States and into Japan where there is a large number of patients with gastric cancer who could benefit from EO-3021,' said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. 'Claudin 18.2 is expressed in most gastric adenocarcinomas and is increasingly recognized as an important therapeutic target, which can be effectively addressed with an antibody drug conjugate (ADC).

Elevation Oncology首席医疗官瓦莱丽·马利万·詹森（ValerieMalyvanhJansen）医学博士说：“我们很高兴将我们的临床开发工作扩展到美国以外的地区，并扩展到日本，那里有大量胃癌患者可以从EO-3021中受益。”Claudin 18.2在大多数胃腺癌中表达，并且越来越被认为是重要的治疗靶标，可以通过抗体-药物缀合物（ADC）有效解决。

We are excited to have dosed our first patient in Japan, as we continue to execute on our mission of delivering novel, selective cancer therapies that can offer better outcomes to patients.'.

我们很高兴能够为日本的第一位患者服用药物，因为我们继续执行我们的使命，提供新颖的选择性癌症治疗，可以为患者提供更好的结果。”。

'Despite recent advancements in the treatment of gastric cancer and improvements in mortality, there remains a significant need for new treatment options that offer patients improved outcomes,' said Kohei Shitara, M.D., Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Kashiwa, Japan and principal investigator on the Phase 1 clinical trial, 'Based on preclinical and early clinical data, I believe EO-3021 has the potential to overcome the limitations of other therapeutic modalities to deliver benefit to patients with varying levels of Claudin 18.2 expression.

“尽管最近在胃癌治疗方面取得了进展，死亡率有所提高，但仍然需要新的治疗方案来改善患者的预后，”日本Kashiwa国家癌症中心医院东消化道肿瘤科科长、第一阶段临床试验首席研究员Kohei Shitara医学博士说，“根据临床前和早期临床数据，我认为EO-3021有可能克服其他治疗方式的局限性，为不同水平Claudin 18.2表达的患者提供益处。

I am excited to dose patients with EO-3021 and to have access to this much-needed option for patients in Japan.'.

我很高兴给患者服用EO-3021，并能够获得日本患者急需的选择。”。

Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021.  An additional objective of the study will be to assess the association of Claudin 18.2 expression and objective response.

Elevation Oncology的1期临床试验（NCT05980416）是一项开放标签，多中心剂量递增和扩展研究，用于评估EO-3021的安全性，耐受性和初步抗肿瘤活性。该研究的另一个目标是评估Claudin 18.2表达与客观反应的关系。

The study is recruiting patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers, at multiple sites in the United States and Japan. Elevation Oncology expects to provide an update from the trial in mid-2024, with additional data expected in the first half of 2025..

该研究正在美国和日本的多个地点招募可能表达Claudin 18.2的晚期不可切除或转移性实体瘤患者，包括胃癌，胃食管癌，胰腺癌或食管癌。Elevation Oncology预计将在2024年年中提供该试验的最新信息，并预计在2025年上半年提供更多数据。。

About EO-3021

关于EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2. EO-3021 is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2.

EO-3021（也称为SYSA1801）是一种分化的临床阶段抗体-药物偶联物（ADC），具有一流的潜力，由靶向Claudin 18.2的免疫球蛋白G1（IgG1）单克隆抗体（mAb）组成。EO-3021通过药物与抗体比（DAR）为2的可切割接头与单甲基auristatin E（MMAE）有效载荷位点特异性缀合。

Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers..

Claudin 18.2是Claudin 18的特定同工型，通常在胃上皮细胞中表达。在恶性转化过程中，紧密连接可能会被破坏，从而暴露出Claudin 18.2，并使Claudin 18.2靶向剂可以接近它们。Elevation Oncology正在一项1期研究（NCT05980416）中评估EO-3021，该研究针对可能表达Claudin 18.2的晚期，不可切除或转移性实体瘤患者，包括胃癌，胃食管癌，胰腺癌或食管癌。。

Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China.

Elevation Oncology拥有在大中华区以外的所有全球地区开发和商业化EO-3021的专有权。

About Elevation Oncology, Inc.

关于Elevation Oncology，Inc。

Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient's unique tumor characteristics.

Elevation Oncology是一家创新的肿瘤学公司，专注于发现和开发选择性癌症疗法，以治疗一系列实体瘤患者，这些患者的医疗需求尚未得到满足。我们正在重新考虑药物开发，寻找创新的选择性癌症治疗方法，可以与患者独特的肿瘤特征相匹配。

Our lead candidate, EO-3021, is a potential best-in-class antibody drug conjugate (ADC) designed to target Claudin 18.2, a clinically validated oncology target. EO-3021 selectively delivers a cytotoxic payload directly to cancer cells expressing Claudin 18.2. We are evaluating EO-3021 in a Phase 1 study in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.

我们的主要候选药物EO-3021是一种潜在的同类最佳抗体-药物偶联物（ADC），旨在靶向Claudin 18.2，这是一种临床验证的肿瘤学靶标。EO-3021选择性地将细胞毒性有效载荷直接递送至表达Claudin 18.2的癌细胞。我们正在一项1期研究中评估EO-3021，该研究针对可能表达Claudin 18.2的晚期，不可切除或转移性实体瘤患者，包括胃癌，胃食管癌，胰腺癌或食管癌。

We are also exploring other opportunities through new or existing partnerships and business development opportunities to expand our oncology pipeline. For more information, visit www.ElevationOncology.com..

我们还通过新的或现有的合作伙伴关系和业务发展机会探索其他机会，以扩大我们的肿瘤学渠道。有关更多信息，请访问www.ElevationOncology.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications.

本新闻稿包含1995年《私人证券诉讼改革法案》中“安全港”条款所指的前瞻性声明，包括但不限于预期的临床开发活动，临床结果公布的预期时间，Elevation Oncology候选产品的潜在益处，Elevation Oncology候选产品的潜在市场机会以及Elevation Oncology候选产品治疗其目标适应症的能力。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'will,' 'would,' and other words and terms of similar meaning.

除历史事实陈述外的所有陈述均为可被视为前瞻性陈述的陈述。这些前瞻性陈述可能伴随着诸如“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“可能”、“计划”、“可能”、“潜力”、“意志”、“将会”等类似含义的词语和术语。

Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain.

虽然Elevation Oncology认为这些前瞻性陈述中反映的期望是合理的，但Elevation Oncology不能保证未来的事件，结果，行动，活动水平，表现或成就，生物技术开发的时间和结果以及潜在的监管批准本质上是不确定的。

Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ab.

前瞻性声明具有可能导致Elevation Oncology的实际活动或结果与任何前瞻性声明中所表达的显着不同的风险和不确定性，包括与Elevation Oncology推进其候选产品的能力，临床前研究和临床试验的时间和结果相关的风险和不确定性，候选产品的批准和商业化，潜在监管名称的接收和时间安排，Elevation Oncology的ab。

Elevation Oncology Investor and Media ContactCandice Masse, 978-879-7273Senior Director, Corporate Communications & Investor Relations[email protected]

Elevation Oncology Investor and Media ContactCandice Masse，978-879-7273企业传播与投资者关系高级总监[受电子邮件保护]

SOURCE Elevation Oncology

源抬高肿瘤学