MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) announced that the Journal of the American Medical Association (JAMA) published a manuscript titled, “Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer with EGFR Variant: A Randomized Clinical Trial.” The publication is based on the results of HARMONi-A, a single region, multi-center, Phase III study conducted in China sponsored by Akeso, Inc.

迈阿密--（商业新闻短讯）--Summit Therapeutics Inc.（纳斯达克：SMMT）（“Summit”，“we”或“公司”）宣布，《美国医学会杂志》（JAMA）发表了一篇题为“Ivonescimab加化疗治疗EGFR变异的非小细胞肺癌：一项随机临床试验”的手稿。该出版物基于HARMONi-a的结果，HARMONi-a是由Akeso，Inc.赞助的在中国进行的一项单区域，多中心的III期研究。

(Akeso, HKEX Code: 9926.HK), with data generated and analyzed by Akeso..

（阿克索，香港交易所代码：9926。HK），数据由阿克索生成和分析。。

HARMONi-A evaluated ivonescimab combined with platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy.

HARMONi-A评估了ivonescimab联合铂类双联化疗治疗表皮生长因子受体（EGFR）突变，局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者，这些患者在用EGFR酪氨酸激酶抑制剂（TKI）治疗后进展，对抗安慰剂加铂类双联化疗。

This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials. The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics..

这是一个临床环境，患者群体中的PD-1单克隆抗体先前在III期全球临床试验中未成功。III期HARMONi-A研究提供了进一步的证据支持ivonescimab的分化作用机制，ivonescimab是一种PD-1/VEGF双特异性抗体，具有协同结合特性。。

Conference Call

电话会议

Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 3, 2024, before the market opens.

Summit Therapeutics Inc.将于2024年6月3日（星期一）市场开放前召开电话会议，讨论与ivonescimab相关的最新更新，包括ASCO发布的数据。

Summit will host a live webcast of the conference call at 8:00am ET, which will be accessible through our website www.smmttx.com, and can also be accessed via the following link: https://events.q4inc.com/attendee/130822402.

Summit将于美国东部时间上午8:00主持电话会议的在线直播，可通过我们的网站www.smmttx.com访问，也可通过以下链接访问：https://events.q4inc.com/attendee/130822402.

The dial-in information for US attendees is toll-free at (800) 715-9871. Additionally, all attendees may access through the toll number, (646) 307-1963. The Conference ID is 4259251.

美国与会者的拨入信息可拨打（800）715-9871免费电话。此外，所有与会者都可以通过收费电话号码（646）307-1963访问。会议ID为4259251。

An archived edition of the webcast will be available on our website later in the day on Monday.

周一晚些时候，我们的网站将提供网络广播的存档版本。

About Ivonescimab

Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Ivonescimab在Summit的许可证地区，美国，加拿大，欧洲和日本被称为SMT112，在中国和澳大利亚被称为AK112，是一种新型的，潜在的一流研究性双特异性抗体，它通过阻断PD-1结合了免疫治疗的作用，具有与阻断VEGF相关的抗血管生成作用。

Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF..

当存在PD-1和VEGF时，Ivonescimab以更高的亲和力显示出与其每个预期靶标的独特协同结合。。

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro.1 This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue.

这可以区分ivonescimab，因为与体内正常组织相比，肿瘤组织和肿瘤微环境（TME）中PD-1和VEGF的表达（存在）可能更高。Ivonescimab的四价结构（四个结合位点）在肿瘤微环境中具有更高的亲和力（多重结合相互作用的累积强度），在体外VEGF存在下对PD-1的结合亲和力增加了18倍以上，并且在体外PD-1存在下对VEGF的结合亲和力增加了4倍以上。这种四价结构是该分子的有意新颖设计，并将这两个靶标转化为具有协同结合特性的单一双特异性抗体，有可能将Ivonescimab导向肿瘤组织与健康组织。

The intent of this design, together with a half-life of 6 to 7 days,1 is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets..

该设计的目的是，除了与这些目标相关的副作用和安全性概况外，还有6至7天的半衰期1，以改善先前确定的疗效阈值。。

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3..

Ivonescimab由Akeso Inc.（香港交易所代码：9926.HK）设计，目前正在进行多个III期临床试验。在全球临床研究中，已有1600多名患者接受了ivonescimab治疗。Summit已开始在非小细胞肺癌（NSCLC）中开发ivonescimab的临床开发，并于2023年开始参加两项III期临床试验HARMONi和HARMONi-3。。

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)..

HARMONi是一项III期临床试验，旨在评估ivonescimab联合化疗与安慰剂加化疗相比，对EGFR突变，局部晚期或转移性非鳞状非小细胞肺癌患者进行治疗后，用第三代EGFR TKI（例如osimertinib）治疗进展。。

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

HARMONi-3是一项III期临床试验，旨在评估ivonescimab联合化疗与pembrolizumab联合化疗治疗一线转移性鳞状NSCLC患者的疗效。

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

Ivonescimab是一种研究性疗法，未经Summit许可区域（包括美国和欧洲）的任何监管机构批准。Ivonescimab于2024年5月被批准在中国上市。

About Lung Cancer

关于肺癌

Lung cancer is believed to impact approximately 600,000 people across the United States, United Kingdom, Spain, France, Italy, Germany, and Japan.2 NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.3 Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.4 Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.5.

据信，肺癌在美国，英国，西班牙，法国，意大利，德国和日本约有60万人受到影响[2]。NSCLC是最常见的肺癌类型，约占所有发病率的80%〜85%[3]。在非鳞状NSCLC患者中，约15%在美国和欧洲有EGFR致敏突变[4]。鳞状组织学患者约占NSCLC患者的25%〜30%。

About Summit Therapeutics

关于Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs..

Summit Therapeutics Inc.是一家生物制药肿瘤公司，专注于患者，医生，护理人员和社会友好药物疗法的发现，开发和商业化，旨在改善生活质量，延长潜在寿命，并解决严重未满足的医疗需求。。

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol 'SMMT'). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

Summit成立于2003年，我们的股票在纳斯达克全球市场（代号“SMMT”）上市。我们的总部位于佛罗里达州的迈阿密，在加利福尼亚州的门洛帕克和英国的牛津都设有办事处。

For more information, please visit https://www.smmttx.com and follow us on X @summitplc.

有关更多信息，请访问https://www.smmttx.com并在X@summitplc上关注我们。

Summit Forward-looking Statements

峰会前瞻性声明

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected use proceeds and uses thereof, and other statements containing the words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

本新闻稿中关于公司未来预期、计划和前景的任何声明，包括但不限于关于公司候选产品的临床和临床前开发、与Akeso Inc.合作的进入和行动、公司的预期支出和现金跑道、公司候选产品的治疗潜力、公司候选产品的潜在商业化、临床试验数据的启动、完成和可用性、潜在的上市申请提交、潜在的收购、关于先前在市场股权发售计划（“ATM计划”）中披露的声明、预期使用收益和用途，以及其他包含“预期”、“相信”字样的声明“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“潜力”、“预测”、“项目”、“应该”、“目标”、“会”，“和类似表述，构成1995年《私人证券诉讼改革法案》含义内的前瞻性陈述。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and t.

由于各种重要因素，包括公司在ATM计划下出售普通股的能力，影响资本市场的条件，一般经济，行业或政治条件，包括我们对ivonescimab开发和商业化活动相关基础数据的评估结果，与监管机构（包括食品和药物管理局）的讨论结果，未来临床试验启动固有的不确定性，可用性和t，实际结果可能与此类前瞻性声明所示的结果存在重大差异。

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1 Zhong, et al, SITC 2023

1钟等人，SITC 2023

2 American Cancer Society: www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 2024; World Health Organization: International Agency for Research on Cancer, Globocan data by country (UK, Spain, France, Italy, Germany); Japan National Cancer Registry.

2美国癌症协会：www.Cancer.org/Cancer/types/lung-Cancer/about/key-statistics.html。2024年4月访问；世界卫生组织：国际癌症研究机构，按国家分列的Globocan数据（英国，西班牙，法国，意大利，德国）；日本国家癌症登记处。

3 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

3 Schabath MB，Cote ML.癌症进展和优先事项：肺癌。癌症流行病学，生物标志物与预防。（2019年）。

4 About EGFR-Positive Lung Cancer | Navigating EGFR (lungevity.org).

4关于EGFR阳性肺癌|导航EGFR（lungevity.org）。

5 Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiology, Biomarkers & Prevention. (2019).

5 Schabath MB，Cote ML。癌症进展和优先事项：肺癌。癌症流行病学，生物标志物与预防。（2019年）。