MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.

迈阿密--（商业新闻短讯）--Summit Therapeutics Inc.（纳斯达克：SMMT）（“Summit”，“we”或“公司”）今天宣布了其新型，潜在的一流研究性双特异性抗体ivonescimab的有希望的数据，该抗体将于今天在捷克共和国布拉格举行的2024年欧洲肺癌大会（ELCC 2024）上发表。

Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period..

中欧时间下午12:00至12:45，将展示两张海报，展示最新的ivonescimab数据。展示期结束后，海报也将在我们的网站上发布。。

The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC.

第一张海报“Ivonescimab单独或联合铂类双联化疗治疗晚期非小细胞肺癌（NSCLC）和脑转移患者的颅内活动”包括基线时无症状脑转移患者的数据。这些患者被纳入AK112-202（NCT04900363），其中ivonescimab作为单一疗法递送，或AK112-201（NCT04736823），其中ivonescimab与铂双联化疗联合递送，两者都是II期临床试验晚期或转移性NSCLC患者。

This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202..

该分析包括35例晚期或转移性NSCLC患者，他们在基线时无症状脑转移；28例患者在AK112-201中接受了ivonescimab联合化疗，7例患者在AK112-202中接受了ivonescimab单药治疗。。

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan.

值得注意的是，所有分析患者的中位颅内无进展生存期为19.3个月。两组患者的颅内缓解率均为34%，根据RANO标准，有8名患者（23%）完全缓解。所有未达到缓解的患者均表现出稳定的疾病或无进展；在初次随访扫描时，没有患者出现颅内疾病进展。

No cases of intracranial bleeding complications were observed in these patients..

这些患者未观察到颅内出血并发症。。

“We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC,” said Dr. H. Jack West, Vice President of Clinical Development at Summit.

Summit临床开发副总裁H.Jack West博士说：“我们很高兴看到ivonescimab在NSCLC脑转移患者亚组中具有良好的颅内反应率和中位无颅内进展生存率，以及有希望的抗肿瘤活性和安全性。”。

“We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso.”.

“我们感谢支持这些试验的患者和临床研究人员，以及我们与Akeso合作伙伴的持续合作。”。

The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)).

第二张海报标题为“Ivonescimab的第二阶段结果一种新型PD-1/VEGF双特异性联合化疗用于晚期/转移性非小细胞肺癌患者的一线治疗”，其中包括来自II期试验AK112-201的最新数据，该试验以患者队列为中心，其中Ivonescimab与化疗联合用于一线治疗鳞状和非鳞状晚期或转移性NSCLC的患者，这些患者没有可行的基因组改变（例如，内皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）阳性）。

Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well..

总结了酪氨酸激酶抑制剂（TKI）后EGFR突变的NSCLC患者和既往接受过PD-（L）1加双重化疗的NSCLC患者的最新进展。。

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months.

重要的是，一线晚期或转移性鳞状NSCLC患者的中位PFS为11.1个月（95%CI:9.5-16.3个月）。此外，一线晚期或转移性非鳞状肿瘤患者的中位PFS为13.3个月（95%CI:8.3-16.4个月）。中位随访时间为22.1个月后，两组患者均未达到中位总生存期。

The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients..

在鳞状和非鳞状肿瘤患者中，导致停用ivonescimab的治疗紧急不良事件（TEAE）的频率分别为11.1%和2.8%。最常见的TEAE是鳞状细胞患者的贫血和中性粒细胞计数减少以及非鳞状细胞患者的贫血和便秘。。

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

海报将由中山大学癌症中心的李章博士和West博士等提供，数据由我们的合作和许可合作伙伴Akeso Inc.（香港交易所代码：9926.HK）生成和分析，并由Summit员工提供。

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

Summit继续其ivonescimab的临床开发，以确定其在两种NSCLC适应症中的有效性和安全性：

HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)

HARMONi III期临床试验：ivonescimab联合化疗治疗EGFR突变、局部晚期或转移性非鳞状NSCLC患者，这些患者在接受第三代EGFR TKI（NCT05184712）治疗后进展

HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)

HARMONi-3 III期临床试验：ivonescimab联合化疗治疗一线转移性鳞状NSCLC患者（NCT05899608）

About the ELCC 2024 Posters

关于ELCC 2024海报

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer

海报标题：新型PD-1/VEGF双特异性联合化疗用于晚期/转移性鳞状非小细胞肺癌患者一线治疗的Ivonescimab的2期结果

ELCC Presentation No.: 68P

ELCC展示编号：68P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

会议日期：2024年3月22日，星期五，欧洲中部时间中午12:00至12:45

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases

海报标题：Ivonescimab单独或联合铂类双联化疗对晚期非小细胞肺癌和脑转移患者的颅内活性

ELCC Presentation No.: 174P

ELCC展示编号：174P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

会议日期：2024年3月22日，星期五，欧洲中部时间中午12:00至12:45

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 an investigational, novel, potential first-in-class 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，是一种研究性的，新颖的，潜在的一流双特异性抗体，结合了免疫治疗的作用通过阻断PD-1与阻断VEGF相关的抗血管生成作用形成单一分子。

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

当同时存在PD-1和VEGF时，Ivonescimab以更高的亲和力显示与其每个预期靶标的协同结合。。

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 (Zhong, et al, SITC, 2023).

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）能够在肿瘤微环境中实现更高的亲和力（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（Zhong等，SITC，2023）。

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. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets..

这种四价结构，分子的有意新颖设计，以及将这两个靶标引入具有协同结合特性的单一双特异性抗体中，有可能将ivonescimab导向肿瘤组织而不是健康组织。除了与这些目标相关的副作用和安全性外，该设计的目的是改进先前确定的功效阈值。。

Ivonescimab was discovered 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..

Ivonescimab由Akeso Inc.（香港交易所代码：9926.HK）发现，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年开始进行两项III期临床试验。。

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

Ivonescimab是一种未经任何监管机构批准的研究性疗法。

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, 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.

本新闻稿中有关公司未来预期、计划和前景的任何声明，包括但不限于有关公司候选产品的临床和临床前开发、与Akeso Inc.的合作关系的签订和行动、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、潜在的收购以及其他包含“预期”、“相信”、“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”等字样的声明潜在的、预测的、项目的、应该的、目标的、将会的以及类似的表述，构成了1995年《私人证券诉讼改革法案》所指的前瞻性陈述。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the 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 timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results.

由于各种重要因素，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，包括我们对与ivonescimab开发和商业化活动相关的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，正在进行和未来临床试验数据的可用性和时间安排，此类试验的结果及其成功，以及可能影响我们临床试验和操作的时间安排和状态的全球公共卫生危机，临床试验的初步结果是否可以预测该试验的最终结果或结果。

Appendix: Glossary of Critical Terms Contained Herein

附录：此处包含的关键术语表

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

亲和力-亲和力是分子（如蛋白质或抗体）与另一分子（如配体）结合的强度。

Avidity – Avidity is the accumulated strength of multiple binding interactions.

亲合力–亲合力是多种结合相互作用的累积强度。

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.i

血管生成-血管生成是血管结构的发育，形成和维持。如果没有足够的血流，组织可能会出现缺氧（氧气不足）或缺乏营养，这可能导致细胞死亡。我

Baseline – The condition of a patient at the start of the clinical trial; a patient’s health status upon starting a clinical trial prior to receiving therapy.

基线-临床试验开始时患者的状况；在接受治疗之前开始临床试验时患者的健康状况。

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.ii.

协同结合-当分子上可被特定配体（例如蛋白质）占据的结合位点数量受到配体浓度的影响时，就会发生协同结合。例如，这可能是由于对配体的亲和力取决于结合的配体的量或基于另一配体浓度的分子与一种配体的结合强度，从而增加了另一种配体与化合物结合的机会。

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.iii

免疫疗法-免疫疗法是一种治疗方法，包括癌症治疗，可以帮助人的免疫系统对抗癌症。例子包括抗PD-1疗法

Intracranial – Within the cranium or skull.

颅内-在颅骨或颅骨内。

PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.iv.

PD-1程序性细胞死亡蛋白1是T细胞和其他细胞表面的一种蛋白质。PD-1在减少无效或有害免疫反应的调节和维持免疫耐受方面起着关键作用。然而，对于癌肿瘤细胞，PD-1可以通过与肿瘤细胞上存在的PD-L1配体结合并阻止T细胞靶向癌性肿瘤细胞而充当停止机制（刹车或检查点）。

PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells. v

PD-L1程序性细胞死亡配体1由癌细胞表达，作为逃避抗肿瘤反应的适应性免疫机制，因此被认为可以抑制免疫系统对癌细胞存在的反应。五

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PD-L1 TPS–PD-L1肿瘤比例评分代表表达PD-L1蛋白的肿瘤细胞的百分比。

PFS – Progression-Free Survival.

PFS–无进展生存期。

RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

RANO–神经肿瘤学中的反应评估，是评估脑或脊髓肿瘤对治疗反应的标准。

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

SQ-NSCLC–鳞状组织学的非小细胞肺癌肿瘤。

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.vi

T细胞–T细胞是一种白细胞，是免疫系统的组成部分，通常可以抵抗感染和有害细胞，如肿瘤细胞。vi

Tetravalent – A tetravalent molecule has four binding sites or regions.

四价-四价分子有四个结合位点或区域。

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.vii.

肿瘤微环境-肿瘤微环境是围绕体内肿瘤的生态系统。它包括免疫细胞、细胞外基质、血管和其他细胞，如成纤维细胞。肿瘤及其微环境不断相互作用并相互影响，无论是积极的还是消极的。

VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.viii

VEGF-血管内皮生长因子是一种促进血管生成的信号蛋白

i Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

i Shibuya M.血管内皮生长因子（VEGF）及其受体（VEGFR）在血管生成中的信号传导：抗血管生成和促血管生成疗法的关键靶标。基因癌症。2011年12月；2（12）：1097-105。

ii Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

ii Stefan MI，Le Novère N.合作绑定。PLoS计算机生物学。2013年；9（6）

iii US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed March 2024.

iii美国国家癌症研究所，国家卫生研究所（NIH）的一部分。https://www.cancer.gov/about-cancer/treatment/types/immunotherapy.2024年3月访问。

iv Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

iv Han Y等人。PD-1/PD-L1途径：癌症的最新研究。Am J Cancer Res.2020年3月1日；10（3）：727-742。

v Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

v Han Y等人。PD-1/PD-L1途径：癌症的最新研究。Am J Cancer Res.2020年3月1日；10（3）：727-742。

vi Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed March 2024.

vi克利夫兰诊所。https://my.clevelandclinic.org/health/body/24630-t-cells.2024年3月访问。

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viii Shibuya M.血管内皮生长因子（VEGF）及其受体（VEGFR）在血管生成中的信号传导：抗血管生成和促血管生成疗法的关键靶标。基因癌症。2011年12月；2（12）：1097-105。