CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced the presentation of the first human imaging data validating the potential of MT1-MMP as a novel target in the treatment of cancer and demonstrating the positive properties of Bicycle Radionuclide Conjugates (BRC®) for radiopharmaceutical use, as well as preclinical data demonstrating optimized BRC radioisotope delivery at the European Association of Nuclear Medicine (EANM) 2024 Congress in Hamburg, Germany..

英国剑桥和波士顿--（商业新闻短讯）--Bicycle Therapeutics plc（纳斯达克：BCYC）是一家制药公司，该公司基于其专有的双环肽（Bicycle®）技术开创了一类新的差异化治疗方法，今天宣布在德国汉堡举行的欧洲核医学协会（EANM）2024年大会上，首次发布人体成像数据，验证MT1-MMP作为癌症治疗新靶点的潜力，并证明自行车放射性核素结合物（BRC®）在放射性药物中的积极特性，以及临床前数据，证明优化了BRC放射性同位素的输送。。

“Since our founding, our goal at Bicycle Therapeutics has been to leverage the power of our platform in areas where we can have the most impact for patients. Over the years, we have built a robust pipeline of oncology therapies that includes targeted drug conjugates, immuno-oncology agents and now, radiopharmaceuticals,” said CEO Kevin Lee, Ph.D.

“自成立以来，我们在自行车治疗领域的目标一直是在我们可以对患者产生最大影响的领域利用我们平台的力量。多年来，我们已经建立了一个强大的肿瘤治疗管道，包括靶向药物偶联物，免疫肿瘤药物，现在还有放射性药物，”首席执行官凯文·李博士说。

“The exciting data presented at EANM underscore the potential of our Bicycle Radionuclide Conjugates to deliver a range of isotopes to novel cancer targets. Through our strategy of pursuing novel targets with first-in-class potential and selecting the isotope that best aligns with the target biology and indication, we have an opportunity to potentially broaden the use of radiopharmaceuticals to diagnose and treat cancer.”.

“EANM上提供的令人兴奋的数据强调了我们的自行车放射性核素结合物为新型癌症靶标提供一系列同位素的潜力。通过我们追求具有一流潜力的新型靶标并选择与靶标生物学和适应症最一致的同位素的策略，我们有机会潜在地扩大放射性药物在癌症诊断和治疗中的应用。”。

In line with Bicycle Therapeutics’ radiopharmaceuticals strategy, the company selected tumor antigen EphA2 as its second BRC target and signed a letter of intent with leading isotope technology company Eckert & Ziegler to put in place an agreement to supply a range of radioisotopes and develop and manufacture BRC molecules.

根据Bicycle Therapeutics的放射性药物战略，该公司选择肿瘤抗原EphA2作为其第二个BRC目标，并与领先的同位素技术公司Eckert＆Ziegler签署了一份意向书，以签订一项协议，提供一系列放射性同位素并开发和制造BRC分子。

Bicycle Therapeutics, through its internal pipeline of wholly owned molecules and strategic collaborations with industry and academic leaders in the field, aims to be at the forefront of the development of next-generation radiopharmaceutical therapies. Bicycle® molecules have ideal properties for radioisotope delivery due to their low molecular weight, high selectivity and affinity for their intended target and rapid systemic clearance..

Bicycle Therapeutics通过其全资拥有的分子内部管道以及与该领域的行业和学术领袖的战略合作，旨在成为下一代放射性药物疗法发展的前沿。Bicycle®分子具有低分子量，高选择性和对预期靶标的亲和力以及快速的全身清除率，因此具有理想的放射性同位素输送特性。。

“The data presented at EANM demonstrate how our Bicycle® platform is a powerful tool for de novo identification of high-quality binders to important cancer targets. We believe the ability to optimize the biodistribution properties of our molecules, significantly reducing kidney retention while retaining rapid, selective uptake in tumors, position Bicycle Radionuclide Conjugates as a potentially best-in-class approach for targeted radionuclide therapy,” said Michael Skynner, Ph.D., chief technology officer of Bicycle Therapeutics.

Bicycle Therapeutics首席技术官迈克尔·斯金纳博士说：“EANM上提供的数据表明，我们的Bicycle®平台是一种强大的工具，可以从头识别高质量的重要癌症靶标粘合剂。我们相信能够优化分子的生物分布特性，显着减少肾脏潴留，同时保持肿瘤的快速选择性摄取，将自行车放射性核素结合物定位为靶向放射性核素治疗的潜在最佳方法。”。

“MT1-MMP is the first target for radiopharmaceutical development that we are pursuing given its expression in many solid tumors such as non-small cell lung cancer, esophageal and triple negative breast cancer.”.

“MT1-MMP是我们正在追求的放射性药物开发的第一个目标，因为它在许多实体瘤中表达，如非小细胞肺癌，食管癌和三阴性乳腺癌。”。

EANM 2024 Congress Data Highlights

EANM 2024年大会数据亮点

During an oral presentation, the German Cancer Consortium (DKTK) presented first human imaging data for a BRC targeting MT1-MMP. They focused on a case study in a 65-year-old male diagnosed with advanced pulmonary adenocarcinoma, the most common type of non-small cell lung cancer, in the lung and lymph nodes confirmed by endobronchial ultrasound (EBUS) biopsy.

在一次口头介绍中，德国癌症协会（DKTK）介绍了第一个针对MT1-MMP的BRC的人体成像数据。他们专注于一名65岁男性的病例研究，该男性被诊断患有晚期肺腺癌，这是最常见的非小细胞肺癌类型，其肺部和淋巴结经支气管内超声（EBUS）活检证实。

The patient received fluorine-18-labelled FDG-PET/CT imaging, and two weeks later received MT1-MMP PET/CT imaging up to one hour post injection of the gallium-68-labelled BRC tracer..

患者接受氟-18标记的FDG-PET/CT成像，两周后接受MT1-MMP PET/CT成像，直至注射镓-68标记的BRC示踪剂后一小时。。

Both scans revealed multiple lymph node metastases and bone metastases in the sternum. MT1-MMP imaging demonstrated tracer uptake in the primary tumor in the lung and lymph node and bone metastases, consistent with FDG imaging. Additionally, the MT1-MMP BRC tracer showed renal excretion, with all other organs showing only negligible tracer uptake.

两次扫描均显示胸骨有多处淋巴结转移和骨转移。MT1-MMP成像显示肺部原发肿瘤和淋巴结以及骨转移中的示踪剂摄取，与FDG成像一致。此外，MT1-MMP BRC示踪剂显示肾脏排泄，所有其他器官仅显示可忽略不计的示踪剂摄取。

Clear imaging contrast was also observed at early time points..

在早期时间点也观察到清晰的成像对比度。。

In an e-poster, Bicycle Therapeutics presented preclinical data demonstrating the suitability of Bicycle molecules to deliver indium to tumors in vivo due to their favorable properties, including specific tumor uptake, rapid tumor penetration and rapid renal elimination. Additionally, imaging showed how the biodistribution profile of BRCs can be optimized to maintain high tumor uptake and retention while significantly reducing kidney uptake and retention.

在一张电子海报中，Bicycle Therapeutics提供了临床前数据，证明了Bicycle分子由于其有利的特性（包括特异性肿瘤摄取，快速肿瘤穿透和快速肾脏消除）而适合在体内将铟递送至肿瘤。此外，成像显示了如何优化BRC的生物分布特征，以维持高肿瘤摄取和保留，同时显着减少肾脏摄取和保留。

These data build on the body of preclinical data the company has published in this area demonstrating the use of Bicycle molecules to effectively deliver various radioisotopes, such as lutetium and lead, to tumors..

这些数据建立在该公司在该领域发布的临床前数据的基础上，证明了自行车分子的使用可以有效地将各种放射性同位素（如镥和铅）传递给肿瘤。。

Altogether, the data presented at EANM validate the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle molecules for targeted radionuclide therapy.

总之，EANM上提供的数据验证了MT1-MMP作为癌症治疗新靶点的潜力，证明了BRC临床前数据的可翻译性，并突出了自行车分子用于靶向放射性核素治疗的潜力。

The e-poster, “Bicycle Radionuclide Conjugates for radioisotope delivery to solid tumors,” is available in the Publications section of the Bicycle Therapeutics website.

电子海报“自行车放射性核素结合物用于放射性同位素递送至实体瘤”，可在自行车治疗学网站的出版物部分获得。

Conference Call Details

电话会议详细信息

Bicycle Therapeutics will host a conference call and webcast today, Oct. 23, at 8 a.m. ET to review the first human imaging data and outline the company’s radiopharmaceuticals strategy. To access the call, please dial 833-816-1408 (U.S.) or +1-412-317-0501 (international) and ask to join the Bicycle Therapeutics call.

Bicycle Therapeutics将于今天（美国东部时间10月23日）上午8点举行电话会议和网络广播，回顾第一批人体成像数据，并概述公司的放射性药物战略。要拨打电话，请拨打833-816-1408（美国）或+1-412-317-0501（国际），并要求加入自行车治疗电话。

A live webcast and replay of the conference call will be accessible in the Investor section of the Company’s website at www.bicycletherapeutics.com..

电话会议的直播和重播将在公司网站的投资者部分进行，网址为www.bicycletherapeutics.com。。

About Bicycle Therapeutics

关于自行车疗法

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry.

Bicycle Therapeutics是一家临床阶段的制药公司，开发了一类新型药物，称为Bicycle®分子，用于治疗现有疗法服务不足的疾病。自行车分子是完全合成的短肽，受小分子支架的约束，形成两个稳定其结构几何形状的环。

This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials.

这种限制促进了具有高亲和力和选择性的靶标结合，使自行车分子成为药物开发的有吸引力的候选物。该公司正在评估zelenectide pevedotin（以前称为BT8009），一种靶向Nectin-4（一种经过充分验证的肿瘤抗原）的Bicycle®毒素偶联物（BTC®）；BT5528，一种靶向EphA2的BTC分子，EphA2是一种历史上不可药用的靶标；和BT7480，一种靶向Nectin-4和激动CD137的自行车肿瘤靶向免疫细胞激动剂®（Bicycle-TICA®），在公司赞助的临床试验中。

Additionally, the company is developing Bicycle Radionuclide Conjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology..

此外，该公司正在开发用于放射性药物的自行车放射性核素结合物（BRC®），并通过各种合作伙伴关系，探索使用自行车®技术开发肿瘤以外疾病的治疗方法。。

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit www.bicycletherapeutics.com.

Bicycle Therapeutics总部位于英国剑桥，其领导团队的许多关键职能和成员位于马萨诸塞州剑桥。有关更多信息，请访问www.bicycletherapeutics.com。

Forward Looking Statements

前瞻性声明

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

本新闻稿可能包含根据1995年《私人证券诉讼改革法案》安全港条款所作的前瞻性声明。这些陈述可以用“目标”、“预期”、“相信”、“可能”、“估计”、“预期”、“预测”、“目标”、“打算”、“可能”、“计划”、“可能”、“潜在”、“寻求”、“将”等词语以及这些词语的变体或旨在识别前瞻性陈述的类似表达来识别，尽管并非所有前瞻性陈述都包含这些词语。

Forward-looking statements in this press release include, but are not limited to, statements regarding validation of MT1-MMP as a target for the treatment of cancer, the suitability of BRCs for radiopharmaceutical use and the potential of this approach; Bicycle’s plans for an agreement with Eckert & Ziegler to develop, manufacture and supply a range of radioisotopes; Bicycle’s anticipated progress across its internal and partnered pipelines in radiopharmaceuticals, the translatability of Bicycle’s BRC preclinical data and the ability of the Bicycle platform to identify binders for cancer targets; Bicycle’s development across its R&D pipeline and the advancement of its product candidates, including zelenectide pevedotin, BT5528 and BT7480; and the therapeutic potential for Bicycles in oncology and other applications.

本新闻稿中的前瞻性声明包括但不限于关于MT1-MMP作为癌症治疗靶点的验证，BRC用于放射性药物的适用性以及这种方法的潜力的声明；Bicycle计划与Eckert&Ziegler达成协议，开发、制造和供应一系列放射性同位素；Bicycle在放射性药物的内部和合作管道方面的预期进展，Bicycle的BRC临床前数据的可翻译性以及Bicycle平台识别癌症靶标粘合剂的能力；自行车在研发过程中的发展及其候选产品的进步，包括zelenectide pevedotin，BT5528和BT7480；以及自行车在肿瘤学和其他应用中的治疗潜力。

Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development .

自行车可能无法真正实现这些前瞻性声明中披露的计划、意图或期望，您不应过度依赖这些前瞻性声明。由于各种因素，实际结果或事件可能与这些前瞻性声明中披露的计划、意图和期望存在重大差异，包括：研究和开发固有的不确定性。