CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced the company will proceed with its plan to expedite development of BT8009 for metastatic bladder (urothelial) cancer following recent discussions with the U.S.

剑桥，英国和波士顿-（商业线）-Bicycle Therapeutics（纳斯达克股票代码：BCYC），一家生物技术公司，基于其专有的双环肽（Bicycle®）技术开创了一种新型和差异化的治疗药物，今天宣布，在最近与美国讨论后，该公司将继续其加速BT8009治疗转移性膀胱（尿路上皮）癌症的计划。

Food and Drug Administration (FDA). The company has aligned with the FDA on a Phase 2/3 registrational trial, called Duravelo-2, that has an innovative design allowing for potential accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. The company plans to initiate the Duravelo-2 trial in the first quarter of 2024..

食品药品监督管理局（FDA）。该公司已与FDA就2/3期注册试验（称为Duravelo-2）达成一致，该试验具有创新设计，可加速批准未经治疗（一线）和先前治疗（二线加）的转移性膀胱癌。该公司计划于2024年第一季度启动Duravelo-2试验。。

“We prepared a robust and innovative clinical development plan for BT8009, with the goal of getting this much-needed therapy to patients as quickly as possible. We are pleased to have reached alignment with the FDA on the registrational trial design, dose selection and clinical trial endpoints that could support potential accelerated approval in a broad metastatic bladder cancer population,” said Santiago Arroyo, M.D., Ph.D., chief development officer at Bicycle Therapeutics.

“我们为BT8009制定了一个强大而创新的临床开发计划，目标是尽快为患者提供急需的治疗方案。我们很高兴与FDA在注册试验设计，剂量选择和临床方面达成一致试验终点，可以支持广泛转移性膀胱癌人群的潜在加速批准“Bicycle Therapeutics的首席开发官Santiago Arroyo博士说。

“In preparation for this positive outcome, we have put in place the clinical infrastructure that will allow us to start the registrational trial early next year.”.

“为了准备这一积极成果，我们已经建立了临床基础设施，使我们能够在明年初开始注册试验。”。

The Phase 2/3 Duravelo-2 trial will assess BT8009 in untreated metastatic bladder cancer (Cohort 1) and previously treated metastatic bladder cancer (Cohort 2). In Cohort 1, two doses of BT8009 plus standard pembrolizumab regimen will be initially assessed. Following selection of the optimal dose, BT8009 plus pembrolizumab will be evaluated against chemotherapy.

2/3期Duravelo-2试验将评估未治疗的转移性膀胱癌（队列1）和先前治疗的转移性膀胱癌（队列2）中的BT8009。在队列1中，最初将评估两剂BT8009加标准pembrolizumab方案。在选择最佳剂量后，将针对化学疗法评估BT8009加pembrolizumab。

Potential accelerated approval will be determined by objective response rate (ORR), and progression-free survival (PFS) will be used to confirm clinical benefit..

潜在的加速批准将由客观缓解率（ORR）决定，无进展生存期（PFS）将用于确认临床获益。。

In Cohort 2, two doses of BT8009 as monotherapy will be initially studied. Following selection of the optimal dose, an additional arm of BT8009 plus standard pembrolizumab regimen will be added. Potential accelerated approval for BT8009 monotherapy and in combination with pembrolizumab will be determined by ORR compared to historical control data.

在队列2中，最初将研究两剂BT8009作为单一疗法。在选择最佳剂量后，将添加BT8009加标准pembrolizumab方案的另外一组。与历史对照数据相比，ORR将确定BT8009单一疗法和与派姆单抗组合的潜在加速批准。

Discussions with the FDA about the design of the confirmatory trial for previously treated metastatic bladder cancer are ongoing..

与FDA讨论有关先前治疗的转移性膀胱癌的验证性试验设计的讨论正在进行中。。

“At Bicycle Therapeutics, we are committed to using our novel platform to develop precision targeted therapeutics and improve the lives of patients who are battling devastating diseases. This is why, in line with the philosophy of the FDA’s Project FrontRunner and following the agency’s recent draft guidance on accelerated approval of oncology therapeutics, we have initially focused on defining the regulatory path for BT8009 in untreated patients.

“在Bicycle Therapeutics，我们致力于利用我们的新平台开发精确的靶向治疗药物，改善正在与毁灭性疾病作斗争的患者的生活。这就是为什么根据FDA项目先驱的理念，并遵循该机构最近关于加速批准肿瘤治疗药物的指南草案，我们最初专注于定义在未经治疗的患者中制定BT8009的监管路径。

We believe today’s announcement is good news for patients, and we are greatly appreciative of the FDA for their collaboration and guidance,” said Kevin Lee, Ph.D., chief executive officer of Bicycle Therapeutics. “As we look to the rest of 2023, we continue to make progress in our research and development programs and look forward to providing updates on BT8009, BT5528 and BT7480 later this year.”.

我们相信今天的公告对患者来说是个好消息，我们非常感谢FDA的合作和指导，“Bicycle Therapeutics首席执行官Kevin Lee博士说。“当我们期待2023年的其余时间时，我们继续在研究和开发计划方面取得进展，并期待今年晚些时候提供BT8009，BT5528和BT7480的更新。”。

Conference Call and Webcast Information

电话会议和网络广播信息

Bicycle Therapeutics will host a conference call and webcast today, September 11, 2023, at 8 a.m. ET to review the BT8009 regulatory update. To access the call, please dial 1-833-816-1408 (U.S.) or +1 412-317-0501 (international) and ask to be joined into the Bicycle Therapeutics call. A live webcast and replay of the conference call will be available in the Investor section of the Bicycle website, bicycletherapeutics.com..

Bicycle Therapeutics将于2023年9月11日上午8点举办电话会议和网络广播，以审查BT8009监管更新。要访问电话，请拨打1-833-816-1408（美国）或+1 412-317-0501（国际），并要求加入Bicycle Therapeutics电话。自行车网站的投资者部分（bicycleetherapeutics.com）将提供实时网络广播和电话重播。。

About BT8009

大约BT8009

BT8009 is an investigational Bicycle Toxin Conjugate (BTC™) targeting Nectin-4, a well-validated tumor antigen with elevated levels of expression in multiple tumor types, including bladder (urothelial) cancer. It is currently being evaluated in a Phase 1/2 clinical trial enrolling patients with Nectin-4 expressing advanced solid tumors.

BT8009是一种研究性自行车毒素结合物（BTC™) 靶向Nectin-4，一种经过充分验证的肿瘤抗原，在多种肿瘤类型（包括膀胱癌（尿路上皮癌））中具有升高的表达水平。目前正在1/2期临床试验中对其进行评估，该试验招募了表达Nectin-4的晚期实体瘤患者。

BT8009 will be evaluated in the Phase 2/3 Duravelo-2 trial, a global, multi-center, adaptive study designed to assess the safety and efficacy of the therapy for metastatic bladder cancer..

BT8009将在2/3期Duravelo-2试验中进行评估，这是一项全球性，多中心，适应性研究，旨在评估转移性膀胱癌治疗的安全性和有效性。。

About Bicycle Therapeutics

关于自行车疗法

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

自行车疗法是一种临床阶段的生物制药公司，开发一类新的药物，称为自行车，用于现有疗法服务不足的疾病。双环是完全合成的短肽，受小分子支架约束，形成两个环，稳定其结构几何形状。

This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. The company is evaluating BT5528, a Bicycle Toxin Conjugate (BTC™) targeting EphA2; BT8009, a BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase 1/2 trials.

该限制以高亲和力和选择性促进靶标结合，使得自行车成为药物开发的有吸引力的候选者。该公司正在评估BT5528，一种自行车毒素结合物（BTC）™) 针对EphA2；BT8009，一种靶向Nectin-4的BTC，一种经过充分验证的肿瘤抗原；和BT7480，一种自行车TICA™ 在公司赞助的1/2期试验中，针对Nectin-4和激动CD137。

In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase 1/2a clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass.

此外，BT1718是一种靶向MT1-MMP的BTC，正在由英国癌症研究中心药物开发中心赞助的正在进行的1/2a期临床试验中进行研究。Bicycle Therapeutics总部设在英国剑桥，拥有许多关键职能，其领导团队成员位于马萨诸塞州剑桥市。

For more information, visit bicycletherapeutics.com..

欲了解更多信息，请访问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”的安全港条款作出的前瞻性陈述。这些陈述可以用诸如“目标”、“预期”、“相信”、“可以”、“估计”、“期望”、“预测”、“目标”、“意图”、“可以”、“计划”、“可能”、“潜力”、“寻求”、“意愿”等词语来识别，这些词语或类似词语的变体旨在识别前瞻性陈述，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 Bicycle’s anticipated advancement of its product candidates, including the timing of initiation and design of the Duravelo-2 Phase 2/3 clinical trial and potential accelerated approval of BT8009; the anticipated progression of Bicycle’s clinical trials; the availability of and timing of updates for clinical candidates BT8009, BT5528 and BT7480; and the therapeutic potential for Bicycles in bladder cancer and other oncologic indications.

本新闻稿中的前瞻性声明包括但不限于关于自行车预期推进其候选产品的声明，包括Duravelo-2 2/3期临床试验的启动和设计时间以及BT8009的潜在加速批准；自行车临床试验的预期进展；临床候选人BT8009，BT5528和BT7480的可用性和更新时间；以及自行车在膀胱癌和其他肿瘤适应症中的治疗潜力。

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 the initiation, progress and completion of clinical trials and clinical development of Bicycle’s product candidates; availability and timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a cli.

自行车实际上可能无法实现这些前瞻性陈述中披露的计划，意图或期望，您不应过分依赖这些前瞻性陈述。实际结果或事件可能与这些前瞻性陈述中由于各种因素而披露的计划，意图和期望有很大不同，包括：自行车产品候选人的临床试验的启动，进展和完成以及临床开发所固有的不确定性；临床试验结果的可用性和时间安排；临床前研究的结果是否可以预测临床试验结果；无论是初始还是中期的cli结果。