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Tubulis

管

announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing of the first patient in the 5-STAR 1-01 Phase I/IIa trial (

今天宣布，其第二个候选药物TUB-030已进入临床评估，并在5STAR 1-01 I/IIa期试验中成功给药了第一名患者(

NCT06657222

NCT06657222 型号

). The study is evaluating TUB-030, Tubulis’ next-generation antibody-drug conjugate (ADC), in patients with advanced solid tumors. The ADC targets 5T4, an oncofetal antigen expressed in a broad range of solid tumors. The program was developed using Tubulis’ proprietary Tubutecan linker-payload platform, which enables superior biophysical properties for precise and sustained on-tumor payload delivery..

)。该研究正在评估晚期实体瘤患者的TUB-030，即小管的下一代抗体-药物偶联物（ADC）。ADC靶向5T4，一种在广泛的实体瘤中表达的癌胚抗原。该程序是使用Tubulis专有的Tubutecan连接器有效载荷平台开发的，该平台具有优异的生物物理特性，可精确持续地进行肿瘤有效载荷传递。。

“This milestone for TUB-030 demonstrates our ability to execute on our strategy to advance innovative programs into our proprietary pipeline and rapidly bring them into the clinic,” said Dominik Schumacher, PhD, Chief Executive Officer and Co-founder of Tubulis. “As an organization, Tubulis has made a large step forward with two differentiated ADC molecules in clinical evaluation in less than a year.

Tubulis首席执行官兼联合创始人多米尼克·舒马赫（DominikSchumacher）博士说：“TUB-030的这一里程碑证明了我们有能力执行我们的战略，将创新项目推进我们的专有渠道，并迅速将其引入临床。”。“作为一个组织，在不到一年的时间里，Tubulis在两种分化的ADC分子的临床评估中取得了重大进展。

Our goal is to continue being an innovation driver in the field by delivering on the transformative potential of our platforms for patients.”.

我们的目标是通过为患者提供平台的变革潜力，继续成为该领域的创新驱动力。”。

The multicenter, first-in-human, dose escalation and optimization Phase I/IIa study 5-STAR 1-01 aims to investigate the safety, tolerability, pharmacokinetics, and efficacy of TUB-030 as a monotherapy to treat a broad range of solid tumors. The trial will enroll a total of 130 patients and will be conducted at sites across the US and Canada.

多中心，首次人体剂量递增和优化I/IIa期研究5-STAR 1-01旨在研究TUB-030作为单一疗法治疗广泛实体瘤的安全性，耐受性，药代动力学和疗效。该试验将招募总共130名患者，并将在美国和加拿大各地进行。

Phase I comprises dose escalation to determine the safety profile and to identify the maximum tolerated dose and/or the identified dose for optimization in patients with advanced solid tumor indications. Phase IIa will focus on dose optimization, safety, and preliminary efficacy of TUB-030 in selected indications..

第一阶段包括剂量递增，以确定安全性，并确定最大耐受剂量和/或确定的剂量，以优化晚期实体瘤适应症患者。IIa期将重点关注TUB-030在选定适应症中的剂量优化，安全性和初步疗效。。

“Building on our strong preclinical efficacy and safety data, we are expecting that targeting 5T4 with our high-performance ADC technology may offer a new precision therapy option for a variety of solid tumor indications. With our differentiated target, a strong bystander effect and efficient and durable target engagement via the Tubutecan platform, TUB-030 provides the potential to induce robust anti-tumor activity in 5T4-expressing tumors,” stated Günter Fingerle-Rowson, MD, PhD, Chief Medical Officer at Tubulis..

Tubutecan首席医学官Günter Fingerle Rowson医学博士表示：“基于我们强大的临床前疗效和安全性数据，我们期望通过我们的高性能ADC技术靶向5T4可能为各种实体瘤适应症提供新的精确治疗选择。凭借我们的差异化目标，强大的旁观者效应以及通过Tubutecan平台进行的高效持久的目标参与，TUB-030提供了在表达5T4的肿瘤中诱导强大抗肿瘤活性的潜力。”。。

TUB-030 consists of a humanized, Fc-silenced IgG1 antibody targeting 5T4 equipped with Tubulis’ proprietary Tubutecan technology, which is based on P5 conjugation chemistry and the topoisomerase-1 inhibitor exatecan. Tubulis previously presented a comprehensive preclinical data set

TUB-030由靶向5T4的人源化Fc沉默IgG1抗体组成，该抗体配备了Tubulis专有的Tubutecan技术，该技术基于P5缀合化学和拓扑异构酶-1抑制剂exatecan。小管以前提出了一个全面的临床前数据集

at AACR

AACR 的

demonstrating TUB-030’s stability and minimal loss of linker-payload conjugation. In a range of preclinical models, TUB-030 produced high and long-lasting anti-tumor responses, including responses at relatively low 5T4 expression levels, while maintaining an excellent safety and tolerability profile.

证明了TUB-030的稳定性和接头有效载荷共轭的最小损失。在一系列临床前模型中，TUB-030产生了高且持久的抗肿瘤反应，包括在相对较低的5T4表达水平下的反应，同时保持了优异的安全性和耐受性。

A single treatment with TUB-030 eliminated tumors in a triple-negative breast cancer mouse model, further underlining its potential efficacy. Preclinical analysis including safety, efficacy and pharmacokinetics demonstrated that TUB-030 has a therapeutic window in a large variety of solid tumors..

TUB-030的单一治疗消除了三阴性乳腺癌小鼠模型中的肿瘤，进一步强调了其潜在功效。包括安全性，有效性和药代动力学在内的临床前分析表明，TUB-030在多种实体瘤中具有治疗窗口。。

About TUB-030 and the Tubutecan Technology

关于TUB-030和Tubutecan技术

Tubulis’ second antibody-drug conjugate (ADC) TUB-030 is directed against 5T4, an oncofetal antigen, expressed in a broad range of solid tumor types. It consists of an IgG1 antibody targeting 5T4 connected to the Topoisomerase I inhibitor exatecan through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8.

Tubulis的第二抗体-药物偶联物（ADC）TUB-030针对5T4，一种在多种实体瘤类型中表达的癌胚抗原。它由靶向5T4的IgG1抗体组成，该抗体通过基于该公司专有的P5缀合技术的可切割接头系统连接到拓扑异构酶I抑制剂exatecan，均匀DAR为8。

P5 conjugation is a novel chemistry for cysteine-selective conjugation that enables ADC generation with unprecedented linker stability and biophysical properties. The candidate is currently being investigated in a multicenter Phase I/IIa study (5-STAR 1-01, .

P5缀合是一种用于半胱氨酸选择性缀合的新型化学，它使ADC产生具有前所未有的接头稳定性和生物物理特性。该候选人目前正在一项多中心I/IIa期研究中进行调查（5星1-01。

NCT06657222

NCT06657222 型号

) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-030 as a monotherapy in advanced solid tumors.

)旨在评估TUB-030作为晚期实体瘤单一疗法的安全性，耐受性，药代动力学和疗效。

About Tubulis

关于小管

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications, including ovarian, lung and head and neck cancers.

小管产生独特匹配的抗体-药物缀合物，具有优异的生物物理特性，已在临床前模型中证明了持久的肿瘤递送和持久的抗肿瘤活性。我们不断发展的管道中的两个主要项目，针对NaPi2b的TUB-040和针对5T4的TUB-030，正在临床上对包括卵巢癌，肺癌和头颈癌在内的高需求实体瘤适应症进行评估。

We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit .

我们将利用专有平台技术，在ADC设计的各个方面继续创新，巩固我们的领导地位。我们的目标是扩大这类药物对我们的管道、合作伙伴和患者的治疗潜力。访问。

www.tubulis.com

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