MUNICH--(BUSINESS WIRE)--Tubulis announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to its lead antibody-drug conjugate (ADC) TUB-040 for the treatment of patients with platinum-resistant ovarian cancer. TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC based on Tubulis’ proprietary P5 technology with superior biophysical properties that demonstrated effective and durable responses in a range of preclinical models, including ovarian cancer.

慕尼黑--（商业新闻短讯）--Tubulis今天宣布，美国食品和药物管理局（“FDA”）已批准其铅抗体药物偶联物（ADC）TUB-040用于治疗铂类耐药卵巢癌患者的快速通道。TUB-040是基于Tubulis专有P5技术的下一代靶向Exatecan ADC的NaPi2b，具有优异的生物物理特性，在包括卵巢癌在内的一系列临床前模型中表现出有效且持久的反应。

The candidate is currently being evaluated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who have exhausted other available treatment options..

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“Almost all patients with ovarian cancer who are not cured by initial therapy will develop resistance to platinum-based therapy over time. Once platinum-resistant, therapeutic options for these patients are poor with highly unsatisfactory outcomes. The FDA´s Fast Track designation of TUB-040 is an important step in the development of TUB-040 to provide these women with urgently needed new therapeutic options,“ said Günter Fingerle-Rowson, MD, PhD, Chief Medical Officer of Tubulis.

“几乎所有未通过初始治疗治愈的卵巢癌患者都会随着时间的推移对铂类药物产生耐药性。一旦铂类药物耐药，这些患者的治疗选择就会很差，结果非常不令人满意。FDA对TUB-040的快速命名是TUB-040开发的重要一步，为这些女性提供急需的新治疗选择，”Tubulis首席医学官Günter Fingerle Rowson博士说。

“The FDA decision brings us one step closer to our goal of delivering the true value of ADCs to patients in need, and we are grateful for the agency’s support on this path to develop TUB-040 fast and efficiently..

“FDA的决定使我们离向有需要的患者提供ADC真正价值的目标又近了一步，我们感谢该机构在这条道路上的支持，以快速有效地开发TUB-040。。

The Fast Track status granted by the FDA is designed to facilitate the development and expedite the review of new therapies that are intended to treat serious conditions and have the potential to address an unmet medical need. Programs granted Fast Track designation are subject to more frequent interactions with the FDA during clinical development and may be eligible for accelerated approval and/or priority review if certain criteria are met..

FDA授予的快速通道状态旨在促进旨在治疗严重疾病并有可能解决未满足医疗需求的新疗法的开发和加速审查。获得快速通道指定的项目在临床开发过程中会与FDA进行更频繁的互动，如果符合某些标准，则可能有资格获得加速批准和/或优先审查。。

TUB-040 is currently being evaluated in a multicenter, first-in-human, dose-escalation and optimization Phase I/IIa study. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as monotherapy and is being conducted in the US, UK, Spain, Belgium and Germany.

TUB-040目前正在一项多中心，首次在人体内，剂量递增和优化I/IIa期研究中进行评估。该试验旨在评估TUB-040作为单一疗法的安全性，耐受性，药代动力学和疗效，目前正在美国，英国，西班牙，比利时和德国进行。

Phase Ia includes dose escalation and will determine the safety and the maximum tolerated dose or identified dose for optimization, while Phase IIa will focus on dose optimization, safety, and preliminary efficacy of TUB-040..

Ia期包括剂量递增，将确定安全性和最大耐受剂量或确定的优化剂量，而IIa期将重点关注TUB-040的剂量优化，安全性和初步疗效。。

About Platinum-resistant Ovarian Cancer

关于铂类耐药卵巢癌

Ovarian cancer (OC) is the leading cause of death among women diagnosed with gynecological cancers. While early-stage disease has a high survival rate, OC is often diagnosed at later stages due to its non-specific clinical symptoms and lack of preventive screening methods.2 The current standard of care is platinum-based therapy, but approximately 20% of patients are platinum-resistant during each treatment line.3,4 Platinum-resistant OC is defined as disease recurrence during or within 6 months after completing the platinum-based chemotherapy.

卵巢癌（OC）是被诊断患有妇科癌症的女性的主要死亡原因。虽然早期疾病的生存率很高，但由于其非特异性临床症状和缺乏预防性筛查方法，OC通常在晚期被诊断出来。目前的护理标准是铂类治疗，但大约20%的患者在每个治疗方案中都有铂类耐药。3,4铂类耐药OC被定义为在完成铂类化疗期间或之后6个月内的疾病复发。

Platinum-resistant OC is associated with poor disease outcomes and low response rates to subsequent chemotherapy treatment. The median survival for these patients is 12-16 months, highlighting the high unmet medical need of this patient population. 5,6.

铂类耐药OC与疾病预后不良和对随后化疗治疗的反应率低有关。这些患者的中位生存期为12-16个月，突显了该患者群体的高度未满足的医疗需求。5,6。

About TUB-040 and the P5 Technology

关于TUB-040和P5技术

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against Napi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting Napi2b 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的铅抗体药物偶联物（ADC）TUB-040针对Napi2b，Napi2b是一种在卵巢癌和肺腺癌中高度过表达的抗原。它由靶向Napi2b的IgG1抗体组成，该抗体通过基于该公司专有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. It originated from the fundamental work of Prof. Christian Hackenberger at the Leibniz-Forschungsinstitut für Molekulare Pharmakologie im Forschungsverbund Berlin e.V.

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。它起源于Christian Hackenberger教授在Leibniz Forschungsinstitut für Molekulare Pharmacologie im Forschungsverbund Berlin e.V.的基础工作。

(FMP), which unlocked the use of phosphorus chemistry for superior bioconjugation. Preclinical pharmacokinetic analysis also demonstrated that TUB-040 efficiently delivers its payload to the tumor while reducing off-site toxicities. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy..

（FMP），它解锁了磷化学用于优异的生物共轭的用途。临床前药代动力学分析还表明，TUB-040有效地将其有效载荷传递给肿瘤，同时降低了场外毒性。该候选人目前正在一项多中心I/IIa期研究（NAPISTAR 1-01，NCT06303505）中进行调查，该研究旨在评估TUB-040作为单一疗法的安全性，耐受性，药代动力学和疗效。。

About Tubulis

关于小管

Tubulis’ suite of proprietary platform technologies generates uniquely matched antibody-drug conjugates with superior biophysical properties for treating solid tumors. By demonstrating durable on-tumor delivery of the payload and long-lasting anti-tumor activity, we have reached the clinic with our first program, TUB-040, in ovarian and non-small cell lung cancer.

Tubulis的一套专有平台技术可产生独特匹配的抗体-药物偶联物，具有优异的生物物理特性，用于治疗实体瘤。通过证明有效载荷的持久肿瘤传递和持久的抗肿瘤活性，我们已经通过卵巢癌和非小细胞肺癌的第一个项目TUB-040到达了临床。

The second candidate from our growing pipeline, TUB-030, is set to follow in the near-term. We will solidify our leadership position by continuing to innovate on all aspects of ADC design to expand their therapeutic potential for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn..

我们正在增长的管道中的第二个候选人TUB-030将在短期内跟进。我们将继续在ADC设计的各个方面进行创新，以巩固我们的领导地位，扩大其对我们的管道、合作伙伴和患者的治疗潜力。访问www.tubulis.com或在LinkedIn上关注我们。。