LAUSANNE, Switzerland & BARCELONA, Spain--(BUSINESS WIRE)--Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, today announced that it has entered a clinical collaboration with MEDSIR (www.medsir.org), a Spanish and US-based, international and innovative research organization in clinical oncology.

瑞士洛桑和西班牙巴塞罗那——（商业新闻短讯）——Debiopharm（www.Debiopharm.com）是一家总部位于瑞士的私营生物制药公司，旨在建立未来治疗癌症和传染病的护理标准，今天宣布，它已与西班牙和美国的临床肿瘤学国际创新研究组织MEDSIR（www.MEDSIR.org）进行临床合作。

The study will evaluate the safety and efficacy of Debio 0123 (Debiopharm's investigational, potential best-in-class WEE1 inhibitor) together with sacituzumab govitecan (Trodelvy®; an antibody-drug conjugate [ADC] owned and commercialized by Gilead Sciences, Inc. [Gilead]). Sites for this Phase 1b/2 investigator-initiated trial in patients with previously treated advanced breast cancer will be opened in Europe, UK, and the USA..

该研究将评估Debio 0123（Debiopharm的研究性，潜在的同类最佳WEE1抑制剂）与sacituzumab-govitecan（Trodelvy®；一种由Gilead Sciences，Inc.拥有并商业化的抗体-药物偶联物[ADC]）的安全性和有效性。该1b/2期研究者发起的先前治疗的晚期乳腺癌患者试验的网站将在欧洲，英国和美国开放。。

“We are thrilled about the launch of this study exploring the combination of our WEE1 inhibitor with Trodelvy and are looking forward to seeing the potential benefits in breast cancer patients” said Esteban Rodrigo Imedio, Executive Medical Director, Oncology, Debiopharm.

Debiopharm肿瘤学执行医学主任Esteban Rodrigo Imedio说：“我们对这项研究的启动感到兴奋，该研究探索了我们的WEE1抑制剂与Trodelvy的组合，并期待着在乳腺癌患者中看到潜在的益处。”。

Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers. It groups estrogen-receptor (ER) and/or progesterone-receptor (PR) expressing cells. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%.

激素受体阳性（HR+）/HER2是最常见的乳腺癌类型，占所有乳腺癌的70%。它将表达雌激素受体（ER）和/或孕激素受体（PR）的细胞分组。几乎三分之一的早期乳腺癌最终会转移，在HR+/HER2转移性疾病患者中，五年相对生存率为30%。

As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. For patients treated with single-agent chemotherapy, the prognosis remains poor [1]. Despite having a more favorable outcome than other breast cancer subtypes like HER2-positive and triple-negative breast cancers (TNBC), relapse still occurs and there remains a high unmet medical need for this patient population [2-3].

随着HR+/HER2转移性乳腺癌患者对内分泌治疗产生耐药性，他们的主要治疗选择仅限于单药化疗。对于接受单药化疗的患者，预后仍然很差（1）。尽管比HER2阳性和三阴性乳腺癌（TNBC）等其他乳腺癌亚型有更有利的结果，但仍会发生复发，并且该患者人群的医疗需求仍然很高[2-3]。

TNBC is an aggressive type of breast cancer that accounts for 10-15% of all breast cancers. It is called “triple negative” as it does not express ER, PR or HER2 receptors. Because of its aggressive nature, TNBC has a high risk of metastasis either at diagnosis or at time of relapse after initial curative therapy, which explains the poor prognosis many TNBC patients face.

TNBC是一种侵袭性乳腺癌，占所有乳腺癌的10-15%。它被称为“三阴性”，因为它不表达ER，PR或HER2受体。由于其侵袭性，TNBC在诊断时或初始治疗后复发时具有高转移风险，这解释了许多TNBC患者面临的不良预后。

Compared to other types of breast cancer, the relapse rate as well as the mortality rate in the 5 years after diagnosis is significantly higher [4-5]..

与其他类型的乳腺癌相比，诊断后5年的复发率和死亡率明显更高[4-5]。。

“It’s great to see companies like Debiopharm that are open to investigating novel combination strategies to support breast cancer patients. I look forward to seeing potential benefits for patients” Dr. Tim Robinson, Principal Investigator, University of Bristol.

布里斯托尔大学首席研究员蒂姆·罗宾逊博士说：“很高兴看到像Debiopharm这样的公司愿意研究新的组合策略来支持乳腺癌患者。我期待看到对患者的潜在益处。”。

Sacituzumab govitecan is a Trop-2-directed ADC currently approved globally for patients with 2L metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer The clinical trial will enroll patients with HR[+]/HER2[-] metastatic breast cancer and metastatic TNBC, and will be sponsored by MEDSIR, and fully funded by Debiopharm.

Sacituzumab-govitecan是目前全球批准用于2L转移性TNBC和预处理HR+/HER2转移性乳腺癌患者的Trop-2定向ADC临床试验将招募HR[+]/HER2[-]转移性乳腺癌和转移性TNBC患者，并将由MEDSIR赞助，并由Debiopharm全额资助。

Gilead will provide supply of sacituzumab govitecan..

吉利德将提供sacituzumab-govitecan的供应。。

“We are honored to develop this Investigator Sponsor Trial (IST) in collaboration with Debiopharm and Gilead to explore new approaches to breast cancer treatment. Together, we're committed to advancing patient care and fostering important partnerships in the oncology field. I believe our work with Debio 0123 and sacituzumab govitecan holds great promise for patients” said Dr.

“我们很荣幸与Debiopharm和Gilead合作开发这项研究者-赞助商试验（IST），以探索乳腺癌治疗的新方法。我们共同致力于推进患者护理，并在肿瘤学领域建立重要的合作伙伴关系。我相信我们与Debio 0123和sacituzumab govitecan的合作对患者有很大的希望，”Dr。

Javier Cortés, MEDSIR Senior Scientific Lead..

Javier Cortés，MEDSIR高级科学负责人。。

The foundations for this clinical trial were set by the promising preclinical data suggesting an existing synergy between Debiopharm’s Debio 0123 and Gilead’s sacituzumab govitecan. These results will be disclosed at the American Association for Cancer Research (AACR) annual meeting 2024 under the title “Anti-tumor activity of Debio 0123 in combination with sacituzumab govitecan in preclinical models of breast cancer” [6]..

这项临床试验的基础是有希望的临床前数据，表明Debiopharm的Debio 0123和Gilead的sacituzumab-govitecan之间存在协同作用。这些结果将在2024年美国癌症研究协会（AACR）年会上以“Debio 0123与sacituzumab-govitecan在乳腺癌临床前模型中的抗肿瘤活性”的标题公布。。

About Debio 0123

关于Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks.

Debio 0123是一种脑渗透性高选择性WEE1激酶抑制剂。WEE1是G2/M期和S期检查点的关键调节因子，可响应DNA损伤而激活，使细胞在恢复细胞周期之前修复其DNA。WEE1抑制，特别是与DNA损伤剂结合使用，会导致DNA断裂过载。

In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cell cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently investigated in clinical trials for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers..

结合其他检查点（如G1）的废除，该化合物推动细胞通过细胞周期而不进行DNA修复，促进有丝分裂灾难并诱导癌细胞凋亡。目前在单一疗法和联合疗法的实体瘤临床试验中进行了研究，Debio 0123正在开发中，以应对患有难以治疗的癌症负担的患者的高度未满足需求。。

About MEDSIR

关于MEDSIR

Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process..

MEDSIR成立于2012年，与合作伙伴密切合作，推动肿瘤学研究创新。该公司总部位于西班牙和美国，管理临床试验的各个方面，从研究设计到出版，利用全球专家网络和综合技术来简化过程。。

The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America.

该公司提供概念验证支持和战略方法，帮助研究合作伙伴从基于行业的临床研究和研究者驱动的试验中体验两个世界的最佳体验。为了促进全球范围内的独立癌症研究，MEDSIR与Oncoclínicas建立了战略联盟，Oncoclínicas是巴西领先的肿瘤学集团，在南美具有最大的研究潜力。

Learn how MEDSIR brings ideas to life: www.medsir.org..

了解MEDSIR如何将想法带入生活：www.MEDSIR.org。。

Debiopharm's Commitment to Patients

Debiopharm对患者的承诺

Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally..

Debiopharm旨在开发针对肿瘤学和细菌感染中高度未满足的医疗需求的创新疗法。弥合破坏性发现产品与现实世界患者接触之间的差距，我们确定了用于许可的高潜力化合物和技术，临床证明了它们的安全性和有效性，然后将管理工作交给大型药物商业化合作伙伴，以最大程度地提高全球患者的接触率。。

For more information, please visit www.debiopharm.com

有关更多信息，请访问www.debiopharm.com

We are on Twitter. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews.

我们在推特上。关注我们@DebiopharmNewshttp://twitter.com/DebiopharmNews.

Sources

来源

[1] Rugo et al., ASCO 2022 Abstract #LBA1001

[1] Rugo等人，ASCO 2022摘要#LBA1001

[2] American Cancer Society. 2021

[2] 美国癌症协会。2021

[3] McAndrew NP, Finn RS. 2022

[3] 芬兰人McAndrew NP RS.2022

[4] Dass SA, Tan KL, Selva Rajan R, Mokhtar NF, Mohd Adzmi ER, Wan Abdul Rahman WF, Tengku Din TADA, Balakrishnan V. 2021

[4] Dass SA、Tan KL、Selva Rajan R、Mokhtar NF、Mohd Adzmi ER、Wan Abdul Rahman WF、Tengku Din TADA、Balakrishnan V.2021

[5] American Cancer Society. 2023

[5] 美国癌症协会。2023

[6] Piggott et al., AACR 2024 Abstract #3370

[6]Piggott等人，AACR 2024摘要3370