CASTRES, France & BOSTON--(BUSINESS WIRE)--Pierre Fabre Laboratories, a global player in oncology, and Scorpion Therapeutics, Inc. (“Scorpion”), a pioneering clinical-stage oncology company dedicated to transforming the lives of cancer patients by redefining the frontier of precision medicine, today announced that the first patient has been dosed in a Phase I/II, first-in-human dose-escalation, dose-optimization and dose-expansion trial.

CASTRES，France&BOSTON——（商业新闻短讯）——全球肿瘤学参与者皮埃尔·法布尔实验室（Pierre Fabre Laboratories）和开创性的临床阶段肿瘤学公司蝎子治疗公司（Scorpion）今天宣布，第一名患者已在I/II期给药，这是首次在人体剂量递增，剂量优化和剂量扩展试验中给药。

This clinical trial evaluates PFL-241/STX-241, a highly differentiated, orally bioavailable, highly selective tyrosine kinase inhibitor ('TKI') targeting epidermal growth factor receptor ('EGFR') Exon 19 or 21 mutations with the co-occurring C797S mutation, a known resistance mechanism to 3rd generation EGFR inhibitors..

该临床试验评估了PFL-241/STX-241，一种高度分化的，口服生物利用的，高选择性的酪氨酸激酶抑制剂（“TKI”），靶向表皮生长因子受体（“EGFR”）外显子19或21突变，同时发生C797S突变，这是一种已知的对第三代EGFR抑制剂的耐药机制。。

The PFL-241/STX-241 Phase I/II trial is an open label, multi-center study that aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical efficacy of PFL-241/STX-241 as a monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring EGFR Exon 19 or 21 mutations with the co-occurring C797S mutation..

PFL-241/STX-241 I/II期临床试验是一项开放标签的多中心研究，旨在评估PFL-241/STX-241的安全性，耐受性，药代动力学（PK），药效学（PD）和初步临床疗效。作为局部晚期或转移性非小细胞肺癌（“NSCLC”）患者的单一疗法，其携带EGFR外显子19或21突变，同时发生C797S突变。。

NSCLC is the most common form of lung cancer and EGFR mutations are one of its most common disease drivers, occurring in up to 38 percent of tumors, depending on geography1,2,3.

NSCLC是最常见的肺癌形式，EGFR突变是其最常见的疾病驱动因素之一，根据地理位置1,2,3，发生率高达38%。

“We are eager to begin the clinical evaluation of PFL-241/STX-241, our mutant-selective 4th generation EGFR inhibitor, a molecule with differentiated properties that we believe has the potential to become a best-in-class therapeutic option for patients developing resistance to current targeted therapy,” said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

Pierre Fabre实验室医疗保健研发负责人Francesco Hofmann说：“我们迫切希望开始对PFL-241/STX-241进行临床评估，PFL-241/STX-241是我们突变的选择性第四代EGFR抑制剂，这种分子具有不同的特性，我们相信它有可能成为对目前靶向治疗产生耐药性的患者的最佳治疗选择。”。

“The initiation of this clinical trial highlights our team’s engagement and execution in strong partnership with Scorpion Therapeutics, and we look forward to demonstrating how patients could potentially benefit from this targeted therapy.”.

“这项临床试验的启动突显了我们团队与Scorpion Therapeutics紧密合作的参与和执行，我们期待着展示患者如何从这种靶向治疗中受益。”。

PFL-241/STX-241 is an oral treatment designed to selectively inhibit the C797S resistance mutation co-occurring with EGFR exon 19 deletion or exon 21 mutation (“double mutant”). Those “double mutants” are emerging as an on-target resistance mechanism in a subset of NSCLC patients. Most recent data suggest that the C797S mutation emerges in approximately 12.5%4-8 of patients undergoing therapy with 3rd generation EGFR inhibitors.

PFL-241/STX-241是一种口服治疗，旨在选择性抑制与EGFR外显子19缺失或外显子21突变（“双突变”）共同发生的C797S耐药突变。这些“双突变体”正在一部分NSCLC患者中成为靶向耐药机制。最近的数据表明，在接受第三代EGFR抑制剂治疗的患者中，约有12.5%的患者出现了C797S突变。

There are currently no approved therapeutic options for patients who develop this “double mutant” EGFR NSCLC..

目前，对于发展这种“双突变”EGFR NSCLC的患者，尚无批准的治疗选择。。

“The initiation of the second clinical trial in partnership with Pierre Fabre Laboratories is an important milestone as we work together to enable the rapid, global advancement of our next-generation EGFR inhibitors for difficult-to-treat NSCLC patients,” said Mark Chao, M.D., Ph.D., Chief Medical Officer of Scorpion.

Scorpion首席医疗官Mark Chao医学博士说：“与Pierre Fabre实验室合作启动第二次临床试验是一个重要的里程碑，因为我们共同努力，使我们的下一代EGFR抑制剂能够在全球范围内快速发展，用于难治性NSCLC患者。”。

“PFL-241/STX-241 is a novel, CNS-penetrant and highly potent and selective treatment option for patients who develop ‘double mutant’ disease for which there is currently no approved treatment, and it’s a pleasure to partner with Pierre Fabre Laboratories, a company who shares our commitment to bringing innovative treatments to this underserved patient population.

“PFL-241/STX-241是一种新型的中枢神经系统渗透剂，对于发展为“双突变”疾病的患者来说是一种高效和选择性的治疗选择，目前尚无批准的治疗方法，很高兴与Pierre Fabre Laboratories合作，这家公司与我们一样致力于为这一服务不足的患者群体带来创新治疗。

We look forward to demonstrating how PFL-241/STX-241’s differentiated preclinical profile translates into clinical benefit for patients.”.

我们期待着展示PFL-241/STX-241的分化临床前概况如何转化为患者的临床益处。”。

About Pierre Fabre Laboratories R&D pipeline

关于Pierre Fabre Laboratories研发管道

Pierre Fabre Laboratories has expanded its efforts in precision oncology by adding several assets to its R&D pipeline. In partnership with Scorpion Therapeutics, PFL-241/STX-241 and PFL-721/STX-721, two mutant-selective EGFR inhibitors, will be developed for the treatment of EGFR-driven non-small cell lung cancer (NSCLC) patients.

皮埃尔·法布尔实验室（PierreFabreLaboratories）通过在其研发管道中增加一些资产，扩大了其在精准肿瘤学方面的努力。与Scorpion Therapeutics合作，将开发两种突变选择性EGFR抑制剂PFL-241/STX-241和PFL-721/STX-721，用于治疗EGFR驱动的非小细胞肺癌（NSCLC）患者。

Through the acquisition of Vertical Bio, PFL-002/VERT-002 will undergo clinical testing in solid tumours driven by MET genetic alterations. More recently, the pan-RAF inhibitor exarafenib was acquired from Kinnate Biopharma with the aim to expand targeted therapy options for RAS/RAF-driven solid tumours.

通过收购Vertical Bio，PFL-002/VERT-002将在MET基因改变驱动的实体瘤中进行临床测试。最近，泛RAF抑制剂exarafenib是从Kinnate Biopharma获得的，目的是扩大RAS/RAF驱动的实体瘤的靶向治疗选择。

These new additions to its clinical development portfolio complement Pierre Fabre Laboratories’ existing precision oncology portfolio targeting BRAF, MEK, HER2, with encorafenib, binimetinib and neratinib, respectively..

这些新增加的临床开发组合补充了Pierre Fabre实验室现有的针对BRAF，MEK，HER2的精确肿瘤学组合，分别使用encorafenib，binimetinib和neratinib。。

About Pierre Fabre Laboratories

关于Pierre Fabre Laboratories

Pierre Fabre Laboratories is one of Europe's leading pharmaceutical companies. For over 40 years, it has established itself as an international player in oncology, mastering the entire value chain from R&D to marketing. Its portfolio of oncology specialties covers colorectal, breast, lung and skin cancers, as well as certain hematologic malignancies and precancerous dermatological conditions such as actinic keratosis.

皮埃尔·法布尔实验室是欧洲领先的制药公司之一。40多年来，它已成为肿瘤学领域的国际参与者，掌握了从研发到营销的整个价值链。。

In 2023, its oncology revenue amounted to nearly 500 million euros, over 90% of which was generated outside France..

2023年，其肿瘤学收入达到近5亿欧元，其中90%以上来自法国以外。。

In 2023, Pierre Fabre Laboratories posted 2.83 billion euros in revenue, 70% of which came from international sales in 120 countries. Its portfolio includes several international brands and medical franchises such as Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Pierre Fabre Pharma Care, Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer and Même Cosmetics..

2023年，皮埃尔·法布尔实验室实现收入28.3亿欧元，其中70%来自120个国家的国际销售。其产品组合包括多个国际品牌和医疗特许经营权，如Pierre Fabre Oncologie、Pierre Fabre Dermatologie、Pierre Fabre Pharma Care、Eau Thermale Avène、Ducray、A-Derma、Klorane、RenéFurterer和Même化妆品。。

Historically based in the southwest of France and manufacturing 95% of its products in France, Pierre Fabre Laboratories employs over 10 000 people worldwide. Its annual R&D budget amounts to nearly 200 million euros, of which about 50% is dedicated to targeted therapies in oncology and 40% to skin health and care solutions..

Pierre Fabre实验室历史上位于法国西南部，95%的产品在法国制造，在全球拥有10000多名员工。其年度研发预算接近2亿欧元，其中约50%用于肿瘤学靶向治疗，40%用于皮肤健康和护理解决方案。。

Pierre Fabre Laboratories' majority shareholder (86%) is the eponymous Foundation, which is recognized by the French government as being a public–interest foundation. This capital structure guarantees the company's independence and long-term vision. Dividends paid to the Pierre Fabre Foundation enable it to design and finance healthcare-access programs in developing countries.

皮埃尔·法布尔实验室（PierreFabreLaboratories）的大股东（86%）是同名基金会，该基金会被法国政府认定为公共利益基金会。这种资本结构保证了公司的独立性和长期愿景。支付给皮埃尔·法布尔基金会的股息使其能够设计和资助发展中国家的医疗保健项目。

Employees are the company's secondary shareholder, through an international employee shareholding plan..

通过国际员工持股计划，员工是公司的第二大股东。。

Pierre Fabre Laboratories’ sustainability policy has been assessed by the independent AFNOR Certification body and has been awarded the 'Exemplary' level of its CSR label (ISO 26 000 standard for sustainable development).

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For more information, visit www.pierre-fabre.com, @PierreFabreGroup

For more information, visit www.pierre-fabre.com, @PierreFabreGroup

About Scorpion Therapeutics

关于蝎子疗法

Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully-integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets.

Scorpion是一家开创性的临床阶段肿瘤公司，它重新定义了精准医学的前沿，为更多的癌症患者提供优化和转化的治疗方法。Scorpion在癌症生物学、药物化学和数据科学领域建立了一个拥有最先进技术的专有和完全集成的平台，目标是始终如一地快速创建针对前所未有的靶标谱的精细选择性小分子化合物。

Scorpion aims to leverage its platform to advance a broad pipeline of wholly-owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.

Scorpion旨在利用其平台，在三个目标类别中推进广泛的全资优化化合物渠道：针对经过验证的癌基因靶标的同类最佳分子；用于先前不可药用靶标的一流分子；以及用于新型癌症靶标的一流分子。

For more information, visit www.scorpiontx.com..

For more information, visit www.scorpiontx.com..

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