SEATTLE, Jan. 5, 2024 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rinatabart sesutecan (Rina-S; PRO1184), a folate receptor alpha (FRα) targeted ADC, for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

2024年1月5日，西雅图/PRNewswire/--开发新型抗体-药物偶联物（ADC）治疗癌症的临床阶段生物技术公司ProfoundBio今天宣布，美国食品和药物管理局（FDA）已批准rinatabart sesutecan（Rina-S；PRO1184）的快速通道指定，这是一种叶酸受体α（FRα）靶向的ADC，用于治疗表达FRα的高度浆液性或子宫内膜样铂类耐药卵巢癌患者。

Fast Track designation is intended to facilitate the development and expedited review of drugs with demonstrated potential to improve over available therapy for serious conditions with unmet medical need..

快速通道指定旨在促进药物的开发和快速审查，这些药物具有改善严重疾病和未满足医疗需求的过度可用治疗的潜力。。

'Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,' said Naomi Hunder, Chief Medical Officer of ProfoundBio. 'FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in our Phase 1 dose escalation study in ovarian and endometrial cancer patients across the full spectrum of FRα expression.

ProfoundBio首席医疗官纳奥米·亨德（NaomiHunder）说：“我们收到美国食品和药物管理局（FDA）的快速通道指定，突显了我们对Rina-S作为一种潜在的一流FRαADC的巨大希望的信念，以满足改善晚期卵巢癌治疗选择的重大需求。”FRα是卵巢癌中高度流行的抗原，Rina-S在我们的卵巢癌和子宫内膜癌患者的1期剂量递增研究中显示出令人鼓舞的抗肿瘤活性和耐受性。

We look forward to working closely with the FDA as we progress further clinical development and registrational studies for Rina-S.'.

我们期待着与FDA密切合作，为Rina-S.进行进一步的临床开发和注册研究。

About Rinatabart Sesutecan (Rina-S, PRO1184)Rina-S is a folate receptor-alpha (FRα) targeted ADC being developed as a novel treatment option for patients with ovarian and endometrial cancer, and potentially other FRα-expressing cancers. Rina-S is comprised of a FRα-directed antibody conjugated to sesutecan, ProfoundBio's novel, proprietary hydrophilic exatecan-based linker-drug, at a homogeneous drug-to-antibody ratio (DAR) of 8.

关于Rinatabart Sesutecan（Rina-S，PRO1184），Rina-S是一种叶酸受体α（FRα）靶向的ADC，被开发为卵巢癌和子宫内膜癌以及其他可能表达FRα的癌症患者的新型治疗选择。Rina-S由与sesutecan偶联的FRα定向抗体组成，sesutecan是ProfoundBio的新型专有亲水性基于exatecan的接头药物，其均相药物与抗体之比（DAR）为8。

Exatecan is a highly potent, membrane permeable topoisomerase-1 inhibitor with strong bystander effect. Sesutecan is a highly hydrophilic, stable, cleavable linker designed to mask the hydrophobicity of conjugated exatecan on the ADC, enabling high DAR and efficient delivery of the exatecan payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC..

Exatecan是一种高效的膜渗透性拓扑异构酶-1抑制剂，具有强烈的旁观者效应。Sesutecan是一种高度亲水，稳定，可切割的接头，旨在掩盖缀合的依替康在ADC上的疏水性，从而能够将依替康有效载荷高DAR和有效递送至肿瘤，同时保持ADC良好的物理化学和药代动力学特性。。

Status of PRO1184-001 Phase 1/2 Study (NCT05579366) PRO1184-001 is a Phase 1/2 study of rinatabart sesutecan to evaluate the safety, tolerability, PK, and antitumor activity of PRO1184 in patients with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.

PRO1184-001 1/2期研究现状（NCT05579366）PRO1184-001是rinatabart sesutecan的1/2期研究，用于评估PRO1184在选定的局部晚期和/或转移性实体瘤患者中的安全性，耐受性，PK和抗肿瘤活性，包括上皮性卵巢癌，子宫内膜癌，乳腺癌，非小细胞肺癌和间皮瘤。

The study consists of two parts, Part A: Dose Escalation and Part B: Dose Expansion. Initial results from Part A were reported in November 2023, demonstrating encouraging antitumor activity at well tolerated doses in heavily pretreated ovarian and endometrial cancer patients unselected for FRα expression.

该研究由两部分组成，A部分：剂量递增和B部分：剂量扩展。2023年11月报道了A部分的初步结果，表明在未选择FRα表达的严重预处理的卵巢癌和子宫内膜癌患者中，耐受性良好的剂量具有令人鼓舞的抗肿瘤活性。

Part B is currently enrolling patients at multiple sites in the U.S. and China..

B部分目前正在美国和中国的多个地点招募患者。。

About ProfoundBioProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple antibody-drug conjugate (ADC) drug candidates targeting solid tumors and hematological malignancies.

关于ProfoundBioProfoundBio是一家临床阶段生物技术公司，专注于开发新型抗体治疗药物，对癌症患者具有治疗潜力。ProfoundBio建立在内部开发的创新和专有技术平台上，开发了一条由针对实体瘤和血液系统恶性肿瘤的多种抗体-药物偶联物（ADC）候选药物组成的管道。

The company's disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting folate receptor-alpha; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens.

该公司公开的开发管道包括rinatabart sesutecan（Rina-s；PRO1184），一种靶向叶酸受体α的ADC；PRO1160，一种靶向CD70的ADC；PRO1107，一种针对PTK7的ADC；和PRO1286，一种靶向两种临床验证的广泛表达的实体瘤抗原的双特异性ADC。

ProfoundBio is headquartered in Seattle, Washington..

ProfoundBio总部位于华盛顿州西雅图。。

For more information, please visit www.profoundbio.com and follow us on LinkedIn.

有关更多信息，请访问www.defoundbio.com并在LinkedIn上关注我们。

SOURCE ProfoundBio

来源：DefoundBio