NEW YORK--(BUSINESS WIRE)--Volastra Therapeutics, a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VLS-1488, the company’s internally discovered KIF18A inhibitor. The designation has been granted for the treatment of patients with platinum-resistant high-grade serous ovarian cancer (HGSOC)..

纽约-（商业新闻短讯）-临床阶段生物技术公司Volastra Therapeutics今天宣布，美国食品和药物管理局（FDA）已授予VLS-1488快速通道名称，VLS-1488是该公司内部发现的KIF18A抑制剂。该名称已被批准用于治疗铂类耐药的高度浆液性卵巢癌（HGSOC）患者。。

“Platinum-resistant high-grade serous ovarian cancer is marked by poor prognosis, highlighting the urgent need for new therapies for this devastating disease,” said Scott Drutman, M.D., Ph.D., Head of Research & Development and Chief Medical Officer. “Fast Track designation for VLS-1488 reaffirms the clear potential of KIF18A inhibition to address this unmet medical need and represents a critical step towards bringing these novel therapeutics to patients.

研究与开发负责人兼首席医疗官斯科特·德鲁特曼（ScottDrutman）医学博士说：“铂类耐药的高度浆液性卵巢癌预后不良，突显出迫切需要针对这种毁灭性疾病的新疗法。”。“VLS-1488的快速命名重申了KIF18A抑制在解决这种未满足的医疗需求方面的明显潜力，并且代表了将这些新型疗法带给患者的关键一步。

We look forward to working closely with the FDA as we advance the development of inhibitors against this promising target.”.

随着我们推进针对这一有希望的目标的抑制剂的开发，我们期待着与FDA密切合作。”。

Fast Track designation is a program intended to facilitate and expedite the development and review of new drugs for the treatment of a serious or life-threatening condition. To qualify for this designation, there must be clear data demonstrating the drug has potential to address unmet medical need in the designated condition..

快速通道指定是一项旨在促进和加速开发和审查用于治疗严重或危及生命的疾病的新药的计划。为了有资格获得这一称号，必须有明确的数据证明该药物有可能在指定的条件下解决未满足的医疗需求。。

In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. Most of these patients will see disease progression on platinum-based chemotherapy. Sovilnesib, the second of Volastra’s two KIF18A inhibitors, which was in-licensed from Amgen in 2023, has previously been granted Fast Track designation in this indication.

仅在美国，每年就有超过20000例卵巢癌新病例，其中超过75%是晚期。这些患者中的大多数将在铂类化疗中看到疾病进展。Volastra的两种KIF18A抑制剂中的第二种是Sovilnesib，该抑制剂于2023年获得安进公司的许可，此前已被授予该适应症的快速通道名称。

Each of Volastra’s two KIF18A inhibitors, VLS-1488 and sovilnesib, has unique profiles and are both enrolling patients in early-phase studies..

Volastra的两种KIF18A抑制剂VLS-1488和sovilnesib都有独特的特征，都在早期研究中招募患者。。

The Phase I/II trial for VLS-1488 is evaluating safety, tolerability and preliminary efficacy in patients with advanced tumors, including HGSOC. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT05902988.

VLS-1488的I/II期试验正在评估包括HGSOC在内的晚期肿瘤患者的安全性，耐受性和初步疗效。该试验的更多细节可以在www.clinicaltrials.gov上找到，NCT标识符为：NCT05902988。

About Volastra Therapeutics, Inc.

关于Volastra Therapeutics，Inc。

Volastra Therapeutics is a New York-based clinical-stage biotechnology company pioneering novel approaches to treating cancer by targeting chromosomal instability. The company was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by investors including Polaris Partners, Arch Ventures, Eli Lilly & Company, B Capital, Droia Ventures, Vida Ventures, and Catalio Capital Management.

Volastra Therapeutics是一家总部位于纽约的临床阶段生物技术公司，开创了通过靶向染色体不稳定性来治疗癌症的新方法。。

Volastra is developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive a pipeline of therapies towards innovative targets. The company leads the field with two differentiated clinical-stage KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650).

Volastra正在开发新技术，以了解染色体不稳定性的生物学，并利用这些见解推动一系列疗法朝着创新目标发展。该公司以两种不同的临床阶段KIF18A抑制剂VLS-1488和sovilnesib（以前称为AMG-650）引领该领域。

A robust discovery pipeline targeting novel approaches to chromosomal instability is progressing internally and in collaboration with Bristol Myers Squibb. Transformational partnerships with Microsoft, Tailor Biosciences, and Function Oncology support the identification of novel biomarkers to inform patient selection..

针对染色体不稳定性新方法的强大发现渠道正在内部进行，并与百时美施贵宝合作。与微软、裁缝生物科学和功能肿瘤学的转型伙伴关系支持鉴定新的生物标志物，为患者选择提供信息。。

For more information, please visit www.volastratx.com.

有关更多信息，请访问www.volastratx.com。