SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

圣地亚哥，2024年4月8日/PRNewswire/--Phanes Therapeutics，Inc（Phanes），一家专注于肿瘤创新药物发现和开发的临床阶段生物技术公司，今天宣布，美国食品和药物管理局（FDA）已授予PT217快速通道指定，用于治疗广泛期小细胞肺癌（ES-SCLC）患者，无论是否使用检查点抑制剂，铂类化疗后疾病进展。

PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022..

2022年，FDA还授予PT217孤儿药，用于治疗小细胞肺癌。。

PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinomas (EP-NECs).

PT217是靶向DLL3和CD47的一流天然IgG样双特异性抗体（bsAb），正在开发用于治疗小细胞肺癌（SCLC），肺大细胞神经内分泌癌（LCNEC）和肺外神经内分泌癌（EP NEC）。

SCLC is an aggressive form of cancer characterized by high mortality rates and significant morbidities. The average survival for patients who present with ES-SCLC without treatment is 2-4 months after diagnosis; the median survival for patients with treatment is 7-11 months.

小细胞肺癌是一种侵袭性癌症，其特征是死亡率高，发病率高。未经治疗的ES-SCLC患者的平均生存期为诊断后2-4个月；接受治疗的患者的中位生存期为7-11个月。

'PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings,' said Ming Wang, Founder and CEO of Phanes Therapeutics. 'Now we have two Fast Track designations in our pipeline. Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.

Phanes Therapeutics创始人兼首席执行官王明（Ming Wang）说，PT217有可能成为各种情况下SCLC、LCNEC和EP NEC患者的变革性治疗选择现在，我们有两个快速通道指定在我们的管道。上个月，PT886被授予快速通道指定，用于治疗转移性claudin 18.2阳性胰腺癌患者。

Both assets are from our optimized anti-CD47 bispecific antibody franchise and currently in clinical studies. We believe the optimized anti-CD47 bispecific antibody approach can unlock the full potential of the innate immunity in targeting solid tumors.'.

这两项资产均来自我们优化的抗CD47双特异性抗体特许经营权，目前正在进行临床研究。我们相信优化的抗CD47双特异性抗体方法可以充分发挥先天免疫在靶向实体瘤方面的潜力。

The multi-center Phase I clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3.

PT217的多中心I期临床试验（NCT05652686）被称为天桥研究，目前正在评估PT217在表达DLL3的晚期或难治性癌症患者中的安全性，耐受性，药代动力学和初步疗效。

About Phanes Therapeutics

关于Phanes Therapeutics

Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217.

Phanes Therapeutics，Inc.是一家临床阶段生物技术公司，专注于肿瘤领域的创新药物发现和开发。目前，它正在进行三项I期临床试验，包括晨星研究及其最佳单克隆抗体（mAb）计划PT199，PT886的TWINPEAK研究和PT217的SKYBRIDGE研究。

Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA..

PT886和PT217都是一流的双特异性抗体，已被FDA授予孤儿药称号和快速通道称号。

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer.

该公司通过利用其专有技术平台PACbody®、SPECpair®和ATACCbody®建立了强大的渠道，以开发新型生物制剂，解决癌症中高度未满足的医疗需求。