CAMBRIDGE, Mass.--(BUSINESS WIRE)--Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), today announced that the first patient has been enrolled in the Phase 1c study of PRTH-101 for the treatment of patients with advanced or metastatic solid tumors..

。。

“In our Phase 1a and 1b studies, we were able to select an optimal dose and identify potential biomarkers to carry forward” said Irena Webster, SVP Development and Operations of Incendia. “The data from this study will inform the design of the Phase 2/3 program, for which planning and global feasibility are currently underway.”.

“在我们的1a期和1b期研究中，我们能够选择最佳剂量并确定潜在的生物标志物进行研究”，Incendia开发和运营高级副总裁艾琳娜·韦伯斯特（IrenaWebster）说。“这项研究的数据将为2/3期项目的设计提供信息，目前正在进行规划和全球可行性研究。”。

Dr. Joseph Paul Eder, CMO, added “Incendia, with its outstanding team of investigators and investigative sites, has determined a recommended Phase 2 dose of PRTH 101. PRTH 101 has shown consistent safety as a single agent and in combination with pembrolizumab. We will now focus on tumor types that have demonstrated signs of clinical activity and patient benefits.”.

CMO的Joseph Paul Eder博士补充道：“Incendia凭借其杰出的调查团队和调查地点，已经确定了推荐的PRTH 101第二阶段剂量。PRTH 101作为单一药物并与pembrolizumab联合使用显示出一致的安全性。我们现在将重点关注已显示出临床活动迹象和患者益处的肿瘤类型。”。

The Phase 1c study will evaluate the safety, tolerability and anti-tumor activity of PRTH-101 as both a monotherapy and in combination with KEYTRUDA® (pembrolizumab).

1c期研究将评估PRTH-101作为单一疗法和与KEYTRUDA®（pembrolizumab）联合使用的安全性，耐受性和抗肿瘤活性。

About PRTH-101

关于PRTH-101

PRTH-101 is a therapeutic antibody that targets DDR1, a collagen binding protein and kinase present on epithelial cells. Some tumor cells are believed to co-opt DDR1 – collagen binding to build an impenetrable barrier around the tumor. By allosterically disabling DDR1, PRTH-101 disrupts tumor associated collagen alignment to permit immune cell access into the tumor core.

PRTH-101是一种靶向DDR1的治疗性抗体，DDR1是一种存在于上皮细胞上的胶原结合蛋白和激酶。据信，一些肿瘤细胞会协同DDR1-胶原结合，在肿瘤周围形成不可穿透的屏障。通过变构禁用DDR1，PRTH-101破坏肿瘤相关的胶原排列，以允许免疫细胞进入肿瘤核心。

In preclinical experiments, PRTH-101 mediated DDR1 blockade has demonstrated both single agent anti-tumor activity as well as marked augmentation of checkpoint inhibitor function. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancer.

在临床前实验中，PRTH-101介导的DDR1阻断已经证明了单药抗肿瘤活性以及检查点抑制剂功能的显着增强。表达高水平DDR1相关胶原屏障的肿瘤类型包括胸腺，结肠直肠癌，胰腺癌，卵巢癌，神经胶质瘤和非小细胞肺癌。

Currently, there are no approved drugs that target DDR1..

目前，还没有针对DDR1的批准药物。。

About the Phase 1 Trial

关于第一阶段试验

The Phase 1 trial (NCT05753722) is a multi-center, open-label, dose escalation and dose expansion study that is expected to enroll up to 270 patients in the US with advanced or metastatic solid tumors. The goals of the study are to assess safety and tolerability of PRTH-101, evaluate anti-tumor activity in select indications alone and in combination with anti-PD-1 inhibitors, and determine dosing regimens for the Phase 2 clinical program.

第一阶段试验（NCT05753722）是一项多中心，开放标签，剂量递增和剂量扩展研究，预计将在美国招募多达270名晚期或转移性实体瘤患者。该研究的目的是评估PRTH-101的安全性和耐受性，评估单独选择适应症和与抗PD-1抑制剂联合使用的抗肿瘤活性，并确定2期临床计划的给药方案。

In addition to examining the clinical profile of PRTH-101, the trial will evaluate DDR1 and pathway-related proteins as predictive biomarkers for patients whose tumors respond to treatment..

除了检查PRTH-101的临床特征外，该试验还将评估DDR1和通路相关蛋白作为肿瘤对治疗有反应的患者的预测生物标志物。。

About Incendia Therapeutics

关于燃烧疗法

Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia’s platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing.

Incendia Therapeutics正在发现和开发一类新的实验疗法，可以重新编程肿瘤微环境（TME）。Incendia的平台基于严格的开创性研究，涉及肿瘤微环境的空间表征，多组学数据集成和广泛的临床前测试。

The Company’s most advanced experimental molecule, PRTH-101, is in a Phase 1c clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendia.com and LinkedIn..

该公司最先进的实验分子PRTH-101正在进行1c期临床试验，用于治疗晚期实体瘤患者。有关更多信息，请访问incendia.com和LinkedIn。。