Incendia Therapeutics Starts Phase 1c Trial of PRTH-101 with First Patient Enrollment

Incendia Therapeutics, a precision oncology firm based in Cambridge, MA, has recently initiated the Phase 1c clinical study of PRTH-101, enrolling the first patient on September 10, 2024. The study will explore the safety, tolerability, and anti-tumor efficacy of PRTH-101 as a standalone therapy and in combination with KEYTRUDA® (pembrolizumab) in patients with advanced or metastatic solid tumors.

PRTH-101 is an innovative therapeutic antibody designed to target DDR1, a collagen-binding protein and kinase prevalent in epithelial cells. Tumor cells often exploit DDR1-collagen binding to form a dense barrier, which hinders immune cell infiltration into the tumor core. By allosterically inhibiting DDR1, PRTH-101 disrupts this collagen alignment, allowing immune cells better access to the tumor. Preclinical studies have shown that blocking DDR1 with PRTH-101 not only provides anti-tumor effects as a monotherapy but also significantly enhances the efficacy of checkpoint inhibitors. Tumors with high levels of DDR1-associated collagen barriers, such as thymic, colorectal, pancreatic, ovarian, glioma, and non-small cell lung cancers, may particularly benefit from this treatment approach. Currently, no approved therapies specifically target DDR1.

The safety profile of PRTH-101 was established in previous Phase 1a and 1b studies, where an optimal dose was determined and potential biomarkers for further investigation were identified. Irena Webster, the Senior Vice President of Development and Operations at Incendia, emphasized that the insights gained from these earlier studies will be crucial in designing the forthcoming Phase 2/3 program, for which planning and global feasibility assessments are in progress.

Dr. Joseph Paul Eder, Chief Medical Officer, highlighted that Incendia, with its proficient team of investigators, has recommended a Phase 2 dose for PRTH-101. He noted the consistent safety of PRTH-101, both as a single agent and in combination with pembrolizumab, and the focus will now shift to tumor types showing clinical activity and patient benefits.

The Phase 1c study is structured as a multi-center, open-label trial designed to escalate and expand dosing. It aims to enroll up to 270 patients across the United States who are suffering from advanced or metastatic solid tumors. The primary objectives are to assess the safety and tolerability of PRTH-101, evaluate its anti-tumor activity both alone and in combination with anti-PD-1 inhibitors, and establish dosing regimens for subsequent Phase 2 clinical trials. Additionally, the study will investigate DDR1 and related proteins as predictive biomarkers to identify patients likely to respond to the treatment.

Incendia Therapeutics specializes in developing a new category of experimental therapies that reprogram the tumor microenvironment (TME). Their platform is built on cutting-edge research encompassing spatial characterization of the TME, multi-omics data integration, and extensive preclinical testing. The company's leading experimental molecule, PRTH-101, is currently being evaluated in a Phase 1c clinical trial for advanced solid tumors.