Incendia Therapeutics Presents Two Posters on its Lead Asset PRTH-101 in Thymic Cancers at the 15th International Thymic Malignancy Interest Group (ITMIG) Annual Meeting

Initial Phase 1 data suggest PRTH-101 contributes to disease control in recurrent/metastatic thymic epithelial carcinoma (TEC) with median progression-free survival (mPFS) of 7.9 months and 1 partial response (PR) observed
Pivotal Phase 2 trial for the treatment of recurrent/metastatic TEC to compare PRTH-101 in combination with pembrolizumab to pembrolizumab alone, planned for 2026

CAMBRIDGE, Mass., Oct. 02, 2025 (GLOBE NEWSWIRE) -- Incendia Therapeutics, a biotechnology company focused on disrupting the tumor microenvironment (TME) to improve cancer outcomes, today announced that it will present two posters at the International Thymic Malignancy Interest Group Annual Meeting to be held in Milan, Italy, October 2-4, 2025. Both posters disclose clinical results with PRTH-101, a first-in-class discoidin domain receptor 1 (DDR1)-targeted antibody therapy, in patients with recurrent/metastatic thymic epithelial carcinoma (TEC).

“PRTH-101 has shown encouraging anti-tumor activity in TEC patients, particularly in those with high DDR1 expression,” said Wendye R. Robbins, M.D., president and CEO of Incendia Therapeutics. “Traditionally, elevated tumor DDR1 has been associated with worsened outcomes. These results support the potential of DDR1 inhibition to overcome immune exclusion and improve outcomes in difficult-to-treat cancers, especially those with no approved therapies such as recurrent/metastatic TEC. Based on the promising Phase 1 findings, we look forward to advancing PRTH-101 into Phase 2 studies and exploring its benefit in advanced thymic malignancies.”

Susan Macdonald, Ph.D., SVP Nonclinical Development and Strategy at Incendia Therapeutics added, “The data we have generated to-date demonstrate that PRTH-101 is engaging its target and delivering meaningful clinical benefit. By attacking the structural and biochemical underpinnings of the TME, PRTH-101 can enable host immune cells to penetrate the tumor core and allow immunotherapies to act on the tumor, offering a potentially transformative treatment for patients with TEC and other immune excluded and fibrotic tumors.”

Presentation Details

Title: A Phase 1 trial of PRTH-101, a monoclonal antibody targeting discoidin domain receptor 1 (DDR1), alone or in combination with pembrolizumab, for the treatment of thymic malignancies.
Abstract ID: AB10
Presenter: Susan Macdonald, PhD
Date and Time: Thursday, October 2, 3:45-4:15 pm CEST

PRTH-101 is being evaluated in an ongoing Phase 1 trial as a monotherapy (Phase 1a), in combination with pembrolizumab (KEYTRUDA®) (Phase 1b), and alone or in combination with pembrolizumab in tumor-specific expansion cohorts (Phase 1c). Key clinical data include:

Two confirmed PRs, multiple patients with minor RECIST and quality of life improvements across tumor types, and multiple with prolonged stable disease beyond published expectations
Correlation between DDR1 expression and PFS with PRTH-101 treatment, when dosed with and without pembrolizumab
Correlation of tumor responses to PRTH-101 and pembrolizumab to expression of their respective targets
Among all TEC patients (n=18 as of September 4, 2025), mPFS of 7.9 months (ongoing) vs. literature reports 4.2 months

Title: A pivotal Phase 2 trial to compare PRTH-101, a monoclonal antibody targeting discoidin domain receptor 1 (DDR1), in combination with an immune checkpoint inhibitor (ICI) to ICI alone, for the treatment of recurrent or metastatic thymic epithelial carcinoma (TEC)
Abstract ID: AB13
Presenter: Irena Webster, MPH
Date and Time: Thursday, October 2, 11:00-11:30 am CEST

Pivotal Phase 2 study protocol highlights:

Global registrational trial planned for 2026 in patients ≥12 years old with recurrent or metastatic TEC
Open-label two-cohort trial design (immune checkpoint inhibitor [ICI]-refractory and ICI-naïve) will evaluate PRTH-101 in combination with pembrolizumab versus pembrolizumab alone
Primary and secondary endpoints to include overall response rate, PFS, and safety, with exploratory assessments including advanced tumor imaging assessments, DDR1 and PD-L1 biomarker expression, and quality-of-life assessments
Trial design discussed with the FDA

The posters will be available on the Incendia website October 2, 2025.

About 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 blocking collagen binding to DDR1, PRTH-101 disrupts tumor-associated collagen alignment to permit immune cell access into the tumor core. 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. Currently, there are no approved drugs targeting DDR1.

About the Phase 1 Trial

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. 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.

About Incendia Therapeutics

Incendia Therapeutics is a clinical-stage biotechnology company focused on disrupting the tumor microenvironment (TME) to improve cancer outcomes. The company’s approach targets immune-excluded solid tumors, an identifiable, prevalent tumor phenotype with high treatment relapse rates. By breaking down barriers in the TME, immune cells can reach tumors and improve treatment outcomes in solid cancers. The Company’s most advanced investigational therapeutic, PRTH-101, is in a Phase 1c clinical trial for the treatment of patients with advanced solid tumors. The Company is targeting initiation of Phase 2 in 2H2026. For more information visit incendia.com and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not historical in nature are forward-looking statements. These statements reflect the Company’s expectations based on currently available information and involve risks and uncertainties. Actual events or results may differ materially from those projected in any of such forward-looking statements due to a variety of factors, including the risks inherent in the development of biopharmaceutical products such as ours. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement and Incendia Therapeutics undertakes no obligation to revise or otherwise update this press release to reflect events or circumstances after the date hereof.

Contacts

Michael Blash
michael.blash@incendiatx.com

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