Kainova Therapeutics announced positive topline results from the Phase I EPRAD study of DT-9081, an oral EP4 receptor antagonist, on March 10, 2026.12
The study in patients with advanced, recurrent, and metastatic solid tumors met all primary objectives, showing favorable safety with no dose-limiting toxicities, robust PK/PD with dose-proportional exposure, sustained EP4 receptor engagement, and early anti-tumor activity.12
Conducted at four sites in France and Belgium; full details on clinicaltrials.gov NCT05582850.12
DT-9081 aims to reverse PGE2-mediated immunosuppression to improve responses to immune checkpoint inhibitors; preclinical data supports use in cancers like triple-negative breast, sarcoma, and colorectal.14
Quotes from PI Jean-Pascal Machiels, CMO Jean-Marie Cuillerot, and CEO Sean A. MacDonald highlight validation of EP4 antagonism for overcoming immunotherapy resistance.12
Sources:
1. https://www.globenewswire.com/news-release/2026/03/10/3252479/0/en/Kainova-Therapeutics-Announces-Positive-Phase-I-Results-for-DT-9081-an-Oral-EP4-Receptor-Antagonist-in-Advanced-Solid-Tumors.html
2. https://pharmatimes.com/news/kainova-therapeutics-reports-positive-phase-1-results-for-dt-9081-in-advanced-solid-tumours/