Kainova Therapeutics, a rising force in immuno-oncology and inflammation therapies, has announced promising topline results from its study of its oral small molecule EP4 receptor antagonist, in patients with advanced, recurrent, and metastatic solid tumors.
The multicenter study, conducted across four sites in France and Belgium, met all primary endpoints.
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile, robust pharmacokinetics (PK) and pharmacodynamics (PD), dose-proportional exposure, and sustained EP4 receptor engagement across all doses, with early evidence of anti-tumor activity.
Importantly, no dose-limiting toxicities were observed, confirming DT-9081’s tolerability and validating its mechanism of action. These results also reinforce the drug’s potential to enhance responses to immune checkpoint inhibitors (ICIs).
Professor Jean-Pascal Machiels, Principal Investigator of the EPRAD study, said: “The results of the study not only validate EP4 receptor antagonism as a powerful mechanism to counteract PGE2-driven immune suppression, but also demonstrate the clinical potential of DT-9081 across a range of tumor types.
"Since chemotherapy and other standard treatments often trigger PGE2 production by cancer cells, restoring competence through selective EP4 inhibition offers a rational and versatile strategy to overcome resistance. It was my honor to contribute to the advancement of DT-9081 through the clinic.”
Dr Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, added: “The Phase I EPRAD study generated a clear and coherent dataset that precisely characterizes DT-9081’s clinical profile. Across all dose levels, we observed consistent safety findings together with robust PK/PD readouts. The high-quality clinical and translational data obtained in this study are essential for understanding how EP4 antagonism behaves in patients with advanced solid tumors in a clinical setting.”
Kainova CEO Sean A. MacDonald emphasized the milestone: “The successful completion of this Phase I study represents an important step for Kainova Therapeutics, highlighting the strength of our innovative approach to targeting the EP4 receptor to overcome tumor-induced immunosuppression.
"The favorable safety and early efficacy signals observed with DT-9081 provide meaningful insight into EP4 biology and its role in immuno-oncology. These findings reflect the depth of expertise within our team and reinforce the relevance of GPCR-modulating strategies in addressing complex immune pathways.”
