Adlai Nortye Announces First Patient Dosed in Randomized Phase II Clinical Trial of Palupiprant (AN0025) for the Treatment of Locally Advanced Rectal Cancer with Radiation Therapy

Core Insights - Adlai Nortye Ltd. has initiated the Phase II clinical trial ARTEMIS to evaluate the efficacy of palupiprant (AN0025) in combination with chemoradiotherapy for treating rectal cancer [1][2][3] Company Overview - Adlai Nortye is a clinical-stage biotechnology company focused on developing innovative cancer therapies, with R&D centers in New Jersey, US, and Hangzhou, China [5] - The company has a robust pipeline of six drug candidates and aims to transform cancer into a chronic and eventually curable disease through combination therapy strategies [6] Clinical Trial Details - The ARTEMIS study is a randomized, multi-center, open-label trial involving 140 patients with moderate to high-risk rectal cancer, comparing total neoadjuvant therapy (TNT) with and without AN0025 [2][3] - The primary endpoint of the study is the clinical complete response (cCR) rate at six months post-radiotherapy [2] Drug Information - Palupiprant (AN0025) is a small molecule EP4 antagonist designed to modulate the tumor microenvironment, currently under development for locally advanced rectal cancer [4] - Previous Phase 1b results indicated that the combination therapy with AN0025 and radiotherapy/chemoradiotherapy was safe and resulted in a 36% cCR or pathologic complete response (pCR) rate [4]