Adlai Nortye Ltd. announced that the first patient was dosed in the Phase II clinical trial known as ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery). This clinical study evaluates palupiprant (AN0025), a small molecule prostaglandin E receptor 4 (?EP4?) antagonist, with chemoradiotherapy and radiotherapy (total neoadjuvant therapy: ?TNT?) (?CRT?) for the treatment of rectal cancer. The study has been developed and is being led by the Cancer Research (?CRUK?) Clinical Trials Unit (?CTU?) at the University of Leeds, with clinical leadership teams from consultant oncologists Prof Simon Gollins and Prof Mark Saunders.

Building upon the encouraging Phase Ib results of the immune modulator AN0025 in combination with chemoradiation in rectal cancer, ARTEMIS is a randomized, Phase II, multi-center, open-label study that compares TNT with or without AN0025 in patients with moderate to high-risk rectal cancer. One hundred and forty patients (70 per arm) will receive either long-course chemoradiation (?LCCRT?) or short-course radiotherapy (?SCRT?) (physician choice) followed by chemotherapy, or a combination of AN0025 and LCCRT/SCRT followed by chemotherapy. The primary endpoint of this study is clinical complete response (cCR) rate at six months post the start of radiotherapy.

AN0025 is a small molecule prostaglandin E receptor 4 (EP4) antagonist, discovered by Eisai Co. Ltd. (Eisai), designed to modulate the tumor microenvironment. Adlai Nortye has been granted exclusive rights concerning the research, development, manufacture and marketing in all regions outside of Japan and part of Asia (excluding China) by Eisai.

It is currently under development for the treatment of locally advanced rectal cancer with radiation therapy in the ongoing global Phase II ARTEMIS study. The company presented Phase 1b results for this indication at the European Society for Medical Oncology (?ESMO?) in October 2019, where combination therapy with AN0025 and RT/CRT was safe and enabled 36% of patients to achieve either a cCR or pathologic complete response (pCR).