Adlai Nortye Begins Phase II Trial Dosing for Rectal Cancer Treatment
May 22, 2024 - Adlai Nortye Ltd. (NASDAQ: ANL), a clinical-stage biotechnology company primarily focused on innovative cancer treatments, has announced the commencement of patient dosing in the Phase II clinical trial known as ARTEMIS. This trial is designed to evaluate the efficacy of palupiprant (AN0025), a small molecule prostaglandin E receptor 4 (EP4) antagonist, in combination with chemoradiotherapy and radiotherapy (total neoadjuvant therapy: ‘TNT’) for treating rectal cancer. The study is being spearheaded by Cancer Research UK (CRUK) Clinical Trials Unit at the University of Leeds, with prominent oncology experts Prof Simon Gollins and Prof Mark Saunders leading the clinical efforts.
Building on the promising Phase Ib results of AN0025 combined with chemoradiation in rectal cancer, ARTEMIS is a randomized, Phase II, multi-center, open-label study. It aims to compare TNT with or without AN0025 in patients who have moderate to high-risk rectal cancer. The study plans to enroll 140 patients, equally divided into two groups. Patients will receive either long-course chemoradiation (LCCRT) or short-course radiotherapy (SCRT), followed by chemotherapy, or a combination of AN0025 with LCCRT/SCRT followed by chemotherapy. The primary goal of this study is to observe the clinical complete response (cCR) rate six months after the initiation of radiotherapy.
"This study is poised to make significant contributions to the evolving landscape of rectal cancer treatment. Traditionally, the standard treatment for locally advanced rectal cancer has involved chemoradiation followed by radical surgery, which carries substantial morbidity. In light of the promising Phase Ib data, this study seeks to determine if AN0025 can increase the probability of achieving a cCR when added to TNT. We are enthusiastic about exploring the potential of AN0025 not only to enhance efficacy but also to reduce the necessity for invasive surgery, offering patients a viable alternative," said Prof Simon Gollins, consultant in clinical oncology at Shrewsbury and Telford Hospital NHS Trust.
Palupiprant (AN0025) is a small molecule EP4 antagonist discovered by Eisai Co., Ltd. It is designed to modulate the tumor microenvironment. Adlai Nortye has exclusive rights to research, develop, manufacture, and market AN0025 outside Japan and parts of Asia (excluding China). AN0025 is currently under development for the treatment of locally advanced rectal cancer as part of the ongoing global Phase II ARTEMIS study. The Phase 1b results for this indication were presented at the European Society for Medical Oncology (ESMO) in October 2019, showing that the combination therapy with AN0025 and RT/CRT was safe and enabled 36% of patients to achieve either a cCR or pathologic complete response (pCR).
Adlai Nortye Ltd. is a global clinical-stage biotechnology company dedicated to discovering and developing cutting-edge cancer therapies. The company has established global R&D centers in New Jersey, US, and Hangzhou, China, and has developed a strong pipeline of six drug candidates focused on oncology.
The company has built a global management team and an influential scientific advisory board to provide strategic guidance across R&D, business development, and operations. Adlai Nortye continues to forge partnerships with leading multinational pharmaceutical companies like Eisai and Novartis to maximize the potential of its pipeline programs. The company aims to become a global leader in the next wave of oncology therapies, employing a combination therapy strategy with the ultimate goal of transforming deadly cancers into manageable and eventually curable diseases.
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