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

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, May 22, 2024 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, recently 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.

“This study aims to contribute to a transformation currently taking place in rectal cancer treatment. For locally advanced rectal cancer, traditionally chemoradiation followed by radical surgery has been the standard of care, despite the significant morbidity associated with surgery. Following the promising published phase 1b data, the current study assesses whether AN0025 increases the likelihood of achieving a cCR, when added to TNT in the treatment of locally advanced rectal cancer. We are very excited to explore the potential of AN0025 to improve efficacy, minimize invasive surgery, and offer patients a viable alternative,” said Prof Simon Gollins, the consultant in clinical oncology at Shrewsbury and Telford Hospital NHS Trust.

About Palupiprant (AN0025)

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. We 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).

About Adlai Nortye

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage biotechnology company focused on the discovery and development of innovative cancer therapies for patients across the spectrum of tumor types, with global R&D centers established in New Jersey, US, and Hangzhou, China. With a strategic emphasis on oncology, the company has identified and developed a robust pipeline of six drug candidates.

Adlai Nortye has assembled a global management team and a scientific advisory board with industry leaders and influential scientists to provide important strategic guidance to its R&D, business development, and operational organizations. In addition to building its own R&D capabilities, the Company continues to seek and secure partnerships with leading multi-national pharmaceutical companies such as Eisai and Novartis, to fully realize the potential of its pipeline programs. The Company strives to become a global leader in the next wave of oncology therapies employing a combination therapy strategy. Its ultimate goal is to transform deadly cancer into a chronic and eventually curable disease.

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Investor Relations:

Charles Zhou

Amanda Kong

Adlai Nortye Ltd.