Adlai Nortye Submits IND Application in China for Class 1 New Drug AN0025, an EP4 Antagonist, in Collaboration with MSD for Combination Therapy with Keytruda

Source: Yiyao Guanlan

On May 21, the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration disclosed that Adlai Nortye had submitted an Investigational New Drug (IND) application in China for its Class 1 novel drug, AN0025. AN0025 is an EP4 antagonist that has completed global Phase 1b clinical trials; this marks the first time the drug has been submitted for clinical trial approval in China. MSD has entered into a collaboration with Adlai Nortye to jointly develop the combination therapy of AN0025 and the PD-1 antibody Keytruda (pembrolizumab).

Image source: CDE screenshot

AN0025 is a highly potent and selective oral antagonist of the prostaglandin E2 receptor 4 (EP4). It modulates the tumor microenvironment by targeting the EP4 receptor, thereby enhancing the body’s immune response. In preclinical in vitro and in vivo studies, AN0025 has demonstrated robust anticancer activity and immunological benefits. Preclinical research has shown that AN0025, in combination with radiotherapy, chemotherapy, and immune checkpoint inhibitors, significantly inhibits the growth of various malignant tumors.

Based on the favorable preclinical performance of AN0025, in January 2019, MSD and Adlai Nortye Biopharma entered into a clinical collaboration to conduct clinical trials evaluating the combination of AN0025 with MSD’s anti-PD-1 cancer immunotherapy Keytruda, aiming to assess the safety and preliminary efficacy of this combination therapy in the treatment of solid tumors.

Currently, AN0025 has completed its Phase 1b clinical trial for advanced colorectal cancer in Europe and the United States. According to data presented by Adlai Nortye at the 2019 European Society for Medical Oncology (ESMO) Annual Congress, AN0025 in combination with standard therapy demonstrated good tolerability as neoadjuvant treatment in patients with high-risk locally advanced rectal cancer, with nearly 40% of patients either avoiding surgery altogether or achieving pathological complete response in postoperative specimens.

Adlai Nortye is a clinical-stage global biopharmaceutical company dedicated to developing differentiated and innovative oncology therapeutics. Currently, the company has three products in clinical development. In addition to AN0025, its PI3K inhibitor buparlisib (AN2025), licensed from Novartis, is poised to enter global multicenter Phase 3 clinical trials, with a clinical trial application recently submitted in China. Another investigational drug in its pipeline, the oncolytic virus AN1004 (pelareorep), has completed Phase 2 clinical studies for breast cancer and will initiate an open-label, randomized, multicenter Phase 3 clinical trial in China evaluating pelareorep in combination with paclitaxel for the treatment of advanced/metastatic breast cancer.

Congratulations to Adlai Nortye Biopharma on the progress made with its investigational products. We hope that their clinical studies will proceed smoothly and benefit patients at an early date.

References

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved May 21, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2] Adlai Nortye Signs Agreement with MSD to Jointly Conduct Clinical Trials of AN0025 (EP4 Antagonist) in Combination with KEYTRUDA for the Treatment of Solid Tumors. Retrieved Jan. 21, 2019, from http://www.adlainortye.com/news_detail.php?cid=66&id=107

[3] Adlai Nortye Biopharma announced Phase 1b clinical data of AN0025 for the treatment of locally advanced rectal cancer at the 2019 European Society for Medical Oncology (ESMO) Annual Meeting. Retrieved Oct. 08, 2019, from http://www.adlainortye.com/news_detail.php?cid=66&id=121

(Original Title: Adlai Nortye's EP4 Antagonist Files for Clinical Trial Approval in China, Reaches Collaboration Agreement with MSD on Combination Therapy Research!)

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