Adla BioPharma Submits IND Application for Oral PD-L1 Inhibitor AN4005 to FDA

Hangzhou, China and New Jersey, USA, May 20, 2021——Adlai Nortye, an innovative global biopharmaceutical company focused on oncology, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AN4005, its novel oral PD-L1 inhibitor.Adlai Nortye will conduct a Phase I clinical trial to evaluate the safety and pharmacokinetics of this drug, and patient enrollment will also commence in the United States.

As an orally active, specific PD-L1 antagonist, AN4005 has demonstrated potent antitumor activity in preclinical studies. AN4005 effectively induces and stabilizes the formation and dimerization of PD-L1 dimers, thereby robustly disrupting the protein-protein interaction between PD-1 and PD-L1. Preclinical studies have shown that AN4005 possesses excellent in vitro activity and in vivo antitumor efficacy, along with favorable druggability and safety profiles. More importantly, compared with approved PD-(L)1 antibodies, AN4005 exhibits comparable in vitro and in vivo activity and, like other immune checkpoint inhibitors, is strictly dependent on the immune system. As a small-molecule drug targeting various solid tumors, AN4005 holds significant potential for both monotherapy and combination therapy.

“As a small-molecule PD-L1 inhibitor, AN4005 has demonstrated robust antitumor activity and holds significant potential for both monotherapy and combination regimens with the company’s other products. Its oral administration route will confer a strong competitive advantage in combination therapy settings.”Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye Biopharmastated, “As clinical trials progress, we are confident that AN4005 will become a significant player in the field of cancer immunotherapy. We look forward to developing more potentially transformative therapies to provide additional treatment options for patients worldwide.”

As an alternative to monoclonal antibodies, small-molecule PD-(L)1 inhibitors are gradually attracting increasing attention in the field of cancer immunotherapy. Compared with monoclonal antibodies, small-molecule PD-(L)1 inhibitors are expected to offer greater benefits, such as improved patient compliance through oral administration; their shorter half-life relative to antibodies allows for better control of immune-related adverse events; and their structural flexibility will provide convenient and effective advantages in future combination therapies. To date, no small-molecule PD-(L)1 inhibitor has been approved or marketed worldwide, making this product poised to become one of the first small-molecule PD-(L)1 inhibitors to reach the global market.

Adlai Nortye is a global, clinical-stage biopharmaceutical company focused on the development of innovative oncology drugs, with R&D and clinical operations centers in both China and the United States. Adlai Nortye has built a global product pipeline through “collaborative innovation” and “independent R&D,” currently comprising more than 10 anti-tumor drug candidates. Among these, three drugs are in clinical development: AN2025 (Buparlisib), which has received FDA Fast Track designation and is undergoing a global multicenter Phase 3 clinical trial; AN1004 (Pelareorep), an intravenously administered oncolytic virus that has also received FDA Fast Track designation and has completed its Phase 2 clinical trial; and AN0025 (Palupiprant), an oral EP4 antagonist in early-stage clinical development for various solid tumors, which is currently being evaluated in combination with other treatment regimens, including chemoradiotherapy and PD-(L)1 inhibitor therapies.

Adlai Nortye has assembled an internationally competitive management team, established a unique drug development technology platform, and forged strategic partnerships with multiple leading global biopharmaceutical companies. Committed to becoming an innovative R&D enterprise that creates “global novel” oncology drugs, Adlai Nortye aims to bring more effective treatments to patients in China and worldwide, fulfilling its mission to transform cancer into a non-fatal disease or even achieve a cure. For more information, please visit www.adlainortye.com.