Adlai Nortye Announces First Patient Dosed in Phase I Clinical Trial of the orally available, small-molecule PD-L1 inhibitor AN4005 for Advanced Tumors

NORTH BRUNSWICK,N.J. and HANGZHOU,China,Jan. 6,2022 -- Adlai Nortye Ltd. ("Adlai Nortye"),a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies,announced that the first patient was dosed in the Phase I clinical trial in the U.S. to evaluate the safety,tolerability,PK and preliminary efficacy of the orally available,small-molecule PD-L1 inhibitor AN4005 in patients with advanced tumors.

"Adlai Nortye aspires to develop differentiated cancer immunotherapy medicines for global markets. The Company's "cocktail" therapy strategy represents the third wave of immuno-oncology therapy,featuring the combination of an immune checkpoint inhibitor with two or more additional cancer therapies. The Company expects it to achieve synergistic and calibrated anti-cancer effects with a significant higher overall response rates than present combination therapies. As a potential first-in-class,orally available,small-molecule PD-L1 inhibitor,AN4005 has exhibited excellent in vitro and in vivo activities,favorable safety profile,as well as the ability to promote adaptive immune response for antitumor efficacy in preclinical studies,and the Company believes that it has the potential to serve as a backbone drug in the emerging next wave of cocktail immuno-oncology therapies,opening a new avenue for tumor immunotherapy based on the PD-1/PD-L1 signaling pathway," said Dr. Lars Birgerson,Chief Medical Officer of Adlai Nortye,and Chief Executive Officer of Adlai Nortye USA.

About AN4005

AN4005 is an orally available,small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. In nonclinical studies,AN4005 has demonstrated significant pharmacological activity,target engagement and acceptable safety profiles,which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies,AN4005 was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. Small molecule PD-(L)1 inhibitors are expected to provide several benefits over mAbs,such as,allowing for oral administration,lower production costs,improved tumor penetration,and lack of immunogenicity.

About Adlai Nortye

Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies,with its R&D centers in both China and the United States. With a strategic emphasis on oncology,the Company has built a global pipeline through collaborations and internal discoveries with more than 10 drug candidates in development. Currently,four of them are being investigated in clinical trials. The FDA Fast Track-designated AN2025 (buparlisib) is undergoing a global multicenter Phase III clinical trial. AN1004 (pelareorep),also an FDA Fast Track-designated intravenously delivered oncolytic virus,has completed a Phase II clinical trial. Oral EP4 antagonist AN0025 (Palupiprant) has completed Phase 1b trial in a neoadjuvant setting in locally advanced rectal cancer and is undergoing Phase 1b trial in combination with Keytruda® in patients with multiple solid tumors. AN4005,our clinically most advanced drug candidate from in-house discovery,is a potential first-in-class,small-molecule PD-L1 inhibitor. In addition,the Company also completed the first patient dosing for its Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025,AN0025 and Tecentriq® (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in September 2021 in the U.S.

Adlai Nortye has assembled an experience management team,built its proprietary immuno-oncology platforms,and established strategic collaborations with multiple global leading biopharmaceutical companies. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with a global vision and strives to bring more effective treatments to patients in China and worldwide. The Company shoulders the mission of transforming deadly cancer into a chronic and eventually a curable disease.

For more information,please visit: www.adlainortye.com.

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