On January 5, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported 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 (Press release, Adlai Nortye Biopharma, JAN 5, 2022, View Source [SID1234598290]).
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"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.