Adlai Nortye (ANL) Investor Presentation summary

Study design and objectives

• Open-label, multicenter Phase I trial evaluated oral PD-L1 inhibitor AN4005 in advanced solid tumors and lymphomas, using a 3+3 dose-escalation design up to 1000mg QD.

• Primary objective was safety, tolerability, and identification of MTD/RP2D; secondary objectives included pharmacokinetics and preliminary efficacy per RECIST 1.1.

• Eligible patients had advanced, unresectable, or metastatic solid tumors or relapsed/refractory lymphomas, with ECOG 0-1.

• Study conducted in the US and China, with data cutoff on 14 Oct 2024.

Safety and tolerability

• 92% of patients experienced at least one treatment-emergent adverse event (TEAE); 36% had Grade ≥3 TEAEs.

• 80% had at least one AN4005-related adverse event, with 8% experiencing Grade 3 related AEs; no Grade 4/5 related AEs observed.

• No dose-limiting toxicities occurred, and maximum tolerated dose was not reached.

• 16% discontinued due to adverse events; immune-related AEs were reported in 8% and were manageable.

Efficacy and pharmacokinetics

• Overall disease control rate was 42% among efficacy-evaluable patients.

• One patient in the 300mg QD cohort achieved a confirmed complete response, with prior resistance to anti-PD-(L)1 mAbs.

• AN4005 exposure increased dose-dependently from 50mg BID to 1000mg QD.

• 600mg QD and 1000mg QD doses selected for further evaluation in expansion cohorts.