AN4005 / Adlai Nortye, Xiamen Biotime Biotech - LARVOL DELTA

A phase I study of AN4005, an orally available PD-L1 inhibitor, in patients with advanced tumors: safety and preliminary efficacy (SITC 2024) - P1 | "All patients enrolled gave informed consent before participating. The IRB/IEC approval numbers were: IRB Tracking Number 20213975 (WCG IRB); Event ID # 189834 (BRANY IRB); NXVCS21.53 (Salus IRB); IEC Number 2022-78 (Harbin Medical University Cancer Hospital); IEC Number 2022-0251 (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology).View this table:View inline View popup Download powerpoint Abstract 691 Table 1 Number of patients per tested dose levelView this table:View inline View popup Download powerpoint Abstract 691 Table 2 Treatment-related adverse events (TRAEs) reported in ≥2 patients across all dose levels (N=24)View this table:View inline View popup Download powerpoint Abstract 691 Table 3 Summary of best overall response (BOR) per RECIST 1.1 by dose level"

Clinical • Metastases • P1 data • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

AN4005X0101: First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

Adlai Nortye Reports Unaudited First Half 2024 Financial Results and Highlights Recent Operational Progress (GlobeNewswire) - "Pipeline updates...The Company is conducting BURAN (NCT04338399), a randomized, open-label phase 3 trial to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic HNSCC that has progressed after prior anti-PD(L)1 treatment...The Company remains on track to present overall survival (OS) data in the first quarter of 2025; In an ongoing Phase 1 study (NCT04999384), the Company is investigating the safety of AN4005, its oral small-molecule PD-L1 inhibitor...The Company plans to provide a clinical update in the second half of 2024; AN8025 is an in-house developed multifunctional fusion protein, which serves as a T cell and APC modulator. The Company anticipates submitting the investigational drug application (IND) in mid-2025; AN9025 is an in-house developed oral small molecule...The Company anticipates submitting the IND in the second half of 2025."

IND • New molecule • P1 data • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Aug 2024

Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Trial primary completion date: Feb 2024 ➔ May 2024

Metastases • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Trial completion date: Aug 2023 ➔ Jun 2024 | Trial primary completion date: May 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1 | N=31 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Trial primary completion date: Aug 2022 ➔ May 2023

Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Adlai Nortye Announces Global License-out Agreement with Biotime for Several Products Including PD-L1 Inhibitor (AN4005) and Anti-hTNFR2 Antibody (AN3025) (PRNewswire) - "Adlai Nortye...announced that it has entered into a Global License Agreement with Xiamen Biotime Biotechnology Co., Ltd. ('Biotime') for several compounds. This includes the rights and interests of Adlai Nortye in the development, manufacturing and commercialization of AN4005 and AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. According to the terms of the agreement, the total amount of this cooperation will reach hundreds of millions of yuan, including the upfront payments, progress-dependent milestone payments and tiered royalties on sales."

Licensing / partnership • Oncology

Adlai Nortye Announces First Patient Dosed in Phase I Clinical Trial of the orally available, small-molecule PD-L1 inhibitor AN4005 for Advanced Tumors (PRNewswire) - "Adlai Nortye...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....'The Company expects it to achieve synergistic and calibrated anti-cancer effects with a significant higher overall response rates than present combination therapies'."

Trial status • Lymphoma • Oncology • Solid Tumor

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1; N=31; Recruiting; Sponsor: Adlai Nortye Biopharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

First in Human, Dose Escalation Study of AN4005 (clinicaltrials.gov) - P1; N=31; Not yet recruiting; Sponsor: Adlai Nortye Biopharma Co., Ltd.

New P1 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Adlai Nortye files IND for oral PD-L1 inhibitor in US (GBI Health) - "China-based Adlai Nortye Biopharma Co., Ltd announced making an investigational new drug (IND) filing with the US FDA for its AN4005, an oral, small-molecule programmed death-ligand 1 (PD-L1) antagonist. The company expects to initiate a Phase I clinical study to assess the safety and pharmacokinetics of the drug in the US."

IND • Oncology