drebuxelimab (AK119) / Akesobio - LARVOL DELTA

A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Akeso | Active, not recruiting ➔ Completed | Phase classification: P1a/1b ➔ P1

Phase classification • Trial completion • Oncology • Solid Tumor

A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting | N=72 ➔ 170 | Trial completion date: Jul 2025 ➔ Aug 2026 | Trial primary completion date: May 2024 ➔ May 2026

Enrollment change • Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6

Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=33 | Terminated | Sponsor: Akeso | N=102 ➔ 33 | Trial completion date: Sep 2024 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2024 ➔ May 2024; Development strategy adjustment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Study of AK119 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Akeso | Recruiting ➔ Completed | N=48 ➔ 16

Enrollment change • Metastases • Trial completion • Oncology • Solid Tumor

Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MLH1 • MSH2 • MSH6

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=87 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients (clinicaltrials.gov) - P1/2 | N=114 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] AK119, a humanized anti-CD73 monoclonal antibody, as Immunotherapy for COVID-19 (SITC 2020) - P1 | "Thus, A119 presented desirable preclinical bioactivities. The safety and pharmacokinetics of single ascending doses of AK119 will be evaluated in healthy volunteers in an upcoming Phase 1, First-in-Human study (NCT04516564)."

IO Biomarker • Oncology

[VIRTUAL] AK119, a humanized anti-CD73 monoclonal antibody, as Immunotherapy for COVID-19 (SITC 2020) - P1 | "Thus, A119 presented desirable preclinical bioactivities. The safety and pharmacokinetics of single ascending doses of AK119 will be evaluated in healthy volunteers in an upcoming Phase 1, First-in-Human study (NCT04516564)."

IO Biomarker • Oncology

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=87 | Not yet recruiting | Sponsor: Akeso

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=23 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting | N=195 ➔ 23

Combination therapy • Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor

Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients (clinicaltrials.gov) - P1/2 | N=114 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of AK119 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Akeso | Trial primary completion date: Oct 2022 ➔ Apr 2023

Trial primary completion date • Oncology • Solid Tumor

Akeso Is Developing Combination Therapies Based on Its PD-1 BsAbs, Ivonescimab (PD-1/VEGF) in Combination with Drebuxelimab (CD73) Approved for a Clinical Trial on Treating Advanced Solid Tumors (PRNewswire) - "Akeso...announced the Phase Ib/II clinical trial of its in-house developed Ivonescimab (PD-1/VEGF bi-specific, AK112) combined with its Drebuxelimab (CD73, AK119) for the treatment of advanced solid tumors, has been approved by the National Medical Products Administration (NMPA). AK112 is the first PD-1/VEGF bi-specific antibody that entered Phase III clinical research.... AK119 targets the key node of CD73 through the adenosine pathway, and its inhibitor has broad therapeutic prospects for tumors that are quite sensitive to the adenosine pathway."

New P1/2 trial • Oncology • Solid Tumor

Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Oncology • Solid Tumor

A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=195 | Recruiting | Sponsor: Akeso | Trial completion date: Jan 2023 ➔ Dec 2023 | Trial primary completion date: Aug 2022 ➔ Jan 2023

Combination therapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of AK119 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

AK131, an anti-PD1/CD73 bispecific antibody for cancer immune therapy (AACR 2022) - "Background: AK131 is a bispecific antibody derived from AK105 (the Akeso PD-1 antibody) and AK119 (the Akeso CD73 antibody). AK131 is a bi-specific antibody targeting both PD-1 and CD73. In pre-clinical studies, AK131 showed potent in-vitro and in-vivo activities. In summary, AK131 effectively blocked PD-1/PDL-1 interaction, promoted the activation of T cells and B cells, inhibited the CD73 enzymatic activity, and induced CD73 endocytosis."

IO biomarker • Oncology • CD69 • IFNG • IL2

Study of AK119 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Akeso

Clinical • New P1 trial • Oncology • Solid Tumor

AK119, A CD73 Targeting Antibody with Dual Mechanism of Action (SITC 2021) - "The in-vivo activity of AK119 was further studied in bleomycin-induced pulmonary fibrosis model in human CD73 transgenic mouse...AK119 show significantly higher bioactivity to induce B cells activation in comparison with MEDI9447 or CPI006 (figure 4)...Results from non-clinical pharmacology studies reveal potent bioactivities as well as favorable safety properties of AK119. AK119 is intended for advanced solid tumors, pulmonary fibrosis and therapy of COVID-19."

Oncology • Solid Tumor • CD69 • CD73 • NT5E

A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=195; Recruiting; Sponsor: Akeso; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2022 ➔ Jan 2023; Trial primary completion date: Dec 2021 ➔ Aug 2022

Clinical • Combination therapy • Enrollment open • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects (clinicaltrials.gov) - P1; N=29; Completed; Sponsor: Akesobio Australia Pty Ltd; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] A phase I study of AK119, an anti-CD73 monoclonal antibody, in combination with AK104, an anti-PD-1/CTLA-4 bispecific antibody, in patients with advanced or metastatic solid tumors. (ASCO 2021) - P1a/1b | "For the dose-expansion phase, cohorts of pts with advanced/metastatic pancreatic cancer or MSS/pMMR colorectal cancer will be enrolled . Cohorts of other tumor types may be added based on emerging pharmacodynamic and anti-tumor response data."

Clinical • Combination therapy • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Pancreatic Cancer • Solid Tumor

Akeso completes Phase I study first patient dosing for PD-1/CTLA-4 BsAb/CD73 mAb combo (GBI Health) - "China-based Akeso Biopharma (9926.HK) announced the first patient dosing in a Phase I clinical trial for cadonilimab (AK104), a novel programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4-targeted (CTLA-4) bispecific antibody (BsAb) combined with an anti-CD73 monoclonal antibody (mAb) AK119 in advanced solid tumors. The multi-center, dose escalation, and expansion study is designed to assess the safety, pharmacokinetics, and antitumor activities of said combo in advanced solid tumors."

Trial status • Oncology • Solid Tumor