AK129 / Akesobio - LARVOL DELTA

AK129 Combination Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=230 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of AK129 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=182 | Recruiting | Sponsor: Akeso | Phase classification: P1a/1b ➔ P1 | Trial completion date: Feb 2025 ➔ Jun 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Phase classification • Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor

A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024 ➔ Jan 2025

Enrollment open • Trial initiation date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=280 | Not yet recruiting | Sponsor: Akeso

Combination therapy • Monotherapy • New P1/2 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=294 | Not yet recruiting | Sponsor: Akeso

Metastases • New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of AK129 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b | N=182 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

A Study of AK129 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b | N=181 | Not yet recruiting | Sponsor: Akeso

New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Akeso Publishes Preclinical Results of PD-1/LAG-3 Bi-specific Antibody (AK129) at the American Association for Cancer Research (AACR) 2022 Annual Meeting (PRNewswire) - "Results and observations from AK129's preclinical study support the development of AK129 as a cancer immunotherapeutic agent in the clinic: AK129 showed good antigen binding to PD-1 and LAG-3. Coinsidently, AK129 potently inhibited the binding of LAG-3 to its ligand MHC-II, and the binding of PD-1 to its ligand PD-L1, thus blocking downstream immune suppression; At the individual target level, AK129 demonstrated a similar PD-1 blocking activity compared to penpulimab, and similar LAG-3 blocking activity compared to relatlimab. Importantly, at the whole cell level, the enhancement effect of AK129 is stronger than the combination of penpulimab and relatlimab, as evidenced by significantly higher level of IL-2 and IFN-γ secretion from PBMCs; AK129 showed favorable anti-tumor activity in BALB/c-hPD1/hLAG3 mice CT26.WT tumor model, with tumor growth inhibition values reaching 99.27% and 89.48% in high dose (20 mg/kg) and low dose (4 mg/kg) group of AK129, respectively."

Preclinical • Oncology