pulocimab (AK109) / Akesobio - LARVOL DELTA

Efficacy and Safety of Cadonilimab Plus Pulocimab in NSCLC Patients Who Progressed Following Prior Immunotherapy: A Phase 1b/2 Study (IASLC-WCLC 2025) - P1/2 | "These findings suggest that this combination may overcome immunotherapy resistance and offer a potential new option for second-line treatment of NSCLC. A further phase III clinical trial is currently in planning."

Clinical • P1/2 data • Hypertension • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • Thrombocytopenia • CTLA4 • PD-1

Cadonilimab(PD-1/CTLA-4) plus Pulocimab (VEGFR-2) Combination Therapy Shows Promising Results in IO-Resistant Non-Small Cell Lung Cancer in Oral Presentation at the 2025 WCLC (PRNewswire) - "As of January 13, 2025, with a median follow-up of 16.7 months, the cadonilimab-based combination achieved a median overall survival (mOS) of 15.6 months and a median progression-free survival (mPFS) of 5.8 months in IO-resistant NSCLC. In the squamous NSCLC (sqNSCLC) subgroup, mOS was 16.7 months, mPFS was 7.1 months, the disease control rate (DCR) reached 96.2%, and the objective response rate (ORR) was 11.5%. In the non-squamous NSCLC (nsq-NSCLC) subgroup, mOS was 12.8 months, mPFS was 5.5 months, DCR was 95.2%, and ORR was 14.3%."

P1/2 data • Non Small Cell Lung Cancer

AK109-102: A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=198 | Recruiting | Sponsor: Akeso | Trial completion date: Dec 2024 ➔ Apr 2027 | Trial primary completion date: Dec 2024 ➔ Apr 2027

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AK109-201: A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Akeso | N=87 ➔ 138 | Trial completion date: Jan 2024 ➔ Jan 2027 | Trial primary completion date: Jul 2023 ➔ Oct 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=506 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. (ASCO 2024) - P1/2 | "The combination of cadonilimab with pulocimab and paclitaxel demonstrated manageable safety profile and encouraging efficacy as second-line therapy in pts with G/GEJ cancer progressed after immunochemotherapy. Incorporation of dual immunotherapy to VEGFR-2 targeting therapy could be a potential strategy to overcome immunotherapy resistance. Additional phase III study is warranted to confirm it."

Clinical • Combination therapy • Metastases • Gastric Cancer • Gastrointestinal Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • CTLA4

A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=198 | Recruiting | Sponsor: Akeso | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Feb 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=506 | Not yet recruiting | Sponsor: Akeso

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

First-in-human, phase I study of AK109, an anti-VEGFR2 antibody in patients with advanced or metastatic solid tumors. (PubMed, ESMO Open) - P1 | "AK109 showed manageable safety profile and promising antitumor activity, supporting further clinical development in a large population."

Journal • Metastases • P1 data • Cardiovascular • Hematological Disorders • Hypertension • Oncology • Renal Disease • Solid Tumor • Thrombocytopenia

A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Akeso | Recruiting ➔ Completed | N=24 ➔ 40 | Trial completion date: Dec 2021 ➔ Oct 2022

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

First-in-human, phase I study of AK109, an anti-VEGFR2 antibody, in patients (pts) with advanced or metastatic solid tumors. (ASCO 2022) - P1, P1/2 | "AK109 showed manageable safety and promising anti-tumor activity. Two phase II studies of AK109 combined with AK104 (anti PD-1/CTLA-4 bi-specific antibody) are ongoing to evaluate the efficacy of AK109 combined with AK104 in patients with multiple solid tumors (NCT05142423, NCT04982276)."

Clinical • P1 data • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Disease • Solid Tumor

A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=198 | Recruiting | Sponsor: Akeso | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2022 ➔ Feb 2023

IO biomarker • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=87 | Recruiting | Sponsor: Akeso | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Jun 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=198; Recruiting; Sponsor: Akeso

Clinical • IO biomarker • New P1/2 trial • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Akeso’s PD-1/CTLA-4 BsAb/VEGFR-2 mAb combo greenlit for Phase Ib/ II study in solid tumors (GBI Health) - "China-based Akeso Biopharma (9926.HK) announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib//II study for its cadonilimab (AK104), a novel programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4-targeted (CTLA-4) bispecific antibody (BsAb) in combination with its AK109, an anti-vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody (mAb). The targeted indication is general advanced solid tumors."

New P1/2 trial • Oncology • Solid Tumor

A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2; N=87; Recruiting; Sponsor: Akeso

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

Phase update (clinicaltrials.gov) - Preclinical➔P1, Oncology

Phase shift • Oncology

A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Akeso

Clinical • New P1 trial • Oncology • Solid Tumor

Kangfang Bio (09926.HK) independently developed the drug AK109, the first patient with advanced solid tumor in China completed enrollment and administration (Eastmoney.com) - "Kangfang Bio-B (09926.HK) released an announcement that the company's self-developed VEGFR-2 new fully humanized monoclonal antibody drug AK109 has successfully completed the first advanced solid tumor patient in China's dose-climbing phase I clinical trial Enrollment and administration. The research was led by the First Affiliated Hospital of Zhejiang University School of Medicine and its professor of medical oncology, Professor Xu Nong , was the main researcher."

Enrollment closed • Oncology • Solid Tumor