Latest Results of a Phase II Clinical Study of PD-1/VEGF Bi-Specific Antibody (AK112) in Combination with Chemotherapy for First-Line Treatment of Advanced NSCLC Published at 2021 CSCO

(HONG KONG, 26 Sept 2021) Akeso, Inc. (the Company, 9926.HK) announces that the preliminary data of first part cohort 1 of the phase II clinical study of the world’s first PD-1/VEGF bi-specific antibody AK112 in combination with chemotherapy for first-line treatment of advanced non-small-cell lung cancer (NSCLC) will be published at the 24th National Clinical Oncology Meeting and the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO) in the form of oral presentation.


Research title: A multi-center, open-label phase II clinical study (AK112-201) of anti-PD-1/VEGF bi-specific antibody AK112 in combination with chemotherapy for treatment of advanced NSCLC

Form of presentation:   Oral presentation

Speaker:  Prof. Zhang Li, Affiliated Tumor Hospital of Sun Yat-sen University


This is a multi-center, open-label phase II clinical study (AK112-201, NCT04736823). The purpose of the study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy for treatment of advanced NSCLC. Primary endpoint is the objective response rate (ORR) assessed by researcher per RECIST1.1.


As of 5 August 2021, a total of 37 treatment-naïve NSCLC enrolled patients have received treatment of AK112 in combination with paclitaxel + carboplatin or pemetrexed + carboplatin. Results have shown that the ≥ grade 3 treatment related adverse event (TRAE) rate was 13.5%, drug related serious adverse event (SAE) rate was 8.1%. No new safety signal has been found other than PD-1 inhibitors and anti-VEGF monoclonal antibodies.


A total of 26 treatment-naïve NSCLC patients have completed at least one post-baseline tumor assessment, among which 18 subjects have non-squamous cancer, 8 subjects have squamous cancer; 12 subjects were PD-L1 negative, 11 subjects were PD-L1 positive and 3 subjects were unknown. Researcher-assessed ORR was 53.8%, disease control rate (DCR) was 100%, of which the tumor size of 12 stable disease (SD) subjects has been reduced. Among the 7 subjects from the high dosage group (20 mg/kg), ORR was 57.1%, DCR was 100%. The tumor size of 3 SD subjects reduced by 23.9%, 27.3%, 29.4%, respectively.


About AK112 (PD-1/VEGF Bi-Specific Antibody)

AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique TETRABODY technology, AK112 blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor microenvironment, AK112, as a single agent to block these two targets, may block these two pathways more effectively and enhance the anti-tumor activity, as compared to combination therapy.



About Akeso, Inc.

Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable   to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.