(HONG KONG, 5 Oct 2021) Akeso, Inc. (the Company, 9926.HK) announces that AK112 (PD-1/VEGF bi-specific antibody), the novel immuno-oncology drug independently developed by the Company, obtained clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China to initiate the phase II clinical trial for the treatment of advanced triple-negative breast cancer.
This is a multi-center, open, randomised phase II clinical trial to evaluate the safety and efficacy of AK112 in combination with chemotherapy for the treatment of patients with advanced triple-negative breast cancer.
AK112 is a humanized anti-PD-1/VEGF bispecific antibody with a symmetrical IgG1-ScFv molecular structure independently developed by the Company, which is of new tetrameric form. Based on the co-expression of PD-1 and VEGF in the tumor microenvironment, AK112 can be accumulated in the tumor microenvironment while effectively blocking the PD-1 pathway and VEGF pathway, thereby enhance the anti-tumor activity by immune cells.
In early clinical trials, AK112 demonstrated a good safety and tolerability profile. As of August 2021, a total of 117 subjects were enrolled in six cohorts receiving AK112 monotherapy at doses ranging from 0.3 mg/kg to 30 mg/kg. The incidence rate of grade 3 and above treatment-related adverse events (TRAEs) was only 16.2% in all cohorts, the grade 3 and above TRAEs rate of 20 mg/kg Q2W cohort was only 12.5%, which was much better than the published data of associated combination therapy of PD-1 monoclonal antibody in combination with VEGF monoclonal antibody.
Meanwhile, AK112 has shown to have excellent anti-tumor activity in lung cancer and gynecological tumors in early clinical trials. Data from phase Ia clinical trial shows that AK112 exhibits good anti-tumor activity at dose 3mg/kg or above in multiple tumor types that are relapsed or refractory to standard treatment (including PD-1/PD-L1 inhibitors and/or bevacizumab), with an overall objective response rate (ORR) of 24.4% and an overall disease control rate (DCR) of 64.4%.
Breast cancer is the malignant tumor with the highest incidence among women worldwide and in China. Triple-negative breast cancer (PR, ER and HER2 all negative) is the subtype with the highest recurrence and mortality rates due to its aggressive nature, high recurrence rate and relatively poor prognosis, accounting for approximately 15% of all breast cancers. AK112 has demonstrated potential efficacy and good safety and tolerability in a variety of tumor types that are recurrent or refractory to standard therapy, expected to bring new hope for the treatment of patients with advanced triple-negative breast cancer.
Currently, the main indications explored for AK112 include lung cancer, ovarian cancer, cervical cancer, endometrial cancer, breast cancer, advanced solid tumors, hepatocellular carcinoma, etc. Among which the registrational/phase III clinical study of AK112 for treatment of non-small-cell lung cancer after EGFR TKI treatment has initiated. Clinical studies of AK112 are about to initiate for first-line treatment of extensive stage small-cell lung cancer and for first-line treatment of PD-L1 positive non-small-cell lung cancer. AK112 is the world’s first PD-1/VEGF bi-specific antibody to enter phase III clinical trial. AK112 is another global first-in-class bi-specific antibody drug that has entered late clinical stage, following the Company’s global first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody), which has entered review and approval stage.
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.
