On August 24, Akeso, Inc. announced that the registered Phase II clinical research of its independently-developed global first new tumor immunotherapy drug, Cadonilimab (PD-1/CTLA-4 bispecific antibody, R&D code: AK104) for the treatment of recurrent or metastatic cervical cancer has reached primary endpoint and achieved significant positive results. CDE has agreed the company to submit a new drug application of Cadonilimab for the treatment of recurrent or metastatic cervical cancer, and the priority of evaluation will be given. Cadonilimab is expected to be the first bispecific antibody drug based on PD-1 with the new drug application submitted and approved.

AK104 is the first PD-1/CTLA-4 bispecific antibody of Akeso, Inc. that has entered clinical trials in the world. In March 2020, the clinical research of AK104 monotherapy for second-line treatment of recurrent or metastatic cervical cancer was approved by FDA to carry out registered clinical research. In May this year, AK104 was used for a registered clinical trial of three-line treatment for patients with metastatic nasopharynx cancer, and the first patient administration was completed, making rapid progress. In mid-August this year, FDA granted AK104 with the qualification of Fast Track Designation (FTD) for injection.

Besides AK104, AK112 (PD-1/VEGF), the bispecific antibody targeting advanced solid tumors and developed by Akeso, Inc., has also been tested in the clinical stage. In addition, Akeso, Inc. has four bispecific antibodies being developed. At present, Akeso, Inc. has developed Tetrabody bispecific antibody platform technology and ACE (end-to-end all-round exploration) platform for the development of its bispecific antibody drugs.

Akeso, Inc. has developed into one of the bio pharmaceutical companies with the richest distribution and the fastest progress of bispecific antibody drugs in China. It has a completely independently-developed antibody pipeline for serious diseases such as tumor, autoimmunity, inflammation and metabolic diseases. 12 innovative products in total are in the clinical stage.

Tumor pipeline -- Penpulimab (AK105)  

Penpulimab (AK105) is a PD-1 monoclonal antibody developed by Akeso, Inc., in which the utilitarian function of Fc receptor and complement-mediated is completely removed through Fc mutation. Its antigen binding dissociation rate is slower compared with the abroad PD-1 antibodies that have been listed. At present, there are 8 indications or schemes of penpulimab in the later stage of clinical Phase III.

The indication with the fastest progress of penpulimab is third-line recurrent or refractory classical Hodgkin's lymphoma (cHL). During the registry study, the complete remission (CR) rate of penpulimab reached 48.2%, the objective remission rate (ORR) was 89.4%, the 6-month progression-free survival (PFS) rate was 87.8%, and the adverse reaction rate and the adverse reaction rate above grade 3 were low.

Metabolic diseases -- AK102  

AK102 is an anti-PCSK9 monoclonal antibody independently developed by Akeso, Inc., which is designed to treat hyperlipidemia. In November 2018, the company completed the Phase I dose escalation clinical trial of AK102 for healthy Chinese volunteers. The first patients in China for two Phase II clinical trials of hypercholesterolemia (HoFH/HeFH) were recruited in May and December 2019 respectively. Now the patients have been enrolled. Akeso, Inc. has entered into a joint venture agreement with Dawnrays to jointly develop AK102, with the former owning 65% of the rights and interests.

Autoimmune field -- AK101 and AK111  

AK101 is the first anti-IL-12/IL-23p40 monoclonal antibody independently developed by Akeso, Inc. in China for the purpose of treating psoriasis, ulcerative colitis and other autoimmune diseases. Now, the Phase I/II clinical research of moderate and severe plaque psoriasis of AK101 has been completed, and the Phase IIb clinical research of dose escalation is conducting.

According to data of clinical Phase I, the proportions of subjects with AK101 reaching PASI75 (psoriasis lesion area and severity index decreases by at least 75% compared with the baseline) and PASI90 at the 28th week were 73.3% and 40.0% respectively, which is expected to be superior to similar products.

AK111 is a new monoclonal antibody independently developed by Akeso, Inc. targeting at IL-17A, the new-generation target spot of autoimmune diseases, aiming at treating such autoimmune diseases as psoriasis, ankylosing spondylitis and axial spondyloarthritis. Secukinumab, the similar drug of this target spot, has recorded a global sales of 3.6 billion US dollars in 2019. AK111 shows similar activity in antigen binding, cytological trials and animal models compared with other commercially available IL-17 antibodies. The Phase I study of AK111 for healthy subjects has been completed, and it shows safe and good tolerance at the maximum dosage of 600mg in subcutaneous single-dose administration. There are many clinical researches of subcutaneous administration currently targeted at patients with moderate or severe psoriasis in China.

Most of the biopharmaceutical enterprises in China focus on biosimilar drugs because they are relatively easy to start with, which causes the current fierce competition in the biosimilar drug market. Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, production and commercialization of innovative antibody drugs affordable to patients all over the world. With the creation of complete antibody drug development platform ACE and Tetrabody technology (bispecific antibody), new drugs with independent intellectual property rights but clinically confirmed targets have been made. Despite the fact that PD-1 is lagged behind, the development of PD-1 single drug is still working in progress. In the meanwhile, efforts are made to develop a new generation of products that are superior to PD-1 based on PD-1 bispecific antibody and others to seize the initiative of bispecific antibody. Akeso, Inc. expects to become a leading biopharmaceutical enterprise in the world by developing new drugs that are the first in the world and with the best therapeutic effect in the similar drugs through efficient and ground-breaking R&D and innovation.  

Reference:

1.https://www.akesobio.com/cn/media/akeso-news/210824/;

2. Official website of Akeso, Inc