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 sever...
(All Rights Reserved)