Akeso, Inc. published two phase Ib clinical results of its innovative CD47 monoclonal antibody ligufalimab (AK117) in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) and treatment-nave acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting. HR-MDS Anemia is a significant symptom of MDS, and effectively managing anemia and minimizing blood transfusion are crucial aspects of disease control. As of August 25, 2023, a total of 86 patients were evaluable for safety.

Anemia (a primary adverse event associated with CD47 blocking antibodies) occurred in only 29.1% of the patients. AK117 has emerged as a potential best-in-class therapy for MDS. In this study, AK117 in combination with AZA was well tolerated with low incidence of anemia and demonstrated promising efficacy in patients with newly diagnosed HR-MDS.

AK117 is expected to be a superior treatment option for MDS patients worldwide. Akeso has received FDA clearance for the Investigational New Drug (IND) application for AK117 in combination with azacitine for the treatment of patients with newly diagnosed higher- risk MDS. This randomized, double-blind, global multi-center Phase II study is underway.

Notably, Akeso is consistently advancing the development of AK117 as a therapeutic agent in combination with various agents such as PD-1/CTLA-4 and PD-1/VEGF bispecific antibodies, for the treatment of multiple hematologic malignancies and solid tumors. AML As of August 25, 20 23, among 20 evaluable patients, the composite complete remission (CCR) rate was 55%, with 50.0% of patients achieving CR. About Ligufalimab (AK 117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect.

AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRP, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azACitidine for hematological tumors, as well as AK117 alone or in combination with PD-1/CTLA -4 and PD-1/veGF bispecific antibodies for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles of AK117, with no observed dose-limiting toxicity events.

Additionally, an international multicenter clinical study evaluating AK117 for the treatment of MDS has been initiated. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing.

Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA the first-in-classPD-1/CTLA- 4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, includingivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally.

Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted granted a combination with a PD-1/VEGF-1/VEGF), a combination with AZA and a combination with AZA, and claudin 18.