On August 6, 2024 Akeso reported the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) (Press release, Akeso Biopharma, AUG 6, 2024, View Source [SID1234645441]).
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Preliminary studies show that combining AK117 with azacitidine for treating MDS is safe and significantly effective. In response to the urgent need for new therapies among global MDS patients and the evolving market landscape, Akeso has launched an international multicenter Phase II clinical trial. This initiative aims to expedite AK117’s global approval and commercialization process.
CD47-targeted drug development for treating MDS shows promising potential. AK117, a next-generation humanized IgG4 anti-CD47 antibody, effectively blocks the CD47-SIRPα interaction to enhance phagocytic activity against tumor cells by phagocytes.
Recent data presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that AK117 combined with azacitidine significantly reduces anemia and transfusion requirements in MDS patients, with favorable safety and notable efficacy. This positions AK117 as a promising treatment option for MDS patients worldwide.
In the United States alone, approximately 40,000 new cases of MDS are diagnosed annually. High-risk MDS patients typically start with azacitidine as standard therapy, but only 20% to 30% achieve complete remission, underscoring significant unmet clinical needs in global MDS treatment.
In addition to ongoing clinical trials for MDS globally, a Phase II study is underway to evaluate AK117 in combination with venetoclax and AZA as frontline therapy for AML patients who are not eligible for intensive chemotherapy.
Akeso is also actively progressing the global market development of AK117 for solid tumors. Multiple clinical trials exploring AK117’s efficacy with other agents, such as PD-1/VEGF bispecific antibodies and PD-1/CTLA-4 bispecific antibodies, are enrolling participants efficiently.
About Ligufalimab (AK117)
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 SIRPα, 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 ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, international multicenter clinical studies evaluating AK117 for treating MDS and AML are enrolling patients.