Akesobio Doses First Patient in Phase 1 Study of AK117, a novel anti-CD47 monoclonal antibody in Australia

May 11th, 2020. Akesobio (HKEX Code: 9926.HK) announced that the first patient has been dosed in a Phase 1 clinical study to evaluate the safety and tolerability of AK117, a novel anti-CD47 monoclonal antibody that targets the CD47-SIRPα axis for the treatment of patients with advanced solid tumors or hematologic malignancies.


“AK117 received IND approval from FDA in April and announced the first patient dosed in Australia today, we are delighted to say that AK117's the global development is making progress smoothly”, said Michelle Xiayu, Chairwoman and CEO of Akesobio, “AK117, with its unique structure can be a next generation anti-CD47 drug with better clinical benefit.. The pre-clinical data so far shows no induction of hemagglutination and reduced phagocytosis of RBCs, while retains its antitumor activity. AK117 will further enrich and advance Akesobio’s innovative product pipeline and increase the flexibility of Akeso’s antibody drugs for the treatment of cancer in combination with other therapies.”


About AK117

AK117 is a novel anti-CD47 monoclonal antibody developed by Akesobio. Elevated expression of CD47 has been observed in multiple tumor types, which could interact with SIRPα expressed on macrophages. CD47-SIRPα interaction releases a “don’t eat me” signal which prevents phagocytosis of tumor cells by macrophages. Drugs targeting CD47 as monotherapy or combination therapy have shown promising antitumor activities in hematological malignancies and solid tumors, which make CD47 a new hotspot for tumor immunotherapy. However, due to expression of CD47 on red blood cells (RBCs), drugs targeting CD47 could induce phagocytosis of RBCs and hemagglutination, which may limit the full potential of anti-CD47 therapy. AK117, with its unique structure, shows no induction of hemagglutination and reduced phagocytosis of RBCs, while retains its antitumor activity. Therefore, it’s foreseeable that AK117 can be a next generation anti-CD47 drug with better clinical benefit.


About Akeso

Akeso,Inc.(HKEX Code: 9926.HK) is a clinical-stage biopharmaceutical company committed to in-house discovery, development and commercialization of first-in-class and best-in-class therapies. The Company dedicated to addressing global unmet medical needs in oncology, immunology and other therapeutic areas. Akeso’s vision is to become a global leader in developing, manufacturing and commercializing innovative, next-generation and affordable therapeutic antibodies for patients worldwide.


The Company’s business is designed to drive success through both efficient and breakthrough R&D innovation. Since its inception, the Company has had the foresight to develop an end-to-end platform, Akeso Comprehensive Exploration platform (“ACE Platform”), encompassing comprehensive drug discovery and development functionalities, including target validation, antibody drug discovery and development, CMC, and GMP-compliant manufacturing.


In oncology therapeutic area, the products in advanced development include an anti-PD-1/CTLA-4 bi-specific antibody (AK104), an anti-PD-1 antibody (penpulimab, AK105), and AK112, a potential first-in-class PD-1/VEGF bi-specific antibody. In immunology therapeutic area, the Company has built one of the richest pipeline targeting autoimmune diseases among China-based biotech companies. Our product candidates in this area include anti-IL12/IL23 monospecific antibody (AK101), an anti-IL17 monospecific antibody (AK111), one drug candidate with IND approved in Australia (AK120, an IL-4R antibody), and one more in IND-enabling stage (AK114, an IL-1 beta antibody).