AACR 2020 | Akesobio presents phase Ib/II preliminary results of AK104, a PD-1/CTLA-4 bispecific antibody in combination with chemotherapy as first-line therapy in patients (pts) with advanced gastric (G) or gastroesophageal junction (GEJ) cancer

Akesobio((HKEX Code: 9926.HK) presents phase Ib preliminary results from first-in-class bispecific drug candidate AK104 (PD1/CTLA4) in combination with mXELOX at American Association for Cancer Research virtual annual meeting (AACR 2020) on April 27-29th.


On Phase I Clinical trial session, Dr. Ji Jiafu form Peking University Cancer Hospital presented the clinical safety and efficacy data of AK104 in combination with mXELOX for advanced G/GEJ adenocarcinoma.. 


As of 2 April 2020, preliminary efficacy data available from 19 patients showed encouraging antitumor activities: 

  • Of 19 pts evaluable for antitumor activity, ORR was 57.9% (11/19) and DCR was 94.7% (18/19).
    • 1 CR,  10 PR, 7 SD
    • One patient progressed due to new lesion and had target lesion reduction of 40%
  • It is noted that the responses were independent of PD-L1 status.
  • The patients have been on treatment from 6 to more than 42 weeks.  Out of 19 patients, 13 patients were still on treatment.


AK104 in combination with mXELOX had a manageable safety profile. Of the 21 patients, we observed 2 patients with Grade 3 irAEs, 1 patient with treatment-related AE leading to discontinuation. Remarkably, there were no reports of colitis, which is commonly seen with anti-PD-1 and anti-CTLA-4 combinations. 


The detail of the report can be viewed at AACR website: https://www.abstractsonline.com/pp8/#!/9045/presentation/10619


About AK104

AK104 is a potential next-generation, first-in-class humanized IgG1 tetrameric bi-specific antibody drug candidate that is based on Akeso’s proprietary “TETRABODY” technology and simultaneously targets two immune checkpoint molecules: PD-1 and CTLA-4. AK104 is in a tetrameric form, which is designed to bind to PD-1 and CTLA-4 simultaneously to achieve the efficacy of PD-1 and CTLA-4 combination blockade with lower toxicity. It is currently in Phase Ib/II and Phase II clinical trials in China and Australia for multiple indications.


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).