On November 11, 2019 Akeso Biopharma ("Akeso") reported that results of phase 1 study of its first-in-class bispecific drug candidate AK104, in patients with advanced solid tumors in 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") (Press release, Akeso Biopharma, NOV 11, 2019, View Source [SID1234550866]). AK104 is a novel, tetrameric bispecific antibody targeting both PD-1 and CTLA-4.

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Dr. Ben Markman, MBBS(Hons) FRACP from Monash Health, Australia gave the oral presentation at the SITC (Free SITC Whitepaper) Single Agent Phase 1 Clinical Trials Session chaired by Dr. Helen Chen from National Cancer Institute and Dr. Naiyer Rizvi of Columbia University Medical Center. "AK104 has shown excellent tolerability so far with encouraging signs of anti-tumor activity. I very much look forward to tracking the further development of this exciting tetrameric bispecific antibody targeting PD1 and CTLA4", commented Dr. Ben Markman.

Updated results from Phase 1a study (NCT03261011):

AK104 showed encouraging anti-tumor activities across a range of tumor types.
– Among 25 PD-1/L1 naïve response-evaluable patients administrated with ≥ 2 mg/kg AK104, ORR: 24% ( DoR ranging from 2+ to 11.1+ months); DCR: 44%.
AK104 had an acceptable safety profile. Early data suggested that AK104 may have improved tolerance compared with the combination of a PD-1 inhibitor and CTLA-4 inhibitor.
– With 55 patients enrolled, most common treatment-related AE includes rash, infusion reaction, nausea, and fatigue.
– ≥ Grade 3 treatment-related AE (TRAE) rate was 11% with only one Grade 4 event reported. Grade 3 immune-related AE (irAE) rate was 3.6%.
AK104 commenced a Phase 1a study in patients with advanced solid tumors in Australia in October 2017, received NMPA IND approval in May 2018, and IND approval from the FDA in April 2019. AK104 is currently in Phase Ib/II clinical trials globally for multiple indications and has exhibited promising clinical safety and efficacy results in monotherapy and combination therapy.

Details of the material used in oral presentation can be found at SITC (Free SITC Whitepaper) website.

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. PD-1 and CTLA-4 co-express in tumor infiltrating lymphocytes (TILs), but not in normal peripheral tissues. 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 lowered toxicity.