Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 252 |
| INN | Ligufalimab |
| Status | Clinical |
| Drug code(s) | AK117 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD47 |
| Indications of clinical studies | Head & neck cancer, Higher-risk myelodysplastic syndrome, Gastric or Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer, Triple-negative Breast Cancer, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Solid Tumors or Lymphomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2020 |
| Start of Phase 2 | February 15, 2022 |
| Start of Phase 3 | October 15, 2024 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Akesobio Australia Pty Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | October 30, 2024 I Akeso Biopharma announced the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso’s next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck. NCT06601335 Phase 3 Study of AK112 in Combination with AK117 in head & neck cancer due to start in Oct 2024. August 6, 2024 I Akeso has announced 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 (NCT06196203 started in Feb 2024). NCT05960955 Phase 2 in GI cancers started in Nov 2023. Mar 2023: Listed as Phase 2 asset in Akesobio pipeline. CTR20221153 / NCT05382442 Phase 2 in colorectal cancer enrolled first patient in July 2022. May 2021: AK117, a novel immuno-oncology drug independently developed by the Company, obtained approval from the National Medical Products Administration (NMPA) of the People’s Republic of China (“China”) for phase I/II clinical trials on the treatment of medium- to high-risk myelodysplastic syndromes; NCT04900350 Phase 1/2 study started in May 2021. NCT04728334 Phase 1 started recruiting in Jan 2021. First patient was dosed in Phase I study in May 2020 (Slide 30, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf). NCT04349969 Phase 1 study not yet recruiting when posted on April 16, 2020. In January 2020, we submitted an IND application in Australia for our AK117 (CD47). https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf |
| Full address of company | Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/ |
Immune checkpoint target.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |