Cadonilimab Approved Bispecific

Antibody Information

Entry ID	12
INN	Cadonilimab
Status	Approved
Drug code(s)	AK104
Brand name	开坦尼®
mAb sequence source	mAb humanized
General Molecular Category	Bispecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	PD-1, CTLA-4
Indications of clinical studies	Pancreatic cancer, Clear Cell Renal Cell Carcinoma, Non-small cell lung cancer, MSI-H/dMMR Solid Tumor, Cervical cancer, Hepatocellular carcinoma, peripheral T-cell lymphoma, Melanoma, Gastric or Gastroesophageal Junction Adenocarcinoma, Solid tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 03, 2017
Start of Phase 2	January 13, 2019
Start of Phase 3
Date BLA/NDA submitted to FDA
Year of first approval (global)	2022
Date of first US approval
INN, US product name	Cadonilimab
US or EU approved indications	None

Company information

Company	Akesobio Australia Pty Ltd
Licensee/Partner	None
Comments about company or candidate	Sep 2024: Adenocarcinoma Of The Gastroesophageal Junction, Gastric Cancer is approved for China on Sep 30, 2024 June 29 2022: Akeso Biopharma Inc. announced that its PD-1/CTLA-4 bi-specific antibody开坦尼® (Candonilimab injection, AK104) has received marketing approval from China Medical Products Administration (NMPA), for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy. Aug 2021: The Company has received the approval from the National Medical Products Administration of the People’s Republic of China (‘‘China’’) to initiate a phase III pivotal registrational clinical trial for the global first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), an immuno-oncology therapy independently developed by the Company, in combination with oxaliplatin and capecitabine (‘‘XELOX’’) versus placebo in combination with XELOX for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (clinical registration number: CTR20211567) and the national researchers’ conference has been successfully held. https://www.akesobio.com/en/media/akeso-news/21-8-3/ Company expects to file NDA in 2H 2021 (Slide 15, https://www.akesobio.com/media/1405/akesoplus2020plusarpluspresentation_ve-website2.pdf) for cervical cancer. The FDA has granted Fast Track Designation to AK104 for the treatment of advanced cervical cancer; Feb 2021 AK 104 receives Orphan Drug status for Cervical cancer (Stage IA2-IV) in USA In May 2020, AK104 obtained approval from NMPA to initiate a registrational trial for third-line treatment of patients with metastatic nasopharyngeal carcinoma. NCT04444167 Phase 1/2 study in hepatocellular carcinoma started in June 2020, and NCT04444141 Phase 1/2 study in peripheral T-cell lymphoma started in May 2020. NCT04380805 Phase 2 study in cervical cancer started July 2020. In January 2020, the company received the written consent from the FDA regarding the overall study design of a planned registrational trial of AK104 (PD-1/CTLA4) in the U.S. for 2L/3L cervical cancer patients and for potentially submitting NDA application to the FDA for cervical cancer via the accelerated approval pathway. Jan 2020: IND filed to start studies in cervical cancer. NCT04220307 Phase 2 in Metastatic Nasopharyngeal Carcinoma not yet recruiting as of first posting on Jan 7 2020. NCT04172454 Phase 1/2 in melanoma not yet recruiting as of Dec 20, 2019. NCT03852251 Phase 1/2 study started in January 2019. NCT03261011 Phase 1 study started in October 2017 still recruiting as of Aug 2018.
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/

Description/comment

Immune checkpoint inhibitor. Described as a PD-1 bispecific on company website. Tetrameric; derived from TETRABODY technology. Anti-PD1 antibody with additional 2 binding scFv-derived sites for CTLA-4 attached to termini of Fc. Mutations (L235A/L236A/G238A) were introduced into the Fc region to eliminate binding to FcγRs and C1q.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None