Pulocimab Clinical Naked monospecific

Antibody Information

Entry ID	249
INN	Pulocimab
Status	Clinical
Drug code(s)	AK109
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
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)	VEGFR2
Indications of clinical studies	Gastric Adenocarcinoma and 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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 15, 2020
Start of Phase 2	November 03, 2021
Start of Phase 3	June 06, 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 information

Company	Akesobio Australia Pty Ltd
Licensee/Partner	None
Comments about company or candidate	NCT06341335 / CTR20241225 Phase 3 in Gastric or Gastroesophageal Junction Adenocarcinoma started in June 2024 NCT04982276 Phase 1/2 in Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma recruiting as of last update in Oct 2022 NCT05142423 is a Phase 1/2 study in solid tumors started in Nov 2021 recruiting as of last update in Oct 2022. NCT04547205 Phase 1 study in solid tumors started in June 2020 completed in Oct 2022. First patient was dosed with AK109 in Phase I study in China (June 2020) (Slide 30, https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.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/

Description/comment

AK109 has the same V domain sequences but different huIgG1 allotype compared to ramucirumab.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None