Picankibart Regulatory review Naked monospecific

Antibody Information

Entry ID	756
INN	Picankibart
Status	Regulatory review
Drug code(s)	IBI112
Brand name	(Pending)
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)	IL-23p19
Indications of clinical studies	Ulcerative Colitis, Psoriasis
Primary therapeutic area	Immune-mediated / inflammatory disorders

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)	Regulatory review China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	December 15, 2019
Start of Phase 2	August 01, 2021
Start of Phase 3	December 30, 2022
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	Innovent Biologics (Suzhou) Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	September 26, 2024 I Innovent Biologics, Inc. announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. NCT06049810 Phase 3 in psoriasis due to start in Nov 2023. NCT05645627 Phase 3 in Psoriasis started, as per Feb 2023 press release; registrational study. Aug 2022: Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Moderate-to-severe Plaque Psoriasis Met Primary Endpoint. "...picankibart also shows potential advantages in long dosing intervals and long-term efficacy. I am confident and looking forward to the success of its upcoming phase 3 study" NCT05003531 Phase 2 is in Psoriasis NCT04511624 is a Phase 1 in healthy people. On Sep 1, 2020, Innovent Biologics, Inc. announced that the Phase I clinical study (CIBI112A101) of recombinant anti-interleukin 23p19 subunit antibody injection (IBI112) has completed the first healthy subject dosing in China. The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety and tolerability in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects. Described as a novel antibody.
Full address of company	Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs

Description/comment

Mutations in Fc fragment of IBI112 extended half-life compared to the wild-type IgG1 version in both human-FcRn-knock-in mice and cynomolgus monkeys.
https://investor.innoventbio.com/media/1147/innovent-2020-rd-day-ppt_20201110.pdf

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None