IBI363 Clinical Immunoconjugate, Immunocytokine

Antibody Information

Entry ID	777
INN	None
Status	Clinical
Drug code(s)	IBI363
Brand name	None
mAb sequence source	mAb - source TBD
General Molecular Category	Immunoconjugate, Immunocytokine
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	IL-2 mutein
Discovery method/technology	None

Therapeutic information

Target(s)	PD-1
Indications of clinical studies	Melanoma, Solid tumors or lymphomas
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 2 pivotal
Status	Active
Start of clinical phase (IND filing or first Phase 1)	March 12, 2022
Start of Phase 2	October 15, 2023
Start of Phase 3	March 01, 2025
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	March 3, 2025 -- Innovent Biologics, Inc. announced that the first patient has been dosed in its registrational study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy versus pembrolizumab (Keytruda®) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. CTR20250280 is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab in subjects with unresectable locally advanced or metastatic mucosal and acral melanoma who have not received prior systemic treatment Feb. 17, 2025: Innovent Biologics, Inc. announced that IBI363, has received its second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy. IBI363 has demonstrated encouraging efficacy and safety across multiple solid tumor types. Sep 4, 2024: The US Food and Drug Administration has granted its fast track designation to Innovent Biologics' IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein to treat advanced unresectable locally advanced or metastatic melanoma. NCT06281678 Phase 2 study in solid tumors started in Aug 2024. CTR20233086 Phase 2 in melanoma started in Oct 2023. Listed as Phase 1 asset in company pipeline accessed Feb 2023. First patient dosing announced in Aug 2022. NCT05460767 and NCT05290597 are A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas CXSL2200168 has event date April 12, 2022
Full address of company	Jiangsu, P. R. China 215123 Asia China https://www.innoventbio.com/AboutUs/ContactUs

Description/comment

A mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None