TORL-1-23 Clinical ADC

Antibody Information

Entry ID	1368
INN	None
Status	Clinical
Drug code(s)	TORL-1-23
Brand name	None
mAb sequence source	mAb - source TBD
General Molecular Category	ADC
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	Cleavable linker
Ave. DAR	___
Conjugated/fused moiety	Tubulin inhibitor, Monomethyl auristatin E (MMAE)
Discovery method/technology	None

Therapeutic information

Target(s)	Claudin-6
Indications of clinical studies	Ovarian cancer, Advanced cancer
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)	November 15, 2021
Start of Phase 2	November 15, 2024
Start of Phase 3
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	TORL Biotherapeutics LLC
Licensee/Partner	None
Comments about company or candidate	November 2024: TORL initiated CATALINA-2 (NCT06690775), a global, multi-institutional randomized, open-label Phase 2 study of TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The study is designed to support accelerated registration in CLDN6+ PROCN CT06690775 Phase 2 in ovarian cancer due to start in Nov 2024. NCT05103683 is a Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer still recruiting as of last update on June 10, 2022.
Full address of company	6100 Bristol Parkway, 90230 Culver City, CA, United States (USA) North America United States of America https://www.life-sciences-usa.com/organisation/torl-biotherapeutics-llc-2018-culver-city-california-federal-2001-51407.html#:~:text=Los%20Angeles%2C%20CA.

Description/comment

TORL-1-23 is an antibody drug conjugate (ADC)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None