Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | Claudin-6 |
| Indications of clinical studies | Ovarian cancer, Advanced cancer |
| Primary therapeutic area | Cancer |
| 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 | 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. |
TORL-1-23 is an antibody drug conjugate (ADC)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |