Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 610 |
| INN | None |
| Status | Clinical |
| Drug code(s) | CTX-009, ES104, TR009, NOV1501, ABL001 |
| Brand name | None |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Bispecific |
| Format, general category | Appended Ig |
| Format details | scFv-scFv-Full-length antibody |
| Isotype (Fc) | TBD |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | DLL4, VEGF |
| Indications of clinical studies | Colorectal cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 18, 2017 |
| Start of Phase 2 | June 22, 2020 |
| Start of Phase 3 | January 15, 2023 |
| 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 | National OncoVenture |
| Licensee/Partner | Compass Therapeutics Inc., Elpiscience Biopharmaceuticals, ABL Bio Inc. |
| Comments about company or candidate | Nov 2024: Fully enrolled the Phase 2/3 trial of lead asset CTX-009 (DLL4 and VEGF-A bispecific antibody) in patients with biliary tract cancers (BTC); top-line data readout is on track for the end of the first quarter of 2025. NCT05506943 Phase 2/3 in Biliary Tract Cancers started in Jan 2023 active not recruiting as of last update in Aug 2024. Nov 1 2021 press release: A Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. May 2021: Compass Therapeutics, Inc. and TRIGR Therapeutics, Inc., a private biotechnology oncology company, today announced that the companies have entered into a definitive merger agreement, under which Compass, through a subsidiary, will acquire TRIGR. Jan 2021: TRIGR Therapeutics, Inc., a US based clinical stage biopharmaceutical company focused on the development of multi-targeted angiogenic and immunomodulatory bispecific antibodies for oncology and certain ischemic indications and Elpiscience Biopharmaceuticals, a leading China based clinical stage company focused on developing next generation of cancer immunotherapies announced today that they have entered into an exclusive licensing agreement for the development and commercialization of TR009 in mainland China, Hong Kong, Macau and Taiwan. NCT04492033 Phase 1/2 in advanced solid tumors started in June 2020. March 25, 2019: TRIGR Therapeutics, Inc., a newly formed privately held company focused on the clinical development and commercialization of targeted and immunomodulatory bispecific antibodies for oncology and ophthalmology indications, announced today that it has completed the second tranche of its seed financing round, with $14 million in aggregate proceeds. TRIGR's pipeline now includes one clinical stage dual angiogenesis bispecific antibody (TR009) which is currently in a dose escalation phase 1a clinical trial being conducted at the Samsung Medical Center in Seoul, South Korea and 3 dual checkpoint and T-cell engaging bispecific antibody candidates. TR009 (ABL001/NOV1501) phase 1a/phase 1b clinical trials are conducted under the auspices of National OncoVenture (NOV), a Korean government funded organization. TRIGR licensed TR009 in Dec 2018. NCT03292783 Phase 1 study started in Sep 2017 last updated in Sep 2017, but results were discussed in March 25 2019 press release: As an update to the Phase 1a dose escalation study, TR009 single agent clinical activity has been demonstrated across all dose levels in heavily pre-treated (5+ lines of prior therapy) cancer patients with solid tumors including gastric, colon, GIST, and ovarian cancers. |
| Full address of company | Madu, Kyonggi-do, South Korea Asia Republic of Korea https://www.crunchbase.com/organization/national-oncoventure |
IgG with 2x c-terminal scFv fusion. Paper "ABL001 [TR009], a Bispecific Antibody Targeting VEGF and DLL4, with Chemotherapy, Synergistically Inhibits Tumor Progression in Xenograft Models" reports that TR009 demonstrates more potent in vitro and in vivo biological activity compared to VEGF or DLL4 targeting monoclonal antibodies alone.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |