Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1344 |
| INN | Ontamalimab |
| Status | Terminated |
| Drug code(s) | TAK-647, SHP647, PF-00547659 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | MADCAM-1 |
| Indications of clinical studies | Non-alcoholic steatohepatitis, Crohn's Disease, Ulcerative Colitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | September 23, 2005 |
| Start of Phase 2 | April 06, 2011 |
| Start of Phase 3 | October 15, 2017 |
| 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 | Pfizer |
| Licensee/Partner | Takeda |
| Comments about company or candidate | Terminated by Takeda as of May 2024. https://assets-dam.takeda.com/image/upload/v1715219664/Global/Investor/Financial-Results/FY2023/Q4/qr2023_q4_qfr_en.pdf July 2023 and Jan 2024: Listed in Takeda pipeline as Phase 1 for non-alcoholic steatohepatitis. NCT03283085 Phase 3 study Long-term Safety Extension Study in UC and CD still recruiting as of May 2021. May 2021: FIGARO and Carmen Phase 3 studies (4 in total) Terminated (Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.) NCT03627091 Phase 3 study started in Feb 2019. On October 26, 2018, Takeda announced that it was in discussions with the European Commission, the EU antitrust regulator, in relation to the future potential overlap in the area of IBD between its marketed product ENTYVIO and Shire’s pipeline compound SHP647, which is currently in Phase III clinical trials, and that it had proposed an antitrust remedy of a potential divestment of SHP647 and certain associated rights. On November 20, 2018, the European Commission granted a Phase I conditional clearance for the Shire Acquisition, subject to Takeda and Shire entering into commitments to divest SHP647 and certain other associated rights (https://www.sec.gov/Archives/edgar/data/1395064/000119312518350381/d608344d20fr12ba.htm). Six Phase 3 studies in Crohn's disease and UC recruiting as of Sep 2018. Listed as Phase 3 for UC and CD in Shire pipeline dated October 2017. May 2017: In Phase 2 study TURANDOT, SHP647, the first anti-MAdCAM antibody in clinical development, met its primary endpoint demonstrating significantly greater remission rates in patients receiving anti-MAdCAM antibody compared to placebo in three of four tested dose groups. Shire continues to work toward the initiation of a pivotal Phase 3 trial for SHP647 in the second half of 2017. The Company licensed the global rights to all indications for PF-00547659 (SHP647) from Pfizer Inc. in June 2016. Four Phase 2 studies recruiting as of Feb 2014. US orphan drug for for the treatment of pediatric patients with ulcerative colitis. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Portfolio prioritization/business decision |