Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2373 |
| INN | Utomilumab |
| Status | Terminated |
| Drug code(s) | PF-05082566 |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Phage display-derived (HuCal library) |
| Target(s) | 4-1BB |
| Indications of clinical studies | Colorectal cancer, breast cancer, diffuse Large B-Cell Lymphoma, Solid tumors, B cell malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 2011 |
| Start of Phase 2 | |
| Start of Phase 3 | February 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 | None |
| Comments about company or candidate | Not listed in Pfizer pipelines dated January and August 2023. May 2023: M.D. Anderson Cancer Center and National Cancer Institute suspends a phase I trial in Ovarian cancer (Combination therapy, Recurrent, Second-line therapy or greater, Late-stage disease) in USA (IV) due principle investigators request (NCT03318900). Dec 2022: Two Phase 2 studies sponsored by non-commercial entities recruting; Pfizer is collaborator. Results of NCT01307267 Phase 1 study of patients with melanoma and NSCLC: Utomilumab was well tolerated, but antitumor activity was low in patients who previously progressed on ICIs. The potential of 4-1BB agonists requires additional study to optimize efficacy while maintaining the tolerable safety profile. Front Immunol. 2022; 13: 897991. Listed as Phase 1 in Pfizer pipeline dated Oct 2020. NCT02951156 Javelin DLBCL Phase 3 study started in Dec 2016 Terminated in Dec 2019 (Study was terminated due to closure of study arms following futility analysis and difficulty in enrolling participants due to evolving treatment landscape); Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma. NCT02554812 Phase 1 in advanced cancers recruiting as of Nov 2015. Phase 1 NCT01307267 started in 2011 still recruiting patients as of June 2014. NCT02444793 Phase 1 in advanced solid tumors recruiting as of Sep 2015 |
| 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 |
Immune checkpoint target. Agonist
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |