Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2370 |
| INN | Ivuxolimab |
| Status | Terminated |
| Drug code(s) | PF-04518600 |
| 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) | OX40 |
| Indications of clinical studies | Kidney cancer, Advanced solid tumors |
| 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) | April 15, 2015 |
| Start of Phase 2 | November 15, 2015 |
| Start of Phase 3 | September 29, 2021 |
| 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, August 2023, Jan 2024. Included in NCT05059522 Phase 3 Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closings, which is recruiting as of last update in Dec 2023 Included in NCT05059522 Phase 3 study, which is a Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies. NCT02554812 Phase 2 Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) still recruiting patients as of last update in March 2021. Listed as terminated for Phase 1 cancer in Pfizer pipeline update dated October 29, 2019 (https://pfe-pfizercom-prod.s3.amazonaws.com/product-pipeline/Pipeline_Update_29OCT2019_Final.pdf), but still included in on-going combo studies with avelumab. Listed as Phase 2 in Pfizer pipeline dated July 29, 2019. Six studies recruiting as of Sep 2018, but only 2 are sponsored by Pfizer. NCT02554812 Phase 2 JAVELIN Medley study in advanced malignancies is evaluating combination therapies. Phase 2 NCT03092856 study in kidney cancer started in July 2017, sponsored by NCI |
| 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 inhibitor. OX40 agonist. PF-04518600 (PF-8600) is a fully human IgG2 agonist antibody to human OX40 with high affinity and specificity. It binds to and activates the OX4O receptors thereby leads to the generation of T cell receptor signaling on the surface of T lymphocytes. OX40 activation leads to inhibition of apoptosis in such T-cells, causing T-cell proliferation, immune attack on tumors and sometimes tumor-specific therapeutic responses. The signaling occurs through tumor-necrosis factor receptor-associated factor 2 (TRAF-2) which activates the transcription factor nuclear factor-kappa-B (NF-kB) leading to downstream target activation and gene transcription. OX40-mediated effects on survival also attributed to increased levels of the anti-apoptotic proteins, BCL-2, BCL-XL and BFL1
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |