Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1100 |
| INN | Sasanlimab |
| Status | Clinical |
| Drug code(s) | PF-06801591 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Clear cell renal cell carcinoma, Non-small cell lung cancer, Non-muscle Invasive Bladder Cancer, melanoma, SCCHN, ovarian carcinoma, sarcoma, or relapsed or refractory cHL (one Phase 1 study), prostate cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | December 30, 2019 |
| 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 | Phase 3 in Pfizer pipeline dated Oct 2024. NCT06218069 Phase 2/3 in NSCLC due to start in Aug 2024. NCT04165317 Phase 3 study in Non-muscle Invasive Bladder Cancer started in Dec 2019, before Phase 2 study; active not recruiting as of April 19, 2023; primary completion date is in June 2024. NCT04181788 Phase 2 study due to start in Feb 2020 not yet recruiting. Sep 30, 2019: ESMO presentation (1275P) Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC); presenter Cho BC. Listed in Pfizer pipeline dated July 29, 2019. Two Phase 1 studies still recruiting as of Sep 2018. NCT02573259 Phase 1 study in MELANOMA; SCHNC; OVCA; SARCOMA; HODGKIN LYMPHOMA recruiting as of Feb 29, 2016. PF-06801591 is under development for the treatment of cancer. U273The drug candidate is a monoclonal antibody which targets programmed cell death protein1 (PD-1). Also being evaluated as part of a Vaccine-based Immunotherapy Regimen in a Phase 1 study. |
| 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
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |