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    DRUG:

    PF-08046049

    i
    Other names: PF-08046049, SGN-BB228, PRS-346, PF08046049, PRS346, SGNBB228, PF 08046049, PRS 346, SGN BB228
    Company:
    Pfizer, Pieris Pharmaceuticals
    Drug class:
    CD137 agonist, Melanotransferrin inhibitor
    Related drugs:
    4ms
    SGNBB228-001: A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov)
    P1, N=275, Recruiting, Seagen Inc. | Trial completion date: Sep 2028 --> Nov 2027 | Trial primary completion date: Oct 2025 --> Nov 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    PF-08046049
    over1year
    Phase 1 study of SGN-BB228, an investigational CD228 x 4-1BB costimulatory antibody anticalin bispecific, in patients with advanced melanoma and other solid tumors (SGNBB228-001). (ASCO 2023)
    Enrollment is ongoing in the US and planned in Europe. Clinical trial information: NCT05571839.
    Clinical • P1 data • Metastases
    |
    BRAF (B-raf proto-oncogene) • MELTF (Melanotransferrin)
    |
    BRAF mutation
    |
    PF-08046049
    over1year
    SGN-BB228, a CD228-directed costimulatory antibody anticalin® bispecific provides potent and conditional 4-1BB costimulation to T cells in vivo and in an in vitro model of T cell exhaustion (AACR 2023)
    Interestingly, in this system, anti-PD-1 (nivolumab) failed to reinvigorate functionally exhausted T cells despite high PD-L1 expression by tumor cells. Together these data highlight SGN-BB228, a first-in-class, investigational CD228 x 4-1BB costimulatory Antibody Anticalin® bispecific with potent and CD228-conditional 4-1BB costimulatory activity with therapeutic potential in multiple solid tumor types. These data support the first-in-human phase 1 clinical trial of SGN-BB228 in advanced melanoma and other solid tumors (NCT05571839), which is currently recruiting.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • MELTF (Melanotransferrin)
    |
    PD-L1 expression • PD-L1 overexpression • MELTF expression • MFI2 expression
    |
    Opdivo (nivolumab) • PF-08046049
    2years
    A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov)
    P1, N=275, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    PF-08046049
    2years
    A Study of SGN-BB228 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov)
    P1, N=275, Not yet recruiting, Seagen Inc.
    New P1 trial • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    PF-08046049
    2years
    SGN-BB228 is a first-in-class CD228-targeted costimulatory Antibody Anticalin bispecific delivering potent and conditional 4-1BB costimulation to tumor-specific T cells (SITC 2022)
    Conclusions Together these data introduce SGN-BB228, a first-in-class, investigational CD228/4-1BB costimulatory Antibody Anticalin® bispecific with potent and CD228-conditional 4-1BB costimulatory activity with therapeutic potential in multiple solid tumor types. These data support future clinical study of SGN-BB228 in a first-in-human Phase 1 trial.
    IO biomarker
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9) • MELTF (Melanotransferrin)
    |
    MFI2 expression
    |
    PF-08046049