^
    6ms
    A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy (clinicaltrials.gov)
    P1/2, N=42, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jun 2024 --> Jun 2026
    Trial primary completion date
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    nezastomig (REGN5678)
    10ms
    A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=370, Recruiting, Regeneron Pharmaceuticals | N=199 --> 370 | Trial completion date: Aug 2026 --> Jan 2027 | Trial primary completion date: Aug 2026 --> Jan 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • Kevzara (sarilumab) • nezastomig (REGN5678)
    12ms
    A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy (clinicaltrials.gov)
    P1/2, N=42, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    nezastomig (REGN5678)
    1year
    A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy (clinicaltrials.gov)
    P1/2, N=42, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    nezastomig (REGN5678)
    over1year
    Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer and Other Tumors (clinicaltrials.gov)
    P1/2, N=297, Recruiting, Regeneron Pharmaceuticals | N=216 --> 297 | Trial completion date: Feb 2025 --> Jul 2026 | Trial primary completion date: Feb 2024 --> Aug 2025
    Enrollment change • Trial completion date • Trial primary completion date • IO biomarker • Metastases
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    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
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    Libtayo (cemiplimab-rwlc) • Kevzara (sarilumab) • nezastomig (REGN5678)
    over4years
    [VIRTUAL] Combinatorial Approaches to Enhance Bispecific Anti-Tumor Efficacy (PEGS 2020)
    This presentation will describe Regeneron’s bispecific platform and present preclinical data on REGN4018, a clinical-stage, T cell-engaging, bispecific-targeting Muc16 for solid tumor indications. In addition, status updates on Regeneron’s other clinical-stage bispecific antibodies (REGN1979, REGN5458, REGN5678) will be presented, as well as a discussion of new combinatorial approaches being taken to enhance bispecific anti-tumor efficacy.
    Clinical
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    MUC16 (Mucin 16, Cell Surface Associated)
    |
    Ordspono (odronextamab) • ubamatamab (REGN4018) • linvoseltamab (REGN5458) • nezastomig (REGN5678)
    over4years
    [VIRTUAL] A phase I/II study of REGN5678 (Anti-PSMAxCD28, a costimulatory bispecific antibody) with cemiplimab (anti-PD-1) in patients with metastatic castration-resistant prostate cancer. (ASCO 2020)
    REGN5678 is a human IgG4-based, first-in-class costimulatory bsAb designed to target prostate tumors by bridging prostate specific membrane antigen expressing tumor cells with the costimulatory receptor, CD28, on T cells, and providing amplified T-cell receptor-CD3 complex-mediated T-cell activation within the tumor through the activation of CD28 signaling. This study is currently open to enrollment. Research Funding: Regeneron Pharmaceuticals Inc.
    Clinical • P1/2 data
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    CD8 (cluster of differentiation 8)
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    Libtayo (cemiplimab-rwlc) • T-cell receptor therapy • nezastomig (REGN5678)