Lynozyfic (linvoseltamab) / Regeneron, Sanofi 
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  • ||||||||||  vonsetamig (REGN5459) / Regeneron
    Trial completion date, Trial initiation date, Trial primary completion date:  An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant (clinicaltrials.gov) -  Feb 21, 2022   
    P=N/A,  N=12, Not yet recruiting, 
    REGN5458 shows early, deep and durable responses with a manageable safety profile in triple- to penta-refractory patients with RRMM. Trial completion date: Feb 2027 --> Jan 2026 | Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Feb 2027 --> Jan 2026
  • ||||||||||  Lynozyfic (linvoseltamab) / Regeneron, Sanofi
    Enrollment change, Trial completion date, Trial primary completion date:  LINKER-MM1: Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Oct 15, 2021   
    P1/2,  N=292, Recruiting, 
    The Phase 2 portion of the study is currently recruiting. N=200 --> 292 | Trial completion date: Dec 2022 --> May 2025 | Trial primary completion date: Dec 2022 --> May 2025
  • ||||||||||  REGN5458 / Regeneron
    Clinical, Journal, CAR T-Cell Therapy:  A BCMAxCD3 bispecific T cell-engaging antibody demonstrates robust antitumor efficacy similar to that of anti-BCMA CAR T cells. (Pubmed Central) -  Jun 1, 2021   
    Here we describe a fully human bsAb (REGN5458) that binds to B-cell maturation antigen (BCMA) and CD3, and compare its antitumor activities vs those of anti-BCMA CAR T cells to identify differences in efficacy and mechanism of action...In head-to-head in vivo studies, BCMAxCD3 bsAb rapidly cleared established systemic MM tumors, whereas CAR T cells cleared tumors with slower kinetics. Thus, using the same BCMA-binding domain, these results suggest that BCMAxCD3 bsAb rapidly exerts its therapeutic effects by engaging T cells already in place at the tumor site, whereas anti-BCMA CAR T cells require time to traffic to the tumor site, activate, and numerically expand before exerting antitumor effects.
  • ||||||||||  REGN4018 / Regeneron, Sanofi, odronextamab (REGN1979) / Regeneron, REGN5458 / Sanofi, Regeneron
    [VIRTUAL] Combinatorial Approaches to Enhance Bispecific Anti-Tumor Efficacy () -  Apr 4, 2021 - Abstract #PEGS2021PEGS_550;    
    This presentation will describe key preclinical data from Regeneron’s clinical stage T cell redirecting bispecific programs (REGN1979, REGN4018, REGN5458) as well as status updates from the ongoing clinical trials. In addition, data from new combinatorial approaches being taken to enhance bispecific anti-tumor efficacy, focusing on costimulatory bispecifics, will be discussed.
  • ||||||||||  [VIRTUAL] Combinatorial Approaches to Enhance Bispecific Anti-Tumor Efficacy () -  Aug 31, 2020 - Abstract #PEGS2020PEGS_131;    
    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.