SAR446523 / Sanofi - LARVOL DELTA

Pre-clinical development of a novel anti-GPRC5D inducing potent anti-tumor effect through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) for multiple myeloma (AACR 2024) - "Like Sarclisa®, other therapies engaging NK cells and mediating tumor cell killing through antibody-dependent cell-mediated cytotoxicity (ADCC) mechanism have demonstrated their efficacy in clinic. SAR446523 led to a robust antitumoral efficacy with a significant improved mouse survival. These data demonstrating potent anti-tumor activity and favorable safety profile of this novel anti-GPRC5D antibody suggest that SAR446523 may be a promising therapy for patients with RRMM and provide consistent support for clinical development."

ADC • IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • FCGR3A • GPRC5D • IFNG • IL6 • TNFA

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2029 ➔ May 2031 | Trial primary completion date: Nov 2028 ➔ May 2031

First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

First-in-Human, Open-Label, Phase 1 Trial Design of SAR446523, a Novel Anti-GPRC5D Antibody-dependent Cellular Cytotoxicity (ADCC)-enhanced Monoclonal Antibody for Multiple Myeloma (IMS 2025) - P1 | "N/A"

Clinical • First-in-human • P1 data • Hematological Malignancies • Multiple Myeloma • FCGR3A

Press Release: Sanofi’s SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma (GlobeNewswire) - "The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, an IgG1-based Antibody-Dependent Cellular Cytotoxicity-enhanced (ADCC) monoclonal antibody (mAb) targeting G-protein coupled receptor family C group 5 member D (GPRC5D) for the potential treatment of patients with relapsed or refractory multiple myeloma (R/R MM)."

Orphan drug • Multiple Myeloma

FIRST-IN-HUMAN, OPEN-LABEL, PHASE 1 TRIAL DESIGN OF SAR446523, A NOVEL ANTI-GPRC5D ANTIBODY-DEPENDENT CELLULAR CYTOTOXICITY (ADCC)-ENHANCED MONOCLONAL ANTIBODY FOR MULTIPLE MYELOMA (EHA 2025) - P1 | "Key secondary endpoints include the duration of response, progression-free survival, minimal residual disease negativity, patient-reported symptomatic adverse events, PK, and potential immunogenicity of SAR446523. The trial is currently recruiting across 3 countries."

Clinical • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology • FCGR3A

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Sanofi | Phase classification: P1/2 ➔ P1

Phase classification • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting | Phase classification: P1 ➔ P1/2

Enrollment open • Phase classification • Hematological Malignancies • Multiple Myeloma • Oncology