SAR440234 / Sanofi - LARVOL DELTA

Vaccine-Educated T cells and a CD123 Bispecific T-Cell Engager for Treatment of Acute Myeloid Leukemia. (PubMed, Blood Adv) - "We demonstrated that the combination of CD123 T cell engager (SAR440234) and veTc boosted tumor specific T cell immunity and enhanced anti-leukemia effect in vitro...This effect was associated with an increase in cytotoxic T cell subsets and clonotypic expansion. Thus, the combination of T cell engager with adoptive T cell transfer of vaccine educated T cells is a novel approach that merits further investigation in clinical trials."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CD123 • IL3RA

Treatment with DC/AML Fusion Vaccine and CD3xCD123 Bi-Specific T-Cell Engager (CD123-CODV-TCE) for Treatment of Acute Myeloid Leukemia (TCT-ASTCT-CIBMTR 2022) - "We demonstrated that the combination of DC/AML fusion vaccine and CD123TCE led to increase in tumor specific Tc immunity, both ex-vivo and in a xenograft murine model when compared to uneducated Tc with CD123TCE or educated Tc with isotype control. Most significantly, the combination treatment was shown to eradicate AML in this model with all animals remaining AML several months post inoculation."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Immunology • Leukemia • Oncology • CD123 • CD8 • GZMB • IFNG • TNFRSF9

CD123-CODV-TCE bispecific T-cell engager for acute myeloid leukemia (AML): Activity on primary AML and safety in non-human primates (AACR 2022) - "Importantly, following the dose-escalation scheme 0.1/1/3/3 µg/kg, only limited cytokine release after the 4th administration was observed, suggesting that mitigation of cytokine release can be obtained by progressive intra-monkey dose escalation. Taken together, these results indicate that CD123-CODV-TCE leads to potent and specific leukemic cancer cell killing independently of CD123 receptor density and E:T ratio, and that studies monitoring cytokine release in monkeys can be useful for future clinical development of TCEs in the setting of R/R AML."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123 • CXCL8 • IFNG • IL6 • TNFA

Treatment with DC/AML Fusion Vaccine and CD3xCD123 Bi-Specific T-Cell Engager (CD123-CODV-TCE) for Treatment of Acute Myeloid Leukemia (ASH 2021) - "We demonstrated that the combination of DC/AML fusion vaccine and CD123TCE led to increase in tumor specific T cell immunity, both ex-vivo and in a xenograft murine model when compared to uneducated T cells with CD123TCE or educated T cells with isotype control molecule. Most significantly, the combination treatment was shown to eradicate AML in this model with all animals remaining disease-free several months post inoculation."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Immunology • Leukemia • Oncology • CD123 • CD4 • CD8 • GZMB • IFNG • TNFRSF9

First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2; N=7; Terminated; Sponsor: Sanofi; N=77 ➔ 7; Trial completion date: Sep 2023 ➔ Jan 2021; Recruiting ➔ Terminated; Trial primary completion date: Sep 2023 ➔ Jan 2021; Sponsor decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER (GlobeNewswire) - "Libtayo® (collaboration with Regeneron) sales were €26 million (up 125.0%) in the first quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches; Sarclisa...First-quarter Sarclisa® sales were €34 million driven by additional country launches. First-quarter sales in the U.S. and in Europe were €12 million and €13 million, respectively. In Rest of the World sales (€9 million) were driven by a strong performance in Japan...SAR440234, T cell engaging multi specific antibody, has been discontinued in leukemia."

Discontinued • Sales • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Squamous Cell Carcinoma

First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2; N=77; Recruiting; Sponsor: Sanofi; Trial completion date: May 2023 ➔ Aug 2023; Trial primary completion date: May 2023 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2; N=77; Recruiting; Sponsor: Sanofi; Trial completion date: Nov 2022 ➔ Feb 2023; Trial primary completion date: Nov 2022 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2; N=77; Recruiting; Sponsor: Sanofi; Suspended ➔ Recruiting; Trial completion date: Jul 2021 ➔ Sep 2022; Trial primary completion date: Jul 2021 ➔ Sep 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date