bexatamig (IPH6101) / Innate - LARVOL DELTA

COMPLETED DOSE ESCALATION FROM THE FIRST-IN-HUMAN, PHASE 1/2 STUDY OF CD123 NK CELL ENGAGER, SAR443579, IN RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA OR HIGH RISK-MYELODYSPLASIA (EHA 2024) - P1/2 | "1%) with** prior exposure to venetoclax. SAR'579 was well tolerated up to doses of 6 mg/kg QW with observed clinical benefit in adult pts with R/R AMLand a maximum response rate seen at a target dose of 1 mg/kg (33% CR/CRi). The bell-shaped dose-responsecurve is also observed in vitro in AML cell models. SAR'579 received breakthrough designation by the US FDAand these data will form the basis for selection of recommended doses for development in the phase 2 portionof TCD17197."

P1/2 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD123 • IDH2 • IL3RA • NRAS • RUNX1 • TET2 • TP53

A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia. (ASCO 2023) - P1/2 | "The median age was 70 years (range: 21 - 80) with 9 patients (39.1%) reporting prior hematopoietic stem cell transplantation (HSCT) and 16 (69.6%) had prior exposure to venetoclax. SAR’579 was well tolerated up to doses of 3000 µg/kg QW with observed clinical benefit in patients with R/R AML. The trial continues to accrue patients. Clinical trial information: NCT05086315."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • CD123 • FCGR3A

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Trial completion date: Apr 2026 ➔ Aug 2025

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

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2032 ➔ Jul 2029

Enrollment open • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: Sanofi | N=82 ➔ 126

Enrollment change • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Juvenile Myelomonocytic Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • IL3RA

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2; N=82; Not yet recruiting; Sponsor: Sanofi

Clinical • New P1/2 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - P1/2 | N=169 | Recruiting | Sponsor: Sanofi | N=126 ➔ 169 | Trial completion date: Nov 2026 ➔ Oct 2030

Enrollment change • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Juvenile Myelomonocytic Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • IL3RA

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Trial completion date: Nov 2027 ➔ Apr 2026

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

TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - P1/2 | N=169 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2030 ➔ May 2029 | Trial primary completion date: Dec 2025 ➔ Nov 2028

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Juvenile Myelomonocytic Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • IL3RA

TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov) - P1/2 | N=101 | Terminated | Sponsor: Sanofi | N=169 ➔ 101 | Trial completion date: May 2029 ➔ May 2025 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2028 ➔ May 2025; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Juvenile Myelomonocytic Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • IL3RA

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Trial completion date: Jul 2029 ➔ Nov 2027 | Trial primary completion date: Oct 2026 ➔ Jun 2024

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

First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS) (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Sanofi | Trial completion date: Aug 2025 ➔ Jan 2027 | Trial primary completion date: Jun 2024 ➔ Feb 2026

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

IPH6101 (ANKET anti-CD123, proprietary): (Innate Pharma Press Release, Innate Pharma Press Release) - "Innate regained the rights to SAR’579/IPH6101 in July 2025. Innate has initiated a research collaboration to further assess next steps of development."

Licensing / partnership • Licensing / partnership • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

IPH6101 (ANKET anti-CD123, proprietary): (Innate Pharma Press Release, Innate Pharma Press Release) - "Innate regained the rights to SAR’579/IPH6101 in July 2025. Innate has initiated a research collaboration to further assess next steps of development."

Licensing / partnership • Licensing / partnership • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Phase 1/2, Open-Label, Multi-Center Study Assessing the Safety, Tolerability and Preliminary Efficacy of CD123 Natural Killer Cell Engager (NKCE), SAR443579, in Combination with Venetoclax and Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy (ASH 2024) - P1/2 | "The expected duration of this sub-study 1 is approximately 5 years with a follow-up period of 2 years post-treatment. The study is currently recruiting."

Clinical • Combination therapy • P1/2 data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Oncology • CD123 • FCGR3A • IL3RA

First-in-Human Study of the CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia or High Risk-Myelodysplasia: Updated Safety, Efficacy, Pharmacokinetics and Pharmacodynamics (ASH 2023) - P1/2 | "Pts had received a median of 2.0 (1.0 –10.0) prior lines of treatment with 13 pts (30.2%) reporting prior hematopoietic stem cell transplantation and 36 pts (83.7%) with prior exposure to venetoclax. SAR'579 was well tolerated up to doses of 6000 µg/kg QW with observed clinical benefit in pts with R/R AML. The results are consistent with the predicted favorable safety profile."

Clinical • First-in-human • P1 data • PK/PD data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Transplantation • CD123 • IL3RA

A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=7 | Terminated | Sponsor: Sanofi | N=18 ➔ 7 | Active, not recruiting ➔ Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns

Enrollment change • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Sanofi | Trial completion date: Jun 2026 ➔ Aug 2025

Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2029 ➔ Jun 2026 | Trial primary completion date: Feb 2029 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

ANTITUMOR CHARACTERIZATION OF IPH6501, A NOVEL IL2V-ARMED TETRASPECIFIC NK CELL ENGAGER TARGETING CD20 B CELLS, IN DLBCL AND FL PATIENT SAMPLES, AND IN PRECLINICAL COMBINATION WITH R-CHOP (EHA 2025) - P1/2 | "Yet, there remains an unmet medical need for patients ineligible, refractory to, or relapsing (R/R) from these therapies.Leveraging natural killer (NK) cells emerges as a promising strategy in hematological malignancies, as reported in a Phase 1/2 study with IPH6101/SAR'579 in R/R AML (Garciaz, EHA 2024). The ex vivo preclinical evaluation of IPH6501 using patient samples provides supportive evidence to explore IPH6501 in R/R DLBCL and FL patients. Furthermore, the strong antitumor activity of IPH6501 in a rituximab-resistant model, together with the significant improvement of its antitumor activity when combined with R-CHOP in a rituximab sensitive model suggests that IPH6501 could be employed in B-NHL patients beyond monotherapy and paves the way for the evaluation of other combinations. IPH6501 is currently under investigation in a global first-in-human Phase 1/2 study (NCT06088654)."

IO biomarker • Preclinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2

Innate Pharma Regains Its Rights on CD123 Targeting ANKET and Announces Sanofi’s Intention to Make a Strategic Investment in the Company (Businesswire) - "Innate Pharma SA...announce review of their January 2016 Research Collaboration and License Agreement (the '2016 Agreement') with Sanofi...As previously disclosed and in alignment with its current strategic priorities, Sanofi will opt to pursue the development of SAR’514/IPH6401 (BCMA ANKET) in autoimmune indications under the terms of the 2016 License Agreement; In alignment with both company's current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET); Innate will regain its rights on SAR’579/IPH6101 (CD123 ANKET)...The continued Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma will be terminated early and SAR’514/IPH6401 will now be refocused to pursue development in autoimmune indications."

Licensing / partnership • Trial termination • Acute Myelogenous Leukemia • Multiple Myeloma

Innate Pharma Highlights Abstracts Selected for the ASH Annual Meeting 2024 (Businesswire) - "Innate Pharma SA...today announced that abstracts related to lacutamab health-related quality of life and translational data from the TELLOMAK trial and SAR443579, Sanofi-partnered ANKET® asset, have been selected for the American Society of hematology (ASH) Annual Meeting."

Clinical data • P2 data • Mycosis Fungoides • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Sanofi | Trial completion date: Feb 2029 ➔ Aug 2029

Trial completion date • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Preclinical characterization of IPH6501: a novel IL2v-armed tetraspecific NK cell engager targeting CD20 in relapsed or refractory B cell non-Hodgkin lymphoma subtypes and post-CAR-T therapy (SITC 2024) - P1/2 | "NK cell engager molecules have shown efficacy in acute myeloid lymphoma (IPH6101/SAR'579, NCT05086315)...In vitro, cytotoxicity assays reveal that IPH6501 stimulates PBMCs from post rituximab R/R B-NHL patients to kill a CD20+ lymphoma cell line...Cell collection were obtained through the CeVi_Collection Project from the CALYM Carnot Institute funded by the French National Research Council (ANR). Additional amples were collected and stored within the biobank of the CRB SUD, CRB HCL (BB-0033-00046), the CRB-Santé Rennes (BB-0033-00056), the CRB Cancer IUCTO (BB-0033-00014), the CRB CHU de Montpellier (BB-0033-00031) and CRB Gustave Roussy (2022- A00472-41) which has been declared to the Ministry of Higher Education and Research after receiving approval from the ethical committee."

IO biomarker • Preclinical • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2RA

Innate Pharma Reports First Half 2024 Business Update and Financial Results (Businesswire) - "In July 2024, Sanofi initiated a new Phase 1 / Phase 2, randomized, open label, multi-cohort, multi-center study (NCT06508489) assessing the safety, tolerability and preliminary efficacy of SAR’579 / IPH6101 administered in combination with azacitidine and venetoclax in patients with CD123 expressing hematological malignancies in newly diagnosed AML...IPH45 continues towards a Phase 1 trial in 2024...The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing. Preliminary results will be presented at the upcoming (European Society of Medical Oncology) ESMO Annual Meeting 2024."

New P1 trial • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor