SAR445514
/ Innate, Sanofi
- LARVOL DELTA
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May 16, 2025
THE BCMA NK CELL ENGAGER SAR'514 INDUCES MACROPHAGE-MEDIATED PHAGOCYTOSIS WHICH IS IMPROVED BY COMBINATION WITH EVORPACEPT, A CD47 BLOCKER, IN MULTIPLE MYELOMA
(EHA 2025)
- P1/2 | "In summary, these results demonstrate the potential of the combination of SAR'514 and evorpacept in improving SAR'514-mediated phagocytosis and provide support for exploring SAR'514 in combination with CD47 blockade in treatment of patients with MM."
Hematological Malignancies • Multiple Myeloma • Oncology • CD47 • FCGR3A • SIRPA
June 12, 2025
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=32 | Terminated | Sponsor: Sanofi | Trial completion date: Apr 2028 ➔ May 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2027 ➔ May 2025; Early discontinuation based on sponsor decision not driven by any safety concerns.
Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
May 15, 2025
Innate Pharma Highlights ANKET Abstracts Selected for the EHA 2025 Congress
(Businesswire)
- "Innate Pharma SA...today announced that an abstract regarding IPH6501, its ANKET targeting CD20 B cells currently developed in relapsed and/or refractory Non-Hodgkin Lymphoma, has been selected for the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy....In addition, an abstract related to SAR’514/IPH6401 (developed by Sanofi) was accepted for online publication."
Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Multiple Myeloma
April 22, 2025
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
March 06, 2025
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=32 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | N=111 ➔ 32
Enrollment change • Enrollment closed • Monotherapy • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
December 07, 2024
The Combination of the Novel Trifunctional BCMA NK Cell Engager SAR445514 with IMiDs and Celmods Enhances Cytotoxicity Against Multiple Myeloma Cells As Compared to Single Agents
(ASH 2024)
- P1/2 | "When SAR'514 was combined with either pomalidomide, iberdomide or mezigdomide, a higher cytotoxic activity was observed as compared to single agent pomalidomide (p=0.1197) and significantly higher as compared to single agent iberdomide (p=0.0035) or mezigdomide (p=0.0026). SAR'514 shows the highest potency in combination with mezigdomide.Conclusion : In summary, these results demonstrate that the combinations of SAR'514 with pomalidomide IMiD or iberdomide and mezigdomide CELMoDs potentiate MM tumor cell killing in vitro and provide consistent support for the evaluation of this combination in patients with multiple myeloma."
Hematological Malignancies • Multiple Myeloma • Oncology • FCGR3A
November 04, 2024
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=111 | Recruiting | Sponsor: Sanofi | Trial primary completion date: Apr 2026 ➔ Mar 2027
Monotherapy • Trial primary completion date • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
August 09, 2024
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=111 | Recruiting | Sponsor: Sanofi | Trial completion date: Aug 2027 ➔ Mar 2028
Monotherapy • Trial completion date • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
January 30, 2024
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=101 | Recruiting | Sponsor: Sanofi | Trial completion date: Mar 2027 ➔ Jun 2027 | Trial primary completion date: Jan 2026 ➔ Apr 2026
Monotherapy • Trial completion date • Trial primary completion date • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
August 18, 2023
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=101 | Recruiting | Sponsor: Sanofi | Trial primary completion date: Mar 2027 ➔ Jan 2026
Monotherapy • Trial primary completion date • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
July 11, 2023
First Patient Dosed in SAR’514 / IPH6401 Phase 1/2 Clinical Trial in Relapsed/Refractory Multiple Myeloma
(Businesswire)
- "Innate Pharma SA...announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626), evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)....The purpose of the dose escalation and dose expansion study is to evaluate the safety, pharmacokinetics and preliminary efficacy of SAR’514 in monotherapy in patients with RRMM and RRLCA."
Trial status • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
June 01, 2023
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=101 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting
Enrollment open • Monotherapy • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
May 30, 2023
Estimating the potential economic impact of the Wasfaty program on costs of antidiabetic treatment: An initiative for the digital transformation of health.
(PubMed, Saudi Pharm J)
- "The savings from the clinical decision support system preventing undesirable medication costs were estimated at USD 9,842,720 (SAR 36,910,201), and savings from the prevention of undesirable adverse events were estimated at USD 137,332,615 (SAR 514,997,308) for a 6% prediction. The total healthcare expenditure savings were USD 258,762,981 to 274,972,971 (SAR 970,361,178 ± 1,031,148,640). Implementing the new digitization and privatization initiatives (i.e., the Wasfaty program) as a result of the transformation in the health care sector had led to a significant reduction in health care expenditures and cost savings with respect to clinical and pharmacy services using diabetes mellitus as an example."
HEOR • Journal • Diabetes • Metabolic Disorders
May 03, 2023
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
(clinicaltrials.gov)
- P1/2 | N=101 | Not yet recruiting | Sponsor: Sanofi
New P1/2 trial • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology
March 14, 2023
The novel trifunctional anti-BCMA NK cell engager SAR’514 has potent in-vitro, in-vivo and ex-vivo anti-myeloma effect through dual NK cell engagement
(AACR 2023)
- "Importantly, SAR’514 exhibits ex vivo efficacy using bone marrow mononuclear cells (BMMC) from MM patients in an autologous setting showing an active and efficient primary MM cell killing against MM cells from patients that have failed diverse therapies, including standard of care treatments. In summary, these results demonstrate the efficacy of SAR’514 for controlling MM tumors in vivo and ex vivo, and provide consistent support for its clinical development."
IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • Thymoma • Thymus Cancer • FCGR3A • IFNG • IL1B • IL6 • TNFA
November 04, 2022
The Novel Trifunctional Anti-BCMA NK Cell Engager SAR'514 Has Potent in-Vitro and in-Vivo Anti-Myeloma Effect through Dual NK Cell Engagement
(ASH 2022)
- "As compared to the control group in which only 20% of mice survived with a median survival day of 44.5 days, SAR'514 induced a significant mouse survival from 0.5 mg/kg to 5 mg/kg with an overall survival of 90% and a median survival day over 90 days. In summary, these results demonstrate the efficacy of SAR'514 for controlling MM tumors in vivo and provide consistent support for its clinical development."
IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • Thymoma • Thymus Cancer • FCGR3A • IFNG • IL1B • IL6 • TNFA
November 04, 2022
Innate Pharma to Present Results From a Preliminary Analysis of the TELLOMAK Phase 2 Trial in Patients With Advanced Sezary Syndrome and ANKET Platform at ASH 2022
(Businesswire)
- "Innate will share preliminary results of the cohort evaluating lacutamab in Sezary syndrome patients post-mogamulizumab from the ongoing TELLOMAK Phase 2 trial. Chief Scientific Officer, Eric Vivier, DVM, PhD, to give an oral presentation on multispecific antibodies platform: ANKETTM. Partner Sanofi will display two posters on SAR’579/IPH6101 and SAR’514/IPH6401...Innate Pharma SA...announced that the following presentations will be presented at the 64th ASH (American Society Hematology) Annual Meeting taking place from December 10-13, 2022, in New Orleans, Louisiana."
P1/2 data • P2 data • Preclinical • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome
July 21, 2022
Second Innate Pharma NK Cell Engager Selected by Sanofi as Drug Candidate for Development
(Businesswire)
- "Innate Pharma SA...announced that Sanofi has made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a €3 million milestone payment....Sanofi will be responsible for all future development, manufacturing and commercialization of IPH6401/SAR’514....This milestone is part of the previously announced research collaboration with Sanofi, under which the companies collaborate on the generation and evaluation of up to two bispecific NK cell engagers, using the ANKET platform from Innate that simultaneously targets two NK activating receptors, NKp46 and CD16, to optimize NK cell activation and Sanofi’s proprietary antibody format as well as anti-tumor target antibodies."
Financing • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
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