What is IPH6101/SAR443579?
IPH6101/SAR443579 (SAR’579) is the first trifunctional anti-CD123 NKp46/CD16 NK cell engager using Innate’s proprietary multispecific antibody format ANKET®. It is part of a research collaboration and licensing agreement with Sanofi, under which the companies collaborate on the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.
IPH6101/SAR443579 has shown anti-tumor activity in pre-clinical models, including supporting pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies, leading to its selection as a drug candidate for development.
Mecanism of action
It induces a dual targeting of the NK activating receptors NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
- The acute myeloid leukemias (AML) are malignant proliferations of medullary blood cell precursors associated with a maturation block at an immature stage. The result is an accumulation of these immature cells, or blasts, in the bone marrow, blood and possibly other organs, and a parallel inability of the bone marrow to produce normal, functional blood cells. CD123, interleukin-3 receptor alpha chain [IL-3 Rα], is highly expressed in AML, particularly within the AML stem cell compartment.
Approximately 3,500 cases are diagnosed each year, with frequency increasing with age (median age around 67-70 years). Depending on age, "white blood cell" count at diagnosis and cytogenetic and molecular abnormalities of the tumor cells, AML is fatal sooner or later, if aggressive treatment is not initiated. - Acute lymphoblastic leukemia includes malignant transformation and uncontrolled proliferation of a hematopoietic progenitor cell can lead to massive infiltration of the bone marrow by malignant cells, the appearance of high numbers of circulating blasts, and the possibility of leukemic infiltration of the central nervous system and testicles. Symptoms include asthenia, pallor, infections, bone pain, central nervous system symptoms (e.g., headache), bruising and hemorrhage.
| IPH6101/ SAR443579 CD123 Collaboration with Sanofi | Clinical trial, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS), sponsored by Sanofi.
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| Preclinical | Phase 1/2 | Phase 3 | |
Under the terms of the license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma is eligible for up to €400m in development and commercial milestone payments as well as royalties on net sales. Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the collaboration.
A new licensing agreement was signed with Sanofi in 2022, to include new drug candidates in the collaboration, bringing the total value of the agreement to 1.75 billion euros.
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