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Agreements

Date: 2016-04-25

Type of information: R&D agreement

Compound: CAR-Treg cellular therapy product

Company: Txcell (France) Ospedale San Raffaele (Italy)

Therapeutic area: Autoimmune diseases - Kidney diseases - Renal diseases

Type agreement:

R&D

Action mechanism:

cell therapy/gene therapy/cell immunotherapy. CAR (chimeric antigen receptor) T-cells are lymphocytes armed with chimeric antigen receptors. T cells are collected from a patient and genetically engineered to produce chimeric antigen receptors on their surface. When chimeric antigen receptors are present at the surface of T-cells, these lymphocytes are able to recognize and kill cells that harbor the targeted protein or antigen on their surface. CARs are constructed by assembling domains from different proteins, each of which enables the chimeric molecule to carry out specific functions.

 

Disease: lupus nephritis

Details:

* On April 25, 2016, TxCell, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe chronic inflammatory and autoimmune diseases, and Ospedale San Raffaele (OSR), one of the most prestigious research institutions in Europe in the field of cell and gene therapy, announced they have entered into a strategic R&D collaboration. The collaboration will include a development arm focused on Lupus Nephritis, as well as a research program dedicated to CAR-Treg biology.

The development part of the collaboration will focus on the non-clinical development of Chimeric-Antigen-Receptor engineered regulatory T (CAR-Treg) cells for the treatment of lupus nephritis. Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. TxCell scientists identified a first relevant antigenic target for its CAR-Treg cellular therapy product. They successfully created a CAR-Treg product candidate by engineering FoxP3+ Treg cells with a CAR. This CAR integrates the binding domain of a pathogenic antibody from patients suffering from lupus nephritis. As per the terms of the agreement announced, TxCell and OSR will conduct the non-clinical pharmacology and toxicology studies with CAR-Treg cells to prepare for a first-in-man study in lupus nephritis patients.  “TxCell looks forward to leveraging its unparalleled technology to contribute to treatments for Lupus Nephritis, one of the world's most devastating yet underserved diseases. In addition to our first program in Lupus Nephritis, TxCell expects to start two additional CAR-Treg programs later this year on the back of additional in vitro and in vivo data”said Dr. Arnaud Foussat, CSO of TxCell.

In parallel, the collaboration will also include a research arm, where OSR will perform research for TxCell on the design and biology of other chimeric antigen receptors for use in Treg cell products addressing other autoimmune indications. Dr. Attilio Bondanza, Head of the Innovative Immunotherapies Unit at Ospedale San Raffaele, will lead the OSR team both in the development of CAR-Tregs in Lupus Nephritis and in the research program on CAR-Treg biology. Prof. Fabio Ciceri, Head of the Hematology and Bone Marrow Transplantation Unit and Deputy Director of the Division of Regenerative Medicine, Stem Cells and Gene Therapy of OSR, will also join the collaboration members. As a result of his pioneering experience in the field of clinical T-cell gene therapy, he will steer the collaboration towards a first-in-man study.

 

Financial terms:

Financial terms of the collaboration have not been disclosed.

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