TxCell SA, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe chronic inflammatory and autoimmune diseases, announced the signature of a strategic R&D collaboration agreement with the Lübeck Institute of Experimental Dermatology (LIED), a leading institution in the field of translational research on skin blistering diseases, part of the University of Lübeck in Germany.
This specific collaboration agreement covers the development of a CAR-Treg-based cellular immunotherapy for bullous pemphigoid, a rare, potentially fatal autoimmune disease characterized by tense inflammatory skin blisters and in some patients, erosions on mucous membranes.
TxCell scientists have already identified a relevant antigenic target for the development of a CAR-Treg product in bullous pemphigoid patients. The CAR construct will be designed to ensure the activation of CAR-Treg cells specifically in the inflammatory skin lesions.
“Launching the latest CAR-Treg development program in a very short period of time is a great achievement for TxCell,” said Dr. Arnaud Foussat, CSO of TxCell. “The program launch follows the recent signature of an R&D partnership with Ospedale San Raffaele for the development of CAR-Treg in lupus nephritis. These collaboration agreements clearly demonstrate that leading scientists recognize the potential of TxCell’s ENTrIA CAR-Treg platform to target a wide range of autoimmune and inflammatory indications. We will combine our expertise of CAR-Treg therapies with LIED’s expertise in the design of preclinical models for bullous pemphigoid.”
Resulting from the agreement announced today, TxCell and LIED will conduct non-clinical pharmacology studies with CAR-Treg cells to prepare for a first in-man study in bullous pemphigoid patients. The collaboration will involve two LIED teams: the Model Systems of Inflammatory Skin Diseases team led by Prof. Ralf Ludwig and the Translational Research team led by Prof. Enno Schmidt.
“LIED is dedicated to improving the diagnosis and treatment of patients with chronic inflammatory skin diseases, using both basic and translational research,” said Prof. Ralf Ludwig, head of the LIED Model Systems of Inflammatory Skin Diseases team. “The cellular therapy approach of TxCell’s ENTrIA platform contains great promise for autoimmune skin diseases like bullous pemphigoid.”
“The prevalence of bullous pemphigoid is continually increasing in both Europe and in the United States,” added Prof. Enno Schmidt, head of the LIED Translational Research team. “There is a high medical need for more specific and safer treatment modalities since patients are still mainly treated with corticosteroids. The development of a CAR-Treg approach with TxCell could represent a very important therapeutic option for patients suffering from bullous pemphigoid who are refractory or intolerant to available treatments.”
TxCell retains all rights on existing and future programs and products developed under this agreement. Financial terms of the collaboration have not been disclosed.
Bullous pemphigoid is a rare potentially fatal autoimmune skin condition that is characterized by large, fluid-filled blisters on the surface of the skin, called bullae. Bullous pemphigoid occurs when the patient’s immune system attacks a thin layer of tissue below the outer layer of skin. The blisters usually develop on the abdomen, legs and arms and are accompanied by severe itching. Occasionally, the inner lining tissue of the mouth, nasal passages, or genitalia can be involved. Bullous pemphigoid is most common in people aged 60 and older, with an estimated prevalence of 1/40,000. If untreated, it will persist for years, with periods of spontaneous remissions and exacerbations. Current treatment is based on long-term use of corticosteroids such as prednisone. Bullous pemphigoid can be life-threatening, especially for elderly people who are already in poor health.
ENTrIA (Engineered Treg for Inflammation and Autoimmunity) is the second TxCell proprietary cellular immunotherapy product platform and is composed of Chimeric Antigen Receptor engineered FoxP3+ Regulatory T cells (CAR-Treg). After their isolation from the blood of patients, FoxP3+ Treg cells are genetically modified by transduction with Chimeric Antigen Receptors (CAR). The CAR introduced into FoxP3+ Treg cells is designed to allow FoxP3+ Treg cell activation and immuno-modulation through in vivo recognition of a protein present in inflamed areas in patients suffering from autoimmune and chronic inflammatory diseases.