Sigilon Therapeutics is an early stage (preclinical) biotechnology company developing an encapsulated cell therapy technology. Its Afibromer™ Living Therapeutic candidate SIG-003 has been granted an Advanced Therapy Medicinal Product (ATMP) designation by the Committee for Advanced Therapies of the European Medicines Agency (EMA). The recommendation applies to allogeneic cells genetically modified to express human factor IX protein embedded in the Afibromer™ biomaterial and used for the long-term treatment of patients with hemophilia B [1]. The Afibromer™ material is designed to protect the cells from the immune system inside the body.
Afibromer™ polymer chemistry prevents the foreign body immune response. The company optimises different Afibromer™ chemistries for the encapsulation of specific cell lines [2]. Encapsulated cell technology has previously encountered problems with fibrosis – a scarring response to isolate foreign bodies and which is responsible for nutrient deprivation and therapeutic cell death. Afibromer™ technology has demonstrated lack of fibrosis in multiple animal species for up to 12 months. The therapy is designed to be stable for more than a year. Clinical studies are yet to commence.
The company is also pursuing Afibromer™ enabled cell therapy for lysosomal storage disorders, and diabetes. Importantly the company uses “off-the-shelf” proprietary allogeneic (banked) cell lines that can be genetically modified in a “plug and play” fashion using different expression cassettes (depending on the targeted therapeutic protein) which increases the efficiency of their preclinical discovery and development program. The cells can provide a steady supply of biotherapeutic to the body avoiding the need for repeat dosing.
ATMP classifications are granted to new medicinal product therapeutics in the gene therapy, somatic cell therapy and/or tissue engineered product categories. The ATMP classification will provide the company regulatory guidelines for preclinical development, manufacturing and product quality testing. Incentives are also offered by the ATMP designation including fee reductions for regulatory advice, recommendations, evaluation and certification of quality of non-clinical data [1].
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