CAMBRIDGE, Mass., March 8, 2018 – Sigilon Therapeutics, a biopharmaceutical company that discovers and develops immune-privileged living therapeutic implants, today announced that 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. The recommendation, adopted by the committee on Nov. 9, 2017, 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.
“This first ATMP classification for our platform technology is an important step in engaging with regulatory authorities for this entirely new category of genetically engineered cell factory therapeutics and is a critical step toward commercialization in Europe for advanced therapies like SIG-003,” commented Paul Wotton, Ph.D., Chief Executive Officer of Sigilon Therapeutics. “As we proceed in development, it is critical that we work with regulators to define a clear path toward market approval from the earliest stages, which includes satisfying established international guidelines and standards for the future introduction of new Living Therapeutics.”
ATMP classifications are granted for new therapeutics which fulfill the definitions for medicinal products that are gene therapy, somatic cell therapy and/or tissue engineered products. The ATMP classification provides regulatory guidelines for preclinical development, manufacturing and product quality testing. The regulation also offers incentives including fee reductions for regulatory advice, recommendations and evaluation and certification of quality and non-clinical data. Additional information on the ATMP confirmation can be found at the European Medicines Agency website at www.ema.europa.eu/ema.
About Sigilon Therapeutics
Founded and created by Flagship Pioneering, Sigilon Therapeutics is a biopharmaceutical company that discovers and develops immune-privileged living therapeutic implants for the treatment of chronic diseases. Treatments based on Sigilon Therapeutics’ Afibromer™ technology platform include cell implants that act as responsive “living therapeutics,” providing more natural control for diseases that are currently treated with intermittent injection or infusion. Initial areas of focus include hematologic, enzyme deficiency, endocrine and metabolic disorders. More natural control would restore health and free patients from the need for therapies that are disruptive to quality of life.