CiMaas recently applied for a classification for its’ Advanced Therapeutic Medicinal Product, adoptive NK cell therapy for multiple myeloma.
Upon this request, the European Medicines Agency / Committee for Advanced Therapies considers that product NK-Xpand-MM1 falls within the definition of somatic cell therapy medicinal product, as provided in Article 2 of Regulation (EC) No 1394/2007.
This classification marks the first step of the regulatory pathway CiMaas has taken to obtain the manufacturing license to produce Natural Killer cells in its’ planned clinical trial for patients with multiple myeloma.