Cell therapy weekly: EMA issues positive opinion for Tecartus, Kite’s CAR- T cell therapy

Written by Megan Giboney

This week: EMA issues positive opinion for Tecartus, Kite’s CAR-T cell therapy, Oxford Biomedica and Orchard Theapeutics joint project will utilize LentiStable™ technology and, Affini-T Therapeutics appoints Dirk Nagorsen as Chief Medical Officer.

The news highlights:


EMA issues positive opinion for Tecartus, Kite’s CAR-T cell therapy

Kite Pharma (CA, USA) has received a positive opinion from the European Medicines Agency’s (EMA; Amsterdam, Netherlands) Committee for Medicinal Products for Human Use for their CAR-T cell therapy, Tecartus®. The CAR-T therapy is for the treatment of adult patients of 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approval by the EMA would address a significant unmet need and make Tecartus the first and only CAR-T cell therapy for this patient population. With current standard-of-care therapies, the median overall survival time for people with acute lymphoblastic leukemia is only approximately eight months.

Christi Shaw, CEO of Kite stated, “Today’s ‘Committee for Medicinal Products for Human Use’ positive opinion in adult [acute lymphoblastic leukemia] brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.”

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Oxford Biomedica and Orchard Therapeutics joint project will utilize LentiStable™ technology

Oxford Biomedica (Oxford, UK), a cell and gene therapy company specializing in the development of gene-based therapeutics, has announced a partnership with Orchard Therapeutics (London, UK), a global gene therapy leader. The project will utilize Oxford Biomedica’s LentiStable™ technology platform to generate a producer cell line that can stably express lentiviral vectors. The focus of the project will be on developing high-performance candidate clones for Orchard Therapeutics’ investigational autologous  hematopoietic stem cell gene therapy, OTL-203, which is in development for treatment of mucopolysaccharidosis type I Hurler’s syndrome.

Nicoletta Loggia, Chief Technical Officer, Orchard Therapeutics, stated: “This project underscores Orchard’s commitment to continued innovation in all aspects of our operations, including manufacturing. The evaluation of stable cell producer lines is part of our focus on establishing a sustainable lentiviral vector manufacturing platform. We look forward to working with Oxford Biomedica to further explore this technology for the hematopoietic stem cell gene therapy field.”

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Affini-T Therapeutics appoints Dirk Nagorsen as Chief Medical Officer

Dirk Nagorsen has been announced as the new Chief Medical Officer of Affini-T Therapeutics (MA, USA), a biotechnology company unlocking the power of T cells against oncogenic driver mutations. Former Vice President Early Development and Therapeutic Area Head, Hematology & Oncology Early Development at Amgen (CA, USA), Nagorsen brings over two decades of experience in oncology and hematology to the role.

“We are seeing rapid advances in both cell therapy and our ability to target oncogenic driver mutations commonly found in hard-to-treat solid tumors,” said Nagorsen. “By combining the potency of T cells with synthetic biology and the specificity of T cell receptors, Affini-T’s team of world-class researchers and drug developers can fully realize the potential of oncogenic driver mutations as the solution to potentially cure patients with solid tumors. With this, I see the company at the forefront of a new chapter in precision immunotherapy and I am proud to join as Chief Medical Officer.”

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