Alessandra Magnani

Head of the Advanced Therapies and Immunotherapy Platform at Hospital Sant Joan de Deu

Speaker

Dr Alessandra Magnani is the Head of the Advanced Therapies and Immunotherapy Platform at Hospital Sant Joan de Déu (HSJD) Barcelona, Spain. She is a pediatric immunologist and researcher with experience ranging from pediatric rheumatology to autoimmunity, Inborn Errors of Immunity (IEI), Hematopoietic Stem Cell Transplantation (HSCT) and Gene Therapy (GT). She obtained in 2004 her Medical Degree at the University of Pavia, Italy, with a thesis on ANA-positive Juvenile Idiopathic Arthritis and initially focused on Pediatric Reumathology with Pr Martini and Pr Ravelli at Gaslini Institute in Genoa, Italy (Felici et al, J Rheum 2005; Bartoli et al, Ann Rheum Dis. 2008; Magnani et al, J Rheum, 2009; Meiorin et al, Clin Exp Rheumatol. 2009; Ravelli A et al, Arthritis Rheum 2011). With Pr AM Prieur in Necker-Enfants malades Hospital, Paris, she obtained a pediatric rheumatology Master («Diplôme Universitaire de Rhumatologie pediatrique», Université Paris Descartes).

During her residency, she started experiencing in primary immunodeficiencies and HSCT in Necker Hospital in Paris under the supervision of Pr Alain Fischer, and in 2009 completed a thesis on the inflammatory complications in Chronic Granulomatous Disease (Magnani et al, JACI 2014; Magnani et al., Paed Drugs 2016).

With the aim of acquiring research skills and a deeper insight into basic immunology and autoimmunity, she completed a PhD program in “Clinic, genetics and immunology of diseases of the developmental age”, between the University of Genoa (Pr R. Ravazzolo, Pr A. Martini) and the Novartis Institute for Biomedical Research in Basel, Switzerland (E. Traggiai, T. Pietzonka) on the pathogenesis of the poliautoimmune APECED syndrome, for which she was awarded with the 2012 ESID-Baxter Fellowship Award. After completing her PhD, she was recruited for a postdoctoral position by Pr Alain Fischer and Dr Rieux-Laucat at the Immunogenetics of pediatric Autoimmune Diseases Laboratory at Imagine Institute in Paris.

In 2014 she joined the Cell and Gene Therapy Laboratory at the Biotherapy Department headed by Pr Cavazzana in Necker-Enfants malades Hospital in Paris, where she worked in both the cell factory and the GMP facility, with the following functions: i) Deputy Qualified Person for cellular therapy and advanced therapy medicinal products (ATMPs), ii) Head of Quality Control for cellular therapy products and ATMPs, and iii) Processing Facility Medical Director of the Laboratory for the Joint Accreditation Committee ISCT-Europe & EBMT (JACIE).

In the cell factory, she specialised in allogeneic and autologous HSCT manipulation especially in children with primary immunodeficiencies and hematologic disorders (Neven et al., Biol Blood Marrow Transplant 2019; Cappelli et al., Haematologica 2019; Boulanger et al., Bull Cancer 2016; Fremond et al., Thorax 2019; Couzin et al., J Clin Apher 2020; Calmels et al., Bull Cancer 2020). This included innovative protocols of cells immunoselection and immunodepletion, including CD45RA and TCRab/CD19 depletions (the only cell factory in France), and innovative approaches like in utero allogeneic HSCT for SCID (Magnani et al., Blood Adv 2019).

In the GMP facility, she was deputy Qualified Person (QP) and Quality Control (QC) Responsible for 8 different Phase I/II GT clinical trials including Primary Immunodeficiencies, Hemoglobinopathies, HIV patients and Human T Lymphocyte Progenitors (HTLP) generation, as follows: - Severe combined immunodeficiency (SCID) Artemis GT clinical trial (EudraCT Number: 2019-003555-11) (QC Responsible, Deputy QP and Scientific Director); - SCID X-linked long-term follow up after gene therapy (GT) (QC responsible and co-investigator); - Wiskott-Aldrich Syndrome (WAS): Long-term follow-up protocol for GT patients (Eudract N° 2014-000274-20) (Magnani et al., Nature Medicine, 2022) (QC Responsible and co-investigator); - Chronic Granulomatous Disease (CGD) GT clinical trial (Six et al., Blood 2020; Cesana et al., Nature Medicine 2021; Touzot et al., Blood 2015; Sobrino*, Magnani* Cell Rep Med. 2023) (QC Responsible and Deputy QP); - β-hemoglobinopathies and sickle cell disease GT clinical trial (NCT02151526) (Magnani et al., Haematologica 2019; Ribeil et al., N Engl J Med 2017; Lagresle-Peyrou et al., Haematologica 2018; Thompson et al., N Engl J Med 2018) Eudract n° 2018-001968-33 (QC Responsible and Deputy QP); - GT clinical trial in HIV patients affected by high risk lymphoma (Eudract N°: 2015-004453-41) (Delville et al., Mol Ther Methods Clin Dev 2019) (QC Responsible and Deputy QP); - 3 clinical trials based on advanced cell therapy for the acceleration of the immune reconstitution through Human T Lymphocyte Progenitors (HTLP) generation (EudractN°: 2018-001029-14) (André et al., Bone Marrow Transplant 2019) (QC Responsible and Deputy QP)

She was Scientific Director of the Phase I/II gene therapy clinical trial for Artemis SCID approved by ANSM in March 2021 (EudraCT Number: 2019-003555-11).

As a pediatric immunologist, she was also dedicated to the clinical and biological follow up of patients with primary immunodeficiencies after GT. In particular, she was the Principal Investigator of the long-term outcome study of WAS GT treated patients (Magnani et al., Nature Medicine, 2022) and co-PI of the study on CGD patients treated by GT (Sobrino*, Magnani* et al, Cell Rep Med. 2023).

In April 2022 Dr Magnani joined Sant Joan de Déu Pediatric Hospital (HSJD) in Barcelona, Spain, as the Head of the Advanced Therapies and Immunotherapy Platform of HSJD, and the responsible of the Gene Therapy program in the Hospital. HSJD’s Advanced Therapies and Immunotherapy Platform is a 1.280 m2 facility of first international level that includes four cleanrooms for ATMPs manufacturing according to international GMP requirements (for gene therapy, lentiviral production, cell therapy and tissue engineering) and an ATMPs research and development area. This provides both infrastructure and knowledge needed to support translational applicability and to facilitate the transition from pre-clinically developed processes into GMP-approved manufacturing procedures in several areas, including monogenic diseases of the hematopoietic system, pediatric oncology and hemato-oncology, and pediatric neuromuscular diseases.

Together with the Hospital Clinic Barcelona (HCB), the HSJD Advanced Therapies and Immunotherapy Platform forms the HSJD-HCB Joint Platform for Immunotherapy, which is at the forefront of the development of cell-based therapies (including academic CAR T-cell therapies and dendritic cell-based vaccines) to treat immune-mediated disorders (inborn errors of immunity, autoimmune and autoinflammatory disorders), and cancer.