2021: a key year for allogeneic cellular cancer immunotherapy?

Published: 10 March 2021
Sven Kili
Sven Kili
Principal, Sven Kili Consulting Ltd, UK
Sven Kili provides specialist strategic consulting services to innovative Regenerative Medicine companies. His clients include small and medium sized companies from company formation through to clinical development and commercialisation. He was previously the Head of Development for the Cell and Gene Therapy division of GSK Rare Diseases where he led teams developing ex-vivo Gene Therapies for a variety of rare genetic disorders including Strimvelis®, the first ex-vivo gene therapy to be approved for children with ADA-SCID; Wiskott – Aldrich syndrome (WAS); Metachromatic Leukodystrophy (MLD) and Beta-Thalassemia. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development, approval and commercialisation activities of the first combined ATMP approval in the EU for MACI®. His team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven led the cell therapy activities and oversaw all UK & Irish regulatory functions and was the QPPV for pharmacovigilance for the Geistlich Pharma. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada; Xintela – a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA and the VP of the Standards Co-ordinating Body for Regenerative Medicine. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.

Perhaps the key trend in 2020 for the cellular immunotherapy field was the emergence and advancement into the clinic of a new wave of novel allogeneic product candidates.

Allogeneic approaches offer clear advantages over autologous cell therapies, ranging from a less complex, more ‘pharma-friendly’ supply chain and less variable, healthier manufacturing starting materials, through to reduced wait manufacturing bringing Cost of Goods efficiencies, and potentially lower price points for a healthcare sector under growing financial constraints. However, there are some imposing obstacles to be addressed relating to demonstrating both safety and efficacy in the clinic, as well as overcoming scalability issues. In this month’s Clinical Trends, we dissect the development plans and ongoing clinical studies of some of the key industry players.

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