Bringing you the latest cutting-edge research and commentary in bioscience.

Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Journal

Welcome to the latest issue of Cell and Gene Therapy Insights – the open access, peer-reviewed publication that brings you the latest insight and commentary from leading experts from academia and industry.

Editorial

The immunosuppressive tumor microenvironment: more than just immune checkpoints

Spotlight Article

Editorial

Mark Lowdell

Cellular Immuno-Oncology 4.0

In this issue we have review articles covering a wide spectrum of tumor immunotherapy options; embracing T cells and NK cells as immune effectors and dendritic cells as immune potentiators. These approaches include genetic manipulation to add function via chimeric receptors and control inhibition by targeted gene editing. The one thing they have in common is that the clinical outcome will be determined to a greater or lesser degree by the microenvironment in which the effector cells encounter tumor. In this second decade of the 21st century, oncologists have become true believers in the role of the immune response in the treatment and cure of cancer but it wasn’t always so. This sea change in belief has been driven by the substantial successes of the use of monoclonal antibodies which block immunoregulatory signals delivered by tumor cells to the patient’s cytotoxic T cells; so called ‘immune checkpoint inhibitors’, or CPIs. The first of these was an antibody to CTLA-4 and this was followed by others targeting PD-1. These off-the-shelf monoclonal antibody drugs have had significant success in a wide range of solid cancers including melanoma, non-small cell lung cancer, pancreatic cancer and prostate cancer. Many more are still in clinical trials and alternative therapies using the same regulatory axes are in development – anti-PD-L1, anti-CD39 and anti-CD73 to name but three. Despite these successes, it is fair to say that the majority of cancer patients are not cured by any of the current CPIs, even when used in combination. Nonetheless, the intense interest they have generated has raised awareness of the highly immunosuppressive nature of the tumor microenvironment which has led to a greater understanding of the complex interactions within a tumor and is leading to broader immunopotentiation strategies and the development of drugs to target those.

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Expert Roundtable

Immuno-oncology manufacturing: progress towards streamlined commercialization

Spotlight Article

Expert Roundtable

Anthony Davies, Øystein Åmellem, Knut Niss, Sanjin Zvonić

Cellular Immuno-Oncology 4.0

Anthony Davies
Executive Chairman, Dark Horse Consulting; Guest Moderator
Anthony founded Dark Horse Consulting in 2014, bringing 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. Anthony has a proven track record in managing pharmaceutical pipelines, is a skilled liaison with international regulatory agencies, and has an intense familiarity with a wide range of biologics, and cell and gene therapies. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.

Øystein Åmellem
Director of R&D at Thermo Fisher Scientific
Øystein is Director of R&D at Thermo Fisher Scientific. For more than 19 years, Dr. Åmellem has held different leadership positions in R&D, Product Management and Business in Thermo Fisher Scientific. In these roles he was responsible for development and commercialization of products and services, including for the cell therapy market. He received his PhD from the University of Oslo in the field of molecular cell biology. During his academic career, he focused on the study of physiological & molecular mechanisms of tumor cell growth and was involved in investigating the method of actions for a novel group of anti-cancer compounds developed by Norsk Hydro.


Knut Niss
Chief Technology Officer, Mustang Bio
Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.


Sanjin Zvonić
WindMIL Therapeutics
In his current role at WindMIL Therapeutics, Dr. Zvonić leads the development of WindMIL’s core technologies and pipeline products, while concurrently contributing to the organizational growth and development. In 2009, Dr. Zvonić joined PCT, where he focused on client engagement and technology transfer into PCT, giving him a comprehensive understanding of cell therapy development, manufacturing and commercialization requirements and strategies. In 2014, he joined Novartis Cell and Gene Therapy Unit, where he focused on the development and commercialization of Novartis C/GT pipeline products. In 2016 Dr. Zvonić returned to PCT, with a focus on driving the growth and development of PCT’s clinical and commercial manufacturing business lines while integrating into Hitachi Chemical.

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Gaining critical characterization insights for development of CAR-T Therapies for Solid Tumors

Spotlight Article

Expert Roundtable

Sadik Kassim, Janani Krishnamurthy, Tamara J Laskowski & John O’Rourke

Cellular Immuno-Oncology 4.0

Sadik Kassim
Executive Director, Kite Pharma, A Gilead Company
With a CV boasting the likes of Johnson & Johnson, the NIH, Novartis and Mustang Bio, Dr Sadik Kassim brings a wealth of experience and expertise spanning rare diseases, AAV-based gene therapy, immunotherapy, oncology, CAR-T cell therapies and CMC to his new role at Kite Pharma.

Janani Krishnamurthy
Senior Scientist, Atara Biotherapeutics
An expert in the fields of immunology, adoptive immunotherapy and neuroimmunology, Dr Janani Krishnamurthy enjoyed stints at MD Anderson, bluebird bio and TCR2 Therapeutics before taking on her current role leading EBV+ve CAR T cell pre-clinical initiatives for targeting solid tumours at Atara Biotherapeutics.

Tamara J Laskowski
Senior Research Scientist – Immunotherapy, Allison Group Department of Immunology, MD Anderson Cancer Center
Having originally joined Dr Laurence J.N. Cooper’s laboratory as a fellow, where her work focused on engineering stem cells with the goal of generating off-the-shelf NK and T-cell immunotherapies for targeting solid tumor malignancies, Dr Tamara Laskowski recently transitioned to Dr. James Allison’s Immunotherapy Platform at MD Anderson Cancer Center. In her new role Dr. Laskowski’s work primarily involves immune-monitoring of patients undergoing clinical trials in Immunotherapy and development of novel immunoassays.

John O’Rourke
Head of Product Development, Cell Analytics, Intellicyt, A Sartorius Company
John O’Rourke completed his Ph.D. in Biochemistry from The Ohio State University where he studied cancer biology and gene regulation. During his postdoctoral training at Nationwide’s Children’s Research Institute and the University of New Mexico, he continued his studies in cancer biology along with the development of viral and nanoparticle-based therapeutics. John O’Rourke completed his MBA at the Andersen School of Management at the University of New Mexico and joined IntelliCyt in 2017.

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Commercial Insights

Cell & Gene Therapy Commercial Insight – May 2019

Commercial Insights

Mark Curtis & Richard Philipson

Cellular Immuno-Oncology 4.0

Providing a critical overview of the sector’s commercial developments – M&As, licensing agreements & collaborations, financial results, IPOs and clinical/regulatory updates, with commentary from our Expert Contributors.

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Cell & Gene Therapy Commercial Insight – April 2019

Commercial Insights

Mark Curtis & Richard Philipson

Cellular Immuno-Oncology 4.0

Providing a critical overview of the sector’s commercial developments – M&As, licensing agreements & collaborations, financial results, IPOs and clinical/regulatory updates, with commentary from our Expert Contributors.

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Interview

Building robustness and scalability into the immuno-oncology supply chain

Spotlight Article

Interview

Lindsey Clarke

Cellular Immuno-Oncology 4.0

Lindsey joined Bio-Techne at the end of 2018 as EMEAs Cell and Gene Therapy Product Manager. Overseeing the portfolio of tools, technologies and instrumentation applicable to Cell and Gene Therapy her role to date has been focused on building the team to support Bio-Techne’s customers Cell and Gene Therapy applications, planning the roll out of a host of new innovations into the European market and developing strategic partnerships within the industry. Prior to this she spent 8 years in Miltenyi Biotec’s Cell and Gene Therapy team, working closely with numerous process development and manufacturing teams to assist them in translating their varied cell therapies to the clinic. During this time she contributed significantly to the national strategy for the successful roll out and market positioning of the CliniMACS Prodigy and GMP products for Cell Therapy manufacturing within the UK. Lindsey holds a First class degree in Pharmacology (MPharmacol) from the University of Bath and a PhD in Immunology from UCL. Her PhD research focused on surrogate markers of endothelial inflammation and repair in paediatric vasculitis and led on to a postdoctoral position at Imperial College in the Department of Bioengineering investigating atherosclerosis.

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Leading the charge: driving allogeneic CAR T cell immunotherapy towards clinical and commercial success

Spotlight Article

Interview

David Chang

Cellular Immuno-Oncology 4.0

David Chang is the President, Chief Executive Officer and Co-Founder of Allogene. He previously served as Executive Vice President, Research & Development, and Chief Medical Officer of Kite, a Gilead Company. He has an industry-leading track record of innovation in the field of oncology drug development, including the development of Yescarta™ (axicabtagene ciloleucel), the first CAR T therapy approved for non-Hodgkin lymphoma. From 2002 to 2014, he held senior leadership roles at Amgen, including Vice President of Global Development and Head of Hematology-Oncology. During this time, David spearheaded personalized therapy strategies underlying the success of Vectibix® (panitumumab). He also provided therapeutic area leadership to pivotal programs for Blincyto® (blinatumomab), a bispecific T cell engager antibody in acute lymphocytic leukemia and for IMLYGIC™ (talimogene laherparepvec), a first-of-its-kind oncolytic immunotherapy in melanoma. Prior to joining Amgen, David held dual appointments as Associate Professor of Medicine and of Microbiology, Immunology and Molecular Genetics at the David Geffen School of Medicine at the University of California, Los Angeles. He obtained a BS in biology from the Massachusetts Institute of Technology and MD and PhD degrees from Stanford University. David completed an internship and residency in internal medicine at Brigham and Women’s Hospital and a fellowship in medical oncology at Dana-Farber Cancer Institute at Harvard Medical School, where he was a Howard Hughes Medical Institute postdoctoral fellow.

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Taking on solid tumors with genetically engineered macrophages

Spotlight Article

Interview

Steven Kelly & Michael Klichinsky

Cellular Immuno-Oncology 4.0

Steven Kelly has been the President and CEO of CARISMA Therapeutics since February 2018. Before leading CARISMA, Mr Kelly was the founding CEO of Pinteon Therapeutics, an early stage Oncology and CNS development company. Prior to this he held a number of leadership positions in the biotechnology industry including: CEO, Theracrine; CCO, BioVex; CEO, Innovive Pharmaceuticals; as well as various commercial and manufacturing roles at Sanofi, IDEC Pharmaceuticals and Amgen. Mr Kelly holds a BS from the University of Oregon and an MBA from Cornell University.

Michael Klichinsky is a co-inventor of the CAR Macrophage technology and a scientific co-founder of Carisma Therapeutics Inc. In his role as VP of Discovery Research, he oversees the research and discovery efforts of the company. Michael developed CAR Macrophages during his doctoral thesis under the co-mentorship of Saar Gill and Carl June at the University of Pennsylvania. Michael’s scientific expertise is in the intersection of immunology, synthetic biology, cancer immunotherapy and translational pharmacology. Michael previously earned a Doctor of Pharmacy degree from the University of Sciences in Philadelphia, and a PhD in Pharmacology from the University of Pennsylvania.

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The promise of tumor-targeted gene-based delivery of immune-activating cytokines

Spotlight Article

Interview

Luigi Naldini

Cellular Immuno-Oncology 4.0

Luigi Naldini is the Director of the San Raffaele Telethon Institute for Gene Therapy and Professor at the San Raffaele University and Milan, Italy. He has pioneered the development and applications of lentiviral vectors for gene therapy and contributed to advance targeted genome editing in cell and gene therapy. He is member of EMBO, past President of ESGCT, and received the Outstanding Achievement Award from ASGCT in 2014 and from ESGCT in 2015, the Beutler Prize from ASH in 2017 and the 2019 Jeantet-Collen Prize for Translational Medicine.

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γδT cells and the future of drug resistant immunotherapy

Spotlight Article

Interview

Lawrence Lamb

Cellular Immuno-Oncology 4.0

Lawrence Lamb As Executive Vice President and Chief Scientific Officer, Dr Lamb currently directs clinical and translational research strategy and operations for Incysus Therapeutics. Dr Lamb was first to describe the association between relapse-free survival and γδT cell recovery in bone marrow transplant patients. For 26 years, most recently as Professor of Medicine and Director of the Cell Therapy Laboratory at the University of Alabama at Birmingham, Dr Lamb developed the scientific support for γδT cell-based immunotherapies. Today, this work has resulted in FDA approval for both the first clinical trials for allogeneic γδT cell therapy in leukemia patients undergoing haploidentical stem cell transplants and the first gene-modified γδT cell therapy for high-grade gliomas.

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Designing your facilities and processes with commercialization in mind

Interview

Peter Walters & Kim Nelson

Cellular Immuno-Oncology 4.0

Peter Walters is a process engineer with 15 years of experience. He specializes in pharmaceutical process and facility design. He is an industry-recognized subject matter expert in the advanced therapy medicinal product field and frequently speaks at industry conferences and events. He has a strong technical background designing equipment and processes for multiprocess facilities predicated on maximum flexibility, logistics optimization and technologies that reduce overhead costs, allow for pipeline expandability and produce a higher quality therapeutic. Coupled with his approachable business acumen, he is well respected for guiding clients to understand the impacts of facility design choices and acts as a steward to clients, assisting with the best decisions for their business and bottom line.

Kim Nelson PhD is a Senior Director at CRB. He is a recognized bioprocess design industry leader with more than 35 years of experience in process and facility design. He specializes in process design and scale-up, facility programming, layout and design, cGMP compliance, biocontainment, and contamination investigations for the biopharmaceutical industry. His operational experience includes hands-on pilot plant work as the Manager and Chief Scientist of large-scale cell culture and microbial pilot plants. Kim has assisted numerous clients with preparing and participating in Type C meetings with the FDA. Current areas of interest focus on cellular therapeutics, gene vectors, gene editing, plasmids and RNA products.

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Conference Insight

ISCT 2019 Commercialization Signature Series

Conference Insight

Miguel Forte

Cellular Immuno-Oncology 4.0

ISCT staged its third Signature Series conference session at the Phacilitate Cell & Gene Therapy World 2019 event in Miami In January this year. Through these events, the ISCT provides the opportunity for the corporate membership to meet face-to-face, to network, and to discuss key topics and issues around which ISCT seeks to provide thought leadership on an ongoing basis.

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Perspective

How biomarkers can be used to optimize the clinical development of dendritic cell vaccines in immuno-oncology

Spotlight Article

Perspective

Marcelo Bravo

Cellular Immuno-Oncology 4.0

Numerous clinical studies with dendritic cell (DC) vaccines to treat cancer have been conducted in the past two decades. While DC-based therapies have been shown to induce immune responses and to be safe, clinical outcomes have been disappointing. Nonetheless, emerging research suggests DC-based treatments might improve survival and there is renewed interest in next generation DC-based vaccine approaches, particularly in combination with other emerging immunotherapies such as checkpoint inhibitors. This article explores how predictive or prognostic biomarkers, either to select patients or to guide treatment, could be applied to improve outcomes of this novel therapeutic approach. Specifically, we discuss two main approaches: establishment of eligibility criteria based on confirmation of expression of the tumor-associated antigens used in the vaccine, and implementation of a delayed type hypersensitivity test to screen responders so as to extend treatment.

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The advantage of allogenicity when using Inflammatory dendritic cells as antitumor immune primers

Spotlight Article

Perspective

Sharon Longhurst, Juliana Kovacka, Emilia Heimann, Margareth Jorvid, Sijme Zeilemaker, Peter Suenaert & Alex Karlsson-Parra

Cellular Immuno-Oncology 4.0

For an allogeneic somatic cell therapy to become commercially successful in the field of oncology, where the patient population is significantly large, there needs to be an abundant supply of starting material, and the final product should be presented in a ready to use format that is available immediately, with no need to coordinate final stages of production with patient treatment schedules. Ideally the product should evade or modulate the immune system to avoid alloreactivity impacting on product efficacy, and the final cost of goods should be a low as is feasibly possible to ensure a cost-effective treatment. The allogeneic inflammatory dendritic cell product, ilixadencel, ticks a number of these boxes. The advantages of ilixadencel from a clinical and manufacturing perspective are discussed, as well as challenges that will need to be appropriately addressed to ensure future commercial success.

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Immunotherapy with iPSC-derived dendritic cells brings a new perspective to an old debate: autologous versus allogeneic?

Spotlight Article

Perspective

Paul J Fairchild, Timothy J Davies, Christopher Horton, Kumaran Shanmugarajah & Marcelo Bravo

Cellular Immuno-Oncology 4.0

The advent of induced pluripotency has raised the prospect of personalized therapies based on the derivation of induced pluripotent stem cells (iPSC) derived from a patient’s own somatic cells. Such bespoke cell products may successfully circumvent issues of rejection by the recipient’s immune system but raise questions of affordability, the costs of generating patient-specific cell lines and their subsequent differentiation under cGMP conditions, proving a challenging business model. However, principles that have guided the decision between autologous and allogeneic cell products in the past may prove less reliable when considering the therapeutic use of dendritic cells (DC) differentiated from iPSC, whose role in the immune system would be adversely compromised in a fully allogeneic setting. Here, we review the immunological concepts that inform the debate between autologous and allogeneic cell therapies and discuss whether recent breakthroughs might provide a novel solution to this long-standing issue, paving the way for the widespread adoption of DC-based immunotherapy and increasing its reach from immune oncology (IO) to the induction of immunological tolerance.

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Expert Insight

CAR T cell therapies in pediatric oncology: access and future development by distributed academic cell manufacturing

Spotlight Article

Expert Insight

Claudia Rössig

Cellular Immuno-Oncology 4.0

CAR T cell therapy is a major innovation in the treatment of B-cell malignancies. Prospective clinical evaluation within large, risk-stratified international multi-center studies is needed to establish its value beyond the salvage of refractory disease. To perform these trials, the academic community needs access to safe and effective uniform CAR T cell products across international borders. Novel automation technologies enable decentralized manufacturing of highly standardized CAR T cell products in academic GMP facilities experienced with the production of patient-individual cell therapies. Academic cell manufacturing in addition to products from pharmaceutical companies will allow the informed dissemination of CAR T cell therapy to patients who benefit from this modality. It will feed back into further preclinical improvements, enable clinical researchers to define the optimum position of CAR T cell therapy within multimodal therapies, and help advance this approach to treat other cancers in both children and adults.

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Natural killer cells may be scaled and engineered as a next generation, off-the-shelf cell therapy for cancer

Spotlight Article

Expert Insight

James B Trager

Cellular Immuno-Oncology 4.0

The advent of immunotherapies for cancer, and more recently of cellular immunotherapies, has substantially altered the treatment landscape. In hematological malignancies, complete response rates to CAR-T cells can exceed 80%. These responses are often durable in nature and have attracted considerable excitement and investment in the development of cell therapies for an expanded range of indications, particularly in solid tumors. The continued progress of cell therapies depends on overcoming key obstacles that include a lengthy and costly manufacturing process, a high degree of product variability, risks of severe adverse events, and limited available targets. Natural killer (NK) cells have the potential to overcome these limitations. NK cells are highly potent lymphocytes that target cancer through multiple broadly expressed activating ligands; they can be used allogeneically without posing a risk of graft-versus-host disease (GvHD). In recent years, technologies have been developed that allow their efficient expansion and engineering. We will describe the current status of development of NK cell therapies as targeted, off-the-shelf, allogeneic cell therapies for cancer, highlighting the different approaches that have been taken for their effective exploitation, and will outline remaining obstacles to the advancement of the field.

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Current state of genetically engineered macrophages for anti-cancer therapy

Spotlight Article

Expert Insight

Nicole AP Lieberman, Shannon Kreuser, Ciana Lopez, Katherine Brempelis, Harrison Chinn, Courtney A Crane

Cellular Immuno-Oncology 4.0

As immunotherapy becomes an increasingly important modality for the treatment of several types of tumors, current approaches that enhance T-cell function, including checkpoint inhibition and Chimeric Antigen Receptor (CAR) expression, have revolutionized the way that cancer is treated. Clinical trials are revealing obstacles in some types of tumors, however, suggesting that transforming the immunosuppressive tumor microenvironment (TME) may be a pivotal event to improve patient outcomes. Anecdotal clinical data suggest that toll like receptor agonists and heat shock proteins may support immune responses to tumors, although underlying mechanisms are poorly understood. Recent studies that improve our understanding of the TME in difficult to treat solid tumors have expanded the options for cell and gene therapy platforms, including the use of engineered dendritic cells and macrophages tailored to improve the recruitment and functions of cytotoxic tumor infiltrating lymphocytes. The development of engineered macrophages is in its infancy, but preliminary studies suggest that they are long-lived cells capable of producing stable and titratable doses of transgenes. Herein, we provide a brief overview of this field, focusing on technical challenges in the study of immunologically ‘cold’ or immunosuppressive solid tumors, and the early data supporting further development of genetic engineering of macrophages to support immune based therapies in patients who have exhausted treatment options.

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Genetically modified natural killer cells: an ‘off-the-shelf’ immunotherapy for cancer

Spotlight Article

Expert Insight

Subhashis Sarkar, Cillian O’Ceallaigh & Michael O’Dwyer

Cellular Immuno-Oncology 4.0

The success of chimeric antigen receptor (CAR)-T cell-based immunotherapy is currently revolutionizing the treatment of hematological malignancies. However, there are numerous hurdles in developing this as an ‘off-the-shelf’ therapeutic for cancer treatment, including cost-of-goods, non-availability of allogeneic T cells, treatment induced toxicities, and disease relapse due to tumor antigen escape. Natural killer (NK) cells may provide a suitable platform to develop a safe ‘off-the-shelf’ cellular immunotherapy, while addressing many of the limitations of CAR-T cells. However, to elicit a successful clinical response using CAR-NK cells, a multi-factorial genetic engineering approach is necessary. In this review, we first discuss how NK cells are biologically different from T cells and summarize the different NK cell sources available for clinical application. Thereafter, based on our understanding of NK cell biology, we describe a list of critical genetic modifications, which in our opinion, are necessary to exploit the maximal therapeutic efficacy of genetically modified CAR-NK cells.

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Gene editing platforms for T-cell immunotherapy

Spotlight Article

Expert Insight

Xiuyan Wang & Isabelle Rivière

Cellular Immuno-Oncology 4.0

Genome editing holds the remarkable potential to transform medicine as a new therapeutic modality enabling correction of genetic defects and customization of genetic addition or ablation. The discovery and optimization of gene editing tools such as meganucleases, ZFNs, TALENs and CRISPR/Cas9 are advancing the prospects of clinical applications. Clinical trials using gene-edited T cells have been conducted or are in progress for the treatment of patients with HIV infection and various cancers. T cells engineered using combinations of gene editing and gene transfer technologies are also being investigated. The development of off-target detection methodologies and the establishment of efficient manufacturing platforms are essential to bring gene-edited T cells to the forefront of novel immunotherapies.

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Innovator Insight

Novel equipment and process changes: implications for your manufacturing strategy

Spotlight Article

Innovator Insight

Nina G Bauer

Cellular Immuno-Oncology 4.0

With Cell and Gene Therapies transitioning through clinical trials and into commercial approvals at an unprecedented speed, process optimization steps are often considered late in the process. Alongside this fast-moving clinical development, tools providers are working hard to optimize equipment to better serve these new modalities. Evaluation, and implementation, of new or novel equipment is therefore, an ongoing process across the industry. Once INDs (or CTAs) have been filed, and first patients have been treated, onboarding new equipment constitutes a major manufacturing change. Such changes need to be appropriately communicated to the regulatory bodies, and thus managed from a data submission and risk profile perspective. In this article, we outline the main considerations from a broad GMP equipment compliance perspective, as well as indicating key resources and referencing guidelines for both Europe and the United States on how to navigate the regulatory aspects of manufacturing changes.

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