The SARS-CoV-2 Toolbox: Innovative Initiatives to Support the Development of Vaccines & Therapeutics

In response to the SARS-CoV-2 outbreak, unprecedented efforts to develop prophylactics and therapeutics have begun. As of March 21st, the number of candidates listed by the World Health Organization (WHO) stood at 43. Participation in this effort is broad, ranging from academic institutions to the largest vaccine manufacturers in the world.

The approaches are also varied, ranging from mRNA approaches put into the clinic by Moderna and NIAID, to Virus-Like Particles (VLP) expressed in various host cells. In addition, neutralizing antibodies targeting the SARS-CoV-2 Spike protein, which would inhibit viral attachment to receptor-bearing host cells, as well as small molecule-based antagonists to ACE2 (the receptor for viral Spike protein) are also being assessed for their potential benefit in COVID-19 therapy. The goal of all of these candidates is to prime the immune system via humoral and/or cell-mediated immunity to limit the virus’ ability to cause disease.

The SARS-CoV-2 Immunology and Preclinical Toolbox

The WHO identified that immune correlates will be a necessary evaluation criterion. A standardized set of assays will provide regulatory agencies with datasets that can be compared across the different modalities.

Working with one organization equipped to run immunogenicity projects from lead screening to Phase III trials provides development teams with significant advantages including timeline efficiencies and knowledge preservation at stage transitions.

Nexelis brings together global expertise in immunology, infectious diseases and vaccines to speed up development programs from the earliest stages of design and candidate optimization, to preclinical studies and clinical trials. Through internal R&D capabilities and external collaborations, innovative tools and technologies are being developed to further advance the field. For example, currently in development is an exhaustive panel of immunoassays that will help reduce vaccine development time by a minimum of three months.

Through a strategic partnership with Public Health England (PHE-Porton), a renowned centre of excellence for infectious diseases, Nexelis leverages unique expertise in high containment microbiology and extensive experience in the development and application of GXP pre-clinical models for the evaluation of pathogenesis and efficacy/potency of vaccines and therapeutics.

Speakers

Luc Gagnon, VP Vaccine Sciences, Nexelis

Luc Gagnon leads the scientific operations at Nexelis to support vaccines and biologics throughout the different phases of clinical trials. Gagnon is a biochemist by training and holds a PhD degree in Microbiology/Immunology from Laval University. He is armed with over 20 years of experience in several biotech, CRO and pharmaceutical companies, with extensive expertise in ligand-binding and functional assay development, qualification and validation.

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Sofie Pattijn, Co-Founder & Chief Technology Officer, ImmunXperts

Sofie Pattijn has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology and Cell and Gene Therapy products. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 to 2013, she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.

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Danielle Poirier, Director Preclinical Research, Nexelis

Danielle Poirier has more than 25 years of experience in preclinical in vivo, ex vivo and in vitro evaluation and assay development to fill proof of concept files into a biotech and pharmaceutical environment. Poirier will be more than happy to help with preclinical evaluations on appropriate model and immunological readouts.

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Bassam Hallis, Head of Preclinical Development, Public Health England

Bassam Hallis has been involved in scientific research for over 25 years including 15 years in regulated activities incorporating vaccine evaluation/characterisation, release/stability and clinical trial serology. He has extensive experience in assay development and validation including cell-based and functional assays as well as technology transfer of early stage and validated tests. Hallis has led a number of projects involving the setting up of new laboratories and operating in compliance with GLP, GCP and cGMP.

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