Using insect cells in biotechnology for better protein production
ExpreS2ion Biotechnologies ApS is a contract research organisation and vaccine development company with a development and production platform based on S2 fruit fly cells. Its ExpreS2 platform plays a key role in drug discovery, R&D, GMP manufacturing and in human clinical trials
For a company that only started in 2010 as a spin out of the proprietary S2 protein expression platform from the Danish company Affitech A/S, ExpreS2ion Biotechnologies ApS is completing 2017 celebrating some key events: a grant for development of a Zika vaccine; agreements including Abivax SA, Integrated BioTherapeutics, Inc., the University of Pennsylvania, Institut Virion/Serion GmbH, and Intravacc; creation of a joint venture, AdaptVac ApS, with NextGen Vaccines ApS; beginning a Phase 2a clinical trial for a malaria vaccine; and proof-of-concept in animals for a prophylactic breast cancer vaccine.
"ExpreS2ion Biotechnologies grew out of our founders' expertise in protein expression, production and vaccine development. We started from a small place, but we are now gaining traction, and getting repeat business for our services," said Bent U. Frandsen, vice president, Business Development.
ExpreS2ion Biotechnologies is built around the ExpreS2 non-viral insect cell expression system. This is based on Drosophila cells and provides high protein expression levels with high batch to batch consistency. ExpreS2 is a protein expression system that can express proteins when other systems fail. The company has several arms: services, diagnostics, tools for R&D, a platform for vaccine development with collaborators, and finally, its own pipeline, through a new joint venture, AdaptVac, established in 2017.
ExpreS2ion provides a range of services based on its protein expression platform. These include feasibility studies confirming that proteins can be expressed by the system, protein production, process development, and the provision of R&D reagents. Process development starts with a DNA sequence and moves through cloning, screening and expression tests, through establishment of stable cell lines and providing production and purification batches, to scale up and developing GMP (good manufacturing practice)-compatible processes. In December 2017, ExpreS2ion signed a collaboration agreement with the Netherlands-based Intravacc (the Institute for Translational Vaccinology), making Intravacc a preferred GMP partner to ExpreS2ion.
"The development timeline of applying ExpreS2 is fast, which is advantageous because speed is important in research. The time from DNA to stable cell line and material can be as little as three weeks. Our platform has been approved for clinical applications," said Frandsen.
ExpreS2ion has a variety of different partners and customers in biotech, big pharma, medtech, diagnostics and academia, including Novartis, Roche and Merck Millipore. The company has made over 250 proteins and virus-like particles for clients to date, with over half targeting parasites and virus for use in vaccines. Other applications include toll-like receptors, cytokines and enzymes. ExpreS2ion also offers licenses to its expression system for use in house.
"These deals typically run for 6 or 12 months initially, but they are often extended," said Frandsen.
A number of vaccines developed using ExpreS2ion's technology platform have moved into preclinical and clinical development with partners and collaborators, validating the company's platform. The France-based company Abivax entered a commercial license agreement to use ExpreS2ion's technology for its preclinical ABX544 Ebola prophylactic and therapeutic anti-serum programme. ExpreS2ion is also involved in two malaria programs, that have moved into clinical trials: a blood stage malaria vaccine candidate developed by the University of Oxford/Jenner institute that is presently in a Phase 2a clinical trial; and a placental malaria vaccine candidate presently in Phase 1a/b trials in collaboration with University of Tübingen and University of Copenhagen made under an EU FP7 grant.
Building a pipeline through a joint venture
Established in June 2017, AdaptVac, the joint venture between ExpreS2ion and NextGen Vaccines, combines ExpreS2ion's ExpreS2 platform and NextGen's virus-like particle technology. The lead candidate, AV001, is a HER-2 VLP protein using ExpreS2 technology for expression, which is currently in preclinical development for breast cancer. In an animal model, the vaccine was able to both prevent and treat breast cancer.
"What makes the AdaptVac vaccines different is that these deliver the right protein to the right target by using VLP technology to deliver direct to the target for a better uptake," said Frandsen.
AdaptVac also has a second vaccine candidate, AV002, in the pipeline for an undisclosed indication.