Pairing with Paragon

BALTIMORE—Paragon Bioservices, which specializes in the manufacturing of biopharmaceuticals and vaccines, recently announced that the International AIDS Vaccine Initiative (IAVI) had awarded it a contract for the process development, analytical development and cGMP manufacturing of an HIV vaccine candidate with encouraging potential. The candidate will undergo animal and then clinical testing. No financial details for the contract were disclosed.

“We are honored to be a part of scientific efforts to prevent HIV, especially considering the enormous progress in the understanding of HIV transmission, immunology and vaccinology in the past few years that is bringing us closer to an effective AIDS vaccine,” Marco Chacon, founder and CEO of Paragon, remarked in a statement. “Paragon has helped develop and manufacture over 50 different biotherapeutics and vaccines. Our Quality, Process Development and GMP manufacturing teams have considerable experience in the development and manufacturing of vaccine candidates, including recent contracts with the U.S. government and ongoing contracts with biotechnology and major pharmaceutical clients.”

The vaccine candidate in question, the eOD-GT8 60mer, was developed in the laboratory led by William Schief, director of Vaccine Design at the IAVI Neutralizing Antibody Center at The Scripps Research Institute and a Scripps professor. Paragon has been chosen to optimize production of the eOD-GT8 60mer and characterize and then manufacture it under GMP conditions, and will first test its safety and toxicity in animal models before moving on to Phase 1 clinical trials.

Paragon offers a variety of CDMO services, with experience in recombinant protein therapeutic and monoclonal antibody manufacturing projects, vaccines, live virus manufacturing, recombinant viral vectors (AAV and adenovirus) and virus-like particles, among others.

IAVI released information on the vaccine candidate in June 2015, noting that it had been shown to stimulate the immune system to block HIV infection in mice. The results were published in studies in both Cell and Science. Schief co-led the Science study with TSRI Professor David Nemazee and Dennis Burton, chair of the TSRI Department of Immunology and Microbial Science and scientific director of the IAVI Neutralizing Antibody Consortium and National Institutes of Health Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery at TSRI. Schief and Michel Nussenzweig of The Rockefeller University co-led the Cell study.

The immunogen eOD-GT8 60mer is a protein nanoparticle designed to mimic a critical part of the HIV envelope protein (also known as the trimer) as well as bind and activate B cells to produce the antibodies necessary to fight HIV. In mouse models, the researchers reported immunization with eOD-GT8 60mer produced antibody “precursors” with some of the traits needed to recognize and block HIV infection, which suggests that eOD-GT8 60mer could be a potential first step in a series of HIV immunizations.

“The results are pretty spectacular,” Burton remarked in a press release announcing the publications.

The researchers’ aim is to design an HIV vaccine that can engender the production of antibodies that bind to the virus and prevent infection by most if not all of its variants. It is expected that, given HIV’s ability to mutant so rapidly, that a successful vaccine will need to consist of several related but different virus proteins (immunogens) in order to train the immune system to generate broadly neutralizing antibodies against HIV.

In other recent news for IAVI’s HIV efforts, the organization announced back in September that it was partnering with CureVac to accelerate the development of AIDS vaccines, using CureVac’s novel messenger RNA (mRNA) technology to deliver novel immunogens developed by IAVI and its partners. For this work, IAVI has selected one of its leading HIV trimer constructs for mRNA evaluation in small-scale clinical trials. mRNA that encodes for the selected trimer mimic will be developed using CureVac’s RNActive technology and injected in hopes of stimulating the immune system to produce HIV trimer proteins and related neutralizing antibodies.

Per the agreement, IAVI will provide several stabilized HIV envelope trimer sequences that CureVac will transfer into its RNActive technology for preclinical and clinical development. IAVI and CureVac will work with U.S., German and African health authorities on this effort, and anticipate beginning clinical trials sometime this year.