After a decade of work, French vaccine developer Imaxio SA achieved a significant milestone when IMX313, its pro-immunogenic technology, was administered for the first time in humans in a Phase I tuberculosis (TB) vaccine trial. The dose escalation study is assessing the safety and immunogenicity of TB vaccine candidate MVA85A-IMX313, a viral vector vaccine encoding the TB antigen 85A fused to IMX313.
Demonstrating efficacy could significantly boost the fortunes of the small biotech, based in Lyon, France.
Imaxio was created in 2006 around the issuance of a patent for the IMX313 technology and the merger of Diagnogene and Avidis SA, spun off in 2000 from the UK’s Medical Research Council and Cambridge University.
Avidis had been focused on protein production and optimization, “and one of the goals was to use this technology and knowhow of protein interactions to develop a proteogenic platform – something that could be used in the context of immunology to prove the immune response of the antigens,” explained Imaxio’s CEO Alexandre Le Vert.
Initially, Imaxio collaborated with the Jenner Institute at Oxford University, UK, to focus on malaria research. In 2009, however, the company’s TB platform leapfrogged malaria when Imaxio demonstrated at the Grand Challenges in Global Health competition, funded by the Bill and Melinda Gates Foundation, that its technology could potentially improve T cell immune response to a TB antigen in the context of viral vaccination.
MVA85A-IMX313 would not be the company’s first vaccine out of the gate. In France, Imaxio already markets Spirolept, a vaccine to prevent the infectious disease leptospirosis in agricultural workers, and Trolovol (D-penicillamine), an orphan drug indicated for Wilson’s disease acquired earlier this year from D&A Pharma, of Paris.
In 2012, the company, which has two dozen employees – half of them engaged in R&D – even generated a small income of €2.7 million (US$3.6 million).
The TB drug would be the first big win for the company, however. Imaxio’s antigen re-engineering technology is designed to enhance the immune response and, therefore, the effectiveness of each vaccine in which it is used. Thus, IMX313 offers significant potential or next-generation vaccines and immunotherapies in major indications, according to Le Vert.
“Generally speaking, our strategy with IMX313 is to develop a platform technology in different indications,” he said. “The idea is to provide a wide spectrum of proofs of concept to show that this technology works not just in one indication but in multiple indications.”
As a lead indication, tuberculosis remains a significant threat, in part, because one-third of the world’s population is estimated to be latently infected with Mycobacterium tuberculosis. The currently available vaccine, BCG, is largely ineffective at protecting against adult pulmonary disease in endemic areas, Le Vert explained, so the MVA85A vaccine candidate was designed to enhance protective efficacy. Though initial studies were promising, a Phase II trial indicated the vaccine candidate did not offer additional protection against TB in South African infants who had already received the BCG vaccine.
In the meantime, the Jenner Institute, which is conducting the TB trial, identified IMX313 as a superior candidate to enhance immune responses in a comparison study funded by a grant from the Foundation for the National Institutes of Health through the Grand Challenges initiative.
In addition to TB and malaria, the technology is being used to develop vaccine candidates for influenza and Staphylococcus aureus infection. In July, Imaxio, the Jenner Institute, the European Vaccine Initiative and Preclin Biosystems received a combined European Union award of €5.5 million to support an additional consortium, called the Bellerophon Project, to develop a vaccine against S. aureus. That funding will be used to complete preclinical testing and a Phase I trial in humans in 2016.
Last year, Imaxio also raised €2.9 million from principal shareholder Pradeyrol Developpement to accelerate the development of IMX313.
The company has no short-term financing needs, according to Le Vert. Long term, “we’re living in a world where we need to be pragmatic,” he told BioWorld Today.
“Either we have enough proof of concepts in different indications that we can sell the overall platform to a credible player that would develop it in multiple indications,” he said, “or we look for partners who would be interested indication by indication. We might want to pursue one of the indications alone if we have enough resources to do that.”