Intercell's adjuvant stimulates Wyeth
Intracell's synthetic adjuvant IC31 in the formulation of five of
its investigational vaccines, aiming to simply mix it with antigens
without the need for conjugation.
Austrian firm Intercell could pocket up to $77m (€60m) in upfront, option and milestone payments as well as royalties on product net sales as a result of the deal, while Wyeth will gain an adjuvant that induces T-cell and B-cell responses by using a unique synthetic formulation.
With the global vaccine market booming, drug manufacturers are currently engaged in an arms race to develop new vaccine formulations that do not use aluminum salt (alum), the conventional widely used adjuvant designed to enhance the body's immune response to the antigen contained within the treatment.
Although alum is regarded as generally safe, cheap and has been used since the 1940s, it only prevents degradation or discharge of the antigen and does not have any immunostimulatory properties in its own right, something expected from a modern adjuvant today.
IC31, on the other hand, stimulates innate immunity through the TLR9 receptor, leading to maturation and activation of antigen presenting cells and efficient antigen presentation.
There are of course competitors, such as MPL, a derivative of the lipid A molecule found in Gram-negative bacteria, developed by US firm Corixa which GlaxoSmithKline (GSK) acquired last year for €233m, relieving itself from the burden of royalties.
Fendrix, a Hepatitis B vaccine by GSK, has already been approved in Europe using MPL, with several more vaccines that use this adjuvant moving forward in the company's pipeline, whereas a tuberculosis vaccine with IC31 developed by Denmark's Statens Serum Institute (Denmark) is still in Phase I and is not expected to reach the market in the next five years.
Nevertheless, Intercell points to the strong cytotoxic T lymphocyte and B cell responses its adjuvant triggers, an established good manufacturing practice (GMP) supply and full analytical methods as evidence of IC31's potential, clearly convincing Wyeth.
The patent-protected adjuvant consists of an anti-microbial peptide, KLK, and an immunostimulatory oligodeoxynucleotide, ODN1a, in a solution which can be simply mixed with antigens.
"We selected IC31 from a shortlist of 20 candidates, it is an adjuvant we have strong faith in," Werner Lanthaler, Intercell's chief financial officer, told In-PharmaTechnologist.com.
"We believe that many deals will follow, that is why we did not want to give Wyeth an exclusive deal, we do not want to share the same destiny with Corixa and MPL."
Whether Intercell sticks to this line remains to be seen. In 2001 the company, through a research collaboration, gave Merck access to its Antigen Identification Programme (AIP) to identify relevant antigens directed towards a specific bacterial target - three years later this turned into an exclusive license agreement.
Wyeth has not revealed the indications of the vaccines it will be using IC31 in but the deal clearly reiterates the company's intentions to compete with the industry's major players such as GSK, Novartis and sanofi aventis.
