Pfizer opts-in on MRSA antibody from Elusys
agreement with Elusys worth up to $200m (€152m) for new antibody
therapies, including an MRSA candidate
The exclusive collaborative research and license agreement involves an initial up-front equity investment, research and development funding and near-term research milestones. The deal includes the ETI-211 antibody that has shown high efficacy in pre-clinical animal studies against methicillin-resistant Staphylococcus aureus (MRSA) as well as research into other indications.
The US Centres for Disease Control (CDC) estimates that there are over two million hospital acquired infections each year in the USA leading to over 90,000 deaths, with S aureus and especially the methicillin-resistant strain (MRSA) being one of the major three causes.
Talking to DrugResearcher.com, Dr Elizabeth Posillico, Elusys president and CEO, said "the deal is a major deal for Elusys and could be worth up to $200m for the ETI-211 antibody if we hit all the milestones."
"Pfizer also have an option to licence the technology for some other (pre-agreed) targets."
Pfizer currently has Zyvox (linezolid) indicated as a treatment for MRSA, and other bacterial infections, which had worldwide sales of $618m in 2005.
The heteropolymer (HP) antibodies consist of pathogen-binding antibodies that are linked to a second red blood cell monoclonal binding antibody. Once antibodies have formed a link between a pathogen and a red blood cell they can then be removed from the blood and destroyed by the liver.
This technology may prove particularly useful for patients with compromised immune systems such as AIDs and cancer patients.
The collaboration includes research and scientific support to help bring the ET1-211 antibody to market. Preclinical studies have demonstrated that mice given ETI-211 were completely protected against a lethal injection of multiple S aureus strains including the MRSA strain. In comparison, the use of the non-conjugated antibodies, even at one hundred times the ET1-211 protected dose, led to no survival.
The HP antibody treated mice could then survive re-exposure to lethal doses of MRSA even 28 days after the initial HP antibody treatment.
Elusys are currently developing a scaled-up production process for the HP antibodies and after expanded animal studies expect to enter a first-in-man Phase I clinical trial in the second half of 2008.
In light of the problems that were discovered during the Northwick Trials of TeGenero's TGN-1412 Elusys have carried out pre-clinical studies to show that no cytokine storms were initiated.
Dr Posillico said: "up until the TeGenero trial antibodies had been found to be extremely safe, the particular receptor targeted by TeGenero's drug must have exacerbated the response."
The HP-antibody platform has already been tested in man in European Phase I trials for a different indication and no problems were observed.
