Isis Innovation, the technology-transfer company of the University of Oxford, said last week that it has licensed intellectual property to Novartis Vaccines and Diagnostics covering a vaccine candidate against one of the bacteria responsible for meningitis.
The technology on which the meningitis vaccine candidate is based may also serve as a platform for developing vaccines against a variety of other pathogenic bacteria, according to one of its inventors.
The agreement contains provisions that would ensure broad access to the technology, especially in developing nations, a condition that has become more common in recent years due to increasing awareness and overlapping interests of academia and industry, according to an Isis official.
Terms of the deal call for Novartis to receive a worldwide exclusive license to an Isis-owned patent on the vaccine against Neisseria meningitides, also referred to as meningococcus, one of three major bacteria types that cause bacterial meningitis.
Tom Hockaday, managing director of Isis Innovation, told BTW this week that the organization talked to a wide range of companies about further developing the vaccine candidate, but settled on Novartis because it is “really [one of] only a few companies in the world at the moment capable of taking a technology like this through to the marketplace.”
Furthermore, he said that a long-term relationship existed between Novartis and the researchers that developed the vaccine candidate. “We know that relationships in business are as important an aspect as anything else,” Hockaday said.
The scientists responsible for developing the vaccine technology include Richard Moxon and colleagues from the Department of Pediatrics at Oxford, and researchers from the UK’s National Institute for Biological Standards and Controls. Isis owns the corresponding IP.
The vaccine, which is in the preclinical testing stage, targets lipopolysaccharide, a macromolecule present in large amounts on the surface of meningococci during an infection.
Existing meningococcus vaccines are also based on polysaccharide surface antigens, but scientists have not been able to produce a comprehensive vaccine against N. meningitides because the bacterium has several subtypes, or serogroups, some of which have been more difficult to target than others.
“It’s just common sense, that where you’ve got solutions to healthcare problems, it’s got to get out to as many people as possible or else it’s not going to do anyone any good.”
The most common serotypes are A, B, C, Y, and W. In particular, it has been particularly difficult to create a vaccine against serogroup B, because unlike other meningococcal capsular polysaccharides, group B is poorly immunogenic and cross-reacts with certain proteins in human tissues.
Moxon’s team at Oxford has developed a method to produce outer membrane protein-based vaccines using a combination of a limited number of antigenic variants of key outer membrane proteins, including those found in serogroup B, according to a description of the technology on Isis’ website.
This approach makes for an effective vaccine against a wide range of invasive strains, according to Isis.
Hockaday cited confidentiality reasons for declining to provide specific terms of Isis’ licensing deal with Novartis, but said that the appropriate provisions have been made in the agreement to ensure the technology will be available in the marketplace as widely as possible, including in developing nations.
“As a matter of practice, Isis and the University of Oxford are very sensitive to the access-to-medicines issue,” Hockaday said. “It’s just common sense, that where you’ve got solutions to healthcare problems, it’s got to get out to as many people as possible or else it’s not going to do anyone any good.”
Indeed, the deal comes four months after the University of Oxford and Emergent BioSolutions formed a joint venture called the Oxford-Emergent Tuberculosis Consortium to further develop a TB vaccine candidate originally discovered by Oxford researchers (see BTW, 7/30/2008).
As part of that agreement, Isis granted the consortium an exclusive license for the vaccine candidate and related technology, while the Wellcome Trust and Aeras Global TB Vaccine Foundation will provide funding and resources to launch clinical trials for the candidate in South Africa.
In exchange, Aeras received rights to purchase the vaccine at very low cost for distribution to the developing world, while Emergent retained rights to commercialize the vaccine in all other parts of the world.
These types of agreements, Hockaday said, are becoming much more commonplace.
“It’s not as big a challenge as it was 10 years ago when people were sort of waking up to this issue,” Hockaday said. “This is an issue where there are very common interests between us and the companies that we talk to about this.”
Typically corporate partners participating in such deals require some kind of incentive. In the case of the meningococcal vaccine, the most lucrative market may actually be in developed nations.
According to the World Health Organization, serogroup B meningococcus is the most common cause of endemic bacterial meningitis in industrialized countries, accounting for 30 to 40 percent of all cases in North America and for 30 to 80 percent of all cases in Europe. The proportion of group B strains is especially high in Denmark, Germany, the Netherlands, and Norway, according to the WHO.
All told, serogroup B global incidence has been estimated at between 20,000 and 80,000 cases per year, accounting for 2,000 to 8,000 deaths annually.
By comparison, in the developing world it is group A meningococcus that is responsible for most epidemics of bacterial meningitis. However, a comprehensive vaccine covering all N. meningitides serogroups could be beneficial to developing and industrialized nations alike, according to the WHO.
“Global elimination of bacterial meningitis may well be an achievable target when potent and affordable vaccines against meningococcus [A, C, Y, W, and B] become available within the next decade,” the agency claims on its website.
Overall, bacterial meningitis accounts for an estimated annual 170,000 deaths worldwide, with fatality rates of 5 to 10 percent in industrialized countries, and higher in the developing world, according to the WHO.
The vaccine technology developed by Moxon and colleagues at Oxford may also be useful for producing other vaccine types, including those that target other bacteria responsible for meningitis such as Haemophilus influenzae and Streptococcus pneumoniae.
In fact, Moxon is one of several inventors on a US patent that is co-assigned to Oxford University, the National Research Council of Canada, and independent Swedish researchers, and covers LPS antigens for H. influenzae.
That licensing status of that patent, which is also under review by the European Patent Office, is unknown.
In a statement, Moxon commented that the “LPS-based approach also has the potential to be a platform technology, spawning a whole new generation of vaccines able to combat Gram-negative bacteria at a time when antibiotic resistance and other factors are on the rise.”