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PATH Funds Genocea, Children’s Hospital Boston to Create New Pneumococcal Vaccine

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Vaccine developer Genocea Biosciences said last week that it will partner with Children’s Hospital Boston to develop a new, less-expensive Streptococcus pneumoniae vaccine for use in the developing world.
 
The agreement, which is funded by non-profit global health charity PATH, will ensure that resulting technology will be made widely available to a subset of countries where need for a new streptococcal pneumonia vaccine is greatest while preserving commercial opportunities for Genocea in middle-income and wealthy nations, the partners said.
 
Under the terms of the deal, PATH is providing an unspecified amount of funding to support researchers from Seattle-based Genocea and Children’s Hospital to develop a new highly multivalent, protein-subunit pneumococcal vaccine based on Genocea’s antigen-discovery technology platform.
 
In particular, the project aims to develop “common protein” vaccines that could provide much broader protection to children worldwide than do existing pneumococcal vaccines, Genocea said.
 
Robert Paull, co-founder and president of Genocea, told BTW this week that the current need for a new pneumococcal vaccine exists on two levels.
 
“Number one is that some of the existing vaccines for strep pneumo have good serotype coverage in the US and Europe, but in developing countries they may not be covering all of the strains that would be relevant,” Paull said. “For the emerging markets and developing countries there is a global need for new antigens to cover those populations.”
 
In addition, Paull said, most existing Streptococcus pneumoniae vaccines are polysaccharide vaccines, and become increasingly expensive to manufacture as greater serotype coverage is needed.
 
“If you go from a 7-valent, to a 13-valent, to a 23-valent vaccine, the cost to manufacture those goes up almost logarithmically,” Paull said. “One of the rationales for funding Genocea’s technology is that we are discovering protein subunit vaccines … that would be cheaper and easier to manufacture than the current strep pneumo vaccines on the market right now.”
 
Perhaps the most well-known pneumococcal vaccine, Prevnar, manufactured by Wyeth, is a seven-valent conjugate-based vaccine that covers seven of the 80 most common strains of Streptococcus pneumoniae. Although this vaccine has “virtually eliminated” the strains of pneumococcus that it covers in developed countries that have adopted it, additional vaccines are needed to expand protection for children in lower-income countries, where most pneumococcal deaths occur.
 

“We believe the technology is something that can help global health issues, and if we can also apply it in a way that becomes commercially attractive for us, then we see that as win-win.”

Worldwide, pneumococcus is the leading vaccine-preventable cause of death in children under 5 years. Up to 1 million children in this age group die each year from the disease, according to World Health Organization estimates. Pneumococcal disease also kills up to 1 percent of all children born in high-mortality areas of the world, making it the leading infectious cause of death in young children worldwide, according to the Global Alliance for Vaccines and Immunization.
 
“Just in terms of disease burden alone there is great need,” Eileen Quinn, a spokesperson for PATH, told BTW. “And even for those companies that have developed products that can be used both in wealthy countries and impoverished countries, one challenge down the line is potentially going to be supply.
 
“We’re assuming that with some of these products we’re going to need multiple products, and multiple companies to create the full supply picture needed for the world,” Quinn added.
 
PATH is not only concerned about third-world countries, she added. The organization is also eyeing countries where vaccines are administered through the public health system but there are large sectors of the population that can’t access such private care.
 
“If you look at a country like Brazil or South Africa, they’re not necessarily eligible for a subsidy from GAVI, but they have a large share of poor families to whom they need figure out a way to provide the vaccine,” Quinn said.
 
Lastly, Quinn noted that it behooves scientists to consider updating vaccines on a regular basis to keep up with new strains. “Bacteria evolve, and they’re sort of cunning opponents, so you want to be continually refreshing your toolbox, so to speak,” she said. “The current vaccines plus new vaccines can make sure that you don’t find yourself with the wrong tools down the road.”
 
Richard Malley, associate professor of pediatrics at Children’s Hospital, will serve as lead academic collaborator on the project. According to Paull, Genocea will conduct the lion’s share of the antigen discovery; Malley will conduct most animal studies of the vaccine; and PATH is providing scientific input and funding.
 
Malley is also “a leader in pneumococcal disease, so his input is important for this, as well,” Paull said. Malley is a principal investigator on a 2006 PATH-supported project to develop a whole-cell pneumococcal vaccine for children in the developing world.
 
Since Genocea is spearheading the antigen-discovery portion of the project, it would likely drive the development of any intellectual property, although Paull said he did not want to speculate as to whether Children’s Hospital might develop pertinent IP also.
 
The financial incentive for Genocea lies in the possibility of retaining rights to vaccine technology so it can sell it in the developed world, where pneumococcal disease is not nearly as large a problem, but still has a market because of the disease’s prevalence and penchant for evolving.
 
In addition, “we do believe this technology is relevant for a whole variety of diseases — there are probably 70 or 80 pathogens where there is no current vaccine, and a global need in the developed and developing world,” Paull said.
 
“We believe the technology is something that can help global health issues, and if we can also apply it in a way that becomes commercially attractive for us, then we see that as win-win,” he added.
 
Detailed terms of licensing and IP-ownership rights were not disclosed by either Genocea or PATH. However, in general, “when PATH enters into an agreement with someone, we try to focus our rights and needs on the impoverished populations, and allow the company to protect its rights and future opportunities in the private market both in the middle-income and wealthy countries,” Quinn said.
 
Founded in 2006, Genocea’s platform for identifying antigenic epitopes that will elicit a competent immune response is based on technology licensed from the University of California at Berkeley and Harvard Medical School, as well as on technology developed within the company.
 
The company is backed by venture capital firms Polaris Venture Partners and Lux Capital Management, which Paull co-founded and currently also serves as a managing partner, although he said that he spends “pretty much 100 percent of my time” working with Genocea.

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