July 2008

In this issue:

 

With the latest edition of Vaccines for the Future, we are pleased to announce several new partnerships to support our work to develop new vaccines against pneumococcal disease and enterotoxigenic Escherichia coli (ETEC). Among these new collaborations, we welcome three new vaccine candidates into our portfolio to address two major killers of children under five. This issue also highlights promising recent data from a rotavirus vaccine trial in India, our progress in establishing an influenza vaccine portfolio, and the success of a recent training held with a partner in China.

In addition to our usual update on upcoming conferences and events, we have added a new section on employment opportunities with the vaccine development program. As our program continues to grow, we hope you enjoy these updates on our work to advance new vaccines against pneumonia, diarrheal disease, and influenza for the developing world.

 

Sincerely,

 

John W. Boslego, MD

Director, Vaccine Development Program

PATH

 

New partnerships and a successful conference on vaccines against childhood pneumonia

PATH’s pneumococcal vaccine project recently established two new vaccine development partnerships. With Genocea Biosciences in Cambridge, Massachusetts, PATH is developing a protein-subunit pneumococcal vaccine. PATH is also collaborating with the University of Glasgow in the United Kingdom to develop protein-based pneumococcal vaccines using novel adjuvant technology. Additionally, PATH recently signed several research agreements to support development of appropriate pneumococcal vaccines for the developing world. PATH is working with the University of Bristol in the United Kingdom to assess human immune responses to candidate pneumococcal protein vaccines; with Johns Hopkins University in Baltimore, Maryland, on conducting invasive pneumococcal disease surveillance in children in Karachi, Pakistan; and with the University of Maryland Baltimore’s Institute for Genome Sciences to characterize antigens and enhance and disseminate the public Streptococcus Pneumoniae Comparative System, which contains published data on S. pneumoniae genomes.

 

In June, PATH also helped sponsor the 6th International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD-6) in Reykjavik, Iceland. The conference brought together more than 950 participants from 86 countries to learn about the latest scientific achievements, exchange ideas, strengthen ongoing research collaborations, and establish new collaborations on pneumococcal disease. Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project, presented on the future of pneumococcal vaccine development. Additionally, PATH hosted an exhibition booth and co-sponsored a luncheon session on advocacy for pneumococcal disease, Science into Public Policy, which drew more than 250 participants.

 

Promising results from Bharat Biotech on rotavirus vaccine candidate

Bharat Biotech International Limited (BBIL) recently announced encouraging results from a Phase 1/2 clinical trial of the live, natural reassortant oral rotavirus vaccine 116E. The trial evaluated two different dosages (104.0 and 105.0 FFU) of the vaccine in nearly 400 infants and was conducted by the Society for Applied Studies (SAS) in New Delhi, India. The vaccine was well tolerated after three administrations with no differences observed in mild, moderate, or severe adverse events among vaccine and placebo recipients in both dosage levels. The vaccine was immunogenic with 62.1 percent and 89.7 percent of the infants seroconverting after three doses of the 104.0 and 105.0 dosages, respectively.

 

The clinical trial was supported by the Indian Rotavirus Vaccine Development Project, a collaborative effort that includes PATH, BBIL, SAS, India’s Department of Biotechnology, US Centers for Disease Control and Prevention, Stanford University, the US National Institutes of Health, the National Institute of Immunology in New Delhi, the Indo-US Vaccine Action Program, and the All India Institute of Medical Sciences. PATH’s rotavirus vaccine development project is partnering with BBIL to accelerate further clinical research on the 116E vaccine.

 

PATH supports training for rotavirus vaccine manufacturing partner in China

PATH is also working with the Wuhan Institute of Biological Products (WIBP) in China on accelerating the development of a new rotavirus vaccine. In May, PATH supported a 15-day training for WIBP conducted by consultant Dr. Nadir Hardee. The training covered how to implement the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and follow international Good Manufacturing Practices (GMP) standards, as well as how to write standard operating procedures and batch production records. Though the training was initially planned just for the WIBP rotavirus team, additional employees were also able to attend. The training provided the WIBP team with invaluable skills for implementing their work with PATH on the human bovine reassortant vaccine. The participants, who received certificates from PATH and WIBP at the close of the training, will also be able to train further WIBP staff in these areas and use their skills to work on other vaccine products.

 

New collaboration for developing vaccine against diarrheal disease

PATH has formed a new partnership with ACE BioSciences, a Danish biotechnology company, to advance the development of a promising vaccine against one of the leading bacterial causes of diarrheal disease, enterotoxigenic E. coli (ETEC). PATH will fund ACE BioSciences to complete Phase 1 and 2 clinical trials up to proof of concept of its ACE527 vaccine. There are currently no licensed vaccines against ETEC available. ACE527 is a live, whole cell, oral vaccine, which is comprised of three attenuated ETEC strains.

 

Earlier this year, ACE BioSciences and PATH entered into a separate research collaboration to develop temperature-stable ETEC vaccine formulations. This research will support and complement the clinical development activities conducted under the new agreement.

 

This agreement is part of PATH’s project to develop vaccines against two of the leading bacterial causes of diarrheal disease, Shigella and ETEC. PATH will continue to build its portfolio through negotiations with several other organizations and anticipates forming additional partnerships later this year.

 

Working to increase protection against influenza

PATH’s influenza vaccine project is making strides in establishing a portfolio of potential partners to accelerate the development of new vaccines against seasonal and pandemic influenza. PATH assembled a scientific advisory board (SAB), which met for the first time in June. The SAB, consisting of eight prominent experts in the field of influenza, vaccine development, and infectious diseases, will play a critical role in guiding PATH’s decisions about which projects to support.

 

In response to a request for letters of intent (LOIs) for advancing the development of new influenza vaccines, PATH received more than 40 submissions. Based on the ongoing LOI review, PATH will work with promising prospective partners to generate full product development plans.

 

Upcoming conferences and events

·         World Vaccine Congress 2008, Lyon, France , October 6 to 9, 2008. Europe’s largest vaccine congress celebrates its tenth anniversary this year by bringing together vaccine industry leaders to discuss an array of vaccine-related topics, including industry outlook, intellectual property management, the development pipeline, and partnering for vaccine development.

·         Modern Mucosal Vaccines, Adjuvants & Microbicides, Porto, Portugal, October 22 to 24, 2008. This conference brings together scientific experts and stakeholders on mucosal environment and immunity, including leaders in industry, government, and international organizations. Participants will learn about topics including approaches to development of modern mucosal vaccines, considerations regarding the route of immunization, and current development of human mucosal vaccines.

·         6th Annual Vaccines: “All Things Considered” Conference, Washington, DC, November 12 to 14, 2008. This conference is a one-stop destination for updates and exposure on all aspects of vaccine research, development, regulations, and policy. Leaders in government, industry, and nongovernmental organizations will share key information with participants on topics ranging from new vaccine technologies to regulatory policies.

·         Developing Country Vaccine Manufacturers Network Meeting, Cape Town, South Africa, November 17 to 19, 2008. This conference brings together vaccine manufacturers from developing countries that are currently involved in vaccine development. Participating manufacturers will learn about new vaccine development efforts, advances in the field, and potential collaboration efforts, among other important topics.

 

Job opportunities

PATH’s vaccine development program has several open positions listed below. Please visit the employment opportunity web page for all open PATH positions.

·         Commercialization (business development) specialist

·         Senior technical advisor, process development, manufacture, and quality assurance

·         Senior scientist/project manager

 

View past issues of Vaccines for the Future

 

PATH’s vaccine development program is working to accelerate the development of innovative, safe, effective, and affordable vaccines against the leading causes of childhood deaths in the developing world, pneumonia (pneumococcal disease) and diarrheal disease (rotavirus, Shigella, and enterotoxigenic Escherichia coli), as well as new influenza vaccines for the global population. PATH is also partnering on vaccine development through its Malaria Vaccine Initiative and the Meningitis Vaccine Program. Additionally, PATH works to ensure the worldwide availability of vaccines through its Immunization Solutions program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation.

 

Learn more about PATH’s work

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