MVI Update: News from the PATH Malaria Vaccine Initiative

This issue: July 2013

Greetings from the director, Dr. David Kaslow

Dear friends of the PATH Malaria Vaccine Initiative,

MVI’s second quarter has been action-packed. Momentum is building in all three of our priority program areas—transmission-blocking vaccines (TBVs), next-generation vaccines, and RTS,S. 

Among the many exciting developments on the TBV front, MVI convened meetings of two technical consulting groups tasked with providing expert guidance on the feasibility of a traditional, cluster-randomized trial and on the potential for an alternative regulatory pathway as the basis of licensure of TBVs. For next-generation vaccines, MVI’s portfolio management committee approved the release of a request for proposals for manufacturing of pre-erythrocytic antigens—a key step in the process of identifying “new” target antigens for future vaccine development. This is the second MVI call for proposals in 2013, the first having focused on TBV expression and delivery technologies (see below for an update). And, RTS,S was among the five vaccines prioritized for further analysis during Phase 1 of GAVI’s recent Vaccine Investment Strategy review

Another highlight of the second quarter was the many events marking World Malaria Day, which drew MVI staff as presenters and participants: in London and Lausanne, Brussels and Baltimore, in Washington, DC, and at Washington University.

While the above is only a fraction of MVI’s activities during the past three months to fulfill our mission of accelerating development of malaria vaccines and catalyzing timely access in endemic countries, nothing would be possible without the creative minds and committed hearts of Team MVI. Further below you will see mention of recent arrivals to MVI. I want to focus on one of these and also to share with you some exciting news about staffing changes for the MVI program and PATH overall.

On the first of July, MVI welcomed Chris Ockenhouse, MD, PhD, as MVI’s new senior clinical research scientist and medical officer. Chris brings to PATH more than two decades of experience in malaria vaccine research and development (R&D), adding his clinical expertise to that of Didier Leboulleux and others on the MVI team. While Chris’s primary focus will be on MVI’s translational R&D projects, he will also provide medical and scientific expertise on clinical malaria, clinical immunology, and trial design across our portfolio.

Chris is a practicing internist and infectious disease specialist with 25 years of experience leading R&D programs focused on discovery, process development, manufacture, and early clinical testing of multiple vaccine candidates against Plasmodium falciparum and P. vivax malaria. Prior to joining MVI, Chris was director of the Malaria Vaccine Program at the Walter Reed Army Institute of Research (also known as WRAIR), where he directed the formation and operations of the first joint US Army-Navy Military Malaria Vaccine Program within the Department of Defense dedicated to developing malaria vaccines. He recently retired from active duty as a colonel in the US Army.

I am also very excited to announce the appointment, effective today, of Ashley Birkett, PhD, as deputy director at MVI—a new position for the program. As MVI’s director of R&D, Ashley has been involved in every major R&D initiative at MVI since joining the program in 2008. He has more than 15 years of vaccine development experience, primarily with biotechnology companies, where he successfully advanced novel influenza and malaria vaccine candidates from research through first-in-human clinical studies. As R&D director, Ashley has led MVI’s efforts to support the development of TBVs, guided MVI’s portfolio of evaluation technology projects, and provided technical support to MVI’s two additional program areas: next-generation vaccines and the RTS,S program. Prior to joining MVI, he was senior director of preclinical research at Acambis (now Sanofi Pasteur Biologics Co.).

I am focusing attention on these two new appointments in particular because they speak to both the continuity of leadership and the continued infusion of new talent at MVI (see below for other additions to Team MVI). They also give me confidence as I prepare to assume the role of vice president of product development at PATH, a transition that will begin in October. In this new role, I will oversee PATH’s five product development programs that represent the organization’s portfolio of work in community-based interventions, devices, diagnostics, drugs, and vaccines. This means that I will continue to be involved in MVI’s work—and indeed will stay closely engaged with the RTS,S project in particular as it continues its progress through the development pipeline. Also, however, I will have the honor of working with the distinguished leaders of key PATH programs that together are developing the next generations of tools needed to realize our vision of a world where health is within reach for everyone.

I hope you will all join me in welcoming Chris to PATH and in congratulating Ashley on his new appointment. And I thank you for your continued interest in MVI’s efforts to help rid the world of malaria.

Sincerely,

David C. Kaslow, MD
Director

 

Update on call for proposals

In January 2013, the PATH Malaria Vaccine Initiative issued a call for proposals pertaining to transmission-blocking vaccine expression and delivery technologies, including expression of GPI-anchored proteins and particle delivery approaches. We received 22 letters of intent from academic and commercial institutions in Australia, Denmark, India, the Netherlands, Switzerland, the United Kingdom, and the United States and invited 11 groups to submit full proposals. Final selections will be announced this summer.

Malaria research & development funding report

The PATH Malaria Vaccine Initiative (MVI) is working to update the 2011 report on investments in malaria research and development (R&D) in collaboration with Sydney-based Policy Cures and three other product development partnerships—Foundation for Innovative New Diagnostics, Innovative Vector Control Consortium, and Medicines for Malaria Venture. This updated report will be jointly released with an analysis of the R&D costs and investments required for malaria elimination and eradication, which is being commissioned by the Malaria Eradication Scientific Alliance (MESA), in collaboration with Policy Cures. MESA and MVI plan to launch the companion reports at the October 2013 Multilateral Initiative on Malaria (MIM) conference in Durban, South Africa.

MVI at MIM

The PATH Malaria Vaccine Initiative is planning a robust presence at the 6th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference, to be held October 6–11, 2013, at the International Convention Centre in Durban, South Africa. As the world’s largest gathering of the malaria community, this scientific conference brings together leading researchers, activists, health workers, public health officials, and policymakers every three to four years at a location within Africa. MIM was established in 1997 with the mission of strengthening and sustaining the capacity of malaria-endemic countries in Africa through collaborative research and training. Additional information about the conference can be found here

Portfolio update

The PATH Malaria Vaccine Initiative (MVI) accelerates the development of malaria vaccines by identifying potentially promising malaria vaccine approaches and systematically moving them through the development process. Through strategic and efficient use of resources, MVI maintains a diversity of feasibility studies, translational projects, and at least one advanced vaccine candidate. Continued support of a project depends on whether the candidate meets a series of clearly defined milestones related to safety, efficacy, and suitability for mass production. Over the last six months, MVI’s portfolio has been updated accordingly.

See the latest portfolio graphic on our website here.

Publications of interest

Malaria vaccine R&D in the Decade of Vaccines: Breakthroughs, challenges and opportunities
Publication date: April 18, 2013 Journal: Vaccine (supplement)

While progress has been made in reducing malaria mortality with other interventions, vaccines are still urgently needed to further reduce the incidence of clinical disease. The most clinically advanced candidate, RTS,S, is presently undergoing Phase 3 evaluation. At the same time, priorities include the development of more highly efficacious vaccines to prevent clinical disease caused by both Plasmodium falciparum and P. vivax, and the development of vaccines to support elimination efforts by inducing immunity that blocks malaria parasite transmission. This article, published in the Vaccine supplement, provides information on breakthroughs and opportunities in the field of malaria vaccine research and development as well as key challenges being faced.

Modeling the public health impact of malaria vaccines for developers and policymakers
Publication date: July 1, 2013 JournalBMC Infectious Diseases

Efforts to develop malaria vaccines show promise. Mathematical model-based estimates of the potential demand, the likely public health impact, and cost and financing requirements can be used to inform investment and adoption decisions on the use of malaria vaccines as complements to existing interventions. However, the complexity of such models may make their outputs inaccessible to non-modeling specialists. This paper describes a Malaria Vaccine Model developed to address the specific needs of developers and policymakers to access sophisticated modeling results and test various scenarios in a user-friendly interface. The model's functionality is demonstrated through a hypothetical vaccine.

Qualification of standard membrane-feeding assay with Plasmodium falciparum malaria and potential improvements for future assays
Publication date: March 6, 2013 Journal: PLOS ONE

Vaccines that interrupt malaria transmission are of increasing interest. A robust functional assay to measure this activity would provide a biologically relevant means of evaluating potential vaccine candidates. The authors of this journal article, therefore, aimed to qualify the standard membrane feeding assay (SMFA). SMFA is one of the few biological assays used in preclinical and early clinical development of transmission-blocking vaccines, and this study strongly supports its further development and application.

A chemiluminescent-western blot assay for quantitative detection of Plasmodium falciparum circumsporozoite protein
Publication date: April 30, 2013 Journal: Journal of Immunological Methods

Highly sensitive and reliable assays based on the quantitation of immunologically relevant component(s) in recombinant or whole parasite-based vaccines would facilitate preclinical and clinical phases and the monitoring of malaria vaccine deployment. The authors of this article report a laboratory-grade Western Blot assay for quantitative detection of Plasmodium falciparum circumsporozoite protein in P. falciparum sporozoite and in recombinant product. To the author’s knowledge, this is the most sensitive immunoassay for the detection of a recombinant or native malarial protein and may have a wider range of applications, including the quantification of immunological component(s) in a vaccine formulation and determination of the antigenic integrity in adjuvanted-vaccine and in stability studies. In addition, this assay can be applied to measure the mosquito infectivity in malaria transmission areas and to determine the effects of intervention measures on malaria transmission.

Inside MVI

The PATH Malaria Vaccine Initiative (MVI) welcomed a number of new staff members this year. More information about these staff members, as well as the entire team, can be found on our website here.

Chris Ockenhouse, MD, PhD
In July, Chris Ockenhouse joined MVI as senior clinical research scientist and medical officer. He provides scientific and clinical guidance to translational project teams in charge of early clinical development, working closely with MVI staff, partners, and academic investigators. He brings a wealth of experience in leading research and development programs focused on discovery, process development, manufacture, and early clinical testing of multiple vaccine candidates against Plasmodium falciparum and P. vivax malaria.

Edward Wu, PhD
In June, Edward Wu joined the team as a project manager in the Research and Development Unit. He works within MVI units and programs to coordinate transmission-blocking vaccine development projects and monitor milestones used to measure program progress toward achieving strategic goals.

Amanda Sanchez
In January, Amanda Sanchez joined MVI as the executive assistant to the MVI director. Amanda has more than ten years of experience providing administrative support to executive-level staff and personnel in both the nonprofit and for-profit sectors.

Maria Gomez, MSc
Also in January, Maria Gomez joined the team as project manager in the Portfolio Management and Translational Projects Unit. She works with external partners and with other units within MVI to coordinate malaria vaccine projects in early clinical testing. She has several years of experience in the development and manufacturing of immunoassays, and she has held numerous process engineering positions as well.

Keep in touch!

Interested in staying abreast of the latest developments in the malaria vaccine and global health fields?

Forward this newsletter to a friend
Click here to unsubscribe

PATH Malaria Vaccine Initiative
455 Massachusetts Avenue NW, Suite 1000
Washington, DC, 20001 USA
Tel: +1 202.822.0033 | Fax: +1 202.457.1466
mvi_info@path.org
www.malariavaccine.org