PATH Malaria Vaccine Initiative and Crucell to test new malaria vaccine approach
Partners seek to protect against deadliest malaria parasite using adenovirus-based transport method to deliver malaria antigen
LEIDEN, The Netherlands, July 29, 2009 - The US-based PATH Malaria Vaccine Initiative (MVI), the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP), and Dutch biopharmaceutical company Crucell N.V. today announced a collaboration to accelerate development of a promising type of malaria vaccine. Through funding from the USAID MVDP, the partners will conduct studies to determine the effectiveness of Crucell's novel prime-boost vaccine approach against the malaria parasite, Plasmodium falciparum. This approach uses Crucell's proprietary recombinant adenoviruses (a type of virus associated with the common cold and other mild respiratory infections) to deliver a malaria antigen to the immune system.
Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell, commented, "This agreement is a strong validation of Crucell's malaria vaccine approach. We are excited to have MVI as our partner and to have the support of USAID. The fact that MVI is backing our program testifies to the importance of our efforts to further progress the development of Crucell's malaria vaccine."
For MVI, this partnership adds to its existing portfolio a vaccine approach with the potential to elicit a more comprehensive immune response than has been seen to date from the circumsporozoite protein (CSP), the only antigen that has proven to be protective against malaria in controlled challenge studies and field studies. Using Crucell's AdVac technology with two different vectors-the adenovirus serotypes Ad35 and Ad26 -as delivery mechanisms, this approach seeks to elicit a protective immune response obtained from delivering the CSP. The safety, immunogenicity and efficacy data from these studies will further advance the research forward development of a safe and highly efficacious malaria vaccine.
"Adenoviruses are one of the most potent vaccine delivery systems tested to date in humans. We are excited about the potential of Crucell's adenovirus-based program and the novel Ad35/Ad26 approach. The prime-boost regimen may be a critical next step in malaria vaccine development and, if successful, could move us toward our goal of having an 80 percent efficacious vaccine in use by 2025," said MVI Director, Dr. Christian Loucq.
Crucell is developing a recombinant malaria vaccine, Ad35-CS, based on the company's AdVac technology and PER.C6 manufacturing platform. The vaccine candidate is made by inserting the CSP gene from the P. falciparum malaria parasite into adenoviral vectors, which act as a 'vehicle' for vaccination delivery. This prime vaccine candidate is currently being tested in a Phase 1 study in partnership with the National Institute of Allergy and Infectious Diseases. This new collaboration will make it possible to clinically develop the Ad26 boost component of the vaccine and allow Crucell to further strengthen and expedite its malaria development program.
Carter Diggs at the USAID MVDP said, "We are pleased to support this adenovirus approach, which could play a vital role in malaria vaccine development."
About AdVac technology
AdVac technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and re-emerging infectious diseases, and in biodefense. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system. Most vectors are based on an adenovirus, such as the virus that causes the common cold.
AdVac technology is specifically designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac technology is based on adenoviruses that do not regularly occur in the human population, such as Ad26 and Ad35. In contrast to Ad26 and Ad35 antibodies, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines. All vaccine candidates based on AdVac are produced using Crucell's PER.C6 production technology.
About PER.C6 technology
Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines. The production-scale potential of the PER.C6 cell line has been demonstrated in an unprecedented successful bioreactor run of 20,000 liters. Compared to conventional production technologies, the strengths of the PER.C6 technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions. These characteristics, combined with its ability to support the growth of both human and animal viruses, make PER.C6 technology the biopharmaceutical production technology of choice for Crucell's current and potential pharmaceutical and biotechnology partners.
Malaria is one of today's top three killers among communicable diseases. The disease currently represents one of the most prevalent infections in tropical and subtropical areas, causing severe illness in approximately 250 million individuals worldwide and causing close to 900,000 deaths every year. Most of these deaths occur among children under the age of five and pregnant women in sub-Saharan Africa. Unfortunately, mortality associated with severe or complicated malaria still exceeds 10 to 30 percent. Malaria is caused by the Plasmodium parasite and transmitted, person-to-person, through the bite of a female Anopheles mosquito. Although the overwhelming majority of illness and death associated with malaria occurs in the developing world, this disease also affects travellers.
About the PATH Malaria Vaccine Initiative (MVI)
MVI is a global program established at PATH through an initial grant of $50 million from the Bill & Melinda Gates Foundation. MVI's mission is to accelerate the development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI's vision is a world free from malaria. For more information, please visit www.malariavaccine.org.
Founded in 1977, PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being. For more information, please visit www.path.org.
About the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP)
The MVDP is a unit of the Division of Infectious Diseases of the Office of Health, Nutrition, and Infectious Diseases of the USAID Global Health Bureau. The MVDP, which was initiated in 1965 in response to the end of the first malaria eradication era, has worked with a variety of partners to contribute early research on the circumsporozoite protein and more recently, the development of blood-stage vaccine approaches leading to many of the investigational malaria vaccines fielded in recent years. Its mission is congruent with that of MVI-to develop and introduce malaria vaccines to protect vulnerable populations in the developing world. For further information, please visit http://www.usaid.gov/our_work/global_health/id/malaria/techareas/vaccine.html
About Crucell N.V.
Crucell N.V. is a global biopharmaceutical company focused on research, development, production, and marketing of vaccines, proteins, and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminium-free hepatitis A vaccine on the market. The company has a broad development pipeline, with several product candidates based on its unique PER.C6 production technology. The company licenses its PER.C6 technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth, GlaxoSmithKline, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the United States. The company employs over 1,000 people. For more information, please visit www.crucell.com.
This press release contains forward-looking statements that involve inherent risks and uncertainties. Crucell has identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the US Securities and Exchange Commission on April 22, 2009, in the section entitled 'Risk Factors.' The company prepares its financial statements under International Financial Reporting Standards.