Crucell And NIH Announce Start Of Malaria Vaccine Trial

Crucell And NIH Announce Start Of Malaria Vaccine Trial In Burkina Faso

Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the start of a Phase I clinical study in Burkina Faso of its AdVac®-based malaria vaccine vector. Crucell is developing its malaria vaccine vector in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), the Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, and the Noguchi Memorial Institute for Medical Research at the University of Ghana.

The study is a randomized, controlled, double-blinded, dosage- escalation clinical trial evaluating the immunogenicity and safety of the recombinant malaria vaccine vector Ad35-CS in malaria semi-immune, healthy adult volunteers living in Burkina Faso. This is the first study evaluating the safety and immunogenicity of this AdVac®-based malaria vaccine vector candidate in a population residing in a malaria endemic area.

"We are very pleased that the collaboration with NIH enables us to enter into this new trial," said Dr. Jerald Sadoff, Crucell's Chief Medical Officer at Crucell. "Using Crucell's technologies, we are on a joint mission to develop a vaccine against malaria, one of the top three killers in the world, causing close to a million deaths every year, mostly amongst children."

The study is funded by NIAID/NIH and conducted by Burkinabè researchers at the CNRFP, lead by the director of the CNRFP Dr. Sodiomon B. Sirima, MD, PhD. "The innovative approach in designing this malaria vaccine vector gives us confidence that it could open a new, promising era in the quest for an effective malaria vaccine, which would save the lives of millions of our children." said Dr. Sirima.

A Phase I clinical study recently completed in the United States demonstrated that the Ad35-CS vector has an acceptable safety and immunogenicity profile in malaria naïve, healthy adult volunteers.

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 reemerging 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.

The AdVac® technology is specifically designed to manage the problem of preexisting 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.

About Crucell's malaria vaccine

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 gene for the CSP 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 I study in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).