Dutch biopharmaceutical company Crucell N.V has signed a binding letter of agreement with GlaxoSmithKline Biologicals (GSK) to collaborate on developing a second generation malaria vaccine candidate. Pre-clinical data from earlier studies indicated significantly enhanced immune responses against the malaria parasite (circumsporozoite stage of the Plasmodium falciparum) when Crucell's Adenovirus (AdVac) technology and GSK's RTS,S/AS technology are used in combination, versus either component alone.

Under the terms of the letter of agreement, Crucell will contribute its recombinant malaria vaccine candidate, Ad35-CS, based on Crucell's AdVac technology and PER.C6 manufacturing platform and GSK will contribute its late stage malaria vaccine candidate RTS,S/AS. Financial details of the agreement were not disclosed.

In October 2003 Crucell announced a programme with the Walter Reed Army Institute of Research and GSK. The parties entered into a Cooperative Research and Development Agreement (CRADA) to evaluate Crucell's malaria vaccine candidate in pre-clinical studies. Crucell's vaccine candidate was tested as a stand-alone and in combination with GSK's malaria vaccine candidate RTS,S/AS. The tests conducted were designed to assess whether a combination of the GSK vaccine candidate with Crucell's vaccine candidate could lead to improved results. These pre-clinical studies showed significant enhancement of the immunological response when both vaccines were used in combination.

This collaboration now intends to progress this concept into human clinical studies. The companies will seek third party funding to advance the Ad35-CS and RTS,S/AS prime-boost candidate into a phase-I/IIa clinical challenge trial in the United States. Pending the results of the phase-I/IIa trial, the companies expect to advance the prime boost candidate in further clinical studies with the support of public or non-profit partners who are interested in accelerating the development of a malaria vaccine.

"We are very excited about this collaboration with GSK, which brings new impulse to the potential of eradicating malaria as one of the top three killers in the world," said Ronald Brus, chief executive officer at Crucell. "Malaria currently represents one of the most prevalent infections in tropical and subtropical areas, causing close to 900,000 deaths every year, mostly amongst children. I am confident a partnership of this kind will allow us to take a vital step towards our goal of bringing meaningful innovation to global health."

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.

Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines.

Crucell is developing a recombinant malaria vaccine, Ad35-CS, based on the company's AdVac technology and PER.C6 manufacturing platform.

Crucell is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases.