Crucell to Collaborate with GSK Biologicals on Malaria Vaccine Candidate

Dutch biopharmaceutical company Crucell N.V. (Leiden, the Netherlands) and GlaxoSmithKline Biologicals (GSK, London, UK) will collaborate on developing a second-generation malaria vaccine candidate. Preclinical 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 agreement, Crucell will contribute its recombinant malaria vaccine candidate, Ad35-CS, based on its 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.

Crucell’s Ad35-CS vaccine candidate is based on the company's AdVac technology and PER.C6 manufacturing platform. It 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 vaccine candidate is currently being tested in a Phase 1 study in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).

In October 2003, Crucell announced a program 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 preclinical 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 preclinical 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 1–2a clinical challenge trial in the United States. Pending the results of the Phase 1–2a trial, the companies expect to advance the prime boost candidate in further clinical studies with the support of public or nonprofit partners who are interested in accelerating the development of a malaria vaccine.