Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Crucell, a Dutch biopharmaceutical company, has signed a binding letter of agreement with GlaxoSmithKline Biologicals (GSK) to collaborate on developing malaria vaccine candidate.
Subscribe to our email newsletter
The pre-clinical data from earlier studies indicated 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.
As per the terms of the letter of agreement, Crucell is expected to contribute its recombinant malaria vaccine candidate Ad35-CS, based on its AdVac technology and PERC6 manufacturing platform and GSK will contribute its late stage malaria vaccine candidate RTS,S/AS.
Earlier, in October 2003 Crucell had 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 pre-clinical studies.
Reportedly, 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.
The collaboration now plans to progress this concept into human clinical studies. The companies are expected to 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 US.
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.
Ronald Brus, CEO at Crucell, said: “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. 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.”