MVI and Crucell Announce Collaboration new Malaria Vaccine Approach
Partners seek to protect against deadliest malaria parasite using
virus-based transport method to deliver malaria antigen
Leiden, The Netherlands (July 29, 2009) - The U.S.-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. (Euronext, Nasdaq: CRXL;
Swiss Exchange: CRX) 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.
We are excited to have the MVI as our partner and 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 in
controlled challenge studies and field studies. Using Crucell's
AdVac® technology with two different adenovirus vectors - 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
advance the research forward in the further development of a safe and
highly effective malaria vaccine.
Dr. Christian Loucq, Director at MVI said: "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
would move us toward our goal of having an 80% efficacious vaccine in
use by 2025."
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). 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.
The 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.
About Malaria
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 10-30 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 MVI
The PATH Malaria Vaccine Initiative is a focused vaccine development
program created in 1999 through a grant from the Bill & Melinda Gates
Foundation. MVI's mission is to accelerate the development of
promising malaria vaccines and ensure their availability and
accessibility in the developing world. PATH is an international, non
profit 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.
About the USAID 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, 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:
http://www.usaid.gov/our_work/global_health/id/malaria/techareas/vaccine.html
About Crucell
Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) 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 aluminum-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, GSK, CSL and Merck &
Co. Crucell is headquartered in Leiden, the Netherlands, with
subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S.
The Company employs over 1000 people. For more information, please
visit www.crucell.com.
Forward-looking statements
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 U.S. 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 (IFRS).
For further information please contact:
Crucell N.V.
Oya Yavuz
Vice President
Corporate Communications & Investor Relations
Tel. +3171 519 7064
ir@crucell.com
www.crucell.com
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