Pharmexa presents preclinical data to support its product development pipeline at vaccine conference

Summary: Pharmexa scientists present data from several ongoing programs at
international vaccine conference in Amsterdam 
 
Pharmexa scientists present preclinical data from a range of programs at the
international scientific conference “Vaccine Congress” which takes place in
Amsterdam from 9 - 11th December 2007. 

Key messages from Pharmexa's presentations:

Pharmexa's malaria vaccine EP1300
Pharmexa presents new data from its malaria EP1300 DNA vaccine administered by
in vivo electroporation to enhance vaccine potency and utility. The vaccine is
based on Pharmexa's polyepitope technology and encodes 38 cytotoxic T
lymphocyte (CTL) epitopes and 14 helper T lymphocyte (HTL) epitopes from four
Plasmodium falciparum strains. It is designed to invoke a broad immune response
targeting infected liver cells and thus, to slow down the infection before
large numbers of the parasites reach the blood stream causing the commonly
recognized symptoms. The results presented today in Amsterdam show that EP1300
is highly immunogenic and give rise to robust CTL and Helper-cell responses,
even at low doses. Furthermore, Pharmexa demonstrates that giving the vaccine
with an electroporation device significantly increases the immunogenicity of
the vaccine, particularly at lower doses. 

1 million people die of malaria each year, a high proportion of which are
children. EP1300 is designed to provide world wide population coverage. 

Pharmexa's influenza vaccines
Pharmexa has two preclinical programs aimed at influenza and new results from
both programs are presented at the Amsterdam conference. 

Pharmexa has designed a recombinant protein vaccine based on the influenza
antigen hemagglutinin 5 (H5 HA) combined with the PADRE® epitope to increase
the immunogenicity of the vaccine. In a pandemic setting, a recombinantly
expressed HA vaccine is a highly attractive vaccine option due to the ease of
manufacture in large quantities. The results presented show that PADRE®
augments the immunogenicity of this vaccine type and that the effect was most
evident at the lowest vaccine doses tested. 

Pharmexa also presents new data from its influenza vaccine candidate EP1450
which is an early stage polyepitope DNA vaccine encoding a large array of
highly conserved CTL and HTL epitopes selected via Pharmexa-Epimmune's
proprietary Epitope Identification System (EIS®). The vaccine is designed to
induce cellular immune responses against all human influenza strains. The
vaccine could be used in a pandemic situation, but also as a seasonal influenza
vaccine where is could be particularly useful in the elderly population, in
which conventional influenza vaccines provide only limited effectiveness. 

Results of a prototype version of EP1450 showed that the vaccine is
immunogenic, giving rise to both CTL and HTL responses. The prototype vaccine
also showed protective efficacy against a lethal influenza virus challenge in a
mouse model. 

Approximately 1 billion people are infected by influenza each year of which
there are 3-5 million cases of severe illness and 300,000-500,000 deaths. In
addition, the recent emergence of avian H5N1 influenza strains has generated
concerns that an influenza pandemic could occur in the next few years. 

Pharmexa's HIV vaccines
Pharmexa also gives an update on its HIV programs which include new preclinical
data obtained using the EP1233 polyepitope DNA vaccine and the MVA-BN32
(developed with Bavarian Nordic) supporting a heterologous prime-boost
strategy. The results show that the combination of DNA and MVA vaccine formats
are well-suited for delivery of T-cell epitope-based vaccines. Even very low
doses of DNA are effective for priming responses that are boosted by MVA. 
EP1233 and MVABN32 are currently being evaluated in a clinical Phase I trial
and the MVA-BN32 as a stand alone vaccine in two Phase I trials. 

HIV infection threatens large percentages of the population of many developing
countries. In 2006, more than four million people were newly infected with HIV,
bringing the total number of people infected close to 40 million worldwide. 

Pharmexa's CRIPTO cancer vaccine
The cancer protein CRIPTO is upregulated in many cancers, including breast,
ovarian and colorectal cancer and therefore CRIPTO could be an attractive
target for a cancer vaccine. Pharmexa has designed a CRIPTO AutoVac™ vaccine
combining Pharmexa's proprietary AutoVac™ and PADRE® technologies. At the
Amsterdam conference Pharmexa presents data showing that this candidate vaccine
leads to the generation of high antibody titers in mice and that these
antibodies effectively bind to CRIPTO. More importantly, the CRIPTO AutoVac™
vaccine significantly delayed tumor growth in a recognized murine tumor model. 

These results once again underline the versatility of Pharmexa's AutoVac™
technology platform, used here with its proprietary PADRE® epitope, for the
design of immunotherapeutic cancer vaccine products. 

Dr. Achim Kaufhold, Pharmexa's Executive Vice President, CSO & CMO, comments:
“The research presented at this international vaccine congress underscores
Pharmexa's efforts to build a sustainable pipeline of product development
candidates to combat cancer and infectious diseases. It requires novel
approaches to successfully address these clinical challenges. Towards this
goal, we are well positioned because of our experience and validated T-cell
epitope platform technologies which we are using to design vaccines to ensure
appropriate immunogenicity and human population coverage.” 

 
Hørsholm, December 11, 2007


Jakob Schmidt
Chief Executive Officer

Additional information: Jakob Schmidt, Chief Executive Officer, telephone +45
4516 2525 
Claude Mikkelsen, Vice President, Corporate Affairs and Communication,
telephone +45 4516 2525 or +45 4060 2558 

Note to editors: Pharmexa A/S is a leading company in the field of active
immunotherapy and vaccines for the treatment of cancer, serious chronic and
infectious diseases. Pharmexa's proprietary technology platforms are broadly
applicable, allowing the company to address critical targets in cancer and
chronic diseases, as well as serious infectious diseases such as HIV,
influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide
vaccine that has entered phase III trials in pancreatic cancer and phase II
trials in liver cancer, and HIV and hepatitis vaccines in phase I/II.
Collaborative agreements include H. Lundbeck, GENimmune, IDM Pharma and
Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs
approximately 105 people and is listed on the Copenhagen Stock Exchange under
the trading symbol PHARMX.