Summary: Professor Gustav Gaudernack presents GV1001 at a prestigious
international scientific conference on Friday, December 7, 2007
At an American Association for Cancer Research (AACR) conference ”The Role of
Telomeres and Telomerase in Cancer Research” held in San Francisco, Professor
Gustav Gaudernack from Rikshospitalet-Radiumhospitalet in Oslo, Norway gives a
scientific presentation entitled “GV1001: A Universal Cancer Vaccine Targeting
Telomerase”. Professor Gaudernack is one of the inventors of GV1001 which today
is owned and developed by Pharmexa A/S.
Key messages in Professor Gaudernack's presentation are:
Background
Telomerase has emerged as an attractive target for cancer therapy. In
particular, the hTERT subunit of telomerase is preferentially re-expressed in
malignant cells and its expression is closely associated with immortalization
of cancer cells. Thus, hTERT is a potential “universal” target in cancer
therapy. The recent identification of a defined subpopulation, the cancer stem
cells, with the capacity of unlimited growth potential, indicate that targeting
hTERT will also target cancer stem cells. The possibility of finding a vaccine
against hTERT has therefore been explored and a broadly immunogenic fragment of
hTERT, corresponding to the amino acid residues 611-626 of the active site of
the enzyme, has been identified. This peptide is called GV1001.
Main results to date
GV1001 has been used to vaccinate more than 170 cancer patients in a series of
Phase I/II clinical protocols, and the immunological and clinical results have
been analysed:
(1) GV1001 elicits potent T-helper immune responses in up to 75% of immunized,
non-HLA typed cancer patients, indicating that it is “universally” applicable
as a vaccine, without the need to restrict inclusion of patients only to
individuals with a certain HLA type.
(2) GV1001 specific T-helper cells recognize GV1001 bound to an unusually broad
range of HLA class-II molecules, encoded by several alleles of the HLA-DR, -DQ
and -DP loci on chromosome 6, demonstrating the promiscuous nature of its
binding.
(3) Responses can be observed even in very advanced stage patients that have
been heavily pre-treated. Vaccination can also be combined with repeated rounds
of chemotherapy (Temozolomide) without impairment of the immune response
against GV1001.
(4) In some patients, repeated vaccinations over a long time period is required
to obtain an immune response.
(5) Long term immune memory (>4 years) against GV1001 can be established.
(6) GV1001 specific T-cells are capable of producing a broad range of
pro-inflammatory cytokines when recognizing their target antigen.
(7) Both in patients with pancreatic and lung adenocarcinomas and in patients
with malignant melanoma, a significant association between immune responses to
GV1001 and survival has been observed. Long term survival (>5years) associated
with disease stabilization and in one patient complete remission, has been
observed in 4 patients with advanced, chemotherapy resistant non-small cell
lung cancer.
(8) Taken together, these results indicate that GV1001 could be a “universal”
cancer vaccine.
GV1001 is presently being tested in two Phase II clinical trials (primary liver
cancer and Stage II lung cancer) and in two large Phase III trials in patients
with inoperable pancreatic cancer.
The presentation will be available on Pharmexa's homepage www.pharmexa.com as
soon as possible.
Hørsholm, December 7, 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.
