Download Clinical Results for DC Vaccine Vaccell® Announced in Clinical

News Release Dated July 30, 2014
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tella, Inc.
Yuichiro Yazaki, President & Representative Director
2191, Tokyo Stock Exchange (JASDAQ)
Kazuyuki Yamamoto, Executive Officer, General
Manager, President Office (Tel: +81-3-5572-6590)
Clinical Results for DC Vaccine Vaccell® Announced in Clinical Cancer Research
—Evaluation for the safety and efficacy of DC vaccine Vaccell® pulsed with WT1 class I peptide and class II
peptide for treating advanced pancreatic cancer—
tella, Inc. (Head office: Minato-ku, Tokyo; President & Representative Director: Yuichiro Yazaki) has signed a
joint research agreement with the Gastroenterological and Liver Internal Medicine Departments of Kashiwa
Hospital of Jikei University School of Medicine in August 2010. Based on this agreement, a Phase I clinical
study has been performed to determine the safety and efficacy of dendritic cell (DC) vaccine Vaccell® pulsed
with WT1 class I peptide and a new class II peptide that is used in combination with an anticancer drug
(gemcitabine hydrochloride) for treating advanced pancreatic and biliary cancers. The results of this clinical
study were published in the electronic version (23 July 2014) of the academic publication of the American
Association for Cancer Research (AACR) “Clinical Cancer Research” (Impact factor 2012: 7.837).
tella's DC vaccine Vaccell® is a therapy in which lymphocytes that recognize the unique characteristics of an
individual’s cancer attack the cancer cells. This is possible because the DC cells recognize the cancer antigen
(cancer characteristics) and then send information about these characteristics to the lymphocytes. tella holds
the exclusive rights to use the WT1 peptide that was developed by Professor Haruo Sugiyama of the Graduate
School of Osaka University. This peptide is reported to occur with almost all types of cancer. WT1 peptides are
used as a cancer antigen at contracted medical institutions of tella. There are two categories of WT1 peptides:
class I and class II. Class I activates killer T-cells (cytotoxic T-cells) and class II activates helper T-cells. WT1
class II peptides differ from cancer antigens that activate only killer T-cells. As a result, WT1 class II peptides
are attracting much attention as a cancer antigen that can increase the efficacy of killer T-cells by activating
helper T-cells.
This research has two objectives. One is to confirm the safety of the DC vaccine Vaccell® pulsed with WT1
class I and class II peptides that is used in combination with an anticancer drug to fight advanced pancreatic
and biliary cancers and obtain clinical data. The other objective is to investigate the distinctive immunological
response with respect to WT1 peptides. There were 11 cases in all. Three used only the WT1 class I peptide
(WT1-I), one used only the WT1 class II peptide (WT1-II), and seven used both classes (WT1-I/II).
Analysis of the clinical results revealed that the delayed type hypersensitivity (DTH) that is a distinctive
characteristic of WT1 peptides occurred in four of the seven cases where WT1-I/II was used with an anticancer
drug to treat pancreatic cancer. But DTH response was not observed in the WT1-I case or the three WT1-II
cases. In the four pancreatic cancer cases where the WT1-specific DTH response occurred, the median survival
time (MST) and progression-free survival (PFS) were both longer than for cases where there was no DTH
response. These are statistically significant improvements in relation to cases with no DTH response. In the
three cases where a particularly strong DTH response was observed, the survival time was longer than one year
(MST: 717 days, PFS: 440 days). Compared to cases where the survival time was shorter than one year, the
three cases where the survival time was longer than year, cytotoxic T-cells that function as memory T-cells
were observed with greater frequency. The results of this clinical study therefore confirmed that the use of the
DC vaccine Vaccell® pulsed with WT1-I/II used in combination with an anticancer drug can induce the
WT1-specific immunology response that targets cancer cells.
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This research has shown that the DC vaccine Vaccell® pulsed with WT1 class I and class II peptides may be
able to contribute to holding down the progress of advanced pancreatic cancer. tella will continue to work on
receiving pharmaceutical approval of DC vaccine Vaccell® that is used with WT1 peptides.
tella will gather more scientific evidence about DC vaccine Vaccell® in order to develop and make available
even better cell therapies.
This matter will have only a negligible effect on results of operations in fiscal 2014.
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