A Phase I Study of Therapeutic Cancer Vaccine IMF-001 in Patients With Malignancies Expressing NY-ESO-1
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries
(SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse
transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the
typical expression pattern of cancer testis antigens (CT antigens). NY-ESO-1 mRNA was
expressed only in testis of normal tissues tested and in various types of cancer, including
lung cancer, breast cancer, malignant melanoma and bladder cancer. Since testis is an
immune privileged organ where HLA molecules are not expressed, these antigens can be
considered tumor-specific.
IMF-001 is a CHP-NY-ESO-1 complex consisting of recombinant NY-ESO-1 protein and cholesteryl
hydrophobized pullulan (CHP). CHP forms colloidally stable nanoparticles in water and
complexes with substrate such as NY-ESO-1 protein.
It is well known that exogenous antigen proteins can induce specific CD4+ T cells but not
specific CD8+ T cell. Dendritic cells pulsed with IMF-001 induced NY-ESO-1 specific CD8+ T
cells in blood samples of 4 healthy volunteers. These data suggest that immunization of
patients with IMF-001 can evoke not only specific CD4+ T cells responses but also specific
CD8+ T cell response to NY-ESO-1 more effectively than NY-ESO-1 protein alone. Similar
results for both cellular and humoral immunity in response to NY-ESO-1 protein were observed
in previous clinical investigational studies with IMF-001.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events as a measure of safety and tolerability of repeat doses.
Date of first dose until 30 days after off-study, or until resolution of related AEs
Yes
DAIJU ICHIMARU, BS
Study Director
ImmunoFrontier, Inc.
United States: Food and Drug Administration
IMF001-PRT001
NCT01234012
May 2011
December 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
New York University (NYU) Cancer Center | New York, New York 10016 |