GRNVAC1 is an autologous product consisting of mature dendritic cells (antigen-presenting
cells) pulsed with RNA for the protein component of human telomerase (hTERT) and a
portion of a lysosomal targeting signal (LAMP). GRNVAC1 is injected into the patient's skin;
from there the dendritic cells travel to the lymph nodes and instruct cytotoxic T-cells to kill
tumor cells that express telomerase on their surface.

The first clinical study of GRNVAC1 was conducted at Duke University Medical Center in
2005 or earlier. Several small additional Phase I/II trials, which concluded in 2006, in patients
with prostate cancer, hematologic malignancies and renal cell carcinoma were performed at
Duke in order to optimize the vaccination process. As a result of positive data from these
studies, Geron brought the vaccine manufacturing process in-house for further optimization
and transferred it to its contract manufacturer.

In the AML Phase II trial, patients enter the study in their first or second complete remission.
Prior to or shortly after completing consolidation chemotherapy, patients undergo
leukapheresis to harvest normal peripheral blood mononuclear cells for vaccine manufacture.
Patient mononuclear cells are differentiated in culture to immature dendritic cells, which are
transfected with messenger RNA encoding hTERT and LAMP. Transfected dendritic cells
are matured, aliquoted and cryopreserved. GRNVAC1 is released for patient dosing
contingent on several product specifications including, identity of mature dendritic cells,
confirmation of positive transfection with hTERT, number of viable cells per dose after
thawing and product sterility. Patients are vaccinated weekly for six weeks, followed by a rest
period of four weeks, and subsequent boost injections every other week for 12 weeks.
Monthly extended boost injections are then administered until the vaccine product supply is
depleted or the disease relapses.

Twenty patients in the study have received GRNVAC1 product. One patient relapsed prior to
vaccination. GRNVAC1 was found to be safe and generally well tolerated over multiple
vaccinations, including one patient who has received 28 serial vaccinations. Idiopathic
thrombocytopenic purpura (grade 4) was reported in one patient. Other toxicities were mild
to moderate, including rash or headache in 15-20% of patients.

Credit: Geron website. July 2010
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