Argos Therapeutics today announced the presentation of positive data
from a Phase 2 trial that evaluated the safety, clinical response and
immune response of AGS-003 treatment in newly diagnosed patients with
metastatic renal cell carcinoma (mRCC). The data were discussed March 7
in a poster presentation at the ASCO Genitourinary Cancers Symposium.
AGS-003 is a product of the Company’s Arcelis™ technology, and is a
personalized, RNA-loaded, dendritic cell-based immunotherapy that is
perfectly matched to each patient’s unique tumor burden. According to
results from the study, AGS-003 induced a tumor-specific immune
response, performed better than interferon-α on a measure of
progression-free survival, and was well tolerated.
“A Phase 1/2 Study of AGS-003, a Personalized
Immunotherapeutic Evaluated in Newly Diagnosed Metastatic Renal Cell
Carcinoma (mRCC) Subjects”
“These results serve as preliminary proof-of-concept for AGS-003,
demonstrating that this immunotherapy is able to induce an immune
response to the very patient-specific tumor antigens that are targeted,”
said Charles Nicolette, Ph.D., Chief Scientific Officer and Vice
President of Research and Development of Argos Therapeutics. “This study
not only demonstrates a favorable safety profile and early signs of
efficacy, but the results also compare favorably to historical results
with standard immunotherapy approaches in mRCC patients. These results
provide a strong basis for the ongoing Phase 2 trial evaluating the
therapy in combination with sunitinib.”
“Patients enrolled in this trial were a higher-risk, poorer-prognosis
population with reduced expectations for clinical response and
survival,” said Theodore Logan, M.D., of the Indiana University Simon
Cancer Center and lead author on the poster. “Thus, the clinical
benefit, excellent safety profile and immunologic responses observed in
this study were quite encouraging. These results compare favorably to
historical results with interferon-α in an unfavorable risk group of
patients and represent an encouraging development in the continued
search for novel, well tolerated immunotherapy approaches in this
patient population.”