Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

Argos Therapeutics today announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC). The data were discussed June 7 in a poster session at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, IL. AGS-003 is a product of the Company's Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is individualized to each patient's unique tumor.

“The combination of a personalized immunotherapy, such as AGS-003, with a standard treatment like sunitinib, represents a potentially promising future treatment for patients with RCC.”

"The interim results with the combination of AGS-003 plus sunitinib in this higher-risk, poorer-prognosis group of advanced RCC patients have been encouraging," said Asim Amin, M.D., Ph.D., Co-Director, Immunotherapy Program for the Blumenthal Cancer Center in Charlotte, North Carolina and lead author on the poster. "The combination of a personalized immunotherapy, such as AGS-003, with a standard treatment like sunitinib, represents a potentially promising future treatment for patients with RCC.

"Sunitinib has been shown to modulate the immune system by decreasing T-regulatory cells that can potentially suppress immune responses in the tumor microenvironment," Dr. Amin continued. "The potential to address the underlying immune suppression in RCC with an active therapy like sunitinib and combine it with a novel immunotherapy like AGS-003, may lead to improved outcomes compared to either approach alone. Further, the lack of overall and additive toxicity observed to date with AGS-003 on this study makes it an ideal candidate to combine with sunitinib."

Jeffrey Abbey, President and Chief Executive Officer of Argos, said: "The data presented at ASCO further support the compelling clinical profile of AGS-003, our personalized dendritic cell-based immunotherapy, which was first established in monotherapy trials. The interim data suggest the observed progression free survival (PFS) for the combination of AGS-003 plus sunitinib may be longer than expected with sunitinib alone in patients with intermediate and poor risk RCC. Final PFS data from this Phase 2 trial are expected by the end of this year and we are planning to start a Phase 2b clinical trial of AGS-003 in combination with sunitinib next year."

This open-label Phase 2 trial enrolled 22 evaluable, newly diagnosed post-nephrectomy patients with metastatic clear cell RCC. Subjects first received four weeks of sunitinib, followed by two weeks off treatment; patients then received five intradermal injections of AGS-003 every three weeks in combination with sunitinib, followed by every three months until disease progression or study end. Interim results from the trial demonstrate that 81% of patients experienced clinical benefit, as defined by partial response or stable disease per RECIST. AGS-003 was well tolerated, with no immunotherapy-related serious adverse events or grade 3/4 adverse events reported. Correlative immune response evaluation is ongoing.