Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialisation of fully individualised immunotherapies for the treatment of cancer based on the Arcelis technology platform, has begun a single-centre pilot clinical trial of AGS-003 as a neoadjuvant immunotherapy in patients with localised renal cell carcinoma.

The study is being conducted at Roswell Park Cancer Institute (RPCI) in Buffalo, New York, and is designed to enroll a maximum of ten patients who will be treated with AGS-003 before nephrectomy in order to assess immune system response and tumour effects.

"There is tremendous potential for approaches that use the body's own defense mechanisms to treat cancer, and we are dedicated to advancing promising approaches in this rapidly expanding area of cancer research," said Thomas Schwaab, MD, PhD, chief of strategy, business development & outreach, associate professor in the departments of urology and immunology and urology clinic director at Roswell Park Cancer Institute and principal investigator for the AGS-003 pilot study.

"AGS-003 has shown strong potential in trials targeting metastatic renal cell carcinoma, and we look forward to advancing research to determine whether this therapy can help the body build an effective immune response to kill tumour cells in patients with localised disease. The goal is to develop a treatment that will interrupt the cancer's progression before it has a chance to spread to additional organs."

AGS-003 is an autologous dendritic-cell-based immunotherapy designed to induce a memory T-cell response specific to each patient's unique tumour antigens. It is produced using a small sample from a patient's own tumour and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavourable-risk metastatic renal cell carcinoma patients. Argos is evaluating AGS-003 in the pivotal phase 3 ADAPT trial in combination with standard targeted therapy for the treatment of metastatic renal cell carcinoma. The ADAPT trial is fully enrolled; interim data analyses are expected next year, with final data expected in the first part of 2017.

The pilot study is in patients with localised renal cell carcinoma, who must be eligible to undergo a partial or radical nephrectomy. Patients will receive five weekly doses of AGS-003 prior to surgery and will remain in the study for approximately six months.

"With this pilot study, for the first time we will be able to assess the effects of AGS-003 in patients with kidney cancer that has not spread to nearby lymph nodes or other parts of the body," said Charles Nicolette, chief scientific officer and vice president of research and development at Argos Therapeutics.

"It is also an important opportunity to manufacture AGS-003 using a needle biopsy procedure for tumour collection prior to surgery and to directly study immune changes within the primary tumour before and after administration of AGS-003."

Dr. Schwaab was also recently named to Argos' inaugural Scientific Advisory Board and receives compensation from Argos for this service.

Arcelis is a fully personalised immunotherapy technology that captures mutated and variant antigens that are specific to each patient's disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialisation challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumour or blood sample and the patient's own dendritic cells, which are optimised from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.