Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer, has recently announced it initiated a single-center pilot study of its AGS-003 investigational drug as a neoadjuvant immunotherapy for the treatment of patients with localized renal cell carcinoma.
The clinical trial is being conducted at Roswell Park Cancer Institute (RPCI) in Buffalo, New York, and the company is expecting to enrol ten patients who will receive AGS-003 before nephrectomy to evaluate its anti-tumour effects and immune system responses.
“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 tumor cells in patients with localized 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 experimental personal immunotherapy developed specifically for every person’s tumor. AGS-003 uses important information taken from each person’s kidney cancer and uses their own dendritic cells to create a personalized therapy. This therapy trains the patient’s immune system to better recognize and attack their own cancer cells.
Results from an open-label phase 2 study showed that AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable-risk metastatic renal cell carcinoma patients. AGS-003 is also being evaluated in a phase 3 clinical trial (ADAPT) in combination with targeted drug therapy for the treatment of metastatic renal cell carcinoma (mRCC). The study is fully enrolled and Argos expects to release interim results in 2016 and the final results in 2017.
This novel pilot study is being conducted in patients with a diagnosis of localized renal cell carcinoma. All patients must be eligible to undergo a radical or partial nephrectomy. Five weekly doses of AGS-003 will be given to patients before surgery, who will remain in the clinical trial for a period of 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 tumor collection prior to surgery and to directly study immune changes within the primary tumor before and after administration of AGS-003.”