Argos Therapeutics Inc., a biopharmaceutical company, has announced that the first patients have been enrolled in the ADAPT Phase III clinical study for AGS-003, its most advanced product candidate.
AGS-003 is an investigational, fully personalized, dendritic-cell based immunotherapy. The ADAPT study is designed to examine the potential for AGS-003 plus standard targeted drug therapy to extend overall survival versus standard therapy alone in newly diagnosed patients with unfavorable risk metastatic renal cell carcinoma (mRCC).
The ADAPT study is a randomized, multicenter, open-label clinical trial expected to enroll 450 patients in approximately 120 sites, mostly in North America, under an approved Special Protocol Assessment by the Food and Drug Administration. Secondary endpoints include progression-free survival, safety, overall response and immune response. By the end of first quarter 2013, the company expects to have nearly 70 active sites, primarily in the US, while the remaining North American and global sites are expected to be activated by summer of 2013.
In a previous Phase II study, treatment with AGS-003 plus sunitinib was associated with encouraging median and long-term survival with no added toxicity in newly diagnosed, unfavorable risk mRCC patients. Compared to historical results with sunitinib alone, the combination was associated with median overall survival nearly double that expected in unfavorable risk mRCC patients.
Approximately 50% of patients in the Phase II study survived longer than 30 months, which is nearly four times the expected long-term survival rate for sunitinib in similar risk patients. Furthermore, results demonstrated a statistically significant correlation between the number of anti-tumor, memory T-cells induced and overall survival, directly supporting the intended AGS-003 mechanism of action.
Arcelis is a fully personalized, active immunotherapy technology that captures all antigens, including mutated and variant antigens that are specific to each patient's disease. It has been shown to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that are associated with toxicity. The technology can be leveraged to manufacture personalized therapies for any cancer or infectious disease.
Jeff Abbey, CEO of Argos Therapeutics, said, "The initiation of enrollment in the Phase III ADAPT study is a major milestone in the clinical development of AGS-003, our first Arcelis technology product candidate. We intend to prove that our fully personalized approach to immunotherapy, uniquely designed to target the entire disease-antigen repertoire, can overcome immunosuppression and extend overall survival for those suffering with metastatic RCC.
"We are fortunate to be working with many of the country's top cancer centers and to have widespread support from national advocacy organizations such as the Kidney Cancer Association and the Society of Urologic Oncology Clinical Trials Consortium."