May 08, 2013 -- Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced the publication of key findings on its proprietary RNA amplification process. The study confirms the Company's improved RNA amplification techniques enhance the quality of the resultant antigen-specific immune response.
The study, which was published in the May issue of Molecular Therapy-Nucleic Acids, a companion journal to Molecular Therapy, evaluated the properties of renal cell carcinoma RNA after amplification and following introduction into dendritic cells using newly developed tests. Investigators found that the improved amplification process resulted in superior protein expression levels and a greater capacity of dendritic cells to induce a strong T-cell response.
"The new RNA amplification techniques we have developed further validate Argos Therapeutics' leadership in the field of RNA-containing therapeutics," said Charles Nicolette , Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics. "With the ADAPT Phase 3 study for AGS-003 well underway, the improved amplification process should help to provoke stronger immune responses in study patients and ultimately lead to positive clinical outcomes."
By tracking specific antigens, researchers were able to demonstrate that the protein antigens were produced inside dendritic cells transfected with the amplified RNA. It was further shown that RNA amplified using the improved process resulted not only in higher levels of antigen expression but also in greater numbers of antigen-specific memory T cell responses. In a completed Phase 2 study with AGS-003, this specific type of immune response was shown to correlate with good clinical outcomes, including improved overall survival.
The improved RNA amplification process is being used in Argos Therapeutics' ADAPT Phase 3 clinical study for AGS-003, the company's most advanced product candidate. To create AGS-003, RNA is isolated from a small tumor sample obtained from standard tumor removal surgery (nephrectomy), and dendritic cells are taken during a single leukapheresis procedure. The tumor RNA is used to "program" the dendritic cells with the entire disease-antigen repertoire to trigger an immune response against the patient's specific cancer. These antigen-loaded dendritic cells are formulated into a ready-to-use, intradermal injection.
For more information about AGS-003 and the ADAPT study, visit www.ADAPTkidneycancer.com.
About the Arcelis™ Technology Platform
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.
The Arcelis process integrates readily into many current treatment paradigms, using only a small tumor or blood sample and the patient's own dendritic cells, which are derived and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient sample to program the dendritic cells to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered as an intradermal injection to produce the desired patient-specific immune response.
Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. Automated processes allow a single facility to serve all of North America and can be used to treat any cancer or infectious disease with the same manufacturing process and equipment.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform. Argos´ most advanced product candidate AGS-003 has initiated a Phase 3 study for the treatment of mRCC, and the Company plans to have data from its Phase 2b study of AGS-004 for the treatment of HIV in late 2013. For more information about Argos Therapeutics, visit www.argostherapeutics.com.