DURHAM, N.C.—June 15 saw Argos Therapeutics Inc., an immuno-oncology company focused on developing individualized immunotherapies for cancer treatment based on the Arcelis technology platform, announce that it is partnering with Seattle-based Adaptive Biotechnologies Corp. to study precise response patterns to Argos’ investigational immunotherapies.
Under the agreement, Adaptive will use its patented immune profiling immunoSEQ Assay to enable a more in-depth characterization of the immune response induced by Argos’s lead product candidate, AGS-003, which is currently being studied in the treatment of metastatic renal cell carcinoma, non-small cell lung cancer and bladder cancer.
In addition, Argos is developing its second Arcelis product candidate, AGS-004, for the treatment and the possible eradication of human immunodeficiency virus (HIV) in patients with HIV-infection or acquired immune deficiency syndrome (AIDS). The application of Adaptive’s immune profiling technology in this setting will enable Argos to further characterize with greater precision the transfer of specific genetic signatures from each patient’s HIV, through AGS-004, to a specific immune response against each patient’s unique virus population.
“We are very excited to be entering into this important research agreement with Adaptive Biotechnologies,” said Dr. Charles Nicolette, Argos’s chief scientific officer. “Adaptive is our preferred partner because of their established expertise in offering high-throughput immune receptor repertoire characterization and advanced bioinformatics that are ideally suited to analyze precision of target-specific immune activation enabled by Arcelis administration with higher resolution.”
“Argos is on the cutting edge of precision immunotherapy with their advanced Phase 3 immuno-oncology agent, and platform extension into individualized HIV treatment,” said Chad Robins, Adaptive’s president, CEO and co-founder. “As the leader in immunosequencing, Adaptive’s technology is well-suited to uncover the dynamics of the adaptive immune system response to Argos’ therapies.”
Adaptive’s immunoSEQ Platform helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology, and it reportedly can identify millions of T cell and B cell receptors from a single sample in extreme detail. Offered as a service or kit, the immunoSEQ Assays are for research use only and are not for use in diagnostic procedures.
Arcelis is a precision 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 commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized 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 with the patient’s plasma and administered via intradermal injection.
In other Argos news recently—a couple days before the collaboration with Adaptive was announced, in fact—the company announced that the independent data monitoring committee (IDMC) for the company’s pivotal Phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) has recommended the continuation of the trial based on results of the IDMC’s scheduled interim data review. The next IDMC meeting is being planned to coincide with the Genitourinary Cancers Symposium in February 2017.
“As the largest global Phase 3 trial ever performed in newly diagnosed, intermediate and poor risk mRCC patients, the ADAPT trial continues to progress,” said Dr. Robert Figlin, the Steven Spielberg Family chair in hematology oncology, professor of medicine and biomedical sciences at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute and the co-principal investigator for the ADAPT trial. “With all the excitement regarding the clinical benefit of the emerging immuno-oncology therapies, a positive outcome of the ADAPT trial, because of AGS-003’s novel mechanism of action, could be a game changer in the treatment of mRCC.”
“The IDMC’s recommendation to continue with the ADAPT trial aligns with our expectations based on the patient population enrolled and the clinical benefit observed in the Phase 2 trial,” said Dr. Lee F. Allen, chief medical officer of Argos. “Based upon our internal projections, we believe that at this point we have reached more than half of the targeted number of events for our survival endpoint, and we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur in the first half of 2017. The focus of our clinical development group is now on the careful oversight of the ADAPT trial execution to ensure study data quality, and we have initiated cross functional activities to begin building the AGS-003 Biologics License Application.”