A new treatment combo for RCC

Preclinical data demonstrate functional activity of AGS-003-like therapy in kidney cancer murine model

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DURHAM, N.C.—Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, and its partner Cellthera Pharm, a subsidiary of Pharmstandard focused on personalized therapeutics, have announced the presentation of data on a murine model developed by Cellthera to determine functional activity of a therapy modeled after Argos’ AGS-003 individualized immunotherapy. The data were presented at the Society for Immunotherapy of Cancer 31st Annual Meeting, held Nov. 11-13, and demonstrated the favorable effects of the AGS-003-like therapy as a single agent, as well as in combination with sunitinib and a PD-1 checkpoint inhibitor in a murine model of renal cell carcinoma (RCC).
“Our model provides some exciting survival data using an AGS-003-like therapy in a murine kidney cancer model that has proven useful in exploring combinations with other agents in a relevant preclinical setting,” said Dr. Alexander Shuster, chairman of Cellthera.
In this experiment, the agents were administered alone or together seven days prior to the inoculation of tumor cells, and then each group was followed for tumor reduction and survival. Shuster continued, “The prophylactic mouse data show the superiority of the AGS-003-like therapy as a single agent vs. control in both survival and enhanced control of tumor growth. Furthermore, the AGS-003-like therapy when combined with sunitinib or a PD-1 checkpoint inhibitor outperformed each agent alone, and the combination of all three therapies demonstrated the strongest survival advantage.”
Argos is currently evaluating AGS-003 in combination with standard-of-care agents in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). Enrollment in this 462-patient study was initiated in February 2013 and completed in July 2015. The independent data monitoring committee (IDMC) for this study most recently recommended continuation of the study following a meeting in June 2016, with the next IDMC meeting planned for February 2017. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of non-small cell lung cancer.
“These mouse data support the expectation of enhanced clinical benefit for the combination of AGS-003 with checkpoint inhibitors and, importantly, also show that amplified total tumor RNA is essential to the antitumor activity of Arcelis-derived dendritic cells,” noted Dr. Charles Nicolette, chief scientific officer and vice president of research and development at Argos. “Additionally, the observation in mice that the AGS-003-like therapy and sunitinib are each active separately and lead to improved control of tumor growth when combined bodes well for our ongoing Phase 3 ADAPT trial in advanced renal cell carcinoma, where AGS-003 is initially being combined with sunitinib.”
Argos also notes on its website that “We are also supporting investigator-initiated Phase 2 trials in patients with early-stage RCC and non-small cell lung cancer, and plan to support investigator-initiated trials of rocapuldencel-T (AGS-003) in muscle invasive bladder cancer and in combination with checkpoint inhibitors in RCC.”
Argos has also recently reported highlights from its Investor Day, held Dec. 7. The company announced rocapuldencel-T as the generic name for AGS-003, its most advanced product candidate currently being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC.
According to Argos’ website, “the combination of rocapuldencel-T (AGS-003) plus sunitinib was associated with a median overall survival that was two times longer than has been reported in independent studies of sunitinib and other targeted therapies alone in patients with newly diagnosed advanced RCC. In this trial, rocapuldencel-T was well tolerated with no serious adverse events attributed to rocapuldencel-T. It was successfully produced at a central manufacturing facility, with delivery to multiple clinical trial sites throughout North America.”
During the meeting, Argos announced the planned implementation of a two-stage manufacturing strategy for rocapuldencel-T and other therapies developed based on the Arcelis platform. Argos is currently completing a lease agreement for 40,000 square feet of manufacturing and office space at the Center for Technology Innovation (CTI) on the Centennial Campus of North Carolina State University in Raleigh, N.C., to prepare for a biologics license application (BLA) to the FDA and to support initial commercialization of rocapuldencel-T. Under this strategy, Argos would seek to complete construction of the 125,000 square foot Centerpoint facility in Durham, N.C., only after approval and product launch of rocapuldencel-T.
“We expect that the implementation of our manufacturing capability in two stages would position us to employ an established and proven-effective manual manufacturing process at CTI with the capacity to support approximately 1,800 patients per year at launch, with expansion capacity to 2,400 patients per year, pending regulatory approval,” said Jeff Abbey, president and CEO of Argos. “This strategy optimizes capital utilization as we prepare for a BLA submission for rocapuldencel-T. It also allows us to assess early commercial uptake and better project capacity requirements for our Centerpoint facility, which can be designed to accommodate our automated manufacturing process.”

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