It’s been a few months since Dendreon got slammed for providing inconsistent data analysis to U.S. regulators for Provenge, its therapeutic cellular immunotherapy for prostate cancer. As Argos Therapeutics recruits the first set of participants for its phase 3 ADAPT clinical trial for its own therapeutic cellular immunotherapy for advanced renal cell carcinoma, it seeks to rival Dendreon’s therapeutic platform as a new contender for this treatment approach.
The Durham, North Carolina drug developer’s randomized, multicenter, open-label study is expected to enroll 450 patients in 120 sites, mostly in North America, under an approved Special Protocol Assessment by the U.S. Food and Drug Administration, a company statement said. Among the secondary endpoints are progression-free survival, safety, overall response and immune response. By the end of March, the goal is to have 70 active sites, mainly in the U.S., and activate the remaining North American and global sites by this summer.
Renal cell carcinoma is the most common form of kidney cancer. Arcelis uses a sample of the tumor and the patient’s own dendritic cells to create an antigen to fight the cancer.
CEO Jeff Abbey told MedCity News that more than 50 percent of patients in a phase 2 study for the therapy survived longer than 30 months — nearly four times the expected long-term survival rate for sunitinib in similar risk patients, according to a company statement.
Efficacy and cost have been the two biggest challenges facing the company, Abbey said. Given the controversy, Dendreon‘s Provenge therapeutic has cast a long shadow of doubt and prompted the pharmaceutical industry to be more skeptical about the efficacy of personalized immunotherapy. Abbey said Argos has met the efficacy challenge by having a product that’s specialized for a patient’s own tumor. “We can measure [efficacy] after five doses and it correlates with survival. No one else has been able to show that up until now.”
Argos has developed an automated manufacturing process for the drug to make its therapeutic more cost-effective to produce. Argos expects to have interim data from the phase 3 ADAPT study by the middle of next year with final data from the trial coming in the late fall of 2015. It would submit its application for FDA approval for the therapy in the first half of 2016.
To date, the company has raised about $115 million including $25 million last year for the set up and initiation of the phase 3 trial. It is looking to raise $50 million to complete the trial. Last year, it called off an initial public offering due to lackluster market conditions.
Although it may be interested in a commercial partner, it is also weighing whether to commercialize the product by themselves since, as Abbey points out, “this is a new business model.” Aside from Dendreon, no one else has commercialized a product like this, Abbey noted.