- Nano cap Argos Therapeutics (NASDAQ:ARGS) jumps 70% premarket on robust volume in response to its announcement of positive data from a Phase 3 clinical trial, ADAPT, assessing lead candidate Rocapuldencel-T (Roca), in combination with Pfizer 's (NYSE:PFE) SUTENT (sunitinib malate), for the treatment of metastatic renal cell carcinoma (RCC). The results were presented at the SITC conference in National Harbor, MD.
- In 146 patients analyzed for immune response, the number of antigen-specific memory T cells were found to increase only after Roca treatment. In patients who received at seven doses of Roca (n=100), there was a statistically significant 2x average increase.
- In the group who received seven doses of Roca, there was also a statistically significant correlation between survival and the change in the number of antigen-specific memory T cells from baseline.
- Patients with higher-than-median levels of IL-12 experienced improved survival that those below the median. IL-12 plays a key role in the activities of immune cells called T lymphocytes and natural killer cells.
- Rocapuldencel-T is an individualized immunotherapy that captures both mutated and variant antigens that are unique to each patient's tumor. It is specifically designed to induce an immune response targeting the patient's particular tumor antigens.
- Shares plummeted in February on the news that the Data Monitoring Committee recommended stopping the study because it was unlikely to demonstrate a treatment benefit. The company subsequently met with the FDA which agreed with its decision to continue the trial and also agreed to a protocol amendment to extend it beyond 290 events with a revised statistical analysis plan.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- Previously: Late-stage study unlikely to show treatment benefit of Argos Therapeutics' lead product candidate; shares plummet 65% premarket (Feb. 22)
- Now read: Foot Locker (NYSE:FL) 36% Broker Target Gains Lead 'Safer' Dividend Challenger Top 10 Dogs Into November
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