- An independent data monitoring committee may have dealt a fatal blow to Argos Therapeutics' lead candidate after determining the drug is unlikely to meet the endpoint of a Phase 3 clinical trial.
- The IDMC reached its conclusion based on interim data from the ADAPT study, which showed Argos' drug rocapuldencel-T in combination with the current standard-of-care, Pfizer's Sutent (sunitinib), didn't improve overall survival in patients with metastatic renal cell carcinoma (mRCC) as compared to sunitinib alone.
- The late-stage trial will continue until Argos can review the preliminary data with the Food and Drug Administration. The company's stock fell more than 66% to $1.48 per share by close of market Wednesday.
"Following our data analysis and these discussions, we expect to make a determination as to the next steps for the company and for the rocapuldencel-T clinical program," Argos CEO Jeff Abbey said in a Thursday conference call, adding that such a determination should come in the next few weeks.
Argos didn't take any questions on the call, and couldn't provide additional information beyond what it included in a Feb. 22 statement.
Even without that information, it's clear the results are a departure from the optimism Argos had very recently and the trajectory it saw its drug heading in. For instance, the company said during an interview with Seeking Alpha that it hoped the combination therapy would have six months on the control arm of study in relation to overall survival. If that goal wasn't reached, Argos said it expects at least a substantial difference between the arms.
What's more, the company just several weeks ago leased out a 40,000 square foot facility at North Carolina State University’s Centennial Campus to build out drug-development operations, according to The News & Observer. The new space is slated to add 70 jobs to Argos' staff of about 120, though it's unclear which drugs would be under development or how the IDMC's recommendations will affect that move.
This isn't the first time Argos' pipeline has disappointed. The company's HIV program took a big hit in 2015 when its sole candidate, AGS-004, failed in a Phase 2 study. Both AGS-004 and rocapuldencel-T function as personalized therapies that promote immune responses to tumors. Argos also has planned or investigator-initiated Phase 2 studies of rocapuldencel-T for other indications, including muscle invasive bladder cancer and non-small cell lung cancer.