Dive Brief:
- Argos Therapeutics disclosed last week it would cut its workforce by 38%, trimming staff after a damning evaluation of a Phase 3 trial studying rocapuldencel-T felled the company's share price by more than two-thirds.
- In mid-February, a data monitoring committee said rocapuldencel-T would not meet its endpoint, citing interim data from a trial that showed treatment with the drug in combination with Pfizer's Sutent (sunitinib) did not improve overall survival compared to Sutent alone in metastatic renal cell carcinoma.
- Argos will lay off 46 employees, saving roughly $5.7 million after costs are factored in, according to a filing with the Securities and Exchange Commission
Dive Insight:
Rocapuldencel-T, Argos' lead candidate, is an individualized cancer immunotherapy based on a patient's own dendritic cells and disease-specific antigens. The goal was to induce an immune response specific to a patient's cancer, but that approach seems to have fell short of expectations.
Argos had recently signed a lease for commercial manufacturing space at North Carolina University in preparation for a BLA filing, suggesting Argos was hadn't expected the negative results. While a path forward isn't clear right now, the company is continuing its data review.
"The principal objective of the reduction is to enable the Company to conserve its financial resources as the Company conducts its ongoing review of the preliminary ADAPT trial data set and discusses the data with the U.S. Food and Drug Administration (FDA), following which the Company will make a determination as to the next steps for the rocapuldencel-T clinical program," the filing stated.
Developing cancer vaccines based on patients' own cells has been challenging. Dendreon's Provenge (sipuleucel-T), a patient-specific prostate cancer vaccine, was the first to reach the market, but the company struggled to stay afloat after sales didn't meet expectations. Others, such as Favrille's Specifid, have had a similarly pockmarked development path.