Argos Therapeutics’ $ARGS Phase III study of its personalized cancer vaccine rocapuldencel-T has ended in disaster. Its independent monitoring committee concluded in an interim analysis that the late-stage trial for metastatic renal cell carcinoma was headed to a near certain failure, calling for an end to the study.
Argos treatment is designed to capture the antigens specific to a patients’ tumor cells, ramping up an immune response to wipe out those cancer cells. Investigators combined their drug with Sutent (sunitinib) and compared it to standard of care.
The setback marks back to back failures of new cancer vaccines, a troubled field that’s seen repeated failures in recent years. These personalized vaccines were seen as a better way to go after cancer, but Argos will be facing some bitter questions over the utility of its platform technology now.
The biotech’s shares imploded with the study, plunging 74% in a matter of minutes.
Argos faced considerable skepticism in early 2015 when it took the same approach to train patients’ T cells to attack HIV and failed. Their Phase IIb trial failed to significantly reduce viral load in chronically afflicted patients.
Investigators recruited 462 patients for the study.
Argos has known earlier setbacks as well.
“We are extremely disappointed with these results, which included seventy-five percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study,” said Argos CEO Jeff Abbey in a statement. “We sincerely appreciate the patients and investigators who have participated in the ADAPT Phase 3 trial, and remain convinced in the ability of precision immunotherapy to improve the lives of patients.”
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