Shares of Alpine Immune Sciences Inc. fell more than 10% on Monday after the U.S. Food and Drug Administration placed a partial clinical hold on one of its studies following the death of a patient.
The Seattle clinical-stage immunotherapy company said the partial hold involves a Phase 1 study of its davoceticept drug candidate in combination with Merck & Co.'s cancer drug Keytruda in adults with advanced malignancies.
Alpine said the patient who died had choroidal melanoma, a cancer that affects part of the eye, and had received a single dose each of davoceticept and Keytruda. The company said the patient suffered cardiogenic shock, a condition in which the heart suddenly can't pump enough blood to meet the body's needs, which it said was likely related to immune-mediated myocarditis, or possibly infection.
The study, which began dosing participants last June after Alpine inked a collaboration and supply agreement with Merck, is aimed at providing insights across a range of cancers and lines of therapy.
Alpine said it can't enroll any more patients until the partial hold is resolved, but it said patients currently enrolled in study can continue to receive treatment.
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