A patient died in a clinical trial testing Alpine Immune Sciences’ cancer immunotherapy, prompting the FDA to place the study on Partially heldThis limited clinical trial pause means that patients already in the study may continue to receive the experimental Alpine treatment davoceticept, but no additional patients will be recruited until questions about the patient’s death are resolved.
According to Alpine, the death was attributed to cardiogenic shock, a condition in which the heart cannot pump enough blood to vital organs. The treating physician believes that this condition may be related to inflammation or infection of the heart muscle. Alpine shares opened Monday at $6.86, down 11.2% from Friday’s close.
Seattle-based Alpine develops protein-based immunotherapies for cancer and autoimmune diseases. Davoceticept, formerly known as ALPN-202, is Alpine’s state-of-the-art cancer program. The drug is a fusion protein that targets two “checkpoint” proteins that prevent immune cells from recognizing and attacking cancer cells. At the same time, the Alpine drug also targets a protein on T cells called CD28, which promotes immune responses. Preclinical studies previously reported by Alpine showed that dual blockade of checkpoint proteins, combined with increased activation of CD28-targeted T cells, had better efficacy than checkpoint blockade alone.
The Phase 1 test, which is currently on a partial hold, is testing the Alpine drug in combination with another checkpoint inhibitor, Merck’s Keytruda. The open-label study was designed to recruit patients whose solid tumors had progressed or spread and were unresectable. According to Alpine, the deceased patient had choroidal melanoma, a cancer that affects the eye. The patient had previously received a combination of two Bristol-Myers Squibb cancer immunotherapies, the checkpoint inhibitor Opdivo and Yervoy.
Alpine is conducting a separate clinical trial testing davoceticept as a monotherapy. The company said the Phase 1 clinical trial was not affected by the partial shelving of the drug’s combination test with Keytruda. Alpine Chief Executive Mitchell Gold said in a prepared statement that the company will work with the FDA, Merck and the study’s independent safety monitoring committee to understand the deaths of patients.
“In view of the davoceticept and [Keytruda] For the benefit of refractory patients, we hope that the study will resume soon after proper safety reviews and appropriate safety precautions are in place,” Gold said.
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