Alpine Immune Sciences Stops Davoceticept Trials In Cancer Indications After Second Patient Death

Alpine Immune Sciences Inc ALPN has voluntarily terminated enrollment in both clinical studies involving davoceticept (ALPN-202), an investigational CD28 costimulator, and a dual checkpoint inhibitor.
The company has stopped enrollment in the NEON-1 study of davoceticept as monotherapy and the NEON-2 study of davoceticept in combination with pembrolizumab.
Following these decisions, the company plans to focus its development resources primarily on ALPN-303 for multiple autoantibody-related inflammatory diseases and acazicolcept in development for systemic lupus erythematosus (SLE) in collaboration with AbbVie Inc ABBV.
The decision to terminate enrollment in the davoceticept studies was made after the company was notified of a second death in the NEON-2 study, attributed to cardiogenic shock.
The participant, who had metastatic colorectal cancer previously treated with colectomy and multiple prior systemic chemotherapies, had received a single dose of davoceticept and pembrolizumab.
NEON-2 had previously been subject to a partial clinical hold due to a death attributed to cardiogenic shock.
The FDA removed the clinical in May after reviewing davoceticept's safety database, revised investigator brochure, and the study protocol.
The company is conducting an ongoing, comprehensive assessment of all NEON study participants.
Price Action: ALPN shares are down 7.93% at $5.28 on the last check Monday.