ALPN - Alpine Immune ends enrollments for cancer studies after patient death
- Alpine Immune Sciences ( NASDAQ: ALPN ) shed ~9% pre-market Monday after the immunotherapy company announced that it decided to end enrollments in trials for cancer candidate davoceticept (ALPN-202) after a study subject died.
- Alpine ( ALPN ) was advancing davoceticept in trials, including NEON-1 and NEON-2, which were designed to evaluate the treatment, as a single agent and in combination with Merck’s ( MRK ) PD-1 inhibitor Keytruda, respectively. The mortality linked to cardiogenic shock was reported in the NEON-2 study.
- “….we will continue to work with the U.S. Food and Drug Administration, Merck, the study Safety Monitoring Committee, and the study investigators to further understand this important safety issue,” Alpine’s ( ALPN ) Chief Executive Mitchell Gold noted.
- Following the decision, the company expects to focus mainly on studies for ALPN-303, a candidate for several autoantibody-related inflammatory diseases, and acazicolcept (ALPN-101), an AbbVie ( ABBV )-partnered systemic lupus erythematosus (SLE) therapy.
- The patient death was the second to report from the NEON-2 study, which was the subject of a partial clinical hold earlier due to another mortality related to cardiogenic shock.
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Alpine Immune ends enrollments for cancer studies after patient death