Alpine Immune Sciences Announces FDA Removes Partial Clinical Hold on NEON-2 Clinical Trial of Davoceticept (ALPN-202) in Combination with Pembrolizumab
The FDA removed the hold after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol. As previously disclosed, under the terms of the hold, previously enrolled participants continued to receive study drug, but no new participants could be enrolled until the partial clinical hold was removed. The ongoing NEON-1 study was not subject to the hold.
About Davoceticept (ALPN-202)
Davoceticept (ALPN-202) is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor intended for the treatment of cancer. Preclinical studies of davoceticept have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 monotherapy dose escalation and expansion trial in patients with advanced malignancies, has completed dose escalation and is currently enrolling its expansion cohorts. NEON-2 (NCT04920383), a combination study of davoceticept (ALPN-202) and pembrolizumab, was initiated in
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ALPN-202, NEON-2 study is being conducted in collaboration with
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