Shots:

• The US FDA has placed a partial clinical hold on the (NEON-2) trial to evaluate davoceticept + pembrolizumab in adults with advanced malignancies
• The US FDA’s decision is based on Alpine’s report of a grade 5 serious AEs (patient death) in the (NEON-2) trial associated with cardiogenic shock. Additionally, enrolled patients may continue to receive davoceticept & pembrolizumab while no additional patients may be enrolled until the partial clinical hold is resolved
• The escalation and initiation of expansion cohorts of P-I (NEON-1) are expected to be complete in H1’22. In preclinical studies, davoceticept showed superior efficacy in tumor models over checkpoint inhibition alone

Ref: Businesswire | Image: Linkedin