- Celldex Therapeutics (NASDAQ:CLDX) announces results from a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 clinical trial evaluating KIT inhibitor CDX-0159 in 32 healthy volunteers.
- Participants received a single IV infusion of one of four doses of CDX-0159 or placebo. Objectives were safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity.
- A single dose of CDX-0159 suppressed tryptase (enzyme released from mast cells when they are activated in an immune response) levels in a dose-dependent manner, indicating systemic mast cell suppression and complete target engagement.
- The most common adverse events were mild infusion-related reactions, all resolved without intervention.
- Phase 1b studies in patients with chronic spontaneous urticaria (hives) and chronic inducible urticaria are next up.
- CDX-0159 is a monoclonal antibody that binds to a protein called the KIT receptor which is expressed in a range of cells, including mast cells, that plays a key role in inflammatory responses. The company says it has the potential to block mast cells at multiple steps upstream compared to current treatments which could be disease-modifying.
- Shares up 17% premarket on average volume.