Celldex Therapeutics to Expand Development of CDX-0159 into Prurigo Nodularis (PN)
--Dermatological indication characterized by chronic, intensely itchy nodules; mast cell activation believed to play an important role in amplifying chronic itch and
--Potential to expand future CDX-0159 development beyond chronic urticarias to chronic pruritic diseases and other significant indications driven by itch and neuroinflammation--
HAMPTON, N.J., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that the Company will expand clinical development of CDX-0159 into prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. Mast cells through their interactions with sensory neurons and other immune cells are believed to play an important role in amplifying chronic itch and neuroinflammation, both of which are a hallmark of PN. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions.
In a Phase 1a single dose, healthy volunteer study, CDX-0159 demonstrated profound and durable reductions of plasma tryptase, indicative of systemic mast cell suppression/ablation. Celldex is evaluating CDX-0159 in two ongoing Phase 1b clinical trials in patients with chronic spontaneous urticaria and chronic inducible urticaria, both mast cell driven diseases. By exploring the potential of CDX-0159 to suppress chronic itch and neuroinflammation in PN, Celldex believes it may have the opportunity to expand future development to also include other chronic pruritic skin conditions and other medically significant conditions driven by itch and neuroinflammation.
Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics stated, “As we look to expand our clinical development plan for CDX-0159, we are considering a number of key factors, including the scientific rationale, patient need, the market opportunity and the clinical and regulatory path forward. We look forward to data this year from ongoing trials in chronic urticarias, and results from these studies will position us to evaluate expansion into other mast cell driven diseases where we believe suppressing mast cells will minimize patient symptoms. We have selected prurigo nodularis for further study because emerging science suggests mast cell activation plays an important role in amplifying a cascade of mediators that drive itch signaling with associated neuroinflammation. Here we aim to learn whether mast cell suppression with CDX-0159 can impact this cascade to diminish itch and allow for lesion healing. PN also offers an opportunity for an early clinical signal and could bring a much-needed treatment to patients while opening a door to development opportunities in other significant conditions driven by itch and neuroinflammation.”