Celldex's barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of mast cells.

Celldex Therapeutics, Inc.’s barzolvolimab is looking good in chronic spontaneous urticaria, according to data from the Phase 1b single-dose cholinergic cohort included in the chronic inducible urticaria (CIndU) trial that was presented at the European Academy of Allergy and Clinical Immunology Annual Congress 202 

Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of mast cells. Data continue to support that mast cell depletion by barzolvolimab, as demonstrated by tryptase suppression, parallels symptom improvement.

. Celldex’s Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria who remain symptomatic despite treatment with antihistamines. 

At week 24, 55% of all patients with chronic spontaneous urticaria in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response (UAS7) and 69% had well-controlled disease. Patients with angioedema treated at these doses had profound and durable angioedema symptom improvement, the study found.

A Phase 2 chronic spontaneous urticaria study nearing enrollment completion with topline data by year-end.

"As we expand development into more patients and new disease settings, the data repeatedly support that barzolvolimab’s mast cell depleting mechanism holds great potential to offer patients a much needed rapid, profound and durable treatment option for chronic urticarias— including patients who are not seeing meaningful benefits from the current standard of care,” says Marcus Maurer, M.D, in a news release.  “In the CSU study, we also observed very significant improvements in angioedema which can be a devastating manifestation of urticaria for many patients. In cholinergic urticaria, barzolvolimab again demonstrated remarkable response rates and impressive improvements in quality of life in this tough to treat form of inducible urticaria."

"We are extremely pleased with these further results which once again demonstrated strong clinical activity, rapid onset and sustained durability with a well-tolerated safety profile, including in patients who had previously taken omalizumab," adds Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. "These strong results support our ongoing Phase 2 studies in urticaria. We look forward completing accrual ahead of schedule in the Phase 2 CSU study later this month and reporting topline data by the end of this year.”