Celldex’s reinvention advances with inflammatory disease drug data

Dive Brief:

• Celldex Therapeutics shares rose in value by as much as 29% Monday morning following the company’s release of results from studies testing its lead experimental drug in two chronic itch conditions.
• In a Phase 2 trial, treatment with Celldex’s drug, called barzolvolimab, tamped down itching and hives in people with a condition known as chronic spontaneous urticaria who were resistant to antihistamines. Celldex plans to advance barzolvolimab into registrational testing next year.
• The other study, a small Phase 1b trial, suggested barzolvolimab might work in another itching disorder: prurigo nodularis. Data showed treatment helped reduce itching, heal lesions and clear skin more effectively than a placebo. Celldex intends to begin a Phase 2 trial in this indication in early 2024.

Dive Insight:

Celldex’s reinvention is well on its way. The biotechnology company pivoted to targeting itching conditions after a series of clinical failures for experimental cancer drugs over its near-two-decade history.

Now, the company is advancing barzolvolimab into mid- and late-stage testing across a range of inflammatory conditions that the drug industry sees as large markets.

“Investors should walk away with higher conviction of Celldex being a platform play,” wrote Cantor Fitzgerald analyst Kristen Kluska in a note to clients. Kluska highlighted how the company has generated positive data in three indications — with the third being an inducible form of chronic urticaria — and has opened the door to targeting other conditions driven by mast cells, which are the immune cells barzolvolimab inhibits.

Of those three indications, testing in chronic spontaneous urticaria is furthest along. The condition describes persistent hives that appear without a clear cause or trigger. Activated mast cells in the skin are thought to drive the inflammation and barzolvolimab, by targeting a protein that helps control them, is meant to block or slow that process down.

In the Phase 2 study, which enrolled 208 people, barzovolimab met its primary goal, showing significant greater responses than placebo on a hives scale known as UAS7. About one-fifth of participants were previously treated with a biologic drug called Xolair that’s one of the few treatment options beyond antihistamines.

In a client note, Thomas Smith, an analyst at Leerink Partners, described the results as “strong,” adding that they signal “best-in-class efficacy in a difficult-to-treat population.”

Most adverse events reported in the study were mild to moderate in severity, with hair color changes, itching and low counts of a white blood cell called neutrophils the most common.

Celldex plans to report data from a study of barzolvolimab in inducible urticaria in the second half of next year. It’s also testing the drug in another inflammatory condition called eosinophilic esophagitis.

Barzolvolimab will face competition, though, should it succeed in further testing. Novartis is testing a drug called remebrutinib in chronic urticarias and plans to seek regulatory approval next year after the success of a Phase 3 trial in August. Sanofi and Regeneron’s top-selling immune disease drug Dupixent, meanwhile, is already on the U.S. market for both prurigo nodularis and eosinophilic esophagitis.

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