Celldex reports positive data for CDX-622 in phase 1 study

HAMPTON, N.J. - Celldex Therapeutics (NASDAQ:CLDX) announced positive results from the ongoing Phase 1 study of its bispecific antibody CDX-622 in healthy volunteers, according to a company press release. The clinical-stage biotech, currently valued at $1.73 billion and trading at $26, is considered slightly undervalued according to InvestingPro Fair Value estimates.

The data, presented Thursday at the Collegium Internationale Allergologicum Biennial Symposium in Dubrovnik, Croatia, showed that CDX-622 was well tolerated and demonstrated a favorable pharmacokinetic profile with a serum half-life of approximately 18 days at the 9 mg/kg dose level.

CDX-622 targets two pathways involved in inflammation and fibrosis by neutralizing stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). The study showed the drug induced rapid and sustained reductions in serum tryptase, indicating mast cell inhibition and depletion.

The Phase 1 trial enrolled 32 participants across four cohorts receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) or placebo. Participants were observed over a 12-week period. No dose-limiting toxicities, serious adverse events, or infusion reactions were reported. This clinical progress comes as InvestingPro data shows Celldex maintains a strong financial position with more cash than debt and a current ratio of 19.67, providing runway for continued development.

A single dose of CDX-622 resulted in approximately 50% decrease in circulating tryptase consistent with systemic mast cell effects. No evidence of antidrug antibodies was observed during the study period.

"Combining this unique approach of mast cell depletion with the blockade of a critical inflammation pathway driven by TSLP could potentially deliver clinical benefit for patients with inflammatory and fibrotic disorders," said Tibor Keler, Executive Vice President and Chief Scientific Officer of Celldex Therapeutics, in the press release.

The company has advanced the study to test multiple ascending doses and plans to initiate a Phase 1b proof of mechanism study in patients with mild to moderate asthma. Celldex expects to report data from the next parts of the study in the third quarter of 2026. Investors should note that Celldex will report its next quarterly earnings on November 5, with analysts maintaining a strong buy consensus and a high price target of $90. For comprehensive analysis of Celldex’s financial health and detailed research reports, visit InvestingPro.

In other recent news, Celldex Therapeutics reported promising data for its experimental drug barzolvolimab, which showed strong efficacy in treating chronic spontaneous urticaria (CSU) regardless of patients’ baseline immunoglobulin E (IgE) levels. This development was presented at the EADV Congress 2025 and suggests potential for treating all CSU patients. Meanwhile, Stifel reiterated its Buy rating on Celldex, maintaining a $58.00 price target, despite barzolvolimab’s failure in an eosinophilic esophagitis (EoE) trial. Celldex has decided not to continue developing the drug for EoE. Analysts at H.C. Wainwright also reiterated a Buy rating with a $42.00 price target, following Novartis’s FDA approval for remibrutinib, a treatment for CSU. Mizuho initiated coverage on Celldex with an Outperform rating and a $48.00 price target, highlighting the potential of barzolvolimab in treating mast-cell mediated diseases. Conversely, Barclays initiated coverage with an Underweight rating and a $25.00 price target, citing concerns about limited upside potential through 2026. These recent developments provide a range of perspectives on Celldex’s future in the pharmaceutical industry.

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