Celldex Therapeutics, Inc. ( CLDX Quick Quote CLDX - Free Report) announced that it has initiated a phase Ib study to evaluate its monoclonal antibody candidate CDX-0159 in patients with chronic spontaneous urticaria (CSU), one of the most frequent skin diseases.
Shares of Celldex were up 3.2% in pre-market trading on Oct 14 following the above news. The stock has surged 669.1% so far this year compared with the
industry’s increase of 2.6%. This significant increase in the share price was primarily owing to encouraging early-stage data on CDX-0159.
The early-stage study will evaluate the safety of multiple ascending doses of CDX-0159, administered intravenously as an add-on treatment to H1-antihistamines or either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists.
The study will enroll patients in four different cohorts with CSU patients who remain symptomatic despite treatment with antihistamines. Data from the study is expected in the second half of 2021.
Notably, the company completed a phase Ia study evaluating CDX-0159 in healthy volunteers. Data from the study demonstrated a favorable safety profile for the candidate. CDX-0159 also achieved profound and durable reductions of plasma tryptase indicating a significant potential as a disease-modifying therapeutic for the mast-cell driven disorders.
The company also plans to initiate a phase Ia study within a few weeks to evaluate CDX-0159 in patients with chronic inducible urticaria.
Apart from CDX-0159, Celldex is developing a CD40 human agonist antibody CDX-1140. The candidate is being developed as a potential treatment of solid tumors and B cell lymphomas as a monotherapy or in combination with Celldex’s CDX-301 or Merck’s (
MRK Quick Quote MRK - Free Report) Keytruda.
The company initiated an early-stage study earlier this year to evaluate its new bispecific product candidate CDX-527 for solid tumors.
However, the company discontinued development of its lead pipeline candidate CDX-3379 earlier this year due to discouraging clinical activity. It was being evaluated in a phase II study in combination with Eli Lilly’s (
LLY Quick Quote LLY - Free Report) Erbitux in patients with head and neck cancer. Zacks Rank and Stock to Consider
Celldex currently carries a Zacks Rank #3 (Hold).
Allena Pharmaceuticals, Inc. (
ALNA Quick Quote ALNA - Free Report) is a better-ranked stock from the biotech sector, carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Allena’s loss per share estimates have narrowed from 98 cents to 92 cents for 2020 and from 93 cents to 84 cents over the past 60 days.
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