U.S. markets close in 52 minutes
  • S&P 500

    4,204.75
    -5.49 (-0.13%)
     
  • Dow 30

    33,315.50
    +5.99 (+0.02%)
     
  • Nasdaq

    12,769.93
    -84.88 (-0.66%)
     
  • Russell 2000

    1,976.54
    +7.30 (+0.37%)
     
  • Crude Oil

    94.20
    +2.27 (+2.47%)
     
  • Gold

    1,803.00
    -10.70 (-0.59%)
     
  • Silver

    20.23
    -0.52 (-2.49%)
     
  • EUR/USD

    1.0326
    +0.0024 (+0.24%)
     
  • 10-Yr Bond

    2.8890
    +0.1030 (+3.70%)
     
  • GBP/USD

    1.2196
    -0.0022 (-0.18%)
     
  • USD/JPY

    132.9450
    +0.0720 (+0.05%)
     
  • BTC-USD

    24,158.81
    +549.80 (+2.33%)
     
  • CMC Crypto 200

    571.80
    -2.94 (-0.51%)
     
  • FTSE 100

    7,465.91
    -41.20 (-0.55%)
     
  • Nikkei 225

    27,819.33
    -180.63 (-0.65%)
     

Celldex (CLDX) Initiates Subcutaneous Skin Disorder Drug Study

  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.

Celldex Therapeutics, Inc. CLDX announced that it has initiated dosing in the first cohort of a phase I study evaluating a subcutaneous formulation of its monoclonal antibody candidate, CDX-0159. The company intends to evaluate the subcutaneous CDX-0159 as a potential treatment for a skin disorder, chronic urticarias, in a phase II study, which is likely to start in the first half of 2022.

The early-stage has been designed with four cohorts to evaluate four doses — 50 mg, 150 mg, 300 mg, and 600 mg — of the subcutaneous CDX-0159 in healthy volunteers primarily for safety and tolerability. The study’s secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.

We note that Celldex is already evaluating an intravenous formulation of CDX-0159 in multiple early-stage studies as a potential treatment of skin disorders — chronic spontaneous and chronic inducible urticarias. The company also plans to start a phase I study later this year to evaluate the intravenous CDX-0159 for treating prurigo nodularis, another skin disorder.

A subcutaneous formulation of any drug provides a better and easy administration alternative compared to the intravenous formulation. Several subcutaneous drugs are available with a self-administration option while intravenous drugs are usually physician-administered and require a visit to the hospital or a physician. A subcutaneous formulation of CDX-0159 is likely to be garner more demand than the intravenous one due to its easy and at-home administration potential.

Shares of Celldex have rallied 208.6% so far this year compared with the industry’s increase of 0.8%.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

Interim data, announced in July, from a phase Ib evaluating the intravenous formulation of CDX-0159 in patients with chronic inducible urticaria demonstrated a statistically significant response rate. The patients showed sustained durability of the clinical response. The antibody candidate also achieved a complete response in three CIU patients who were previously treated with Novartis NVS/Roche’s RHHBY urticaria drug, Xolair (omalizumab). Two among these patients were refractory to Xolair treatment.

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 Keytruda.

The company initiated an early-stage study earlier this year to evaluate its new bispecific product candidate, CDX-527 for solid tumors.

Celldex Therapeutics, Inc. Price

Celldex Therapeutics, Inc. Price
Celldex Therapeutics, Inc. Price

Celldex Therapeutics, Inc. price | Celldex Therapeutics, Inc. Quote

Zacks Rank

Celldex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Novartis AG (NVS) : Free Stock Analysis Report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Celldex Therapeutics, Inc. (CLDX): Free Stock Analysis Report

To read this article on Zacks.com click here.