Canada markets open in 2 hours 9 minutes
  • S&P/TSX

    21,188.19
    +101.20 (+0.48%)
     
  • S&P 500

    4,536.19
    +16.56 (+0.37%)
     
  • DOW

    35,609.34
    +152.03 (+0.43%)
     
  • CAD/USD

    0.8104
    -0.0016 (-0.19%)
     
  • CRUDE OIL

    82.74
    -0.68 (-0.82%)
     
  • BTC-CAD

    80,933.20
    +1,677.52 (+2.12%)
     
  • CMC Crypto 200

    1,559.14
    +78.33 (+5.29%)
     
  • GOLD FUTURES

    1,783.20
    -1.70 (-0.10%)
     
  • RUSSELL 2000

    2,289.77
    +13.85 (+0.61%)
     
  • 10-Yr Bond

    1.6360
    0.0000 (0.00%)
     
  • NASDAQ futures

    15,343.50
    -34.00 (-0.22%)
     
  • VOLATILITY

    16.03
    +0.33 (+2.10%)
     
  • FTSE

    7,184.29
    -38.81 (-0.54%)
     
  • NIKKEI 225

    28,708.58
    -546.97 (-1.87%)
     
  • CAD/EUR

    0.6958
    -0.0007 (-0.10%)
     

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.

Our goal is to create a safe and engaging place for users to connect over interests and passions. In order to improve our community experience, we are temporarily suspending article commenting