U.S. Markets closed
  • S&P 500

    4,349.93
    -6.52 (-0.15%)
     
  • Dow 30

    34,168.09
    -129.64 (-0.38%)
     
  • Nasdaq

    13,542.12
    +2.82 (+0.02%)
     
  • Russell 2000

    1,976.46
    -27.57 (-1.38%)
     
  • Crude Oil

    87.25
    -0.10 (-0.11%)
     
  • Gold

    1,818.80
    -10.90 (-0.60%)
     
  • Silver

    23.56
    -0.25 (-1.04%)
     
  • EUR/USD

    1.1237
    -0.0008 (-0.0674%)
     
  • 10-Yr Bond

    1.8480
    +0.0650 (+3.65%)
     
  • Vix

    31.96
    +0.80 (+2.57%)
     
  • GBP/USD

    1.3455
    -0.0007 (-0.0552%)
     
  • USD/JPY

    114.6980
    +0.0380 (+0.0331%)
     
  • BTC-USD

    37,046.17
    +297.66 (+0.81%)
     
  • CMC Crypto 200

    846.02
    -9.79 (-1.14%)
     
  • FTSE 100

    7,469.78
    +98.32 (+1.33%)
     
  • Nikkei 225

    26,922.10
    -89.23 (-0.33%)
     

Allogene's (ALLO) CAR T Therapy Gets Orphan Drug Status

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

Allogene Therapeutics, Inc. ALLO recently announced that the FDA has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.

ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.

This designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the United States. ODD also include incentives including tax credits for clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity in the event of regulatory approval.

In April 2021, the candidate was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.

A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor,

Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.

The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).

Shares of Allogene have declined 16.1% so far this year compared with the industry’s decrease of 0.3%.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

While the CAR T space promises a lot of potential, competition is stiff. Earlier in the year, the FDA approved bluebird bio BLUE/ Bristol Myers Squibb BMY’s CAR T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.

Other approved CAR T cell therapies in the United States include Gilead’s GILD Yescarta and Novartis’ Kymriah.

Allogene currently has 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

Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

bluebird bio, Inc. (BLUE) : Free Stock Analysis Report

Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research