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

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  • 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%.

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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.

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