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Precigen (PGEN) Up on FDA Fast Track Tag for CAR-T Candidate

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Precigen, Inc. (PGEN - Free Report) announced that the FDA granted Fast Track designation to its early-stage candidate, PRGN-3006 UltraCAR-T, for treating patients with relapsed or refractory (r/r) acute myeloid leukemia (“AML”).

The FDA provides a Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions.

A phase I study is currently evaluating the candidate in adult patients with r/r AML.

Precigen’s PRGN-3006 UltraCAR-T is a multigenic autologous chimeric antigen receptor (“CAR”) T cell therapy candidate that targets CD33, an antigen, which is over-expressed on AML blasts. The candidate simultaneously enhances in vivo expansion and persistence by generating membrane-bound IL-15. The candidate also has a kill switch to eliminate CAR-T cells conditionally for an improved safety profile. The company uses its non-viral Sleeping Beauty system and UltraCAR-T platform to develop this multigenic CAR T therapy.

The company stated that its UltraCAR-T platform helps to design CAR T therapies, which have the potential to overcome limitations of currently available CAR-T therapies, including exhausted phenotype of T cells resulting from lengthy ex vivo expansion.

The company’s PRGN-3006 UltraCAR-T was granted Orphan Drug designation by the FDA in 2020.

Precigen’s shares rose 11.5% on Apr 4, following the Fast Track status. However, the stock has declined 31.8% so far this year in comparison with the industry’s 11.9% decrease.

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Precigen is focused on developing the next generation of gene and cell therapies targeting immuno-oncology, autoimmune disorders, and infectious diseases. The company is developing six pipeline candidates, apart from PRGN-3006 UltraCAR-T, in early-stage clinical studies.

The candidates target different cancer indications including ovarian cancer and human papillomavirus-positive, rare diseases like myelodysplastic syndromes and type I diabetes mellitus. The targeted indications represent significant opportunities.

Although Precigen’s CAR T therapies hold potential, there are multiple FDA-approved CAR T therapies available currently targeting different oncology indications. These include bluebird bio (BLUE - Free Report) and Bristol-Myers’ (BMY - Free Report) Abecma, Gilead’s (GILD - Free Report) Yescarta and Novartis’ Kymriah.

Gilead and Novartis were one of the first companies to get FDA approval for a CAR T cell therapy in 2017. Gilead added Yescarta to its portfolio following the acquisition of Kite Pharma in the same year.

bluebird Bio and Bristol-Myers developed Abecma under a collaboration and received FDA approval for treating relapsed or refractory multiple myeloma last year. Abecma is the only approved CAR T therapy in bluebird Bio’s portfolio while Bristol-Myers has another commercialized CAR T therapy, Breyanzi, approved for treating r/r large B-cell lymphoma in 2021.

Zacks Rank

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