Precigen

Precigen, Inc. (Nasdaq: PGEN) is a clinical-stage biopharmaceutical company focused on developing gene and cell therapies. The company, originally founded as Intrexon Corporation in 1998, rebranded to Precigen in early 2020 to reflect its strategic shift to exclusively human healthcare. This transition was spearheaded by President and CEO Helen Sabzevari, Ph.D., who took the helm in 2020 after leading the Precigen subsidiary since 2017. Dr. Sabzevari is a recognized leader in immuno-oncology with over two decades of experience, including prior executive roles at Merck KGaA and the National Institutes of Health (NIH), where she was instrumental in developing novel cancer treatments.

The company's business model is centered on its internal innovation engine, which advances a pipeline of proprietary therapies through clinical proof-of-concept and towards commercialization. As a clinical-stage entity, Precigen's revenue is not yet driven by product sales but by collaboration agreements and services. Financial reports indicate revenues are primarily generated through its subsidiary, Exemplar, which provides research models and services. Precigen's core therapeutic areas are immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen's key offerings are built upon two proprietary technology platforms: the UltraCAR-T® platform and the AdenoVerse® platform. The UltraCAR-T platform is designed to overcome significant limitations of conventional CAR-T therapies. It features a non-viral gene delivery system, multigenic expression for enhanced efficacy and persistence, and a kill switch for improved safety. A defining feature is its decentralized, overnight manufacturing process using the proprietary UltraPorator® system, which allows CAR-T cells to be produced at the medical center and administered to the patient the next day, a stark contrast to the weeks-long, centralized manufacturing required for current treatments. Key clinical programs using this platform include PRGN-3005 for ovarian cancer, PRGN-3006 for acute myeloid leukemia (AML), and PRGN-3007 for ROR1-positive tumors.

The AdenoVerse platform utilizes a library of proprietary gorilla adenovectors for the efficient gene delivery of immunomodulators and vaccine antigens. This platform is engineered to generate durable T-cell immune responses and allows for repeat administration. Clinical candidates from this platform include PRGN-2009 for HPV-associated cancers and PRGN-2012 for recurrent respiratory papillomatosis (RRP). The company has received FDA priority review for its PRGN-2012 therapeutic, signaling a potential first-in-class treatment for RRP.

Keywords: gene therapy, cell therapy, immuno-oncology, autoimmune disorders, CAR-T, UltraCAR-T, AdenoVerse, Helen Sabzevari, clinical-stage biopharmaceutical, non-viral gene delivery, overnight manufacturing, UltraPorator, PRGN-3005, PRGN-3006, ovarian cancer treatment, acute myeloid leukemia therapy, RRP treatment, PRGN-2012, HPV-associated cancers, precision medicine, biotherapeutics, PGEN