Precigen to cut 20% of its workforce, pause all preclinical programs

Precigen announced Tuesday a strategic reprioritization of the company’s clinical portfolio and streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of the PRGN-2012 AdenoVerse gene therapy for the treatment of recurrent respiratory papillomatosis. These strategic changes substantially reduce required resources for non-priority programs and will enable the company to focus on pre-commercialization efforts on PRGN-2012, including supporting submission of a rolling biologics license application under an accelerated approval pathway anticipated in the second half of 2024, conducting the confirmatory clinical trial, and manufacturing of commercial product. Additionally, the company will continue acceleration of commercial readiness efforts for a potential launch in 2025, led by the company’s new Chief Commercial Officer, Phil Tennant. Strategic prioritization will also include: The company plans to continue PRGN-2009 Phase 2 trials under a cooperative research and development agreement with the National Cancer Institute in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 clinical trial enrollment at non-NCI clinical sites will be paused. The company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia, which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. The company will pause all other UltraCAR-T clinical programs, including PRGN-3005 and PRGN-3007. The company will minimize UltraCAR-T spend and focus on strategic partnerships to further advance UltraCAR-T programs. The company will pause all preclinical programs. The company has initiated a shutdown of its Belgium-based ActoBio subsidiary operations, including planned elimination of all ActoBio personnel. In conjunction with this shutdown, ActoBio’s portfolio of intellectual property will be made available for prospective transactions.