Precigen Prioritizes Portfolio for First Gene Therapy Launch
Precigen, Inc., a biopharmaceutical company focused on gene and cell therapies, has announced a strategic shift in its clinical portfolio and resource allocation. This realignment involves a significant reduction of over 20% of its workforce to concentrate on the potential commercialization of PRGN-2012, a gene therapy aimed at treating recurrent respiratory papillomatosis (RRP).
The company's strategic changes are designed to reduce resources for non-priority programs and enhance efforts towards the pre-commercialization of PRGN-2012. These efforts include the submission of a rolling biologics license application (BLA) under an accelerated approval pathway, which is expected in the latter half of 2024. Additionally, the company will focus on conducting the necessary confirmatory clinical trial and ramping up the manufacturing of commercial products. Preparations for a potential product launch in 2025 are also being accelerated under the leadership of the newly appointed Chief Commercial Officer, Phil Tennant.
Key areas of strategic focus include:
1. PRGN-2009 Gene Therapy Clinical Trials: The company will continue Phase 2 trials of PRGN-2009 in partnership with the National Cancer Institute (NCI) for recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer. However, enrollment for PRGN-2009 at non-NCI sites will be paused.
2. UltraCAR-T Clinical Programs: Precigen has completed enrollment for the Phase 1b trial of PRGN-3006 in acute myeloid leukemia (AML), which has Fast Track designation from the FDA. The company is preparing for a meeting with the FDA to discuss the next steps post-Phase 1b. All other UltraCAR-T programs, such as PRGN-3005 and PRGN-3007, will be paused, and spending in this area will be minimized. The company plans to seek strategic partnerships to advance these programs.
3. Preclinical Programs: All preclinical programs will be paused.
4. ActoBio Subsidiary: Precigen is shutting down its Belgium-based ActoBio subsidiary, including the elimination of all associated personnel. The intellectual property portfolio of ActoBio will be available for potential transactions.
Helen Sabzevari, PhD, President and CEO of Precigen, expressed confidence in the company's progress towards submitting the rolling BLA for PRGN-2012 within the year. She emphasized that these steps will allow Precigen to better prepare for the potential commercialization of PRGN-2012, which could become a leading therapy for RRP if approved.
Precigen is dedicated to advancing innovative gene and cell therapies using precision technology to address complex diseases in immuno-oncology, autoimmune disorders, and infectious diseases. The company leverages its proprietary AdenoVerse platform for efficient gene delivery, which has demonstrated the ability to generate durable antigen-specific immune responses.
PRGN-2012, part of the AdenoVerse gene therapy platform, aims to elicit immune responses against HPV 6 or HPV 11 infected cells. It has received Breakthrough Therapy Designation and an accelerated approval pathway from the FDA, as well as Orphan Drug Designation from both the FDA and the European Commission. Results from the Phase 1 portion of its study have been published in a leading scientific journal.
With these strategic changes, Precigen aims to concentrate its efforts and resources on the most promising areas of its portfolio, ensuring rapid progress towards commercialization and the potential launch of PRGN-2012.
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