Precigen
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1998-01-01
- Employees
- 202
- Market Cap
- $330.8M
- Website
- http://www.precigen.com
- Introduction
Precigen, Inc. is a biotechnology company, which engages in the research and development of synthetic biology technologies. It operates through the following segments: Biopharmaceuticals, Exemplar, and Trans Ova. The Biopharmaceuticals segment is involved in advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. It also engages in pioneering a proprietary class of microbe-based biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics. The Exemplar segment is focused on developing research models and services for healthcare research applications. The Trans Ova segment provides bovine reproductive technologies. The company was founded by Thomas David Reed in 1998 and is headquartered in Germantown, MD.
Clinical Trials
5
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials
Confirmatory Study of PRGN-2012 in Patients With RRP
- Conditions
- Recurrent Respiratory PapillomatosisPapillomaviridaePapillomavirus Infection
- Interventions
- First Posted Date
- 2024-08-05
- Last Posted Date
- 2025-07-09
- Lead Sponsor
- Precigen, Inc
- Target Recruit Count
- 42
- Registration Number
- NCT06538480
- Locations
- 🇺🇸
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
🇺🇸National Institute of Health, Bethesda, Maryland, United States
🇺🇸University of Cincinnati, Cincinnati, Ohio, United States
PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer
- Conditions
- Cervical CancerHPV-Related CarcinomaHPV-Related MalignancyRecurrent Cervical CarcinomaMetastatic Cervical Cancer
- Interventions
- First Posted Date
- 2023-12-05
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Precigen, Inc
- Target Recruit Count
- 46
- Registration Number
- NCT06157151
- Locations
- 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸National Institute of Health, Bethesda, Maryland, United States
🇺🇸University of Washington, Seattle, Washington, United States
Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis
- Conditions
- Papillomavirus InfectionsRecurrent Respiratory PapillomatosisPapillomaviridae
- Interventions
- Drug: PRGN-2012 - Phase I; Dose Level 1Drug: PRGN-2012 - Phase I; Dose Level 2Drug: PRGN-2012 - Phase II; Dose Level 2
- First Posted Date
- 2021-01-26
- Last Posted Date
- 2025-06-11
- Lead Sponsor
- Precigen, Inc
- Target Recruit Count
- 38
- Registration Number
- NCT04724980
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndromes
- Interventions
- First Posted Date
- 2019-04-25
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Precigen, Inc
- Target Recruit Count
- 88
- Registration Number
- NCT03927261
- Locations
- 🇺🇸
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Conditions
- Platinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRefractory Fallopian Tube CarcinomaRefractory Ovarian CarcinomaStage III Fallopian Tube Cancer AJCC V8Stage III Ovarian Cancer AJCC V8
- Interventions
- Biological: PRGN-3005 UltraCAR-T cells
- First Posted Date
- 2019-04-09
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Precigen, Inc
- Target Recruit Count
- 71
- Registration Number
- NCT03907527
- Locations
- 🇺🇸
National Institutes of Health (NIH), Bethesda, Maryland, United States
🇺🇸Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
News
FDA Grants Priority Review to Precigen's PRGN-2012 for Recurrent Respiratory Papillomatosis
• The FDA has accepted Precigen's Biologics License Application for PRGN-2012 with priority review, setting a PDUFA target action date of August 27, 2025 for the potential first-ever approved therapy for recurrent respiratory papillomatosis. • PRGN-2012, an AdenoVerse gene therapy, demonstrated remarkable efficacy in clinical trials with over 50% of patients achieving complete response and more than 85% experiencing reduced surgical interventions, addressing a significant unmet need. • If approved, PRGN-2012 would transform treatment for approximately 27,000 adult RRP patients in the US who currently rely on repeated surgeries that don't address the underlying HPV 6/11 infection.
Precigen Advances PRGN-2012 for RRP Towards BLA Submission
Precigen is set to submit a rolling BLA for PRGN-2012 in recurrent respiratory papillomatosis (RRP) in Q4 2024 under an accelerated approval pathway.
Precigen Announces Progress on PRGN-2012 for Recurrent Respiratory Papillomatosis
Precigen completed a pre-BLA meeting with the FDA, achieving full alignment on the BLA content for PRGN-2012, targeting a rolling submission in Q4 2024.