Precigen (I5X) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| PRGN-2012 | Recurrent Respiratory Papillomatosis, Papillomaviridae, Papillomavirus Infection | Phase III | Suspended | Confirmatory Study of PRGN-2012 in Patients With RRP | Aug 01, 2024 | ― |
| Prgn-2009 Plus Pembrolizumab, Pembrolizumab Alone | Cervical Cancer, Hpv-Related Carcinoma, Metastatic Cervical Cancer, Hpv-Related Malignancy, Recurrent Cervical Carcinoma | Phase II | Recruiting | PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer | Nov 27, 2023 | ― |
| Prgn-2012 - Phase I; Dose Level 1, Prgn-2012 - Phase I; Dose Level 2, Prgn-2012 - Phase Ii; Dose Level 2 | Papillomavirus Infections, Recurrent Respiratory Papillomatosis, Papillomaviridae | phase1AndPhase2 | Active Not Recruiting | Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis | Jan 23, 2021 | ― |
| Prgn-3006 T Cells | Acute Myeloid Leukemia, Myelodysplastic Syndromes | Phase I | Active Not Recruiting | PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS | Apr 23, 2019 | ― |
| Prgn-3005 Ultracar-T Cells | Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Refractory Fallopian Tube Carcinoma, Refractory Ovarian Carcinoma, Refractory Primary Peritoneal Carcinoma, Stage Iii Fallopian Tube Cancer Ajcc V8, Stage Iii Ovarian Cancer Ajcc V8, Stage Iii Primary Peritoneal Cancer Ajcc V8, Stage Iiia Fallopian Tube Cancer Ajcc V8, Stage Iiia Ovarian Cancer Ajcc V8, Stage Iiia Primary Peritoneal Cancer Ajcc V8, Stage Iiia1 Fallopian Tube Cancer Ajcc V8, Stage Iiia1 Ovarian Cancer Ajcc V8, Stage Iiia2 Fallopian Tube Cancer Ajcc V8, Stage Iiia2 Ovarian Cancer Ajcc V8, Stage Iiib Fallopian Tube Cancer Ajcc V8, Stage Iiib Ovarian Cancer Ajcc V8, Stage Iiib Primary Peritoneal Cancer Ajcc V8, Stage Iiic Fallopian Tube Cancer Ajcc V8, Stage Iiic Ovarian Cancer Ajcc V8, Stage Iiic Primary Peritoneal Cancer Ajcc V8, Stage Iv Fallopian Tube Cancer Ajcc V8, Stage Iv Ovarian Cancer Ajcc V8, Stage Iv Primary Peritoneal Cancer Ajcc V8, Stage Iva Fallopian Tube Cancer Ajcc V8, Stage Iva Ovarian Cancer Ajcc V8, Stage Iva Primary Peritoneal Cancer Ajcc V8, Stage Ivb Fallopian Tube Cancer Ajcc V8, Stage Ivb Ovarian Cancer Ajcc V8, Stage Ivb Primary Peritoneal Cancer Ajcc V8 | Phase I | Active Not Recruiting | Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer | Apr 05, 2019 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| PRGN-2012 | Phase III | Recurrent Respiratory Papillomatosis, Papillomaviridae, Papillomavirus Infection | Suspended | Confirmatory Study of PRGN-2012 in Patients With RRP | Aug 01, 2024 | ― |
| Prgn-2009 Plus Pembrolizumab, Pembrolizumab Alone | Phase II | Cervical Cancer, Hpv-Related Carcinoma, Metastatic Cervical Cancer, Hpv-Related Malignancy, Recurrent Cervical Carcinoma | Recruiting | PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer | Nov 27, 2023 | ― |
| Prgn-2012 - Phase I; Dose Level 1, Prgn-2012 - Phase I; Dose Level 2, Prgn-2012 - Phase Ii; Dose Level 2 | phase1AndPhase2 | Papillomavirus Infections, Recurrent Respiratory Papillomatosis, Papillomaviridae | Active Not Recruiting | Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis | Jan 23, 2021 | ― |
| Prgn-3006 T Cells | Phase I | Acute Myeloid Leukemia, Myelodysplastic Syndromes | Active Not Recruiting | PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS | Apr 23, 2019 | ― |
| Prgn-3005 Ultracar-T Cells | Phase I | Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Refractory Fallopian Tube Carcinoma, Refractory Ovarian Carcinoma, Refractory Primary Peritoneal Carcinoma, Stage Iii Fallopian Tube Cancer Ajcc V8, Stage Iii Ovarian Cancer Ajcc V8, Stage Iii Primary Peritoneal Cancer Ajcc V8, Stage Iiia Fallopian Tube Cancer Ajcc V8, Stage Iiia Ovarian Cancer Ajcc V8, Stage Iiia Primary Peritoneal Cancer Ajcc V8, Stage Iiia1 Fallopian Tube Cancer Ajcc V8, Stage Iiia1 Ovarian Cancer Ajcc V8, Stage Iiia2 Fallopian Tube Cancer Ajcc V8, Stage Iiia2 Ovarian Cancer Ajcc V8, Stage Iiib Fallopian Tube Cancer Ajcc V8, Stage Iiib Ovarian Cancer Ajcc V8, Stage Iiib Primary Peritoneal Cancer Ajcc V8, Stage Iiic Fallopian Tube Cancer Ajcc V8, Stage Iiic Ovarian Cancer Ajcc V8, Stage Iiic Primary Peritoneal Cancer Ajcc V8, Stage Iv Fallopian Tube Cancer Ajcc V8, Stage Iv Ovarian Cancer Ajcc V8, Stage Iv Primary Peritoneal Cancer Ajcc V8, Stage Iva Fallopian Tube Cancer Ajcc V8, Stage Iva Ovarian Cancer Ajcc V8, Stage Iva Primary Peritoneal Cancer Ajcc V8, Stage Ivb Fallopian Tube Cancer Ajcc V8, Stage Ivb Ovarian Cancer Ajcc V8, Stage Ivb Primary Peritoneal Cancer Ajcc V8 | Active Not Recruiting | Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer | Apr 05, 2019 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Precigen, Inc. (DE:I5X) have in its pipeline
Precigen DE:I5X is currently developing the following drugs: PRGN-2012, Prgn-2009 Plus Pembrolizumab, Pembrolizumab Alone, Prgn-2012 - Phase I; Dose Level 1, Prgn-2012 - Phase I; Dose Level 2, Prgn-2012 - Phase Ii; Dose Level 2, Prgn-3006 T Cells, Prgn-3005 Ultracar-T Cells. These drug candidates are in various stages of clinical development as the company works toward FDA approval.