Precigen announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Precigen's PRGN-3005, a first-in-class investigational therapy using autologous chimeric antigen receptor T (CAR-T) cells to treat advanced-stage platinum-resistant ovarian cancer patients.
PRGN-3005 is the second candidate to clear IND utilizing Precigen's UltraCAR‑T platform that reduces manufacturing time to less than two days following non-viral gene transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell treatment utilizing Precigen's clinically-validated Sleeping Beauty system to co-express a chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control in targeting advanced ovarian cancer. This is an open-label, first-in-human Phase 1 dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3005 UltraCAR-T.
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"This patient population has limited treatment options and ovarian cancer remains one of the most challenging with minimal advances in long-term survival for patients with advanced disease," said Mary L. (Nora) Disis, MD, professor of medicine at the University of Washington and lead investigator for the PRGN-3005 study. "Clinical advancements and new research, including the PRGN-3005 UltraCAR-T study, are needed to make progress in fighting this intractable disease."
Precigen's UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements:
- Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus;
- Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies;
- T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and
- Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.
"We are pleased our PRGN-3005 UltraCAR-T investigational therapy received clearance from the FDA to advance into the clinic. This is an exciting milestone as it represents the first UltraCAR-T to enter the clinic targeting solid tumors," said Helen Sabzevari, PhD, President of Precigen. "This is an important step for patients and our dedicated employees who continue to work with urgency to execute our important mission of creating innovative medicines with meaningful benefit for patients."
Worldwide, nearly 300,000 women are diagnosed with ovarian cancer every year and around 22,000 are diagnosed in the US. Five-year survival rates depend on stage and type of ovarian cancer; however, stage IV survival can drop to as low as 20 percent.