Precigen has begun dosing participants in a Phase 1 trial testing its experimental therapy PRGN-3005 UltraCAR-T in patients with advanced, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
The open-label trial (NCT03907527), which is still recruiting patients, will be carried out in collaboration with the University of Washington and the Fred Hutchinson Cancer Research Center. Its aims to evaluate the safety and optimal dose of PRGN-3005 given intravenously (into the bloodstream) or intraperitoneally (into the abdomen).
Eligible participants are women with advanced ovarian, fallopian tube, or primary peritoneal cancer who are resistant to platinum-based therapies and whose cancer progressed after receiving standard-of-care treatment or are not eligible for currently available therapies.
“This is an important milestone in our efforts to develop a new treatment option for patients with ovarian cancer,” Helen Sabzevari, PhD, president of Precigen, said in a press release. “With the first ovarian cancer patient dosed with Precigen’s PRGN-3005 UltraCAR-T investigational therapy, we remain steadfast in our goal of delivering critical new therapies to solid tumor patients with high unmet need.”
PRGN-3005 is a next-generation chimeric antigen receptor (CAR) T-cell therapy. The treatment uses T cells — those that orchestrate immune responses — extracted from the patient and modified in the lab to recognize a specific cancer protein.
PRGN-3005 relies on Precigen’s UltraCAR-T therapeutic platform, specifically designed to overcome the main limitations of traditional CAR T-cell therapies. It does not rely on viral molecules to deliver the treatment. Instead it uses so-called multigenic vectors that activate several genes at the same time, thus increasing tumor targeting.
The mode of delivery eliminates the need to reproduce the extracted cells in the lab, reducing the time to produce the therapy from several weeks to less than two days.
Because the cells are also engineered to produce interleukin‐15, a protein that promotes T-cell survival, PRGN-3005 also provides a sustained effect after injection, avoiding T-cell exhaustion, a common process among CAR-T therapies in which the therapy loses anti-tumor activity over time.
It also includes a kill switch, in case the cells become harmful to the patient, allowing for better precision and control.
“Many women with ovarian, fallopian tube, and primary peritoneal cancer have historically poor outcomes,” said Mary L. (Nora) Disis, MD, faculty member at the University of Washington and lead investigator of the study. “Dosing the first patient with the PRGN-3005 UltraCAR-T represents a potentially significant development for the use of CAR-T cell therapies in solid tumors.”