TriSalus Life Sciences touted results today from a Phase Ib trial of its pressure-enabled drug-delivery tech for immunotherapy.
The company reported that delivering a concentrated dose of CAR-T cells at the site of a solid tumor using its technology was safe and contributed to positive clinical results.
In the early-stage trial, five patients with carcinoembryonic antigen-positive, unresectable stage IV adenocarcinoma with liver metastases received three hepatic artery infusions of Sorrento Therapeutics‘ (NSDQ:SRNE) autologous anti-CEA CAR-T cells. These patients had previously failed at least one round of systemic chemotherapy.
Two of the four pancreatic cancer patients showed no viable liver metastases following the treatment. One person with stage IV pancreatic carcinoma had no evidence of liver metastases after 12 months. A second person with stage IV pancreatic cancer also showed no signs of liver metastases six weeks after treatment, TriSalus touted.
One patient died due to causes unrelated to the study, the company noted. No participant experienced a severe adverse event related to the CAR-T treatment or TriSalus’ device.
The company, which used to be known as SureFire Medical, reported that the median overall survival for its study participants was 8.3 months, higher than the 3-6 months associated with the standard of care.
“PEDD significantly increased CAR-T within liver metastases when compared with low-pressure microcatheters, and this was associated with encouraging clinical activity in two subjects,” principal investigator Dr. Steven Katz said in prepared remarks. “These early results suggest we may be able to achieve a therapeutic dose in solid tumors and avoid severe side effects, such as neurotoxicity and cytokine release syndrome, that are prevalent with conventional systemic CAR-T administration methods.”
“Although this is an early study, we are hopeful CAR-T immunotherapy in combination with our PEDD technology can help prolong the lives of patients with pancreatic and other high-pressure solid tumors,” president & CEO Mary Szela added “Localized infusion with the company’s technology has been used in nearly 8,000 procedures worldwide for liver cancer, with proven ability to improve tumor uptake.”