On November 6, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) ("Sorrento") reported the release of data from a phase 1b clinical trial administering anti-CEA CAR-T by utilizing a unique Pressure-Enabled Drug Delivery (PEDD) manufactured by TriSalus Life Sciences (Press release, Sorrento Therapeutics, NOV 6, 2018, View Source [SID1234532249]). The preliminary data for the Hepatic Immunotherapy for Metastases (HITM-SURE) clinical trial results will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held November 7-11 in Washington, DC.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Five patients, four pancreatic and one colorectal, with carcinoembryonic antigen–positive (CEA+), unresectable stage IV adenocarcinoma with liver metastases, who had failed one or more lines of systemic chemotherapy, each received three hepatic artery infusions of Sorrento autologous anti-CEA CAR-T cells using the Hepatic Immunotherapy for Metastases (HITM) method. The immunotherapy was delivered by means of PEDD technology, which overpowers the high pressure within solid tumors that limits the reach and efficacy of therapeutic agents.
Two out of the four pancreatic cancer patients had no viable liver metastases by PET scan after treatment. After 12 months, one patient with stage IV pancreatic carcinoma still showed no evidence of liver metastases on PET imaging, and his primary pancreatic tumor was well-controlled. A second patient with stage IV pancreatic cancer also had no evidence of liver metastases six weeks after CAR-T/PEDD infusions. Median overall survival (OS) post-treatment is 8.3 months and the mean OS is 9.8 months to date. No patient suffered any severe adverse event related to the CAR-T infusions.
"PEDD significantly increased CAR-T, more than five-fold, within liver metastases when compared with low-pressure microcatheters, and serum CEA levels declined on-study in all subjects," said Steven Katz, MD, director of the Office of Therapeutic Development at the Roger Williams Medical Center, and the principal investigator of the trial. "These early results suggest we may be able to achieve a therapeutic dose in solid tumors and avoid the severely limiting systemic side effects, such as neurotoxicity and cytokine release syndrome, that are prevalent with conventional systemic CAR-T administration methods. Furthermore, our delivery approach limits the number of circulating CAR-T cells compared to systemic delivery, which has the potential to improve the safety profile of CAR-T therapies for solid tumors in several critical organs."
"With our CD38 and CEA CAR-T programs, we are addressing the challenges of treating both liquid and solid tumors," stated Henry Ji, PhD, President and CEO. "We are scheduled to discuss with the FDA the continued development of this program towards Licensure."