CAR-T cell therapy demonstrates therapeutic activity
Sorrento Therapeutics (SRNE), cellular therapy focused subsidiary TNK Therapeutics and Surefire Medical announced initial results from the Hepatic ImmunoTherapy for Metastases-Surefire, or HITM-SURE, a Phase 1b single arm trial testing its autologous anti-CEA CAR-T cells administered regionally by hepatic artery infusion via pressure directed microvalve infusion technology in heavily pre-treated patients with refractory CEA-positive liver metastases.
This Phase 1b trial follows the HITM and HITM-SIR Phase 1 studies we believe demonstrated the safety and biological activity of the anti-CEA CAR-T administered with hepatic artery infusions alone or with selective internal radiotherapy.
The data of HITM-SURE were provided by Dr. Steven Katz, the Principal Investigator of the Study and Associate Professor of Surgery at The Roger Williams Medical Center.
The study is also open at Colorado University and funded in part by the Colorado Office for Economic Development and International Trade. In total, three patients have completed the ongoing HITM-SURE protocol, two with stage IV pancreatic cancer and one with colorectal cancer.
All patients presented with unresectable, chemotherapy refractory CEA+ liver metastases. Patients received three HAI of anti-CEA CAR-T cells along with low dose IL-2 infusion. CAR-T HAI were administered via a Surefire MVI technology. The primary objective of the study was to establish the safety of the CAR-T HAI with the pressure directed MVI device.
Secondary objectives included response assessed by modified RECIST, immune-related response criteria, and tumor marker kinetics. Reduction in post-treatment serum CEA was noted in all patients.
Two patients have progressive disease, with a pancreatic cancer patient alive at 7 months and a colorectal cancer patient alive at 4.8 months. A patient with stage IV pancreas adenocarcinoma has no evidence of liver metastases 11 months on PET scan following three CAR-T HAIs.
In the phase III MPACT study, treatment of stage IV pancreas adenocarcinoma patients with gemcitabine plus albumin-bound paclitaxel resulted in a median overall survival time of 8.7 months.
It will be of interest to determine if the results from upcoming phase 2 liver metastasis HITM studies will confirm the encouraging results from our small number of patients.
The initial findings from the currently enrolling HITM-SURE trial follows the results of two other trials. In one of the previous trials, a patient survived 51 months following 3 anti-CEA CAR-T HAIs and a patient from another trial is alive 25 months after treatment.
SRNE closed at $7.20.
To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.
This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.