- Two out of four patients showed complete resolution of liver metastases on PET scan
- Median overall survival (OS) 8.3 months and mean OS 9.8 months, compared to the standard of care 3 to 6 months
- Meeting scheduled with FDA for discussion on the path towards Licensure
SAN DIEGO, CA, USA I November 06, 2018 I Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”) announced today 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. 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) Annual Meeting, being held November 7-11 in Washington, DC.
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.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as clinical stage fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“CAR-T”), antibody-drug conjugates (“ADC”), and oncolytic virus (“Seprehvir®”).
Sorrento’s commitment to life-enhancing therapies is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) as well as to promote newly-launched ZTlido™. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients as well as in trial for osteoarthritis (OA) pain management. ZTlido was approved by the FDA on February 28, 2018 for the treatment of post-herpetic neuralgia.
For more information visit www.sorrentotherapeutics.com
SOURCE: Sorrento Therapeutics
Post Views: 158
- Two out of four patients showed complete resolution of liver metastases on PET scan
- Median overall survival (OS) 8.3 months and mean OS 9.8 months, compared to the standard of care 3 to 6 months
- Meeting scheduled with FDA for discussion on the path towards Licensure
SAN DIEGO, CA, USA I November 06, 2018 I Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”) announced today 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. 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) Annual Meeting, being held November 7-11 in Washington, DC.
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.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as clinical stage fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“CAR-T”), antibody-drug conjugates (“ADC”), and oncolytic virus (“Seprehvir®”).
Sorrento’s commitment to life-enhancing therapies is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) as well as to promote newly-launched ZTlido™. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients as well as in trial for osteoarthritis (OA) pain management. ZTlido was approved by the FDA on February 28, 2018 for the treatment of post-herpetic neuralgia.
For more information visit www.sorrentotherapeutics.com
SOURCE: Sorrento Therapeutics
Post Views: 158
