TriSalus Life Sciences Enrolls First Patient in PERIO-02 Clinical Trial, Studying the Delivery of SD-101 via Pressure-Enabled Drug Delivery in Adults with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

TriSalus Life Sciences®, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, today announced the enrollment of the first patient in its Pressure-Enabled Regional Immuno-Oncology (PERIO^™-02) clinical study.

The trial is evaluating SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in adults with locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). SD-101 will be administered using the Pressure-Enabled Drug Delivery™ (PEDD™) method in combination with systemic checkpoint inhibitors.

Initiated at The University of Texas MD Anderson Cancer Center, with additional sites anticipated, the study is the second in a series of clinical trials assessing TriSalus’ immunotherapy platform across multiple indications. The platform integrates an immunotherapeutic and proprietary drug delivery technology to address the unique challenges facing patients with tumors in the liver. The PERIO-02 clinical trial will first evaluate the safety of SD-101 delivered by PEDD™ in varying doses and with checkpoint inhibitors in patients with HCC or ICC. Efficacy will be evaluated based on the tumor response.

The initial trial using this platform, the PERIO-01 study, is actively enrolling and is evaluating the safety of SD-101 administered by PEDD™ in combination with checkpoint inhibitors in patients with uveal melanoma with liver metastases. The PERIO-01 study has provided initial safety validation for the platform, and early data indicate the ability of SD-101 to favorably reprogram the tumor microenvironment of liver tumors.

“Patients with advanced HCC or ICC often have limited options when seeking treatment, as checkpoint inhibitors have had some success in these indications but results are not what we want them to be in most cases,” said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. “The PERIO-02 clinical trial has potential to advance the scientific foundation required to help address this unmet need, deliver new therapies to improve clinical outcomes, and ultimately, give patients a better chance to respond more reliably to different forms of immunotherapy.”

While immunotherapy has yielded significant advances in cancer treatment, unique properties of liver tumors, including immune response suppression and high intratumoral pressure, can prevent optimal delivery and performance of therapeutics and limit the overall effectiveness of immunotherapy for patients with liver cancers.^|1-4|

TriSalus’ platform is designed to address these treatment challenges. The platform consists of an investigational immunotherapy, SD-101, that aims to reactivate the immune system within the liver, and a proprietary drug delivery method, PEDD™, that modulates pressure and flow within blood vessels to improve therapy uptake and tumor response.

“With the PERIO-02 trial, we’re striving to enable immunotherapy for the most common primary liver tumors,” said Dr. Katz. “The study is implementing a multifaceted approach by testing the integration of an immunotherapeutic, SD-101, with an FDA-cleared delivery device, to hopefully induce the type of immune response that we’re so eager to see for patients with HCC and ICC.”

As the second of three Pressure-Enabled Regional Immuno-Oncology studies planned, PERIO-02 builds upon TriSalus’ collaboration with leading cancer research centers to further develop the company’s organ-specific platform and rapidly bring new treatments to patients. The phase 1b/2 study will enroll up to 89 patients with HCC or ICC, while future studies will seek to validate this platform in additional liver and pancreatic tumor types.

Milind Javle, MD, professor in the Department of Gastrointestinal Medical Oncology at MD Anderson, will serve as principal investigator on the PERIO-02 trial.

For Patients

To learn more about the clinical trial treatment protocol and enrollment, visit www.clinicaltrials.gov and search NCT05220722.

About TriSalus Life Sciences

TriSalus Life Sciences is an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors. By integrating an immunotherapeutic with innovative drug delivery technologies, TriSalus’ platform seeks to address two of the most significant barriers that limit the effectiveness of current treatments for liver and pancreatic tumors: immunosuppression and high intratumoral pressure.

The company is studying the ability of SD-101, a potentially first-in-class, investigative TLR9 agonist, to reactivate the immune system within the liver and pancreas to enable more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) and improve patient outcomes. The platform, which leverages TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration, modulates pressure and flow within blood vessels to improve the amount of therapy delivered to the tumor. While meaningful progress in these difficult-to-treat diseases will not be easy, TriSalus is focused on advancing science and technological innovation to transform outcomes for patients. To learn more, visit www.trisaluslifesci.com and follow us on Twitter @TriSalusLifeSci and LinkedIn.

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¹ Shirota H, Klinman DM. Effect of CpG ODN on monocytic myeloid derived suppressor cells. Oncoimmunology. 2012;1(5):780-782. doi:10.4161/onci.19731

² Hossain DMS, Pal SK, Moreira D, et al. TLR9-Targeted STAT3 Silencing Abrogates Immunosuppressive Activity of Myeloid-Derived Suppressor Cells from Prostate Cancer Patients. Clin Cancer Res. 2015;21(16):3771-3782. doi:10.1158/1078-0432.CCR-14-3145

³ Thorn M, Guha P, Cunetta M, et al. Tumor-associated GM-CSF overexpression induces immunoinhibitory molecules via STAT3 in myeloid-suppressor cells infiltrating liver metastases. Cancer Gene Ther. 2016;23(6):188-198. doi:10.1038/cgt.2016.19

⁴ Jain RK. Barriers to drug delivery in solid tumors. Sci Am. 1994;271(1):58-65. doi:10.1038/scientificamerican0794-58

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