Clinical Studies

CLINICAL STUDIES: STP705

Our lead product, STP705, currently in Phase Ⅱb clinical trials for the treatment of in situ squamous cell carcinoma (isSCC) in the U.S. and in China, as part of a global multicenter clinical trial. These studies will further evaluate the two most efficacious dosing regimens identified in our Phase Ⅱa clinical trial, with primary endpoints of histological clearance of isSCC lesions as determined by central pathology review upon completion of treatment.

STP705 is also being studied in a Phase Ⅱ clinical trial to evaluate the safety and efficacy of intralesional injection for the treatment of basal cell carcinoma. The primary endpoint is complete histological clearance of tumor cells.

Our Phase Ⅰ/Ⅱ clinical trial, currently underway for the evaluation of the safety and efficacy of various doses of STP705 for keloid scar prevention, will follow 50 patients in a randomized, double-blind, multiple-arm, controlled study. The primary endpoint of this trial is to measure the rate of recurrence in patients who have undergone keloidectomy surgery alone versus those who have undergone surgery plus administration of STP705 evaluated at three months, six months, and 12 months post-surgical excision.

Our Phase I clinical trial for STP705 in liver cancer will evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of STP705 in a “basket study” of patients diagnosed with Cholangiocarcinoma (CCA), Hepatocellular Carcinoma (HCC) or liver metastases from other cancers for patients with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. The patients in this study have previously failed multiple rounds of standard of care therapy and represent a very resistant class of tumor. The primary endpoints are to determine the maximum tolerated dose and to establish the recommended dose for future Phase Ⅱ clinical trials.

Additionally, STP705 is in pre-clinical studies as a medical aesthetic treatment for fat sculptingsince administration into the skin has shown  a reduction of subcutaneous adipose tissue. STP705 has also been compared to treatment with Kybella (deoxycholic acid), an FDA-approved drug indicated to improve the appearance and profile of moderate to severe fullness associated with submental fat on the chin. A single dose of STP705 resulted in better subcuticular thickness when compared to double doses of Kybella.

CLINICAL STUDIES: STP707

Our second core product, STP707, is currently in Phase Ⅰ clinical trials for the treatment of Liver Fibrosis in Primary Sclerosing Cholangitis, a rare disorder in the U.S., which will allow us to assess the safety, tolerance, and anti-tumor activity of this therapy. The clinical trial is a step forward in our liver fibrosis drug development program, and will help to inform dosing recommendations for Phase Ⅱ trials.

 

Combination Therapy

  • We are developing combination therapies with STP705 and immune checkpoint therapeutics for liver cancer.
  • We are also developing combination therapies with STP707 and immune checkpoint therapeutics for liver cancer, isSCC, and NSCLC.
  • We currently are collaborating with Innovent in the U.S. to explore the efficacy of STP705 plus sintilimab, a novel anti-PD-1 monoclonal antibody approved by the National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration) for use in the treatment of advanced cancers such as NSCLC.
  • We also are collaborating with Shanghai Junshi to conduct preclinical studies in the U.S. using STP705 plus Shanghai Junshi’s novel anti-PD-1 monoclonal antibody approved by the NMPA for use in treatment in advanced melanoma, squamous cell carcinoma and other indications.