STP707 / Sirnaomics - LARVOL DELTA

Sirnaomics Announces Completion of STP707 Phase I Clinical Study with Strong Safety Profile and Disease Activity for the Treatment of Pancreatic Cancer Patients (PRNewswire) - P1 | N=50 | NCT05037149 | Sponsor: Sirnaomics | "Sirnaomics Ltd...today announced that the Group has completed STP707 Phase I clinical study with strong safety profile and stable disease activity for treatment of pancreatic cancer patients...The average days for stable disease for all 11 patients with STP707 treatment was 92 days, while 31 days for the 12mg group, 65 days for 24mg group and 112 days for 48mg group, including one patient ongoing at 281 days. No treatment related adverse events (TRAE) were reported for the 11 patients, except for one patient with a Grade 2 infusion reaction...The maximum tolerated dose of STP707 for all 50 late-stage cancer patients was not reached even at 48mg dosage level. STP707 was very well-tolerated in a heavily pretreated cancer patient population."

P1 data • Trial completion • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Study of STP707 Administered by IV in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Sirnaomics | Active, not recruiting ➔ Completed | N=50 ➔ 20

Enrollment change • Trial completion

Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Mar 2024 | Trial primary completion date: Sep 2024 ➔ Mar 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Sirnaomics Publishes Novel Mechanism of Action of RNAi Cancer Therapeutic STP707 for Solid Tumors (PRNewswire) - "Sirnaomics Ltd...announced today the Company published a research article with NAR Cancer. The article reveals a novel mechanism of action of lead RNAi cancer drug candidate, STP707, a polypeptide nanoparticle (PNP) formulation comprised of two active siRNA (small interfering RNA) inhibitors targeting TGF-β1 and COX-2 for intravenous treatment of solid tumors....The published study...demonstrates how PNP delivered the siRNA to multiple cell types besides hepatocytes in the liver. It also demonstrates that STP707 can simultaneously deliver the siRNAs targeting TGF-β1 and COX-2 to tumor cells. Systemic administration of the PNP packaged with dual-targeted siRNAs (2mg/kg) in mice bearing orthotopic hepatocellular carcinoma (HCC) tumors induced tumor growth inhibition to an undetectable level."

Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Sirnaomics Announces Successful Phase I Clinical Study of RNAi Therapeutic STP707 for Treatment of Multiple Solid Tumors (PRNewswire) - P1| N=40 | NCT05037149 | Sponsor: Sirnaomics | "Sirnaomics Ltd...today announced the Group has completed all dosing regimens for its Phase I study of STP707 for the treatment of multiple solid tumors in patients with various types of late-stage cancers who did not respond to multiple rounds of other oncology treatments. Approximately 74% of evaluable patients demonstrated a best response of stable disease (SD) and several patients exhibited reduction in tumor burden per Response Evaluation Criteria in Solid Tumors (RECIST)....The multi-center, open-label, dose escalation study evaluated the safety, tolerability and antitumor activity of STP707 with 50 participants receiving doses at 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and 48 mg via intravenous administration."

P1 data • Trial status • Oncology • Solid Tumor

A Study of STP707 Administered by IV in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Sirnaomics | Trial completion date: Mar 2023 ➔ Jun 2023

Trial completion date

Sirnaomics Announces Interim Data from Phase I Clinical Trial of RNAi Therapeutic STP707 for Treatment of Multiple Solid Tumors (PRNewswire) - P1 | N=40 | NCT05037149 | Sponsor: Sirnaomics | "Sirnaomics...announced today the interim results from a Phase I clinical trial evaluating the safety, tolerability and anti-tumor activity of...STP707 with intravenous (IV) administration in the United States. This is a basket study which enrolls various solid tumor types. The analysis included the first three cohorts in a five-cohort dose escalation study....'The 20 subject data set demonstrates an encouraging efficacy signal with duration of response equal to or exceeding two treatment cycles or 56 days in 8 subjects examined over all dosing cohorts. There have also been a number of tumor types including liver, pancreatic, colon and uveal melanoma cancers that have exhibited stable disease beyond 100 days of treatment.... As all subjects demonstrated progressive disease on prior treatment regimens, this group of subjects represents a subset of resistant tumor types that have not responded to all prior therapies'."

P1 data • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Melanoma • Ocular Melanoma • Oncology • Pancreatic Cancer • Skin Cancer • Solid Tumor • Uveal Melanoma

A Study of STP707 Administered by IV in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Sirnaomics | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of STP707 Administered by IV in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Sirnaomics

New P1 trial

Sirnaomics Launches Phase I Clinical Trial of RNAi Therapeutic STP707 Delivered Systemically for the Treatment of Solid Tumors (PRNewswire) - "Sirnaomics Ltd...announced the start of a Phase I clinical trial for evaluation of the safety, tolerability and anti-tumor activity of the Company's siRNA (small interfering RNA) drug candidate, STP707 with intravenous (IV) administration in the United States. The first two patients in the clinical trial have received treatment...The first dosing of STP707 in patients with hepatocellular carcinoma and other types of solid tumors through IV administration is a significant milestone as we seek to advance this novel siRNA therapeutic, which has demonstrated promising activity in our preclinical efficacy and safety studies..."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Ph. 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Sirnaomics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Phase 1, Evaluation of Safety, Tolerability, PK, Anti-tumor Activity of STP707 IV in Subjects With Advanced Metastatic or Surgically Unresectable Solid Tumors Refractory to Standard Therapy (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Sirnaomics

Clinical • New P1 trial • Oncology • Solid Tumor

Sirnaomics Receives FDA Approval of IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 for Solid Tumor Treatment (PRNewswire) - "Sirnaomics, Inc...announced today that the company's IND application for a systemic siRNA (small interfering RNA) drug candidate, STP707, received the U.S. Food and Drug Administration (FDA) acknowledgment 'Study May Proceed' in patients with advanced solid tumors....This 'Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP707 Administered Intravenously in Subjects with Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy' is expected to begin enrolling in coming months."

IND • Oncology • Solid Tumor