Emerging Data From Phase I Clinical Study for Pancreatic Cancer Show Stable Disease Activity
Preliminary results from study of small interfering RNA drug candidate, STP707, indicated the average days for stable disease in patients was 92.
Sirnaomics has announced its small interfering RNA (siRNA) drug candidate, STP707, showed a strong safety profile and stable disease activity in patients with pancreatic cancer following the completion of a Phase I clinical trial. 1
The dose escalation study was conducted in 11 oncology clinics in the United States and involved six cohorts, consisting of 50 patients with various cancers, of which 11 had pancreatic cancer.
According to Sirnaomics, patients were heavily pre-treated and received, on average, three lines of therapy prior to enrollment in the study (including Gemcitabine, Paclitaxel, and Folfirinox). The preliminary results indicated that the mean treatment cycles completed was three cycles (average 12 doses). 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.
The maximum tolerated dose of STP707 for all 50 late-stage cancer patients enrolled in the study was not reached, even at the 48mg dosage level. The siRNA candidate was very well-tolerated in a heavily pretreated cancer patient population. No treatment related adverse events were reported for the 11 pancreatic cancer patients, except for one patient with a Grade 2 infusion reaction.
"We are very excited to see STP707, our leading siRNA drug product for the treatment of heavily pre-treated pancreatic cancer (one of the deadliest tumor types), shows these strong results upon intravenous administration. This is a very promising result for RNAibased cancer therapeutics for the treatment of metastasized tumors." Patrick Lu, PhD, founder, chairman of the board, executive director, president and chief executive officer of Sirnaomics said in a press release. "The strong safety profile, long-lasting stable disease efficacy and dose-dependent antitumor activity of this intravenously administered STP707 formulation, present a potential novel cancer therapeutic, either as a single drug or in combination with immune check point inhibitor drugs."
According to the American Cancer Society, pancreatic cancer accounts for about 3% of all cancers in the United States. Estimates suggest about 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer in 2024.2
In August 2023, Sirnaomics announced it had completed all dosing regimens for the Phase I study of STP707. The basket study enrolled 50 patients with late-stage solid tumors, who all exhibited progressive disease on prior rounds of treatment with marketed oncology drugs. Data showed approximately 74% of evaluable patients demonstrated a best response of stable disease and several patients exhibited reduction in tumor burden per Response Evaluation Criteria in Solid Tumors.3
"This is the first time in the field of RNAi cancer therapeutics that a Phase I study has demonstrated very promising clinical potential for metastasized tumors. We observed patients achieving stable disease status with some realizing a reduction in tumor size treated with STP707," Lu said in an earlier press release. "The results from this basket study encourages us to explore STP707 as a potential single drug or a combination treatment with immune check point inhibitor drugs."
References
1. Sirnaomics Announces Completion of STP707 Phase I Clinical Study with Strong Safety Profile and Disease Activity for the Treatment of Pancreatic Cancer Patients. News release. Sirnaomics. June 28, 2024. Accessed July 3, 2024. https://www.prnewswire.com/apac/news-releases/sirnaomics-announces-completion-of-stp707-phase-i-clinical-study-with-strong-safety-profile-and-disease-activity-for-the-treatment-of-pancreatic-cancer-patients-302185499.html
2. Key Statistics for Pancreatic Cancer. American Cancer Society. February 5, 2024. Accessed July 3, 2024. https://www.cancer.org/cancer/types/pancreatic-cancer/about/key-statistics.html
3. Sirnaomics Announces Successful Phase I Clinical Study of RNAi Therapeutic STP707 for Treatment of Multiple Solid Tumors. News release. Sirnaomics. August 31, 2023. Accessed July 3, 2024. https://www.prnewswire.com/apac/news-releases/sirnaomics-announces-successful-phase-i-clinical-study-of-rnai-therapeutic-stp707-for-treatment-of-multiple-solid-tumors-301914383.html
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
