HONG KONG, GERMANTOWN, Md. andĀ SUZHOU, China, June 28, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company“, together with its subsidiaries, the “Group” or “Sirnaomics“; stock code: 2257), a leading biopharmaceutical company engaging in discoveryĀ and development of advanced RNAi therapeutics, today announced that the Group hasĀ completed STP707 Phase I clinical study with strong safety profile and stable diseaseĀ activity for treatment of pancreatic cancer patients. This is a dose escalation study conductedĀ in 11 oncology clinics in the U.S. The study involved six cohorts, consisting of 50 patients with various cancers, of which 11 had pancreatic cancer.
In an earlier news release from the Company in August 2023, the Group noted completion of all dosing regimens for its Phase I study of STP707 for the treatment of multiple solidĀ tumors. This basket study has enrolled patients suffering from various types of late-stageĀ cancers and failing after multiple rounds of treatments. The study is to evaluate the safety,Ā tolerability and anti-tumor activity of the Group’s siRNA (small interfering RNA) drugĀ candidate, STP707, through intravenous infusion (IV) with six cohorts of escalating doses.Ā Patients including pancreatic, colorectal, liver, melanoma and other cancers, with advanced/Ā metastatic or surgically unresectable solid tumors, refractory to standard therapy, were recruited. Six dose levels (3mg, 6mg, 12mg, 24mg, 36mg and 48mg) were explored in ascending doses. Patients received IV infusion on Day 1, 8, 15 and 22 of a 28-days cycle.
11 pancreatic patients (five males and six females, average age 64 years) were enrolled in the study. Patients were heavily pre-treated and received, on average, three lines of therapyĀ prior to enrollment in the study (including Gemcitabine, Paclitaxel and Folfirinox). TheĀ preliminary results indicated that the mean treatment cycles completed was three cyclesĀ (average 12 doses). The average days for stable disease for all 11 patients with STP707 treatment was 92 days,Ā while 31 days for the 12mg group, 65 days for 24mg group and 112 days for 48mgĀ group, including one patient ongoing at 281 days. No treatment related adverse eventsĀ (TRAE) were reported for the 11 patients, except for one patient with a Grade 2 infusionĀ reaction. Non-treatment related adverse events were secondary to their advanced metastaticĀ disease including intestinal obstruction, abdominal distention, gastrointestinal obstruction,Ā embolism, gastrointestinal hemorrhage, tumor pain, hypoxia and dyspnea.
The maximum tolerated dose of STP707 for all 50 late-stage cancer patients was notĀ reached even at 48mg dosage level. STP707 was very well-tolerated in a heavily pretreatedĀ cancer patient population. The 11 pancreatic subset of patients showed low toxicityĀ and relatively long stable disease at various dosages (106, 281 and 302 days), and warrantsĀ further study with STP707 alone or in combination with immune check point inhibitors,Ā given the preclinical documented ability of STP707 to recruit T-cells to the tumor microenvironmentĀ (TME). This is the first time a polypeptide nanoparticle-based siRNA cancer therapeutic has demonstrated early positive safety and efficacy results for the treatment of late-stage pancreatic cancer patients.
“We are very excited to see STP707, our leading siRNA drug product for the treatmentĀ of heavily pre-treated pancreatic cancer (one of the deadliest tumor types), shows theseĀ strong results upon intravenous administration. This is a very promising result for RNAibasedĀ cancer therapeutics for the treatment of metastasized tumors.” said Dr. Patrick Lu,Ā Ph.D., Founder, Chairman of the Board, Executive Director, President and Chief ExecutiveĀ Officer of Sirnaomics. “The strong safety profile, long-lasting stable disease efficacy andĀ 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.”
For more information about Sirnaomics’ clinical trials please visit ClinicalTrials.gov (Identifier NCT05037149) and the Company’s website at www.sirnaomics.com.
About STP707
STP707 is composed of two siRNA oligonucleotides, targeting TGF-Ī²1 and COX-2Ā mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-PolymerĀ (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier usedĀ in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit theĀ expression of their target mRNAs and combining the two siRNA’s produces a synergisticĀ effect that diminishes pro-inflammatory factors. Over-expression of TGF-Ī²1 and COX-2Ā have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinicalĀ studies with STP707, IV administration resulted in knock-down of TGF-Ī²1 and COX-2Ā gene expressions in various organs including liver, lung and xenograft tumor. In addition,Ā in preclinical models STP707 had shown strong antitumor activity in various solid tumorĀ types. Using a mouse liver orthotopic tumor model, a combination regimen of STP707 withĀ an immune checkpoint antibody has demonstrated a potent antitumor activity.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company with product candidates inĀ preclinical and clinical stages that focuses on the discovery and development of innovativeĀ drugs for indications with medical needs and large market opportunities. Sirnaomics is theĀ first clinical-stage RNA therapeutics company to have a strong presence in both Asia andĀ the United States. Based on its proprietary delivery technologies: Polypeptide NanoparticleĀ Formulation and the 2nd generation of GalNAc conjugates, the Group has established anĀ enriched drug candidate pipeline. Sirnaomics is advancing RNAi therapeutics for oncologyĀ application with multiple successes of its clinical programs for STP705 and STP707.Ā STP122G represents the first drug candidate of GalAheadā¢ technology entering clinicalĀ development. With the establishment of the Group’s manufacturing facility, SirnaomicsĀ currently is undergoing a transition from a biotech company to a biopharma corporation.Ā Learn more at: www.sirnaomics.com.
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