Sirnaomics has concluded the Phase I clinical trial of a small interfering RNA (siRNA) therapeutic candidate, STP707, to treat patients with pancreatic cancer.
STP707 comprises two siRNA oligonucleotides, acting on TGF-β1 and COX-2 mRNA, respectively, and are combined in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier.
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Carried out in 11 oncology clinics in the US, the basket, dose-escalation study included six groups of 50 individuals with different malignancies, 11 of whom had pancreatic cancer.
It was designed to assess the safety, tolerability, and anti-tumour activity of STP707, using intravenous infusion (IV) with six cohorts of increasing doses.
The trial data indicated a robust safety profile and stable disease activity following treatment with the siRNA candidate.
The preliminary results showed that the average number of treatment cycles completed was three (average of 12 doses).
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By GlobalDataAll 11 patients on STP707 therapy had an average of 92 days of stable disease, compared to 31 days for the 12mg group, 65 days for the 24mg group, and 112 days for the 48mg group, with one patient still on the medication after 281 days.
Except for one subject who experienced a Grade 2 infusion reaction, no treatment-related adverse events (TRAE) were identified among the 11 participants.
Non-treatment-related adverse effects associated with advanced metastatic illness included intestinal obstruction, gastrointestinal obstruction, abdominal distention, embolism, gastrointestinal haemorrhage, tumour pain, hypoxia, and dyspnoea.
Even at a dosage of 48mg, the maximum tolerable dose of STP707 was not met by all 50 late-stage cancer patients.
STP707 was found to be well tolerated in a highly pretreated cancer patient population.
The subset of pancreatic cancer patients demonstrated low toxicity and long stable disease at various dose levels and permits the further study of STP707 alone or in combination with immune checkpoint inhibitors.
Sirnaomics founder, chairman of the board, executive director, president and CEO Dr Patrick Lu said: “This is a very promising result for RNAi-based cancer therapeutics for the treatment of metastasized tumours.
“The strong safety profile, long-lasting stable disease efficacy and dose-dependent antitumour activity of this intravenously administered STP707 formulation, present a potential novel cancer therapeutic, either as a single drug or in combination with immune checkpoint inhibitor drugs.”
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