Answer: DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma (“NHL”). On March 2, 2022, the clinical trial sponsor publicly updated to May 2022 the possible start date for enrollment. The design of the existing investigator-sponsored clinical protocol for DUET-01, including the number of study visits, together with constraints on mobility and travel due to the COVID-19 pandemic, has caused delays in enrollment. The company has been engaged in ongoing discussions with the sponsor, who has been evaluating the applicable protocol with a view to reducing and/or more closely concentrating subject visits. As a small interfering RNA (“siRNA”)-based technology, DUET-01 is delivered intratumorally. Pursuant to a sponsored research agreement, research is being initiated to evaluate increasing the stability of novel siRNA-based molecules to enable systemic delivery. DUET-02 is being developed for systemic delivery. We are, through Duet, developing DUET-02, which has a similar mechanism of action to DUET-01, except the STAT3 inhibitor is an antisense (“ASO”) RNA molecule rather than a small interfering RNA (“siRNA”). The STAT3ASO molecule binds directly to the STAT3 mRNA, recruiting ribonuclease H1 (“RNase H1”) to degrade the STAT3 mRNA. The use of ASO permits other chemical modifications resulting in greater stability in human blood. This allows for systemic treatment of harder-to-reach solid tumors such as prostate or kidney cancers. Dose-range finding studies, good laboratory practice (“GLP”) toxicology studies, and good manufacturing process (“GMP”) manufacturing of the drug substance and product are all currently in process. Duet expects to file an investigational new drug application (“IND”) for DUET-02 in Q4 2022 in advanced solid malignancies, with Phase 1 clinical trials anticipated to begin in Q1 2023 in the United States. DUET-03 uses an alternative to the destruction of mRNA to silence STAT3 activity, such as with DUET-01 and DUET-02, instead targeting the actual STAT3 transcription factor protein. Duet is also evaluating combination therapies with checkpoint inhibitors. On an ongoing basis, the company continues to refine, update and enhance its immuno-oncology pipeline and target indications, including prioritizing solid tumor indications. The company also continually evaluates the possibilities of additional studies with a view to enhancing, among other things, the effectiveness and method of delivery of our drug candidates and identifying additional protections for our intellectual property.
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