Biosplice Therapeutics has announced that the first patient has been dosed in a Phase 1 clinical trial of its candidate cirtuvivint in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), according to the company.
The study is being conducted under an agreement with the National Cancer Institute (NCI), via the Experimental Therapeutics Clinical Trials Network, and overseen by the NCI’s Cancer Therapy Evaluation Program. The trial (NCT06484062) is evaluating safety, pharmacokinetics, pharmacodynamics and early signs of efficacy of cirtuvivint as a monotherapy and in combination with ASTX727 (INQOVI), an FDA-approved hypomethylating agent for MDS.
Enrollment is focused on patients with relapsed or refractory AML or MDS, and the trial is led by Dr. Evan Chen at Dana-Farber Cancer Institute.
Cirtuvivint is a selective pan-CLK and pan-DYRK inhibitor that modulates RNA splicing, targeting oncogenic pathways. The company said that preliminary research supports the rationale for combining its splicing-modulating mechanism with the hypomethylating action of ASTX727.
According to the company, the trial underscores the ongoing collaboration between Biosplice and the NCI, aiming to address significant unmet needs in AML and MDS by exploring complementary treatment mechanisms.
