Biosplice Announces First Patient Dosed in Phase 2 Trial of Cirtuvivint for Advanced Soft-Tissue Sarcomas

Multicenter study sponsored by SELNET to evaluate cirtuvivint as a second-line monotherapy in selected sarcoma subtypes

/EIN News/ -- SAN DIEGO, May 01, 2025 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering advancements in small molecule inhibition of CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating cirtuvivint in patients with advanced soft-tissue sarcomas. The multicenter, open-label trial, led by Principal Investigator Dr. Javier Martin Broto, is sponsored by SELNET (Sarcoma European and Latin American Network) and is being conducted at eight clinical sites across Spain.

This Investigator Initiated Trial follows a preclinical collaboration and focuses on specific sarcoma subtypes, aiming to assess the safety and efficacy of cirtuvivint as a monotherapy. SELNET elected to sponsor the trial following a comprehensive review of preclinical data, which demonstrated compelling activity of cirtuvivint across multiple soft-tissue sarcoma cell lines and xenograft models that were refractory to other treatments.

The “Multicenter, Open-Label Phase 2 Trial of Cirtuvivint as a Second-Line Therapy in Selected Advanced Soft-Tissue Sarcomas" will evaluate cirtuvivint monotherapy in approximately 30 patients whose disease has progressed following initial standard of care. The trial focuses on specific sarcoma subtypes and aims to assess the safety and efficacy of cirtuvivint in this difficult-to-treat patient population.

“This trial represents a critical step forward for patients with advanced soft-tissue sarcomas, who currently face limited therapeutic options after first-line treatment,” said Dr. Yusuf Yazici, Chief Medical Officer of Biosplice. “We are grateful to SELNET and the participating investigators for their partnership in evaluating cirtuvivint in this patient population. Cirtuvivint has shown compelling activity in preclinical sarcoma models, and this study is a key milestone in our efforts to bring new therapeutic options to patients with high unmet need.”

Soft-tissue sarcomas (STS) are a heterogeneous group of rare cancers originating in connective tissues, and treatment-resistant forms of the disease remain a significant challenge. Biosplice is exploring cirtuvivint’s utility across multiple tumor types based on its unique mechanism of action and encouraging safety and pharmacokinetic profile observed in earlier studies.

Additional information about the study can be found on euclinicaltrials.eu, EUCT 2024-511987-10-00.

About Biosplice:
Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for knee osteoarthritis (completed Phase 3) and cirtuvivint for numerous cancers, with a broad preclinical pipeline that encompasses Alzheimer’s disease, diabetes and other degenerative conditions.

About Cirtuvivint:
Cirtuvivint is a small molecule inhibitor of CLK and DYRK kinases, which are increasingly recognized as key drivers of various cancers. By targeting these kinases, cirtuvivint modulates alternative pre-mRNA splicing, which reduces the expression of genes vital for tumor growth, survival, and drug resistance. The compound has shown broad anti-tumor activity across a range of solid and liquid tumors in extensive preclinical studies.

Cirtuvivint has also been investigated for the treatment of advanced solid tumors in two clinical trials. The first, SM08502-ONC-01 (NCT03355066), was a first-in-human dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The second, SM08502-ONC-03 (NCT05084859), was a Phase 1b trial assessing the efficacy of cirtuvivint in combination with standard treatments for patients with advanced castration-resistant prostate cancer, advanced non-small cell lung cancer, and advanced colorectal cancer. A study sponsored by the National Cancer Institute will explore cirtuvivint in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).

About SELNET:

The Sarcoma European and Latin American Network (SELNET) is a transnational consortium committed to improving outcomes for patients with sarcomas through collaboration in clinical research, education, and access to innovation across Europe and Latin America.

Learn more at https://www.biosplice.com

Corporate Contact:

Erich Horsley

erich.horsley@biosplice.com