Biosplice Begins Phase 2 Trial of Cirtuvivint for Advanced Soft-Tissue Sarcomas

Biosplice Therapeutics, a biotechnology company focused on developing small molecule inhibitors for specific kinases, has initiated a Phase 2 clinical trial to evaluate the effectiveness of cirtuvivint in patients with advanced soft-tissue sarcomas. This trial is sponsored by the Sarcoma European and Latin American Network (SELNET) and is being conducted across eight clinical sites in Spain. The study is led by Dr. Javier Martin Broto and follows extensive preclinical research that indicated significant activity of cirtuvivint in treating various soft-tissue sarcoma cell lines.

The trial will assess cirtuvivint as a monotherapy in approximately 30 patients whose disease has advanced despite receiving initial standard care. This open-label, multicenter trial is particularly focused on specific subtypes of sarcomas, aiming to determine the safety and efficacy of cirtuvivint in this challenging patient group. Dr. Yusuf Yazici, Chief Medical Officer of Biosplice, emphasized the importance of this study, highlighting the limited treatment options available for patients with advanced soft-tissue sarcomas after first-line therapy has failed. The trial represents a significant advancement for patients facing this condition.

Soft-tissue sarcomas are rare cancers that occur in connective tissues, and they present a significant treatment challenge when they become resistant to conventional therapies. Biosplice is exploring the potential of cirtuvivint across various tumor types. This exploration is based on the drug's unique action mechanism and the encouraging results from previous safety and pharmacokinetic studies. Cirtuvivint has demonstrated promising anti-tumor activity in preclinical models, offering hope for new therapeutic options for patients with high unmet medical needs.

Cirtuvivint functions by inhibiting CLK and DYRK kinases, which play crucial roles in the development and progression of cancers. By targeting these kinases, cirtuvivint affects the alternative splicing of pre-mRNA, leading to reduced expression of genes essential for tumor growth and survival. This approach has shown broad anti-tumor effects against various solid and liquid tumors in preclinical research.

The drug has been previously evaluated in two clinical trials for advanced solid tumors. The first, a dose-escalation study, aimed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced tumors. The second trial evaluated the efficacy of cirtuvivint in combination with standard treatments for advanced castration-resistant prostate cancer, non-small cell lung cancer, and colorectal cancer. Additionally, a study by the National Cancer Institute will investigate cirtuvivint's potential in treating Acute Myeloid Leukemia and Myelodysplastic Syndromes.

Biosplice Therapeutics is at the forefront of research into kinases, which are vital for cell cycle regulation, splicing, and neurodevelopment. The company focuses on developing highly selective kinase inhibitors for various diseases, including cancer, osteoarthritis, neurological disorders, and diabetes. Biosplice's pipeline includes drugs like lorecivivint for knee osteoarthritis and cirtuvivint for multiple cancers, supported by a robust preclinical platform targeting conditions such as Alzheimer's disease and diabetes.

SELNET, the sponsor of the trial, is a consortium dedicated to enhancing outcomes for sarcoma patients through collaborative research, education, and innovation across Europe and Latin America. Through their partnership with Biosplice, SELNET aims to explore new therapeutic avenues for treating sarcomas, offering hope for patients with these challenging conditions.