• 02 Feb 2022
• Admin
• News Article

Viracta Therapeutics Begins Patient Dosing In Phase 1B/2 Trial Of Nana-Val In Patients With Advanced Epstein-Barr Virus-Positive Solid Tumours

Viracta Therapeutics, Inc., A Precision Oncology Company Targeting Virus-Associated Malignancies, Announced That The First Patient Has Been Dosed In The Multinational Phase 1B/2 Trial Of Its All-Oral Combination Product, Nana-Val (Nanatinostat And Valganciclovir), In Patients With Epstein-Barr Virus-Positive (Ebv+) Recurrent Or Metastatic Nasopharyngeal Carcinoma (R/M Npc) And Other Advanced Ebv+ Solid Tumors. The Trial Is Designed To Evaluate The Safety And Preliminary Efficacy Of Nana-Val Alone And In Combination With The Pd-1 Inhibitor Pembrolizumab."The Initiation Of Dosing In This Clinical Trial Represents An Important Milestone For Viracta And Is A Critical Step In Potentially Expanding The Clinical Applicability Of The Targeted All-Oral Nana-Val Combination Beyond Lymphoma," Said Lisa Rojkjaer, M.D., Chief Medical Officer Of Viracta. "Advanced Npc Patients Have Poor Outcomes And Are In Urgent Need Of Effective Treatment Options. We Are Looking Forward To Evaluating The Clinical Profile Of This Novel Combination Therapy And Exploring Potential Synergies With A Pd-1 Inhibitor."The Phase 1B/2 Trial (Nct05166577) Is An Open-Label, Multinational Trial Evaluating Nana-Val Alone And In Combination With Pembrolizumab. The Phase 1B Dose Escalation Portion Is Designed To Evaluate Safety And To Determine The Recommended Phase 2 Dose (Rp2D) Of Nana-Val In Patients With Ebv+ R/M Npc. In Phase 2, Up To Sixty Patients With Ebv+ R/M Npc Will Be Randomized To Receive Nana-Val At The Rp2D With Or Without Pembrolizumab, To Evaluate Safety, Overall Response Rate, And Potential Pharmacodynamic Markers. Additionally, Patients With Other Advanced Ebv+ Solid Tumors Will Be Enrolled To Receive Nana-Val At The Rp2D In A Phase 1B Dose Expansion Cohort.Nanatinostat (Vrx-3996) Is An Orally Available Histone Deacetylase (Hdac) Inhibitor Being Developed By Viracta. Nanatinostat Selectively Inhibits Specific Isoforms Of Class I Hdacs, An Activity That Is Key To Inducing Viral Genes Epigenetically Silenced In Ebv-Associated Malignancies. Nanatinostat Is Currently Being Investigated In Combination With The Antiviral Agent Valganciclovir As An All-Oral Combination Therapy, Nana-Val, In Various Subtypes Of Ebv-Associated Malignancies. Ongoing Trials Include A Pivotal Global, Multicenter, Open-Label Phase 2 Basket Trial In Multiple Subtypes Of Relapsed/Refractory Ebv+ Lymphoma (Naval-1) As Well As A Multinational Phase 1B/2 Trial In Patients With Ebv+ Recurrent Or Metastatic Nasopharyngeal Carcinoma And Other Ebv+ Solid Tumors.Approximately 90% Of The World'S Adult Population Is Infected With Epstein-Barr Virus (Ebv), Which Persists As A Life-Long Latent Infection And Remains Dormant In Cell Nuclei. Cells Containing Latent Ebv Are Increasingly Susceptible To Malignant Transformation. Ebv Infection Is Directly Linked To The Development Of Multiple Forms Of Human Lymphoid And Epithelial Cancers Contributing To Approximately 2% Of All New Cancer Cases Globally. The Lack Of Approved Therapies For Ebv+ Cancers Creates A Pressing Unmet Medical Need As These Malignancies Have Poor Prognoses And Are Responsible For Approximately 180,000 Annual Deaths.Viracta Is A Precision Oncology Company Targeting Virus-Associated Malignancies. Viracta'S Proprietary Investigational Drug, Nanatinostat, Is Currently Being Evaluated In Combination With The Antiviral Agent Valganciclovir As An Oral Combination Therapy, Nana-Val, In A Pivotal Phase 2 Clinical Trial For Epstein-Barr Virus-Positive (Ebv+) Lymphoma And A Phase 1B/2 Trial In Patients With Ebv+ Nasopharyngeal Carcinoma And Other Ebv+ Solid Tumours