Viracta Therapeutics (VIRX) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Strategic focus and clinical development

• Nana-val targets EBV-associated cancers, addressing a high unmet need with a novel, all-oral combination therapy.

• The mechanism of action enables application across multiple EBV-associated lymphoma subtypes and solid tumors, with initial focus on PTCL, DLBCL, and PTLD.

• Approximately 2% of global cancer cases are EBV-associated, representing over 300,000 patients annually.

• The lead program is a pivotal phase II basket trial in relapsed/refractory EBV-positive lymphomas, using a Simon two-stage design.

• The company is prioritizing lymphoma programs and pausing solid tumor development pending additional financing or partnership.

Clinical data and efficacy

• In PTCL, 70% of patients relapse after first-line therapy, with no standard of care for second-line EBV-associated cases.

• Nana-val demonstrated a 60–70% overall response rate (ORR) in second-line PTCL patients, with durable responses and manageable safety profile.

• Median duration of response has not yet been reached, with several patients ongoing at data cutoff.

• Prior studies in DLBCL showed a 67% ORR and 33% complete response rate, with some patients maintaining response for up to five years.

• Adverse events were mostly manageable, with only one grade five event among over 150 treated lymphoma patients.

Regulatory and operational milestones

• Recent FDA meeting clarified the need for compelling ORR and a randomized control study for accelerated approval.

• Interim analysis planned after enrolling 40 second-line PTCL patients; a 120-patient randomized control study will be initiated.

• NDA submission targeted for 2026, with additional PTCL and DLBCL data releases planned for Q4 2024 and H1 2025.

• Solid tumor program paused after phase 2 dose determination; company executed a 23% workforce reduction in August.

• The company aims to resume solid tumor development with new financing or partnerships.