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Viracta Therapeutics
Viracta Therapeutics (VIRX) investor relations material
Viracta Therapeutics has been delisted
Viracta Therapeutics H.C. Wainwright 26th Annual Global Investment Conference 2024 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 26th Annual Global Investment Conference 2024 summary11 Sep, 2024
Company mission and lead asset
Focused on treating and preventing virus-associated cancers, especially EBV-associated cancers, with a lead late-stage asset, Nana-val.
Nana-val is an all-oral combination therapy targeting EBV cancer cells with a novel mechanism of action applicable to multiple cancer types.
EBV-associated cancers represent a high unmet medical need, with worse outcomes than EBV-negative cancers.
Approximately 2% of cancers worldwide are EBV-associated, affecting over 300,000 patients annually.
Clinical trial design and results
Ongoing pivotal phase II basket trial in relapsed/refractory EBV-positive lymphomas, focusing on PTCL, DLBCL, and PTLD.
PTCL cohort has passed both stage one and two, now enrolling in post stage two expansion.
In 21 PTCL patients, observed 33% ORR (intent-to-treat), 41% ORR (efficacy-evaluable), and higher response rates in second-line patients (up to 67% ORR).
Responses were prompt and durable, with median duration not yet reached and several patients ongoing at data cutoff.
Nana-val was generally well-tolerated, with manageable adverse events; only one grade five event among over 150 treated.
Regulatory and development strategy
Recent FDA meeting clarified requirements for accelerated approval: compelling ORR and a randomized control study.
Interim analysis planned at 40 second-line patients; randomized control study of 120 patients to be initiated.
NDA submission targeted for 2026, with additional data presentations planned for Q4 2024 and H1 2025.
Solid tumor program paused after phase 2 dose determination, pending additional financing or partnership.
Workforce reduced by 23% in August to focus resources on lymphoma program.
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Frequently asked questions
Viracta Therapeutics Inc. is a precision oncology company focused on developing treatments for virus-associated cancers. The company's leading product candidate, Nana-val, is an all-oral combination therapy comprising its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir. Beyond Nana-val, Viracta is exploring the "Kick and Kill" approach for other virus-related cancers, aiming to leverage its expertise in oncology to address the needs of patients with virus-associated malignancies globally. Headquartered in Cardiff-by-the-Sea, California, Viracta Therapeutics Inc.'s shares are listed on the Nasdaq.
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