Therapeutics Company Reports Positive Phase 2 Trial Data For Virus Treatment
Therapeutics Company Reports Positive Phase 2 Trial Data For Virus Treatment
Viracta Therapeutics: Positive Phase 2 NAVAL-1 Trial Data, Regulatory Progress, and Future Clinical Plans.
Disclaimer: This article provides an in-depth overview of recent developments in clinical trials and should not be construed as medical advice. Any medical decisions should be made in consultation with qualified healthcare professionals.
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Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company, recently shared positive data from the Phase 2 NAVAL-1 trial, which focuses on relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL).
Viracta Therapeutics and Nana-val
Viracta Therapeutics specializes in the development of therapies for virus-associated cancers. Their lead product candidate, Nana-val, is an oral combination therapy consisting of nanatinostat—a histone deacetylase (HDAC) inhibitor—and valganciclovir, an antiviral agent. Nana-val is being evaluated in various clinical trials, including the NAVAL-1 trial, which targets multiple subtypes of relapsed or refractory EBV+ lymphoma. The NAVAL-1 trial employs a Simon two-stage design to evaluate Nana-val in patients with R/R EBV+ lymphoma. In the first two stages of the relapsed or refractory EBV+ PTCL cohort, 21 patients with predominantly Stage III-IV disease received nanatinostat (20 mg orally once daily, 4 days/week) and valganciclovir (900 mg orally once daily, 7 days/week). The results, as of June 28, 2024, are as follows:
Overall Response Rate (ORR): 33% in the intent-to-treat (ITT) population and 41% in the efficacy-evaluable (EE) population.
Complete Response Rate (CRR): 19% in the ITT population and 24% in the EE population.
Second-line EBV+ PTCL Subpopulation: ORR of 60% and CRR of 30% in the ITT population; ORR of 67% and CRR of 33% in the EE population.
Median Duration of Response (DOR): Not yet reached.
Two patients who responded to the treatment proceeded to hematopoietic stem-cell transplant without relapse, with one remaining in response for over 16 months. Nana-val demonstrated a generally well-tolerated safety profile. The most common treatment-related adverse events included fatigue, nausea, decreased appetite, diarrhea, decreased platelet count, and anemia. These adverse events were primarily mild to moderate in severity and were generally manageable or reversible. Viracta recently received valuable feedback from a meeting with the U.S. Food and Drug Administration (FDA). This meeting provided the company with clarity on the potential regulatory pathway to initial registration of Nana-val for patients with R/R EBV+ PTCL. According to the feedback, Viracta plans to initiate a randomized controlled trial (RCT) of Nana-val in the second half of 2025.
Mark Rothera, President and CEO of Viracta, emphasized the importance of this regulatory alignment: "Aligning with the FDA on the potential path forward in relapsed or refractory EBV-positive PTCL marks a critical step towards bringing Nana-val to patients. The updated clinical development plan addresses the urgent need for targeted EBV therapy to improve patient outcomes."
Updated Nana-val Clinical Development Plan
Given the robust response rates observed, particularly in the second-line treatment setting, Viracta plans to focus Nana-val's clinical development on patients with R/R EBV+ PTCL. The key steps in this updated plan include:
Primary Analysis on Second-line EBV+ PTCL Subpopulation: This will be the focus in the ongoing NAVAL-1 trial's expansion phase.
Initiation of Randomized Controlled Trial (RCT): Planned for the second half of 2025, targeting second-line EBV+ PTCL patients.
Potential NDA Filing: Viracta aims for a New Drug Application (NDA) filing in 2026, seeking accelerated approval based on interim analysis of second-line EBV+ PTCL patient data from the NAVAL-1 trial.
This strategy aims to expedite the regulatory process and create opportunities for accelerated or full approval based on trial outcomes. Viracta has made strategic decisions to align resources with their EBV+ lymphoma program. These include:
Pause EBV+ Solid Tumor Program: Resources will be reallocated to the more advanced EBV+ lymphoma program.
Resource Optimization: A reduction in force impacting approximately 23% of the company's employees has been implemented.
Key Milestones
Viracta plans to achieve key milestones in the Nana-val development timeline:
Second Half of 2024: Determination of the recommended Phase 2 dose in patients with advanced EBV+ solid tumors.
Fourth Quarter of 2024: Additional data from the NAVAL-1 trial's expansion phase in second-line EBV+ PTCL patients.
First Half of 2025: Stage 1 data from R/R EBV+ diffuse large B-cell lymphoma (DLBCL) patients and a meeting with the FDA to finalize the RCT design.
Second Half of 2025: Initiation of the RCT.
2026: Presentation of interim analysis outcomes from the NAVAL-1 trial and potential NDA filing for accelerated approval.
Nana-val combines nanatinostat, a selective Class I HDAC inhibitor, with valganciclovir, an antiviral agent. This combination aims to target viral genes epigenetically silenced in EBV-associated malignancies. Nana-val is currently being evaluated in various clinical trials, including the NAVAL-1 trial and a multinational Phase 1b/2 clinical trial for recurrent or metastatic EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors.
Peripheral T-cell lymphoma (PTCL) comprises a diverse group of rare and aggressive malignancies. Approximately 70% of patients are either refractory to first-line therapy or relapse. PTCL subtypes, including PTCL not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL), have poor outcomes, with median progression-free survival of 3.7 months and median overall survival of 6.5 months. EBV+ PTCL is associated with inferior outcomes compared to EBV-negative PTCL, representing a high unmet medical need. The Epstein-Barr virus (EBV) infects approximately 90% of the world's adult population. While infections are often asymptomatic, the virus remains latent in a small subset of cells, increasing the risk of malignant transformation. EBV is linked to around 2% of global cancer cases, including lymphomas, nasopharyngeal carcinoma (NPC), and gastric cancer.
Viracta Therapeutics' recent announcements highlight progress in their efforts to address the unmet needs of patients with virus-associated cancers. The positive data from the Phase 2 NAVAL-1 trial, coupled with regulatory advancements and a refined clinical development plan, positions Nana-val as a promising therapy for R/R EBV+ PTCL. As Viracta continues to focus its resources and efforts on this critical area, the oncology community eagerly anticipates further developments and potential breakthroughs in the treatment of EBV-associated malignancies.
Disclaimer: This article provides an in-depth overview of recent developments in clinical trials and should not be construed as medical advice. Any medical decisions should be made in consultation with qualified healthcare professionals.
We are working endlessly to provide free insights on the stock market every day, and greatly appreciate those who are paid members supporting the development of the Stock Region mobile application. Stock Region offers daily stock and option signals, watchlists, earnings reports, technical and fundamental analysis reports, virtual meetings, learning opportunities, analyst upgrades and downgrades, catalyst reports, in-person events, and access to our private network of investors for paid members as an addition to being an early investor in Stock Region. We recommend all readers to urgently activate their membership before reaching full member capacity (500) to be eligible for the upcoming revenue distribution program. Memberships now available at https://stockregion.net