Partial response (PR) observed in third dose level of the Phase 1b dose escalation study of Nana-val in EBV+ recurrent/metastatic (R/M) nasopharyngeal carcinoma (NPC); enrollment into forth dose level is ongoing
Anticipates clinical program updates from pivotal NAVAL-1 study in EBV+ relapsed/refractory (R/R) lymphoma and Phase 1b/2 trial in EBV+ R/M NPC and other advanced EBV+ solid tumors over 2023
Cash, cash equivalents, and investments of over
“We begin 2023 with important new data from our advanced EBV-positive solid tumor trial. A partial response at this point in the dose escalation phase is highly encouraging, particularly given the safety data to-date and the lack of dose-limiting toxicities in the first three dose levels. We are now enrolling patients into the trial’s fourth dose level, with a further update expected after the completion of the dose escalation portion of the study,” said
New Phase 1b data on Nana-val in patients with EBV+ R/M NPC
- One PR and one disease progression were reported in evaluable patients in the third dose level
- Preliminary safety data from the first three dose levels was previously presented at the
European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) inDecember 2022 , showing Nana-val was well-tolerated with no dose limiting toxicities - Enrollment in the fourth dose level is ongoing
Key 2023 Clinical Objectives
Nana-val in patients with EBV+ R/R lymphoma
- Pivotal NAVAL-1 study open for enrollment at more than 60 sites globally; the study footprint is expected to expand further in 2023
- Anticipate providing an update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 in the first half of 2023
- Expect to provide additional updates from other lymphoma subtype(s) throughout 2023
Nana-val in patients with advanced EBV+ solid tumors
- Anticipate completion of the Phase 1b dose escalation portion of the trial and selection of the recommended Phase 2 dose (RP2D) in 2023
- Anticipate initiating the Phase 2 randomized expansion portion of the trial, designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with EBV+ R/M NPC, in the second half of 2023
- Anticipate initiating the exploratory Phase 1b cohort designed to evaluate Nana-val at the RP2D in other EBV+ solid tumors in the second half of 2023
Cash Position and Anticipated Runway
Viracta strengthened its balance sheet by exercising its option to draw the
About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (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.
About
Viracta is a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed/refractory Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 trial for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers.
For additional information please visit www.viracta.com.
Forward Looking Statements
This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated trials and updates regarding the same, including the Phase 1b/2 trial of Nana-val in EBV+ solid tumors. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.
These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the
The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.
Investor Relations Contact:
Head of Investor Relations & Corporate Communications
abarreto@viracta.com
SOURCE
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