Viracta Therapeutics’ Pivotal NAVAL-1 Trial Achieves Efficacy Threshold for Expansion in Relapsed or Refractory EBV-positive Peripheral T-Cell Lymphoma (R/R EBV+ PTCL)
28 Junio 2023 - 7:00AM
Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology
company focused on the treatment and prevention of virus-associated
cancers that impact patients worldwide, today announced that the
relapsed or refractory EBV+ peripheral T-cell lymphoma (R/R EBV+
PTCL) cohort of its pivotal NAVAL-1 clinical trial has met the
pre-specified efficacy threshold for expansion into Stage 2 of the
study. The efficacy threshold for expansion of NAVAL-1 cohorts from
Stage 1 to Stage 2 is based upon a pre-specified minimum number of
objective responses achieved within the first 10 patients enrolled.
“Initial data from the PTCL cohort in NAVAL-1
show a strong signal of efficacy that is in-line with our promising
Phase 1b/2 data and sufficient to advance to Stage 2. We now look
forward to completing enrollment in Stage 1 and are taking steps to
further accelerate enrollment through Stage 2,” said Mark Rothera,
President and Chief Executive Officer of Viracta. “Given the lack
of effective therapies available for patients with PTCL, today’s
announcement represents an important step towards addressing a
pressing unmet medical need. The advancement of the first cohort
into Stage 2 establishes PTCL as the leading indication for the
NAVAL-1 clinical trial and provides added momentum to our global
clinical program.”
NAVAL-1 enrollment continues worldwide with
updates on potential additional cohort advancements expected in the
second half of 2023.
About NAVAL-1NAVAL-1
(NCT05011058) is a global, multicenter trial of Nana-val in
relapsed or refractory (R/R) EBV+ lymphoma. The trial employs a
Simon two-stage design where, in Stage 1, participants are enrolled
into six indication cohorts based on EBV+ lymphoma subtype. If a
pre-specified activity threshold is reached within a lymphoma
subtype in Stage 1 (n=10), additional patients will be enrolled in
Stage 2 for a total of 21 patients. EBV lymphoma subtypes
demonstrating promising activity in Stage 2 may be further expanded
following discussion with regulators to potentially support
registration.
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 or 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 EBV-Associated
CancersApproximately 90% of the world’s adult population
is infected with Epstein-Barr virus (EBV). Infections are commonly
asymptomatic or associated with mononucleosis. Following infection,
the virus remains latent in a small subset of cells for the
duration of the patient’s life. Cells containing latent virus are
increasingly susceptible to malignant transformation. Patients who
are immunocompromised are at an increased risk of developing
EBV+ lymphomas. EBV is estimated to be associated with
approximately 2% of the global cancer burden including lymphoma,
nasopharyngeal carcinoma and gastric cancer.
About Viracta Therapeutics,
Inc.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 or 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
advanced 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 StatementsThis
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
progress and potential cohort advancements of NAVAL-1. 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 SEC from time to
time and available at www.sec.gov.
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:Ashleigh BarretoHead of Investor Relations &
Corporate CommunicationsViracta Therapeutics,
Inc.abarreto@viracta.com
SOURCE Viracta Therapeutics, Inc.
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