SAN DIEGO, Nov. 29, 2021 /PRNewswire/ -- Viracta
Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company
targeting virus-associated malignancies, today announced that the
U.S. Food and Drug Administration (FDA) has granted its all-oral
combination product candidate, nanatinostat and valganciclovir
(Nana-val), orphan drug designation (ODD) for the treatment of
Epstein Barr virus-positive diffuse large B-cell lymphoma, not
otherwise specified (EBV+ DLBCL, NOS). DLBCL is the most
common subtype of non-Hodgkin lymphoma (NHL) in the U.S. and
worldwide, accounting for approximately 25% of newly diagnosed
cases of NHL in the U.S, of which a subset are EBV+.
Viracta has previously received ODD from the FDA for the treatment
of T-cell lymphoma, post-transplant lymphoproliferative disorder
(PTLD) and plasmablastic lymphoma.
"This latest orphan drug designation underscores the potential
benefits of our all-oral kick and kill approach to targeting
EBV-positive cancers," said Ivor
Royston, M.D., President and Chief Executive Officer of
Viracta. "Nana-val has shown promising preliminary efficacy across
multiple subtypes of relapsed/refractory EBV-positive lymphoma,
including DLBCL. We are dosing patients in the pivotal NAVAL-1
trial, which includes patients with EBV-positive DLBCL, and look
forward to its continued momentum with sites now open for
enrollment in the U.S., Europe,
and Asia. Through NAVAL-1's
progress, we aim to further develop Nana-val as a new and
actionable therapy in indications where many patients recur from
the standard of care and have particularly poor prognoses."
The FDA grants orphan drug designations to investigational drugs
and biologics that are intended for the treatment of rare diseases
that affect fewer than 200,000 people in the U.S. Orphan drug
status is intended to facilitate drug development for rare diseases
and may provide several benefits to drug developers, including tax
credits toward qualified clinical trial costs, assistance with
clinical study design and drug development, exemptions from certain
FDA application fees, and seven years of market exclusivity
upon regulatory approval for the disease or condition for which the
drug has the orphan drug designation. In 2020, 31 of the 53 novel
drug approvals, or 58%, in the FDA's Center for Drug Evaluation and
Research, were orphan designated products.
About NAVAL-1
NAVAL-1 (Nanatinostat in Combination with
Valganciclovir) is a global, multicenter, open-label Phase 2
basket trial. The trial, which will include patients with multiple
subtypes of relapsed/refractory EBV-positive (EBV+)
lymphoma, is designed to evaluate the anti-tumor activity of
Nana-val and enroll approximately 140 patients. The primary
endpoint of the trial is objective tumor response rate as assessed
by an independent review committee. If successful, Viracta believes
this trial could potentially support multiple new drug application
filings across various EBV+ lymphoma subtypes. The
study employs a Simon two-stage design where a limited number of
patients are enrolled into each cohort in Stage 1 and, if a
pre-specified activity threshold is reached, additional patients
will be enrolled in Stage 2. During Stage 2, Viracta anticipates
discussing the preliminary results with the FDA and may amend the
protocol to include additional patients as necessary to enable
registration.
About Nanatinostat
Nanatinostat (VRx-3996) is an orally available histone
deacetylase (HDAC) inhibitor being developed by Viracta.
Nanatinostat is selective for specific isoforms of Class I HDACs,
which is key to inducing viral genes that are epigenetically
silenced in EBV-associated malignancies. Nana-val (nanatinostat and
valganciclovir) is being investigated in multiple subtypes of
relapsed/refractory EBV+ lymphoma and in advanced
EBV+ solid tumors in three ongoing trials, one of which
is a registration-enabling global, multicenter, open-label Phase 2
basket trial in relapsed/refractory EBV+ lymphoma
(NAVAL-1).
About EBV-Associated Cancers
Approximately 95% 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 lymphatic cells for the
duration of the patients' life. Cells containing latent virus are
increasingly susceptible to malignant transformation. Patients who
are immunocompromised are at an increased risk of developing
EBV+ lymphomas. In addition, EBV is also associated
with a variety of solid tumors, including nasopharyngeal carcinoma
and gastric cancer.
About Viracta Therapeutics, Inc.
Viracta is a precision oncology company targeting
virus-associated malignancies. Viracta's proprietary
investigational drug, nanatinostat, is currently being evaluated in
combination with the antiviral agent valganciclovir as an oral
combination therapy in two Phase 2 clinical trials for EBV-positive
(EBV+) lymphoma and one Phase 1b/2 trial in
patients with EBV+ nasopharyngeal carcinoma and other
EBV+ solid tumors. Viracta is also pursuing the
application of its inducible synthetic lethality 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
importance of the orphan drug designation in EBV+ DLBCL,
NOS; the details, timeline and expected progress for Viracta's
ongoing trials, including plans to discuss preliminary results with
the FDA in the future; and other statements that are not historical
facts. 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 Barreto
Head of Investor Relations & Corporate Communication
Viracta Therapeutics, Inc.
abarreto@viracta.com
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