Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage
precision oncology company focused on the treatment and prevention
of virus-associated cancers that impact patients worldwide, today
announced that additional data from the Phase 1b/2 clinical trial
of Nana-val (nanatinostat in combination with valganciclovir) in
patients with recurrent or metastatic (R/M) Epstein-Barr
virus-positive (EBV+) nasopharyngeal carcinoma (NPC) showed two
ongoing confirmed partial responses (PRs) at higher dose levels.
These data were featured in an oral presentation made by A.
Dimitrios Colevas, M.D., Professor of Medicine (Oncology) at the
Stanford Cancer Institute, during the European Society for Medical
Oncology (ESMO) Asia Congress being held in Singapore. Nana-val is
the company’s all-oral investigational therapy targeting
Epstein-Barr virus (EBV)-associated cancers.
“The initial efficacy, safety, and
pharmacokinetic data from the first five dose cohorts of the Phase
1b trial in patients with recurrent or metastatic EBV-positive NPC
are very encouraging,” said Darrel P. Cohen, M.D., Ph.D., Chief
Medical Officer of Viracta. “These results support the continued
advancement and dose escalation of the study, especially given the
two durable confirmed partial responses, the emerging dose-response
relationship, and the favorable safety and tolerability profile
observed to date.”
Dr. Cohen continued, “There is a high unmet
medical need to address the adverse survival outcomes seen in
patients with recurrent or metastatic EBV-positive NPC. Planning
for success, we incorporated FDA’s Project Optimus initiative into
the Phase 2 study design, which is intended to confirm the
recommended Phase 2 dose of Nana-val that maximizes efficacy as
well as safety and tolerability in patients with advanced
EBV-positive solid tumors. Study sites are now open and enrolling
the sixth dose cohort of the study, which is investigating the
novel split daily dosing regimen at higher dose levels of Nana-val,
and we are on track to expand into the Phase 2 portion of the study
in 2024.”
Key Data from the Oral ESMO Asia
Congress PresentationInterim data from the Phase 1b/2
study of Nana-val in patients with R/M EBV+ NPC revealed two
ongoing confirmed partial responses (PRs) at higher dose levels
plus new nonclinical data that support the evaluation of a novel
split daily dosing (SDD) regimen.
- Best antitumor responses to date
have included two PRs (both ongoing for >10 months and >four
months on study treatment) at the higher dose levels plus five
stable diseases out of 17 patients treated to date.
- Confirmed PR at the third dose
level demonstrated >50% reduction in tumor size through 50 weeks
and confirmed PR at the fifth dose level demonstrated ~30-40%
reduction in tumor size through 14 weeks.
- Increased antitumor activity
observed in a preclinical murine EBV+ gastric cancer xenograft
model supports investigation of Nana-val on an SDD schedule as a
next step.
- In comparison to once daily dosing,
split dosing four hours apart each day increased the expression of
EBV protein kinase, which translated into increased antitumor
activity.
- In comparison to intermittent (four
days on/three days off) dosing, daily (seven days/week) dosing
increased the exposure to Nana-val leading to a more sustained
antitumor effect.
A copy of the ESMO Asia Congress presentation
titled, “A Phase 1b/2 Study of Nanatinostat (Nstat) Plus
Valganciclovir (VGCV) in EBV+ Solid Tumors and with Pembrolizumab
(PEM) in Recurrent/Metastatic Nasopharyngeal Carcinoma (R/M NPC),”
will be accessible on the Events and Webcasts page in the Investors
section of Viracta’s website.
Investigative sites are now open for enrollment
into the sixth dose cohort of the Phase 1b dose escalation portion
of the study, which incorporates Nana-val’s novel SDD regimen. Once
the Phase 2 dose (RP2D) is determined, the company plans to
incorporate a dose-optimization cohort to confirm the RP2D based on
safety and efficacy by randomizing up to 40 patients with R/M EBV+
NPC to receive either the RP2D or a dose level below the RP2D.
About the Phase 1b/2 Study of Nana-val
in R/M EBV+ NPC and Other
EBV+ Solid TumorsThis
Phase 1b/2 trial (NCT05166577) is an open-label, multinational
clinical trial evaluating Nana-val alone and in combination with
pembrolizumab. The Phase 1b dose escalation part is designed to
evaluate safety and to select the recommended Phase 2 dose (RP2D)
of Nana-val in patients with recurrent or metastatic (R/M)
Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC).
Along with the U.S. Food and Drug Administration’s Project Optimus
initiative at the start of Phase 2, up to 40 patients with R/M EBV+
NPC will be randomized to receive either the RP2D or a dose level
below the RP2D in a dose-optimization cohort. Once the RP2D has
been confirmed, up to 60 patients with R/M EBV+ NPC will be
randomized to receive Nana-val at the RP2D with or without
pembrolizumab to further evaluate antitumor activity, safety and
tolerability, pharmacokinetics, and potential pharmacodynamic
biomarkers. Additionally, patients with other advanced EBV+ solid
tumors will be enrolled to receive Nana-val at the RP2D in a Phase
1b dose expansion cohort.
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 (R/R) EBV+ lymphoma (NAVAL-1) as well as
a multinational Phase 1b/2 clinical trial in patients with
recurrent or metastatic (R/M) EBV+ NPC and other EBV+ solid
tumors.
About EBV-Associated
CancersApproximately 90% of the world’s adult population
is infected with 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-positive (EBV+) lymphomas. EBV is estimated to be associated
with approximately 2% of the global cancer burden including
lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.
About Viracta Therapeutics,
Inc.Viracta is a clinical-stage 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 (R/R)
Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a
multinational, open-label Phase 1b/2 clinical trial for the
treatment of patients with recurrent or metastatic (R/M) EBV+
nasopharyngeal carcinoma (NPC) 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 clinical trials and updates regarding the same, the
Company’s expectations of the significance and implications of the
preliminary interim data from its clinical trials and preclinical
studies disclosed herein, the Company’s expectations related to the
FDA submission process and timelines and expectations regarding our
target patient populations. 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 and Viracta’s ability to manufacture
or supply nanatinostat, valganciclovir, and pembrolizumab for
clinical testing.
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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