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 it plans to highlight new preliminary clinical and
preclinical data from studies of nanatinostat and valganciclovir
(Nana-val), its all-oral investigational therapy targeting
Epstein-Barr virus (EBV)-associated cancers, during an R&D Day
today, Wednesday, October 4, 2023, at 8:00 a.m. EDT.
“We are pleased by the growing clinical data
that we believe underscores the therapeutic potential of Nana-val’s
innovative ‘Kick and Kill’ approach to target EBV-positive cancer
cells and address the adverse survival outcomes seen with most
EBV-associated cancers,” said Mark Rothera, President and Chief
Executive Officer of Viracta. “The clinical responses and favorable
safety profile observed in multiple relapsed or refractory
EBV-positive lymphoma patient populations continue to be
encouraging. New Stage 1 clinical data from patients in the PTCL
cohort of the NAVAL-1 trial demonstrated preliminary overall and
complete response rates of 40%, which are consistent with our
previous Phase 1b/2 study data. Importantly, the combination of
response rates and duration of response observed to date in these
studies exceeds the current standard of care in this
relapsed/refractory patient population. We are on track to complete
Stage 2 of the PTCL cohort, targeting to engage with FDA in 2024 on
additional requirements for a potential accelerated approval. In
addition, we are excited about the emerging signal of dose response
in patients with recurrent or metastatic EBV-positive
nasopharyngeal carcinoma, now with responses observed at the higher
dose levels without dose-limiting toxicities. We look forward to
the evaluation of our novel split daily dosing regimen in patients
with advanced EBV-positive solid tumors based on compelling
preclinical data.”
The R&D Day will feature presentations by
members of Viracta’s senior management team focusing on its highest
priority EBV+ lymphoma indications in the pivotal NAVAL-1 trial,
namely, peripheral T-cell lymphoma (PTCL) and diffuse large B-cell
lymphoma (DLBCL), as well as its advanced EBV+ solid tumor program
in patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal
carcinoma (NPC). In addition, the R&D Day will feature
presentations by expert key opinion leaders who will discuss the
high unmet medical needs of EBV-associated lymphomas.
External speakers will include:
- Pierluigi Porcu, M.D., Professor of
Medical Oncology, Director of the Division of Hematologic
Malignancies and Hematopoietic Stem Cell Transplantation,
Department of Medical Oncology at Thomas Jefferson University
- Robert A. Baiocchi, M.D., Ph.D.,
Professor of Internal Medicine, Associate Director for
Translational and Clinical Science in the Division of Hematology at
The Ohio State University
Key R&D Day Topics and
Highlights
Initial preliminary data from the pivotal
NAVAL-1 clinical trial of Nana-val in patients with relapsed or
refractory (R/R) EBV+ lymphoma
- As of the data cutoff date of June
30, 2023, initial results from the first five patients with R/R
EBV+ PTCL treated with Nana-val showed an overall response rate
(ORR) and complete response rate (CRR) of 40%.
- The EBV+ PTCL cohort met the
efficacy threshold for expansion into Stage 2 of the study, which
was based upon having achieved two objective responses within the
first five of 10 patients to be enrolled in Stage 1 of the
study.
- Median duration of response (DoR)
has not yet been reached.
- Anticipated 2024 milestones:
- Completion of enrollment into Stage
2 of the R/R EBV+ PTCL cohort,
- Engagement with FDA on additional
requirements for accelerated approval,
- Presentation of Stage 2 data.
Additional response and durability assessments
from the Phase 1b/2 trial (Study 201) of Nana-val in patients with
R/R EBV+ lymphoma as of the May 4, 2023 data cutoff date
- Median DoR for patients with R/R
EBV+ PTCL was 17.3 months with an ORR/CRR of 50%/38% (n=8).
- In patients with R/R EBV+ DLBCL,
additional response assessments from a formulation pharmacokinetics
bridging substudy included two additional responders, one complete
response (CR) and one partial response (PR), resulting in an
ORR/CRR of 67%/33% (n=9).
- Median DoR in the R/R EBV+ DLBCL
cohort has not yet been reached, with three patients remaining in
response and on continued study treatment with DoRs of 11.1 months
(CR), 36.8 months (PR), and 41.9 months (CR).
- Additional follow-up further
demonstrated that Nana-val was generally well tolerated with
manageable, if not reversible, low-grade toxicities; the most
commonly observed treatment-emergent adverse events were
hematologic or gastrointestinal in nature as well as low-grade
creatinine elevations.
New interim clinical data in Phase 1b/2 study of
Nana-val in advanced EBV+ solid tumors (Study 301) highlight the
opportunity to dose escalate further with an innovative dosing
regimen supported by new preclinical data to potentially drive
additional responses in this patient population
- Enrollment completed through the
fifth dose level of the Phase 1b dose escalation portion of the
trial without any dose-limiting toxicities reported.
- Best responses to date included two
PRs (one ongoing for more than seven months) at the higher dose
levels plus five stable diseases in 17 patients with R/M EBV+
NPC.
- In a preclinical murine EBV+
gastric cancer xenograft model, split daily Nana-val dosing had
superior anti-tumor activity than intermittent (four days on/three
days off) once-daily dosing, which supports the evaluation of this
split daily dosing (SDD) regimen in patients with advanced EBV+
solid tumors.
- Anticipated 2024 milestones:
- Up to three additional dose levels
are planned with Nana-val on an SDD schedule to select a
recommended Phase 2 dose,
- Initiation of the clinical trial’s
randomized Phase 2 expansion cohort designed to evaluate Nana-val
at the recommended Phase 2 Dose (RP2D) with or without
pembrolizumab in patients with R/M EBV+ NPC,
- Initiation of the clinical trial’s
exploratory Phase 1b expansion cohort designed to evaluate Nana-val
at the RP2D in patients with other advanced EBV+ solid tumors,
including gastric carcinoma, leiomyosarcoma, and
lymphoepithelioma.
R&D Day Webcast
InformationA live video webcast of the presentation will
be available here and on the Investors section of the Viracta
website under "Events and Webcasts". A replay of the presentation
will be available approximately one hour after the presentation and
will be archived and available for at least 30 days following the
event at the same location.
About NAVAL-1NAVAL-1
(NCT05011058) is a global, multicenter, clinical trial of Nana-val
in patients with relapsed or refractory (R/R) Epstein-Barr
virus-positive (EBV+) lymphoma. This trial employs a Simon
two-stage design where, in Stage 1, participants are enrolled into
one of three prioritized indication cohorts based on EBV+ lymphoma
subtype. If a pre-specified antitumor activity threshold is reached
within a lymphoma subtype in Stage 1 (n=10), then additional
patients will be enrolled in Stage 2 for a total of 21 patients.
EBV+ lymphoma subtypes demonstrating promising antitumor activity
in Stage 2 may be further expanded following discussion with
regulators to potentially support registration.
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 determine 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).
In Phase 2, 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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