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 the publication of clinical data from an open-label,
multicenter, Phase 1b/2 study of Nana-val in 55 patients with R/R
EBV+ lymphoma in Blood Advances. Results showed complete responses
(CRs) achieved and ongoing durable responses observed out to
approximately 36 months across multiple EBV+ lymphoma subtypes,
including some of the most aggressive cancers: peripheral T-cell
lymphoma (PTCL), diffuse large B-cell lymphoma (DLBCL), and
post-transplant lymphoproliferative disease (PTLD). This paper
titled, “Targeted therapy with nanatinostat and valganciclovir in
recurrent Epstein-Barr virus-positive lymphoid malignancies: a
Phase 1b/2 study,” can be found here.
“Results from both retrospective and prospective
clinical studies link EBV-positivity to significantly inferior
survival in multiple lymphoma subtypes, highlighting the pressing
need for novel therapies for this underserved patient population,”
said 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, and corresponding author on the paper. “The
newly published Phase 1b/2 study data showcase the potential of
Viracta’s innovative ‘Kick and Kill’ approach to effectively
address this need, with results demonstrating Nana-val’s favorable
safety and tolerability profile and promising durable signal of
efficacy in heavily pre-treated patients. These data served as a
catalyst for the advancement of Nana-val into the confirmatory
NAVAL-1 trial, which has an elegant multi-stage design to
potentially support registration.”
Darrel P. Cohen, M.D., Ph.D., Viracta's newly
appointed Chief Medical Officer added, “Having these Phase 1b/2
clinical trial data peer-reviewed and published in such a
prestigious journal of the American Society of Hematology provides
important external validation for Nana-val’s therapeutic potential.
The substantial number, depth, and durability of Nana-val's
clinical responses with a favorable safety profile observed in this
heavily pre-treated EBV-positive lymphoma patient population are
impressive, several of which are still ongoing. This publication
further supports the recently announced expansion of the NAVAL-1
trial’s EBV-positive peripheral T-cell lymphoma cohort,
representing an exciting time for our clinical trial program, and
we look forward to providing more updates on its progress in the
future.”
Data published from the study showed that CRs
were achieved across multiple EBV+ lymphoma subtypes, with a
reported overall response rate (ORR)/CR rate of 40%/19% in 43
evaluable patients. In patients with EBV+ PTCL, which was recently
established as the leading indication in Viracta’s pivotal NAVAL-1
trial, ORR/CR rates of 67%/50% were reported (n=6 including both
EBV+ PTCL-not otherwise specified [PTCL-NOS] and angioimmunoblastic
T-cell lymphoma [AITL] patients). Of note, one of the CRs was
achieved in a patient whose disease never responded to second-line
histone deacetylase inhibitor (HDACi) treatment. In 6 patients with
EBV+ DLBCL, a rare aggressive and distinct B-cell lymphoma subtype
characterized by an adverse clinical outcome, ORR/CR rates of
67%/33% were reported. Of note, one of the CRs was achieved in a
patient whose disease never responded to first-line R-CHOP
chemotherapy.
The published paper includes an additional
10-month follow-up period, which demonstrated durable response
durations across multiple EBV+ lymphoma subtypes. As of the
expanded data cutoff date of September 1, 2022, multiple patients
remained in an ongoing durable response in excess of 30 months,
with two patients in an ongoing response of approximately 36
months. The median time to response was 1.8 months, and the median
duration of response was approximately 10 months in a heavily
pre-treated patient population. Overall, trial participants
received a median of two prior therapies before entering the trial,
with 75% (41/55) being refractory to their last therapy.
Data also showed that all-oral Nana-val was well
tolerated with reversible low-grade AEs. The most commonly observed
treatment-emergent AEs were reversible cytopenias, low-grade
creatinine elevations, and gastrointestinal symptoms. Initial data
from the Nana-val Phase 1b/2 clinical trial were previously
presented at the 2021 American Society of Hematology (ASH) Annual
Meeting.
About Nana-val (Nanatinostat and
Valganciclovir)Nanatinostat is an orally available HDACi
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 clinical 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 in combination with pembrolizumab in a multinational
Phase 1b/2 trial in patients with recurrent or metastatic EBV+
nasopharyngeal carcinoma 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+
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 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
Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a
multinational, open-label Phase 1b/2 trial for the treatment of
patients with recurrent or metastatic EBV+ 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 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 clinical 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; 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
Media Contact:Kathy Vincent Greig
Communicationskathy@greigcommunications.com
SOURCE Viracta Therapeutics, Inc.
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