Company to present pooled data from the pivotal
Phase 2 TRUST-I and TRUST-II studies at the European Society of
Medical Oncology (ESMO) Congress 2024, which will support Nuvation
Bio’s New Drug Application (NDA) in the United States
Company to present data from the global,
pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung
Cancer (WCLC)
Taletrectinib granted Orphan Drug Designation
by the U.S. Food and Drug Administration (FDA) for the treatment of
ROS1-positive non-small cell lung cancer (NSCLC) and other NSCLC
indications
Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global
biopharmaceutical company tackling some of the greatest unmet needs
in oncology, today announced multiple updates for its taletrectinib
program. Data from the global, pivotal Phase 2 TRUST-II study has
been accepted for an oral presentation at WCLC 2024 taking place
September 7-10 in San Diego, California. Pooled data from both
pivotal Phase 2 studies, TRUST-I and TRUST-II, has been accepted
for a poster presentation at ESMO 2024 taking place September
13-17, in Barcelona, Spain. The pooled data presented at ESMO will
support the Company’s NDA in the United States. Additionally, the
U.S. FDA has granted Orphan Drug Designation to taletrectinib for
the treatment of multiple NSCLC indications, including
ROS1-positive NSCLC.
“We are excited to share these program updates as we continue
toward our goal of bringing taletrectinib to patients with
ROS1-positive NSCLC. We look forward to sharing the latest TRUST-II
data at WCLC 2024 and pooled TRUST-I and TRUST-II data at ESMO
2024. The pooled data to be presented at ESMO will support our NDA
in the U.S. and, we believe, position us to commercialize
taletrectinib in 2025,” said David Hung, M.D., Founder, President,
and Chief Executive Officer of Nuvation Bio. “Further, we are
pleased with the FDA’s recent determination that taletrectinib
qualifies for Orphan Drug Designation, which represents another key
regulatory milestone for this important program.”
Taletrectinib was granted Orphan Drug Designation for the
treatment of ROS1- positive, NTRK-positive, ALK-positive,
LTK-positive, ACK1-positive, or DDR1-positive NSCLC. The FDA's
Office of Orphan Drug Products grants this designation to support
drug candidates in development for underserved patient populations
or rare disorders that affect fewer than 200,000 people in the
United States. Orphan Drug Designation qualifies a candidate for
various development incentives, including tax credits for eligible
clinical trials, waiver of application fees and potential market
exclusivity for seven years upon FDA approval.
Taletrectinib is being evaluated for the treatment of patients
with ROS1-positive NSCLC in two pivotal Phase 2 studies, TRUST-I
(NCT04395677) in China and TRUST-II (NCT04919811), a global pivotal
study.
WCLC Presentation Overview:
Title: Efficacy and Safety of Taletrectinib in Patients
with ROS1+ Non–Small Cell Lung Cancer: The Global TRUST-II Study
Presenter: Geoffrey Liu, MD Date: September 10, 2024
Session Time: 11:15 a.m. – 12:30 p.m. PDT Session:
MA06 - New Strategies in ALK, ROS1, NTRK, BRAF, and MET NSCLC
Abstract: 1752
ESMO Presentation Overview:
Title: Pooled Efficacy and Safety From 2 Pivotal Phase 2
Trials of Taletrectinib in Patients (Pts) With Advanced or
Metastatic ROS1+ Non–Small Cell Lung Cancer (NSCLC)
Presenter: Maurice Perol, M.D. Date: September 14,
2024 Session Time: Poster Lunch, 12:00-1:00 p.m. CEST (on
display from 9:00 a.m. - 5:00 p.m. CEST) Session: Poster
Display, NSCLC, Metastatic Abstract: 1289P
The materials will be made available on the Publications section
of nuvationbio.com the day of the respective presentations.
About Taletrectinib
Taletrectinib is an oral, potent, central nervous system-active,
selective, next-generation ROS1 inhibitor specifically designed for
the treatment of patients with advanced ROS1-positive NSCLC.
Taletrectinib is being evaluated for the treatment of patients with
advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal
studies: TRUST-I (NCT04395677) in China, and TRUST-II
(NCT04919811), a global study. Taletrectinib has been granted
Orphan Drug Designation by the U.S. Food and Drug Administration
(FDA) for the treatment of patients with ROS1-positive NSCLC and
Breakthrough Therapy Designations by both the U.S. FDA and China’s
National Medical Products Administration (NMPA) for the treatment
of patients with advanced or metastatic ROS1-positive NSCLC. Based
on results of the TRUST-I clinical study, China’s NMPA has accepted
and granted Priority Review Designations to New Drug Applications
for taletrectinib for the treatment of adult patients with locally
advanced or metastatic ROS1-positive NSCLC who either have or have
not previously been treated with ROS1 tyrosine kinase inhibitors
(TKIs).
About ROS1-positive NSCLC
More than one million people globally are diagnosed with NSCLC
annually, the most common form of lung cancer. It is estimated that
approximately 1-3% of people with NSCLC are ROS1-positive. Up to
35% of people newly diagnosed with metastatic ROS1-positive NSCLC
have tumors that have spread to their brain, increasing up to 55%
for those whose cancer has progressed following initial treatment.
While people with other types of lung cancer have seen great
advances, there has been limited progress for people with
ROS1-positive NSCLC who remain in need of new options.
About Nuvation Bio
Nuvation Bio is a late clinical-stage, global biopharmaceutical
company tackling some of the greatest unmet needs in oncology by
developing differentiated and novel product candidates. Nuvation
Bio’s portfolio of development candidates includes taletrectinib
(ROS1), safusidenib (mIDH1), NUV-868 (BET), and NUV-1511 (DDC).
Nuvation Bio was founded in 2018 by biopharma industry veteran
David Hung, M.D., who previously founded Medivation, Inc., which
brought to patients one of the world’s leading prostate cancer
medicines. Nuvation Bio has offices in New York, San Francisco, and
Shanghai. For more information, please visit www.nuvationbio.com
and https://www.linkedin.com/company/nuvationbio/.
Forward Looking Statements
Certain statements included in this press release that are not
historical facts are forward-looking statements for purposes of the
safe harbor provisions under the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
sometimes accompanied by words such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,”
“would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,”
“outlook” and similar expressions that predict or indicate future
events or trends or that are not statements of historical matters.
These forward-looking statements include, but are not limited to,
our expectations regarding a U.S. NDA, the expected timing of
becoming a commercial organization, and the potential therapeutic
benefit of taletrectinib. These statements are based on various
assumptions, whether or not identified in this press release, and
on the current expectations of the management team of Nuvation Bio
and are not predictions of actual performance. These
forward-looking statements are subject to a number of risks and
uncertainties that may cause actual results to differ from those
anticipated by the forward-looking statements, including but not
limited to the challenges associated with conducting drug discovery
and initiating or conducting clinical studies due to, among other
things, difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or acquiring necessary products; the
emergence or worsening of adverse events or other undesirable side
effects; risks associated with preliminary and interim data, which
may not be representative of more mature data; and competitive
developments. Risks and uncertainties facing Nuvation Bio are
described more fully in its Form 10-Q filed with the SEC on May 14,
2024 under the heading “Risk Factors,” and other documents that
Nuvation Bio has filed or will file with the SEC. You are cautioned
not to place undue reliance on the forward-looking statements,
which speak only as of the date of this press release. Nuvation Bio
disclaims any obligation or undertaking to update, supplement or
revise any forward-looking statements contained in this press
release.
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Nuvation Bio Investor Contact: ir@nuvationbio.com
Nuvation Bio Media Contact: nuvation@argotpartners.com
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