Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors
January 08 2024 - 4:05PM
Business Wire
NUV-1511 is the first clinical candidate from
the company’s novel drug-drug conjugate platform
Company anticipates initiating a Phase 1/2
clinical study of NUV-1511 in 1H 2024
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company
tackling some of the greatest unmet needs in oncology by developing
differentiated and novel therapeutic candidates, announced today
that the U.S. Food and Drug Administration (FDA) has cleared its
investigational new drug (IND) application to evaluate NUV-1511,
the first clinical candidate from the company’s novel drug-drug
conjugate (DDC) platform.
“This IND clearance expands our clinical pipeline and validates
the approach of our proprietary DDC platform to design potent
oncology-focused chimeric small molecules which combine
tumor-targeting specificity with the anti-cancer activity of known
oncology agents,” said David Hung, M.D., Founder, President, and
Chief Executive Officer of Nuvation Bio. “We believe NUV-1511 has
the potential to provide favorable clinical benefit for patients
with various solid tumors and we look forward to initiating the
Phase 1/2 study.”
The dose escalation portion of the Phase 1/2 study will
initially evaluate safety and tolerability, and explore the
potential for clinical efficacy, in patients with advanced solid
tumors who previously received and progressed on or after treatment
with Enhertu® and/or Trodelvy® per approved FDA labeling, human
epidermal growth factor receptor 2-negative (HER2-) metastatic
breast cancer, metastatic castration-resistant prostate cancer
(mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer
(PROC).
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the
greatest unmet needs in oncology by developing differentiated and
novel therapeutic candidates. Nuvation Bio’s proprietary portfolio
includes mechanistically distinct oncology therapeutic product
candidates, each targeting some of the most difficult-to-treat
types of cancer. 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 and San Francisco. For more information, please visit
www.nuvationbio.com.
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,
statements regarding the potential therapeutic benefit of Nuvation
Bio’s product candidates, the ability of Nuvation Bio’s proprietary
DDC platform to design potent oncology candidates, and Nuvation
Bio’s plans to initiate a Phase 1/2 study for NUV-1511 in 1H 2024.
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
trials 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 November 2, 2023, 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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