NextCure Announces Acceptance of IND Application for LNCB74
10 Dicembre 2024 - 2:05PM
NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical
company committed to discovering and developing novel,
first-in-class, and best-in-class therapies to treat cancer, today
announced that the U.S. Food and Drug Administration (FDA) accepted
an Investigational New Drug (IND) application for initiation of a
Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting
antibody-drug conjugate (ADC) as a therapeutic for treating
multiple cancers.
“Acceptance of the IND application for LNCB74 represents an
important milestone for NextCure as we focus our resources on
advancing our ADC program,” said Michael Richman, NextCure’s
president and CEO. “The IND application leverages LNCB74
preclinical data that highlights the differentiation of our B7-H4
ADC from other ADCs targeting B7-H4. We believe LNCB74 has the
potential to transform treatment for patients and we look forward
to advancing LNCB74 into clinical development.”
An IND is a request submitted to the regulatory authorities
seeking permission to test a new drug or therapeutic substance in
humans. The IND includes detailed information about the drug, its
composition, pharmacology, toxicology, data from preclinical
studies, proposed clinical trial protocols, and information on
manufacturing and quality control. With the IND application
acceptance now complete, NextCure can proceed with the Phase I
trial.
LNCB74 is being developed in partnership with LigaChem
Biosciences, Inc. as part of a collaboration and co-development
agreement.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is
focused on advancing innovative medicines that treat cancer
patients that do not respond to, or have disease progression on,
current therapies, through the use of differentiated mechanisms of
actions including antibody-drug conjugates, antibodies and
proteins. We focus on advancing therapies that leverage our core
strengths in understanding biological pathways and biomarkers, the
interactions of cells, including in the tumor microenvironment, and
the role each interaction plays in a biologic response.
www.nextcure.com
Forward-Looking Statements
Some of the statements contained in this press release are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including with respect to
funding for our operations, objectives and expectations for our
business, operations and financial performance and condition,
including the progress and results of clinical trials, development
plans and upcoming milestones regarding our therapies. Any
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uncertainties that could cause actual results to differ materially
from those projected in any forward-looking statement. Such risks
and uncertainties include, among others: positive results in
preclinical studies may not be predictive of the results of
clinical trials; NextCure’s limited operating history and not
having any products approved for commercial sale; NextCure’s
history of significant losses; NextCure’s need and ability to
obtain additional financing on acceptable terms or at all; risks
related to clinical development, marketing approval and
commercialization; and NextCure’s dependence on key personnel. More
detailed information on these and additional factors that could
affect NextCure’s actual results are described under the heading
“Risk Factors” in NextCure’s most recent Annual Report on Form 10-K
and in NextCure’s other filings with the Securities and Exchange
Commission. You should not place undue reliance on any
forward-looking statements. Forward-looking statements speak only
as of the date of this press release, and NextCure assumes no
obligation to update any forward-looking statements, even if
expectations change.
Investor InquiriesTimothy Mayer, Ph.D.NextCure,
Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com
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