NextCure initiates Phase 1 study of LNCB74, an antibody-drug conjugate targeting B7-H4 for multiple cancers.
Quiver AI Summary
NextCure, Inc. has announced that it has dosed its first patient in a Phase 1 clinical trial for LNCB74, an antibody-drug conjugate targeting B7-H4 for the treatment of multiple cancers. This milestone is part of NextCure's efforts to advance its B7-H4 ADC program, with expectations to assess the drug's safety, tolerability, and preliminary anti-tumor activity. The clinical study follows the clearance of the Investigational New Drug application by the FDA in December 2024, and is being developed in collaboration with LigaChem Biosciences, Inc. NextCure aims to provide innovative cancer treatments for patients who do not respond to existing therapies.
Potential Positives
- NextCure has successfully dosed the first patient in its Phase 1 study for LNCB74, marking a significant milestone in the development of their B7-H4-targeting antibody-drug conjugate.
- The FDA's clearance of the Investigational New Drug application for LNCB74 demonstrates regulatory acceptance and support for the drug's clinical development.
- The collaboration with LigaChem Biosciences, Inc. positions NextCure to leverage additional expertise and resources in advancing the LNCB74 program.
- The announcement highlights NextCure's commitment to addressing treatment options for cancer patients who do not respond to existing therapies, potentially expanding their market impact.
Potential Negatives
- NextCure has a limited operating history and does not have any products approved for commercial sale, which may raise concerns about its viability in the biopharmaceutical market.
- The company has a history of significant losses, indicating financial instability and potential challenges in sustaining operations and development efforts.
- The forward-looking statements highlight substantial risks and uncertainties that could cause actual results to differ materially from projections, emphasizing the speculative nature of their current developments.
FAQ
What is LNCB74 and its purpose?
LNCB74 is a B7-H4-targeting antibody-drug conjugate aimed at treating multiple cancers, currently in Phase 1 clinical study.
When was the first patient dosed in the LNCB74 study?
The first patient was dosed on January 10, 2025, marking a significant milestone for NextCure.
Who is collaborating with NextCure on LNCB74?
NextCure is developing LNCB74 in partnership with LigaChem Biosciences, Inc. through a collaboration agreement.
What outcomes is NextCure expecting from the Phase 1 study?
NextCure aims to establish LNCB74's safety, tolerability, and preliminary anti-tumor activity in the study.
What makes NextCure's approach unique?
NextCure focuses on developing innovative therapies using differentiated mechanisms, targeting patients with resistant or progressing cancers.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
BELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) --
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 the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.
“Dosing the first patient in the LNCB74 Phase 1 study is a significant milestone for NextCure as we continue to advance our B7-H4 ADC program,” said Udayan Guha, M.D., Ph.D., NextCure’s Senior Vice President, Clinical & Translational Development. “We look forward to establishing the safety, tolerability, and preliminary anti-tumor activity of LNCB74. We believe this novel ADC could potentially transform treatment options for multiple cancers.”
In December 2024, NextCure announced that the U.S. Food and Drug Administration had cleared its Investigational New Drug application for LNCB74.
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 statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.
Forward-looking statements involve substantial risks and 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 Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
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