NextCure Announces Acceptance of IND Application for LNCB74

Rhea-AI Summary

NextCure announced the FDA's acceptance of an Investigational New Drug (IND) application for LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) developed in partnership with LigaChem Biosciences. This acceptance allows NextCure to proceed with a Phase 1 clinical trial to evaluate LNCB74 as a treatment for multiple cancers.

The company's CEO, Michael Richman, highlighted that this milestone aligns with their focus on advancing their ADC program. The IND application was supported by preclinical data demonstrating LNCB74's differentiation from other B7-H4-targeting ADCs, suggesting potential transformative treatment outcomes for patients.

Positive

• FDA acceptance of IND application enables progression to Phase 1 clinical trials
• Preclinical data shows differentiation from other B7-H4-targeting ADCs
• Strategic partnership with LigaChem Biosciences for drug development

Negative

• None.

Insights

Medical Research Analyst

The FDA's acceptance of NextCure's IND for LNCB74, a B7-H4-targeting ADC, marks a significant regulatory milestone but comes with substantial development risks ahead. B7-H4 is an emerging target in cancer therapy, with its expression across multiple tumor types making it an attractive therapeutic approach. ADCs represent a sophisticated class of cancer therapeutics, combining the specificity of antibodies with potent cytotoxic payloads. The preclinical differentiation mentioned suggests potential competitive advantages, though actual clinical performance remains to be proven. For a small-cap company ($32.2M), successful progression through clinical trials is important but will require significant capital investment. Phase 1 trials typically take 1-2 years to complete and primarily focus on safety and dosing, making this a long-term development story rather than an immediate revenue opportunity.

Financial Analyst

This IND acceptance is strategically important for NextCure's pipeline advancement but should be viewed with measured optimism. While it enables clinical trial initiation, the company's modest market cap of $32.2M raises questions about funding the potentially expensive clinical development program. The partnership with LigaChem Biosciences helps share development costs and risks, though specific financial terms aren't disclosed. Early-stage biotech investors should note that Phase 1 trials typically cost $2-5M, with costs escalating significantly in later phases. The B7-H4 ADC space is competitive and while differentiation claims are encouraging, commercial success remains years away. This milestone may provide near-term support for the stock but sustainable value creation depends on clinical trial execution and future funding capacity.

LNCB74 is a B7-H4-targeting antibody-drug conjugate being developed for multiple cancers in partnership with LigaChem Biosciences

BELTSVILLE, Md., Dec. 10, 2024 (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 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 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

FAQ

What is the status of NextCure's (NXTC) LNCB74 IND application?

The FDA has accepted NextCure's IND application for LNCB74, allowing the company to proceed with Phase 1 clinical trials.

What type of drug is NextCure's (NXTC) LNCB74?

LNCB74 is a B7-H4-targeting antibody-drug conjugate (ADC) being developed for the treatment of multiple cancers.

Who is NextCure (NXTC) partnering with for LNCB74 development?

NextCure is developing LNCB74 in partnership with LigaChem Biosciences through a collaboration and co-development agreement.

What is the next development phase for NextCure's (NXTC) LNCB74?

NextCure will proceed with Phase 1 clinical trials to evaluate LNCB74 as a therapeutic for treating multiple cancers.