NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers
NextCure (NXTC) has announced the dosing of its first patient in a Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) designed to treat multiple cancers. This milestone follows the FDA's clearance of the Investigational New Drug application for LNCB74 in December 2024.
The study aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of LNCB74, which is being developed in partnership with LigaChem Biosciences through a collaboration and co-development agreement.
NextCure (NXTC) ha annunciato la somministrazione della sua prima dose a un paziente in uno studio di Fase 1 di LNCB74, un coniugato anticorpo-farmaco (ADC) mirato a B7-H4, progettato per trattare diverse forme di cancro. Questo traguardo segue l'autorizzazione da parte della FDA della domanda di Nuovo Farmaco Investigativo per LNCB74 nel dicembre 2024.
Lo studio ha l'obiettivo di valutare la sicurezza, la tollerabilità e l'attività anti-tumorale preliminare di LNCB74, che viene sviluppato in collaborazione con LigaChem Biosciences attraverso un accordo di collaborazione e co-sviluppo.
NextCure (NXTC) ha anunciado la dosificación de su primer paciente en un estudio de Fase 1 de LNCB74, un conjugado anticuerpo-fármaco (ADC) dirigido a B7-H4, diseñado para tratar múltiples tipos de cáncer. Este hito sigue a la autorización por parte de la FDA de la solicitud de Nuevo Medicamento en Investigación para LNCB74 en diciembre de 2024.
El estudio tiene como objetivo evaluar la seguridad, la tolerabilidad y la actividad antitumoral preliminar de LNCB74, que se está desarrollando en asociación con LigaChem Biosciences a través de un acuerdo de colaboración y co-desarrollo.
NextCure (NXTC)는 LNCB74에 대한 1상 연구에서 첫 환자의 투약을 발표했습니다. 이는 여러 종류의 암을 치료하기 위해 설계된 B7-H4를 표적하는 항체-약물 접합체(ADC)입니다. 이 이정표는 2024년 12월 FDA의 LNCB74에 대한 신약 연구 신청 승인이 있은 후 이루어진 것입니다.
이 연구는 LNCB74의 안전성, 내약성 및 초기 항종양 활성을 평가하는 것을 목표로 하며, LigaChem Biosciences와의 협업 및 공동 개발 계약을 통해 개발되고 있습니다.
NextCure (NXTC) a annoncé l'administration de sa première dose à un patient dans le cadre d'une étude de Phase 1 de LNCB74, un conjugué anticorps-médicament (ADC) ciblant B7-H4, conçu pour traiter plusieurs cancers. Ce jalon fait suite à l'autorisation de la FDA accordée à la demande de médicament expérimental pour LNCB74 en décembre 2024.
L'étude vise à évaluer la sécurité, la tolérabilité et l'activité antitumorale préliminaire de LNCB74, qui est développé en partenariat avec LigaChem Biosciences par le biais d'un accord de collaboration et de co-développement.
NextCure (NXTC) hat die Dosisverabreichung an seinen ersten Patienten in einer Phase-1-Studie von LNCB74 angekündigt, einem auf B7-H4 abzielenden Antikörper-Wirkstoff-Konjugat (ADC), das zur Behandlung mehrerer Krebsarten entwickelt wurde. Dieser Meilenstein folgt auf die Genehmigung durch die FDA für den Antrag auf einen neuen investigativen Arzneimittelantrag für LNCB74 im Dezember 2024.
Die Studie soll die Sicherheit, Verträglichkeit und die vorläufige antitumorale Aktivität von LNCB74 bewerten, das in Partnerschaft mit LigaChem Biosciences durch eine Zusammenarbeit und Ko-Entwicklungsvereinbarung entwickelt wird.
- FDA clearance received for LNCB74 IND application
- Advancement to Phase 1 clinical trials with first patient dosed
- Strategic partnership with LigaChem Biosciences for drug development
- None.
Insights
The initiation of Phase 1 trials for LNCB74 represents a important development in NextCure's oncology pipeline. B7-H4 is a compelling target in cancer therapy, as it's highly expressed in various tumor types while showing expression in normal tissues. The antibody-drug conjugate (ADC) approach is particularly promising, combining the specificity of antibody targeting with potent cytotoxic payload delivery.
The collaboration with LigaChem Biosciences adds significant value, potentially leveraging their proprietary ADC technology platform. Early clinical validation of LNCB74's safety profile and anti-tumor activity could position NextCure favorably in the competitive ADC landscape, where recent successful ADCs have garnered substantial industry attention and deal values.
For a small-cap biotech (
The advancement of LNCB74 into clinical trials marks a critical inflection point for NextCure's valuation potential. ADC therapeutics have become highly attractive assets in the pharmaceutical industry, with recent acquisitions valued in the billions. Notable examples include Pfizer's
The partnership structure with LigaChem Biosciences could provide cost-sharing benefits, important for a company with NextCure's market capitalization. This arrangement might help extend their operational runway while maintaining significant economic interest in LNCB74's potential success. The FDA's IND clearance and subsequent trial initiation demonstrate regulatory confidence in the program's preclinical package.
However, the company's small market cap raises concerns about future financing needs. Positive early clinical data could catalyze partnership opportunities or enable more favorable financing terms, making the initial safety and efficacy readouts particularly significant for the stock's trajectory.
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
FAQ
What is the current phase of NextCure's LNCB74 cancer treatment trial?
When did NextCure (NXTC) receive FDA clearance for LNCB74?
What type of cancer treatment is NXTC's LNCB74?
Who is NextCure's development partner for LNCB74?
What are the primary objectives of NextCure's LNCB74 Phase 1 study?
