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NextCure Announces Publication of Preclinical Data for NC410

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NextCure, a clinical-stage biopharmaceutical company, announced the publication of preclinical data in Frontiers in Immunology regarding NC410, a first-in-class immunomedicine. The study indicates that collagen fragments in cancer can suppress T cell activity via LAIR-1, but this effect can be reversed by LAIR-2 and NC410. Currently in a Phase 1/2 clinical trial for advanced solid tumors, NC410 aims to provide a new therapeutic option for patients resistant to existing immunotherapies. Initial clinical data will be shared at a conference in November.

Positive
  • NC410 shows potential to reverse LAIR-1 mediated immune suppression.
  • Preclinical data published in a reputable scientific journal.
  • Ongoing Phase 1/2 trial aims to evaluate safety, tolerability, and efficacy.
Negative
  • Dependence on successful outcomes from ongoing clinical trials.
  • Limited operating history with no products approved for commercial sale.

BELTSVILLE, Md., Oct. 07, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of preclinical data in the online journal Frontiers in Immunology, which indicate that collagen fragments produced in cancer can mediate T cell suppression through LAIR-1, an immunomodulatory receptor expressed on T cells and myeloid cells, including dendritic cells. This immune suppression could be reversed by LAIR-2, a natural decoy of LAIR-1, and NC410, a LAIR-2 fusion protein. NC410 is currently being evaluated in a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors and is a first-in-class immunomedicine designed to block LAIR-1-mediated immune suppression.

“Collagen fragments, present in the tumor microenvironment and in circulation of certain cancer patients, mediate immune inhibition by binding to LAIR-1. High expression of collagen fragments and LAIR-1 correlate with worse disease outcomes and resistance to current immunotherapies,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “NC410, a LAIR-2 fusion protein, is able to block LAIR-1-mediated immune suppression which supports its potential as a valuable therapeutic option for patients who are resistant to current immunotherapies. We look forward to continuing the evaluation of NC410 in its ongoing Phase 1/2 clinical trial, for which we will report initial clinical data at the Society for Immunotherapy of Cancer conference in November.”

The publication, titled “Collagen fragments produced in cancer mediate T cell suppression through Leukocyte-Associated Immunoglobulin-like Receptor 1,” details an analysis of historic datasets to evaluate the negative impact of collagen fragments and LAIR-1 expression in patients with cancer and new data demonstrating that collagen fragments can bind to and induce LAIR-1 immune suppression, which can be reversed by NC410.

The paper was published in collaboration with Linde Meyaard, principal investigator at the Center for Translational Immunology, University Medical Center Utrecht, and an Oncode investigator at Oncode Institute.

About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and myeloid cells, including dendritic cells, a type of antigen presenting cell. In preclinical research, it has been shown that LAIR-1 inhibits T cell function and myeloid activity. In preclinical studies, NC410 blocks the negative effects of LAIR-1 and promotes T cell function and myeloid cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

About NC410 Phase 1/2 Clinical Study
The NC410 Phase 1/2 study is a multi-center, first in human, open-label, single-armed study to determine the safety and tolerability, define maximum tolerated dose (MTD) and/or pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers of NC410 in patients with advanced or metastatic solid tumors. Phase 1 is a classic 3+3 dose escalation design to determine the safety, tolerability, MTD and recommended phase 2 dose (RP2D). Ongoing exploratory analyses include the assessment of predictive biomarkers associated with treatment benefit, and pharmacodynamic markers associated with study drug activity. Phase 2 is going to enroll NSCLC, cervical, colorectal, pancreatic, head and neck and other cancers depending on biomarker data available from the Phase 1 part of the study. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04408599). 

About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. Through our proprietary FIND-IO™ platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. Our initial focus is to bring hope and new treatments to patients who do not respond to current cancer therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies. www.nextcure.com

Forward-Looking Statements
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding NextCure’s expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “may,” “will,” “potential,” “expects,” “believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions. Examples of forward-looking statements in this press release include, among others, statements about the development plans for NC410 and expected upcoming milestones, the potential benefits of NC410, and NextCure’s plans, objectives and intentions with respect to the discovery and development of immunomedicines. 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: the impacts of the COVID-19 pandemic on NextCure’s business, including NextCure’s clinical trials, third parties on which NextCure relies and NextCure’s operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCure’s FIND-IO™ platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including in Item 1A of NextCure’s most recent Form 10-K and elsewhere in the Company’s filings with the SEC. 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 purpose of the NC410 clinical trial?

The NC410 clinical trial aims to determine safety, tolerability, and preliminary efficacy in patients with advanced or metastatic solid tumors.

When will NextCure report initial clinical trial data?

NextCure will report initial clinical trial data at the Society for Immunotherapy of Cancer conference in November.

What key findings were published regarding NC410?

The key findings indicate that collagen fragments cause T cell suppression via LAIR-1, which can be reversed by NC410, highlighting its therapeutic potential.

What is the significance of the publication in Frontiers in Immunology?

The publication underscores the immune suppression mechanisms in cancer and the potential of NC410 to overcome these challenges.

What types of cancer are being targeted in the NC410 trial?

The trial will enroll patients with non-small cell lung cancer, cervical, colorectal, pancreatic, head and neck cancers, among others.

NextCure, Inc.

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