BELTSVILLE, Md., May 19, 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 that clinical trial investigator, Martin Gutierrez, M.D., Director, Phase 1 Program and Co-Chair of Thoracic Oncology at Hackensack University Medical Center, will present a Trials in Progress poster for NC410 at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
“NC410 targets a unique mechanism in the tumor microenvironment (TME) and represents an innovative approach for patients who do not respond to current available therapies by targeting tumors with collagen-rich areas where LAIR-1+ immune cells localize,” said Dr. Gutierrez. “LAIR-1 expression on immune cells in the TME inhibits T cell responses, through binding to collagen therefore leading to tumor growth. NC410 is designed to act as a LAIR-1 decoy to prevent LAIR-1 mediated immunosuppression. This leads to restoration of immune function as evidenced by increased production of several cytokines, and anti-tumor responses in preclinical models. I look forward to a continued collaboration with NextCure to advance this product through the clinic.”
“We are excited to discuss our rationale for developing NC410 as a first-in-class cancer therapeutic targeting the LAIR pathway as well as our Phase 1/2 clinical trial strategy with the clinical oncology community at ASCO,” said Han Myint, M.D., NextCure’s chief medical officer. “NC410 demonstrates anti-tumor activity in preclinical models, and we believe it has significant potential across multiple tumor types, including gastric, ovarian, lung head and neck. We look forward to continuing to evaluate NC410 in first-in-human trials and reporting initial clinical data in the second half of 2021.”
Collagens are a primary component of the extracellular matrix (ECM) in the TME and are functional ligands for the inhibitory immune receptor leukocyte associated immunoglobulin-like receptor (LAIR)-1. LAIR-1 binding to collagens suppresses anti-tumor immunity through the inhibition of key stimulatory signaling pathways. NC410 is designed as a fusion protein of LAIR-2, a soluble homolog of LAIR-1 fused to human IgG1 Fc domain, and it acts as a LAIR-1 decoy by binding collagen with higher affinity than LAIR-1 to prevent LAIR-1 mediated immunosuppression and promoting anti-tumor response. Because NC410 binds to collagen rich areas, it also induces alterations in the ECM to promote immune cell infiltration and function in the TME. LAIR-1 expression has been observed across tumor types, including non-small lung cancer (NSCLC), gastric, colorectal, pancreatic, ovarian and head & neck cancers. In this trial we plan to evaluate the measurement of collagen fragments in serum as potential biomarkers to non-invasively interrogate cell reactivity in the TME and predict response to treatment, which may be important for patient stratification for the Phase 2 portion of the study.
Details of the poster presentation are as follows:
Poster Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
Session Title: Developmental Therapeutics—Immunotherapy
Abstract #: TPS2659
The abstract is available through the ASCO Meeting Library at https://meetinglibrary.asco.org/.
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells, a type of antigen presenting cell. In preclinical research, it was observed that LAIR-1 inhibited T cell function and monocyte activity allowing tumor cells to grow. In preclinical studies, NC410 blocked the negative effects of LAIR-1 and promoted T cell function and monocyte 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, ovarian, colorectal, pancreatic, and gastric cancers and other tumors 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
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 NC762 and expected upcoming milestones, the potential benefits of NC762, 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.
Timothy Mayer, Ph.D.
Chief Operating Officer