NextCure Announces Development of a Highly Specific Immunohistochemical Diagnostic for Siglec-15-positive Tumors as reported in Laboratory Investigation

BELTSVILLE, Md., July 06, 2022 (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 a paper titled “Development of an Immunohistochemical Assay for Siglec-15” in Laboratory Investigation. The publication outlines data from a study, conducted in collaboration with researchers in the Department of Pathology at Yale School of Medicine, utilizing a newly developed antibody to Siglec-15 (S15) and an immunhistochemical (IHC) assay to investigate S15 expression in solid tumors.

“The data resulting from our study with Yale support NextCure’s focus on targeting S15, an immunosuppressive protein expressed in a wide variety of cancer types,” said Sol Langermann, Ph.D., NextCure’s chief scientific officer. “We believe that these data support our work developing therapeutic candidates like NC318, which target S15 to restore immune cell function and anti-tumor responses in patients with cancer. We look forward to continuing the evaluation of our S15-targeted candidate, NC318.”

Data from the current study show the creation and validation of an IHC assay for detecting S15 in tumor samples. The IHC assay was created with a novel S15 monoclonal antibody that recognizes a unique cytoplasmic domain of the protein. A scoring system was generated for the assay that had high concordance amongst pathologists. The IHC assay was used for a study involving two cohorts of non-small cell lung cancer (NSCLC) where high levels of S15 staining were shown on both tumor cells and immune cells. S15 expression was also shown to be predominantly mutually exclusive of PD-L1 expression. Expression of S15 on NSCLC supports clinical trials evaluating therapeutics targeting S15 and highlights the importance of patient selection in the ongoing NC318 clinical trial.

About NC318
NC318 is a first-in-class immunomedicine against Siglec-15 (S15), a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

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 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.

Cautionary Statement Regarding 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 our immunomedicines, statements about the progress and evaluation and expected timing of results of NextCure’s ongoing clinical trial of NC318, expectations regarding the potential benefits, activity, effectiveness and safety of NC318, expectations regarding the investigator initiated trial conducted by Yale, NextCure’s financial guidance, expected upcoming milestones, 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-Q 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, except as required by law, even if expectations change.

Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486

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