NextCure Initiates Phase 1/2 Clinical Study of NC410, a Novel Immunomedicine, for Solid Tumors

BELTSVILLE, Md., July 07, 2020 (GLOBE NEWSWIRE) -- (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 initiation of a Phase 1/2 clinical trial for NC410, a novel immunomedicine developed to block immune suppression mediated by an immune modulator called LAIR-1.

The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC410 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of NC410 will be evaluated in select tumor types.

“We are pleased to initiate this first clinical trial of NC410, our second product candidate to reach the clinic, after a brief delay announced in April as a result of the COVID-19 pandemic. This is a significant step in building our pipeline of next-generation immunomedicines to treat cancer,” said Michael Richman, NextCure’s president and chief executive officer. “We are the first company to target the LAIR protein family in the clinic. NC410 is a biomimic of LAIR-2, a naturally occurring immune regulatory protein. We look forward to continuing development of both NC318 and NC410, as well as advancing our preclinical pipeline.”

Leukocyte-Associated Immunoglobulin-like Receptor 1, or LAIR-1, is a co-inhibitory receptor expressed on T cells, monocytes, macrophages and dendritic cells. LAIR-2 is a naturally occurring soluble version of LAIR-1, which binds to and blocks the inhibitory activity of LAIR-1 and thus acts as a decoy protein. NC410 is a recombinant LAIR-2 fusion protein designed to mimic the natural decoy effects of LAIR-2. Preclinical research showed that LAIR-1 inhibits T cell function and dendritic cell activity, allowing tumor cells to grow. In preclinical studies, NC410 blocked LAIR-1 mediated inhibition of T cells and dendritic cells, thus promoting their activity.

The company anticipates initial data from the Phase 1 portion of the trial by the second half of 2021.

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.

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 NextCure’s ongoing clinical study of NC410, NextCure’s expectations regarding the potential benefits, activity, effectiveness and safety 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; and the unproven approach to the discovery and development of product candidates based on NextCure’s FIND-IO platform. 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 NextCure’s most recent Form 10-K and subsequent Form 10-Q. 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.