NextCure Initiates Phase 1/2 Clinical Trial of NC762 for Solid Tumors
NextCure, Inc. (Nasdaq: NXTC) has commenced a Phase 1/2 clinical trial for NC762, a humanized B7-H4 monoclonal antibody targeting advanced solid tumors. Michael Richman, CEO, affirmed this trial extends their innovative immunomedicine pipeline for cancers inadequately treated by existing therapies. The trial evaluates NC762's safety and tolerability, with initial data expected by mid-2022. NC762 aims to inhibit tumor growth through a unique mechanism, with applications across several cancer types, including non-small cell lung cancer.
- Initiation of Phase 1/2 clinical trial for NC762 indicates progress in development.
- NC762 targets multiple cancer types, potentially expanding market opportunities.
- Initial data from the trial is expected by mid-2022, providing potential insights for investors.
- Risks related to clinical development and marketing approval could impact future success.
- Dependence on external factors, including COVID-19, may hinder trial progression.
- Company's history of significant losses raises concerns about financial sustainability.
BELTSVILLE, Md., July 06, 2021 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company 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 NC762, a humanized B7-H4 monoclonal antibody.
“We are pleased to have initiated the clinical trial of our third product candidate,” said Michael Richman, NextCure’s president and chief executive officer. “This represents an important expansion of our pipeline of novel immunomedicines designed to treat patients who are not adequately addressed by currently available therapies. We look forward to reporting initial data from this trial in mid-2022.”
“NC762 is an innovative immunomedicine that directly inhibits tumor growth by a unique, T cell independent mechanism,” said Han Myint, M.D., NextCure’s chief medical officer. “As B7-H4 is widely expressed on multiple tumor types, including non-small cell lung cancer, ovarian cancer and breast cancer, we believe NC762 has the potential to provide benefit in multiple cancer indications.”
The Phase 1 dose-escalation portion of this open-label trial is designed to evaluate the safety and tolerability of NC762 in patients with advanced or metastatic solid tumors and to determine its pharmacologically active and/or maximum tolerated dose. After a recommended dose for the Phase 2 portion of the trial is determined, NC762 will be evaluated in select tumor types. A B7-H4 Immunohistochemistry (IHC) assay has been successfully developed and will be used for patient selection in Phase 2.
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 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.
FAQ
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