Press Releases April 21, 2026 10:15 AM

NextCure and Simcere’s SIM0505 (CDH6 ADC) Phase 1 Data to be Presented at ASCO 2026

NextCure and Simcere to present promising Phase 1 data for SIM0505 ADC targeting solid tumors at ASCO 2026

By Jordan Park NXTC
NextCure and Simcere’s SIM0505 (CDH6 ADC) Phase 1 Data to be Presented at ASCO 2026
NXTC

NextCure, Inc. announced that Phase 1 clinical data for SIM0505, an investigational antibody drug conjugate targeting Cadherin-6 for the treatment of advanced solid tumors, will be presented at ASCO 2026. The results underscore forward progress in NextCure's oncology pipeline, focusing on innovative therapies for cancer including difficult-to-treat platinum resistant ovarian cancer. The partnership with Simcere Zaiming enables NextCure to retain global rights outside China and select Asian markets.

Key Points

  • Phase 1 multicenter, first-in-human study of SIM0505 data to be presented at ASCO 2026, a leading oncology conference.
  • SIM0505 is a novel ADC with a proprietary topoisomerase 1 inhibitor payload targeting Cadherin-6, designed for broad anti-tumor activity and improved therapeutic window.
  • NextCure holds exclusive global rights outside China, Hong Kong, Macau, and Taiwan where Simcere retains rights, reinforcing a strategic global partnership in oncology R&D.

BELTSVILLE, Md., April 21, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a poster will be presented at ASCO 2026 highlighting Phase 1 data for SIM0505 in the treatment of solid tumors. ASCO 2026 is being held May 29 – June 2 in Chicago, Illinois. SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

“We are very pleased to announce that the Phase 1 results for SIM0505 have been accepted as a poster presentation at ASCO 2026. This important milestone validates our collaborative clinical approach and highlights our mission of advancing innovative medicines to treat cancer patients,” said Michael Richman, President and CEO of NextCure.

Presentation Details:

  • Title: Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors
  • Poster Abstract #: 5580
  • Poster Board: 246
  • Presenter: Xiaohua Wu, MD, PhD, Chief Physician and Chairman of the Multidisciplinary Team in Gynecologic Oncology at Fudan University Shanghai Cancer Center, Shanghai, China
  • Session: Gynecologic Cancer
  • Session Date: Monday June 1, 2026
  • Session Time: 9:00 AM CST to 12:00 PM CDT

A full copy of the poster will be available on the NextCure website under the Investor Relations “Events & Presentations” tab following the presentation.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response.

About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®. The Company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.

Forward-Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.

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: market and other conditions; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s reliance upon collaborators and international vendors for advancing clinical programs; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. 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
[email protected]

Mike Moyer
Managing Director,
LifeSci Advisors, LLC
Phone: (617) 308-4306
[email protected]


Risks

  • SIM0505 is still in early clinical development; positive Phase 1 results may not translate to later-stage efficacy or approval, which impacts biotech and pharma sectors.
  • NextCure's limited operating history and history of losses raise financing risks potentially affecting clinical trial progression and commercialization.
  • Dependence on collaborations and international partners like Simcere introduces operational and regulatory uncertainties in different markets, especially in Asia.

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