- Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC)
- Phase 1 data readout to be presented at ASCO 2026
BELTSVILLE, Md., May 04, 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 initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.
“Initiation of dose optimization highlights the promise of our novel CDH6-directed ADC and our focus on bringing SIM0505 to patients as quickly as possible. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe,” said Michael Richman, President and CEO of NextCure. “We look forward to presenting Phase 1 data at the upcoming 2026 American Society of Clinical Oncology (ASCO) conference as we continue to build momentum in the program.”
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. The Food and Drug Administration granted Fast Track to SIM0505 for 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
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