- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SIM0505 for the treatment of women with platinum resistant ovarian cancer (PROC)
- Phase 1 data for SIM0505 to be presented at ASCO 2026; dose optimization in ovarian cancer expected to begin in Q2 2026
BELTSVILLE, Md., April 07, 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, today announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of 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.
“Securing Fast Track designation for SIM0505 validates the urgent, unmet need for new treatments for platinum resistant ovarian cancer and enables us to work more closely with FDA to accelerate development. We believe this designation will help to streamline and de-risk development through proactive and ongoing engagement with FDA,” said Michael Richman, President and CEO of NextCure. “We are committed to bringing SIM0505 to patients as quickly as possible and we plan to initiate dose optimization in ovarian cancer patients in the second quarter of 2026. In addition, we look forward to presenting Phase 1 data on the program at the upcoming 2026 American Society of Clinical Oncology conference.”
About Fast Track Designation
Fast Track Designation is an FDA process designed to facilitate the development of new therapies to treat serious conditions and fulfill an unmet medical need. Drug candidates that receive Fast Track Designation are eligible for more frequent meetings and written interactions with the FDA, rolling review and priority review.
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.
Forward-Looking Statements
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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
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