NextCure, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIM0505, an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6), for the treatment of platinum-resistant ovarian cancer.

The Fast Track Designation will allow for more frequent meetings and written interactions with the FDA, rolling review, and priority review, helping to streamline and de-risk the development of SIM0505. Dose optimization in ovarian cancer is expected to start in Q2 2026 as the designation enables closer FDA engagement to accelerate development.

Clinical Timeline and Upcoming Data

NextCure plans to present Phase 1 data on the program at the 2026 American Society of Clinical Oncology (ASCO) conference and initiate dose optimization in ovarian cancer patients in the second quarter of 2026.

Addressing Unmet Needs in Ovarian Cancer

Ovarian cancer is a deadly disease with limited treatment options, especially for patients with platinum-resistant disease. The FDA's Fast Track Designation for SIM0505 recognizes the urgent, unmet need for new therapies in this patient population and will help accelerate the development of this investigational ADC, which has the potential to provide a new treatment option for women with advanced ovarian cancer.

Mechanism of Action: What is 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 currently being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum-resistant ovarian cancer.

Key Entities & Glossary

NextCure, Inc.

A clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates.

SIM0505

An investigational antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

U.S. Food and Drug Administration (FDA)

The regulatory agency that has granted Fast Track Designation for SIM0505 in the treatment of platinum-resistant ovarian cancer.