NextCure Gets FDA Fast Track for SIM0505 in Ovarian Cancer

Dose optimization in ovarian cancer expected to start in Q2 2026 as designation enables closer FDA engagement to accelerate development.

Apr. 7, 2026 at 12:05pm

Got story updates? Submit your updates here. ›

An extreme close-up X-ray image revealing the intricate molecular structure of an ovarian cancer cell, with glowing lines and shapes against a dark background, conceptually representing the search for new targeted treatments.A ghostly X-ray view of the complex internal structure of an ovarian cancer cell, highlighting the urgent need for new targeted therapies like NextCure's SIM0505 ADC.Beltsville Today

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

Why it matters

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.

The details

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 for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer.

  • NextCure plans to present Phase 1 data on SIM0505 at the 2026 American Society of Clinical Oncology conference.
  • NextCure expects to initiate dose optimization in ovarian cancer patients in the second quarter of 2026.

The players

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.

Got photos? Submit your photos here. ›

What they’re saying

“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.”

— Michael Richman, President and CEO of NextCure

What’s next

NextCure plans to initiate dose optimization in ovarian cancer patients for SIM0505 in the second quarter of 2026.

The takeaway

The FDA's Fast Track Designation for NextCure's SIM0505 ADC in platinum-resistant ovarian cancer highlights the significant unmet need for new treatment options in this deadly disease. The designation will help accelerate the development of this promising investigational therapy, bringing hope to patients who currently have limited effective therapies.