NXTC News & Events

NextCure and Simcere Zaiming Pharmaceutical announced positive Phase 1 dose escalation data for SIM0505, an antibody-drug conjugate targeting CDH6, presented at the American Society for Clinical Oncology Annual Meeting. In gynecologic cancers, patients within therapeutic dose cohorts achieved an objective response rate of 55%. "Positive Phase 1 data presented at ASCO 2026 validate our conviction in SIM0505 as a potential best-in-class CDH6-directed therapy for gynecologic cancers," said Michael Richman, president and CEO of NextCure. "Meaningful response rates at 12 weeks, alongside a manageable safety profile, give us strong confidence in this program and reinforce our enthusiasm for the ongoing dose optimization study. We believe SIM0505 has broad potential in gynecologic cancers and beyond, and these data put us on a solid track toward pivotal studies and our goal of bringing this treatment to patients."

"Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients."