BELTSVILLE, Md. - NextCure Inc. (NASDAQ:NXTC) and Simcere Zaiming Pharmaceutical Co., Ltd. presented Phase 1 dose escalation data for SIM0505, an investigational antibody drug conjugate targeting Cadherin-6, at the American Society for Clinical Oncology conference in Chicago on Monday, according to a press release statement.The clinical data comes as NextCure’s stock has faced significant headwinds, with shares down roughly 57% year-to-date and trading at $6.20, giving the company a market capitalization of just $22.4 million.
The Phase 1 study evaluated SIM0505 in 59 heavily pre-treated cancer patients at doses ranging from 1.6 mg/kg to 9.6 mg/kg. Patients were enrolled at sites in the U.S. and China without preselection for CDH6 expression, with data cutoff on April 7, 2026.
For patients within therapeutic dose cohorts of 4.8 to 8.0 mg/kg who had minimum 12 weeks of follow-up, the objective response rate was 55% for gynecologic cancers, 52.9% for ovarian cancer, and 66.7% for uterine serous carcinoma. Response rates were determined by best response according to RECIST 1.1 criteria. Of nine ovarian patients with partial response, one was unconfirmed and one was pending confirmation at next follow-up scan.Despite the company’s current unprofitability, with losses of $15.32 per share over the last twelve months, InvestingPro data shows NextCure maintains a strong balance sheet with more cash than debt and a current ratio of 4.61. Analysts remain optimistic, with price targets ranging from $15 to $25—suggesting substantial upside potential from current levels. For investors seeking deeper insights, InvestingPro offers 10 additional exclusive tips on NXTC, along with comprehensive financial health scores and Fair Value analysis.
The study enrolled patients with a median of five prior systemic anti-cancer regimens. The median age was 58 years, and 96.6% of participants were female. Tumor types included 78% ovarian cancer, 16.9% uterine serous carcinoma or other endometrial cancer, and 5.1% renal cell carcinoma.
Treatment-related adverse events were predominantly hematological, nausea and vomiting. Three patients required dose discontinuation due to treatment-related adverse events.
NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers in May 2026, initially focusing on patients with platinum-resistant ovarian cancer. The global study is expected to enroll up to 120 patients at sites in the U.S., Canada, the EU and China.
The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for treatment of platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan.
In other recent news, NextCure Inc. has initiated a dose optimization study for its investigational drug SIM0505, targeting patients with platinum-resistant ovarian cancer. This study is part of the Phase 1 clinical trial, aiming to finalize dose selection for potential future studies. NextCure plans to present clinical trial data for SIM0505 at the upcoming American Society for Clinical Oncology annual meeting. This drug, developed in collaboration with Simcere Zaiming Pharmaceutical Co., Ltd., is an antibody-drug conjugate focusing on Cadherin-6 and utilizing a topoisomerase 1 inhibitor payload.
Additionally, Lucid Capital Markets has initiated coverage on NextCure with a buy rating, setting a price target of $25.00. The firm emphasized the potential of NextCure’s antibody-drug conjugate pipeline, particularly SIM0505, as a core focus for the company. NextCure had in-licensed SIM0505 from Simcere Zaiming, securing rights outside Greater China with milestone payments and royalties. These developments highlight NextCure’s ongoing efforts and focus on advancing its cancer treatment pipeline.
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