NextCure Presents Positive SIM0505 Phase 1 Dose Escalation Data in Patients with Gynecologic Cancers at ASCO 2026
Rhea-AI Summary
NextCure (Nasdaq:NXTC) and partner Simcere Zaiming reported positive Phase 1 dose escalation data for SIM0505, an anti-CDH6 ADC, in advanced gynecologic cancers at ASCO 2026.
Among therapeutic-dose patients (4.8–8.0 mg/kg) with ≥12 weeks follow-up, ORR was 55% in gynecologic cancers, 52.9% in ovarian and 66.7% in USC, with favorable overall safety in 59 heavily pretreated patients. A virtual KOL event is scheduled for June 2, 2026 at 8:00 AM ET.
AI-generated analysis. Not financial advice.
Positive
- Gynecologic cancer ORR 55% (11/20) at 12 weeks in Phase 1
- Ovarian cancer ORR 52.9% (9/17) within 4.8–8.0 mg/kg dose range
- USC ORR 66.7% (2/3) in therapeutic SIM0505 dose cohorts
- Favorable overall safety profile reported in 59 heavily pretreated patients
- Grade 3/4 TEAEs mainly hematologic and manageable without primary prophylaxis
Negative
- Gynecologic efficacy data based on small cohort of 20 patients
- USC efficacy based on only 3 treated patients in therapeutic cohorts
- Three treatment-related adverse events led to SIM0505 dose discontinuation
- Data from early Phase 1 dose-escalation; no late-phase outcomes yet reported
News Market Reaction – NXTC
On the day this news was published, NXTC declined 45.48%, reflecting a significant negative market reaction. Argus tracked a peak move of +17.6% during that session. Argus tracked a trough of -59.3% from its starting point during tracking. Our momentum scanner triggered 94 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $19M from the company's valuation, bringing the market cap to $22.39M at that time. Trading volume was exceptionally heavy at 12.4x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
NXTC was down 3.13% while momentum peers showed mixed action: BIVI and IMNN were up about 5.6–7.0%, and BCTX was down nearly 9.9%. Broader biotech peers in the sector list mostly posted modest declines, indicating today’s move leaned stock-specific rather than a clean sector rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 21 | ASCO data preview | Positive | -6.2% | Announced upcoming SIM0505 Phase 1 data presentation at ASCO 2026. |
| Apr 07 | Fast Track win | Positive | +0.9% | FDA granted Fast Track designation for SIM0505 in ovarian cancer. |
| Nov 17 | PIPE financing | Positive | +2.7% | Closed $21.5M PIPE to fund SIM0505 and LNCB74 proof-of-concept work. |
| Oct 16 | Phase 1 expansion | Positive | +27.8% | Expanded SIM0505 Phase 1 trial into U.S. with favorable safety data. |
| Jul 24 | Preclinical results | Positive | +17.3% | Reported promising preclinical data for NC605 in osteogenesis imperfecta. |
Clinical and pipeline updates have often led to positive moves, but ASCO-related SIM0505 headlines previously saw at least one notable selloff.
Over the past year, NextCure has steadily advanced its pipeline, especially ADC candidate SIM0505. The company expanded a Phase 1 trial into the U.S. in Oct 2025 and raised about $21.5M via a PIPE in Nov 2025 to fund proof-of-concept work. Subsequent updates included Fast Track designation for SIM0505 and announcements that Phase 1 data would be presented at ASCO 2026. Earlier preclinical data in osteogenesis imperfecta also drew strong interest. Today’s Phase 1 efficacy and safety data represent the clinical readout these prior steps were building toward.
Historical Comparison
Past clinical-trial headlines for NXTC moved the stock by an average of 8.48%, with several strong rallies on SIM0505 and preclinical updates. Today’s ASCO Phase 1 results continue that clinical narrative but come after earlier ASCO-related news that once saw a notable pullback.
Clinical news has progressed from preclinical data in 2025 to SIM0505 Phase 1 expansion, financing to support ADC proof-of-concept, Fast Track designation, and finally detailed Phase 1 efficacy and safety data at ASCO 2026.
Regulatory & Risk Context
An effective S-3 shelf filed on Nov 26, 2025 registers 2,523,477 shares for resale from a prior private placement that raised about $21.5 million. NextCure does not receive proceeds from these resales, aside from a small amount if pre-funded warrants are exercised, so the shelf mainly facilitates liquidity for existing holders rather than new primary capital issuance.
Market Pulse Summary
The stock dropped -45.5% in the session following this news. A negative reaction despite positive Phase 1 data would fit earlier patterns where ASCO-linked announcements, such as the April 2026 data-preview, coincided with a 6.24% decline. Investors may focus on balance-sheet strain highlighted in recent SEC filings and the presence of a resale shelf registered for 2.52M shares. Past clinical news has often produced sharp upside moves as well, so sentiment around funding and dilution risk can heavily influence downside follow-through.
Key Terms
orr medical
recist 1.1 medical
antibody drug conjugate (adc) medical
topoisomerase 1 inhibitor medical
treatment emergent adverse events (teaes) medical
ecog performance status medical
first-in-human (fih) medical
AI-generated analysis. Not financial advice.
55% ORR in gynecologic cancers with52.9% in ovarian and66.7% in USC at 12 weeks by best response per RECIST 1.1 within the therapeutic dose range (4.8 – 8.0 mg/kg)- Favorable safety and tolerability in heavily pretreated population supports ongoing Phase 1 dose-optimization with emphasis on PROC
- NextCure to host virtual Key Opinion Leader (KOL) Event June 2, 2026 at 8 AM ET
BELTSVILLE, Md., June 01, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere Zaiming) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced the presentation of positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. NextCure plans to host a virtual KOL Event on Tuesday, June 2, 2026 (register here) to review these data.
Platinum-resistant ovarian cancer (PROC) and uterine serous carcinoma (USC) represent two of the most challenging gynecologic malignancies. In PROC, once platinum resistance develops, response rates to available therapies drop to as low as 10–
The Phase 1 dose escalation study (NCT06792552) evaluated SIM0505 in 59 heavily pre-treated cancer patients, with a data cutoff of April 07, 2026. Patients in the U.S. (n=25) and China (n=34) received SIM0505 at doses ranging from 1.6 mg/kg to 9.6 mg/kg, regardless of CDH6 expression.
Positive efficacy data were observed, with an objective response rate (ORR) of:
55% (11/20) for gynecologic cancers (ovarian cancer and USC)52.9% (9/17) for ovarian cancer66.7% (2/3) for USC- Responses were observed across a range of CDH6 expression
ORRs, above, are reported for patients within therapeutic dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with partial response (PR), there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.
“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. 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," said Michael Richman, President and CEO of NextCure.
“Data presented at ASCO 2026 underscore the promise of our ADC platform and SIM0505, purpose-designed to deliver better efficacy, safety and tolerability, combining a carefully selected EC1 CDH6 epitope with our proprietary CPT116 topoisomerase payload. These results validate the science behind the SIM0505 construct and the accelerating pace of the global development program. Together with our partner, we remain deeply committed to advancing innovative medicines for patients facing hard-to-treat cancers,” said Renhong Tang, PhD, CEO of Simcere Zaiming.
“Treatment of gynecologic cancers has advanced meaningfully in recent years, yet the need for safer and more effective treatments remains real. CDH6 is an attractive target given its expression across ovarian, uterine, and other solid tumors. ADCs directed at this target have the potential to deliver the deeper, more durable responses these patients need. The early response rates observed for SIM0505 at ASCO 2026 are encouraging, and I believe the safety profile is manageable in routine clinical practice. I am enthusiastic about this program and its potential to advance the standard of care in gynecologic cancers,” said Udayan Guha, MD, PhD, Chief Medical Officer of NextCure.
ASCO Poster Overview: “Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors”
Table 1: Study Subject Overview:
| Baseline Characteristics | All Patients (n=59) |
| Age, years: median (range) | 58 (42-78) |
| Sex, %: Male/Female | |
| Race, n (%) | |
| Asian | 34 ( |
| Black or African American | 3 ( |
| White | 20 ( |
| Other | 2 ( |
| Tumor Type, n (%) | |
| Ovarian | 46 ( |
| USC/other endometrial | 10 ( |
| Renal cell carcinoma (RCC) | 3 ( |
| ECOG performance status, n (%) | |
| 0 | 16 ( |
| 1 | 43 ( |
| Prior systemic anti-cancer regimen: median (range) | 5 (1-12) |
Table 2: Efficacy Overview:
| Patient Group | ORR* |
| All gynecologic patients (n=20) | |
| |
| |
| *Reported for patients within therapeutic SIM0505 dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the April 7, 2026 data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with PR, there was one unconfirmed PR and one PR pending confirmation at next follow-up scan. | |
Overall safety: Favorable overall data, potentially manageable in routine practice setting (n=59):
- Grade 1 and 2 treatment emergent adverse events (TEAEs) predominantly hematological, nausea and vomiting
- Grade 3 and 4 TEAEs predominantly hematological and manageable without primary prophylaxis for hematological toxicities
- Treatment related adverse events (TRAEs) requiring dose discontinuation: n=3
A full copy of the poster will be available on the NextCure website under the Investor Relations “Events & Presentations” tab following the presentation.
Virtual KOL Event
NextCure will host a virtual KOL Event to discuss the ASCO 2026 data.
- Date: June 2, 2026
- Time: 8:00 AM ET
- Registration Link: Click here
A replay of the webinar will be accessible on the Events page of the NextCure website for 90 days.
About SIM0505
SIM0505 is a novel ADC directed to CDH6, featuring a proprietary 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 PROC. The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for the treatment of PROC. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming.
About the Phase 1 Trial of SIM0505
SIM0505 is being evaluated in a global Phase 1 open-label, multicenter study (NCT06792552) with sites in the U.S. and China. The Phase 1 dose escalation segment has evaluated SIM0505, at dose levels from 1.6 mg/kg to 9.6 mg/kg, in heavily pre-treated cancer patients with solid tumors including gynecologic cancers and renal cell carcinoma. As of the April 7, 2026 data cutoff, 59 patients were enrolled without preselection for CDH6 expression. Follow-up is ongoing.
In May 2026, NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers, initially focusing on patients with PROC. The global study is expected to enroll up to 120 patients, with initial doses of 5.6, 6.4 and 7.2 mg/kg, at sites in the U.S., Canada, the EU and China.
About Ovarian Cancer4-8
Ovarian cancer is the fifth leading cause of cancer-related death among women. It is characterized by vague, easily overlooked symptoms like bloating, pelvic pain, and frequent urination that often go undetected until late stage. Risk factors include age, family history, BRCA1/2 mutations, and hormone therapy use. The median age at diagnosis is 63, and the overall 5-year relative survival rate is
About Uterine Serous Cancer2
Uterine serous carcinoma is a rare but highly aggressive subtype of endometrial cancer, accounting for approximately
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.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to address the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.
Sources:
- Based on Lheureux S, Braunstein M, Oza AM. CA Cancer J Clin. 2019;69(4):280–304. PMID: 31099893, DOI: 10.3322/caac.21559
- Based on Ferriss JS, Erickson BK, Shih IM, Fader AN. Int J Gynecol Cancer. 2021;31(8):1165–1174. PMID: 34210768, DOI: 10.1136/ijgc-2021-002753
- Based on Hamilton CA, Cheung MK, Osann K, et al. Br J Cancer. 2006;94(5):642–646. PMID: 16495918, DOI: 10.1038/sj.bjc.6603012
- Based on Cabarca S, Ili C, Vanegas C, Gil L, Vertel-Morrinson M, Brebi P. Drug resistance biomarkers in ovarian cancer: a bibliometric study from 2017 to 2022. Front Oncol. 2024 Nov 11;14:1450675. doi: 10.3389/fonc.2024.1450675. PMID: 39588300; PMCID: PMC11586235.
- National Cancer Institute SEER Program
- Ovarian Cancer Research Alliance (OCRA)
- American Cancer Society
- American Cancer Society / NCI SEER
All trademarks are the property of their respective owners.
Forward-Looking Statements
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, our expected cash runway, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.
Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: our expectations regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any other product candidates we develop; our estimates regarding our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations, market and other conditions; the timing or likelihood of regulatory filings for SIM0505, LNCB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the identification, analysis and use of biomarkers and biomarker data; our drug product sourcing and manufacturing strategy, including the scalability of our methods and processes; our expectations regarding the potential benefits, activity, effectiveness and safety of SIM0505, LNCB74 and any other product candidates we develop; our intentions and ability to successfully commercialize, including through partnering, our product candidates; our expectations regarding the nature of the biological pathways we are targeting; our expectations regarding our ability to discover and advance product candidates using our technologies; the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc., Simcere Zaiming Pharmaceutical Co., Ltd., and other third-party vendors and collaborators; our ability to retain key personnel; our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; changes in international relations, tariffs, and other trade regulations between the U.S. and China; our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; developments and projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations.
More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and 10-Q and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
Investor Inquiries
Timothy Mayer, PhD
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
Mike Moyer
Managing Director,
LifeSci Advisors, LLC
Phone: (617) 308-4306
mmoyer@lifesciadvisors.com
