STOCK TITAN

NextCure and Simcere Zaiming Announce Expansion of Ongoing Phase 1 Trial of SIM0505 (CDH6 ADC) into the United States

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Positive)

NextCure (Nasdaq: NXTC) and Simcere Zaiming announced expansion of the ongoing Phase 1 trial of SIM0505 (CDH6 ADC) into the United States on Oct 16, 2025. The first U.S. patient was dosed at a mid-tier dose level where multiple responses have been observed, while dose escalation continues in China.

NextCure holds an exclusive global license (excluding Greater China) for SIM0505. The trial evaluates safety, tolerability, pharmacokinetics and efficacy in advanced solid tumors; current data are described as well tolerated with a favorable safety profile. Both companies expect to accelerate enrollment and aim to present proof-of-concept data in 1H 2026.

NextCure (Nasdaq: NXTC) e Simcere Zaiming hanno annunciato l'espansione dello studio di fase 1 in corso di SIM0505 (CDH6 ADC) negli Stati Uniti in data 16 ottobre 2025. Il primo paziente USA è stato dosato a un livello di dose medio, dove sono state osservate multiple risposte, mentre l'aumento della dose continua in Cina.

NextCure detiene una licenza globale esclusiva (esclusa la Grande Cina) per SIM0505. Il trial valuta sicurezza, tollerabilità, farmacocinetica ed efficacia in tumori solidi avanzati; i dati attuali sono descritti come ben tollerati con un profilo di sicurezza favorevole. Entrambe le aziende si aspettano di accelerare l'arruolamento e mirano a presentare dati di proof-of-concept nel 1° semestre 2026.

NextCure (Nasdaq: NXTC) y Simcere Zaiming anunciaron la expansión del ensayo de fase 1 en curso de SIM0505 (CDH6 ADC) a Estados Unidos el 16 de octubre de 2025. El primer paciente en EE. UU. recibió una dosis a un nivel de dosis medio donde se han observado múltiples respuestas, mientras que la escalada de dosis continúa en China.

NextCure posee una licencia global exclusiva (excluida la Gran China) para SIM0505. El ensayo evalúa seguridad, tolerabilidad, farmacocinética y eficacia en tumores sólidos avanzados; los datos actuales se describen como bien tolerados con un perfil de seguridad favorable. Ambas compañías esperan acelerar el reclutamiento y apuntan a presentar datos de prueba de concepto en la 1ª mitad de 2026.

NextCure (Nasdaq: NXTC)와 Simcere Zaiming은 SIM0505 (CDH6 ADC)의 현재 1상 임상시험을 미국으로 확장한다고 2025년 10월 16일에 발표했습니다. 미국의 첫 환자는 중간 고용량에서 투여되었고, 이때 여러 반응이 관찰되었으며, 중국에서는 용량 증가가 계속되고 있습니다.

NextCure는 SIM0505에 대해 글로벌 독점 면허(그레이터 차이나 제외)를 보유하고 있습니다. 이 연구는 진행성 고형암에서 안전성, 내약성, 약동학 및 효능을 평가합니다; 현재 데이터는 잘 견디고 있으며 우수한 안전성 프로필로 설명됩니다. 양사는 모집 속도를 가속화할 것으로 기대하고 2026년 상반기에 개념검증 데이터를 제시하는 것을 목표로 합니다.

NextCure (Nasdaq : NXTC) et Simcere Zaiming ont annoncé l'extension de l'essai de phase 1 en cours de SIM0505 (CDH6 ADC) vers les États-Unis le 16 octobre 2025. Le premier patient américain a été dosé à un niveau de dose moyen où plusieurs réponses ont été observées, tandis que l'augmentation des doses se poursuit en Chine.

NextCure détient une licence mondiale exclusive (à l'exception de la Grande Chine) pour SIM0505. L'essai évalue la sécurité, la tolérance, la pharmacocinétique et l'efficacité chez des tumeurs solides avancées; les données actuelles sont décrites comme bien tolérées avec un profil de sécurité favorable. Les deux sociétés s'attendent à accélérer le recrutement et visent à présenter des données de preuve de concept au 1er semestre 2026.

NextCure (Nasdaq: NXTC) und Simcere Zaiming kündigten die Erweiterung der laufenden Phase-1-Studie von SIM0505 (CDH6 ADC) in die Vereinigten Staaten am 16. Oktober 2025 an. Der erste US-Patient wurde in einer mittleren Dosisstufe dosiert, bei der mehrere Reaktionen beobachtet wurden, während die Dosissteigerung in China fortgesetzt wird.

NextCure hält eine exklusive globale Lizenz (außerhalb von Greater China) für SIM0505. Die Studie bewertet Sicherheit, Verträglichkeit, Pharmakokinetik und Wirksamkeit bei fortgeschrittenen soliden Tumoren; aktuelle Daten werden als gut verträglich mit einem vorteilhaften Sicherheitsprofil beschrieben. Beide Unternehmen erwarten eine beschleunigte Rekrutierung und streben an, Beweis-der-Konzept-Daten im 1. Halbjahr 2026 vorzulegen.

NextCure (ناسداك: NXTC) وSimcere Zaiming أعلنوا توسيع تجربة المرحلة 1 قيد التنفيذ لـ SIM0505 (CDH6 ADC) إلى الولايات المتحدة في 16 أكتوبر 2025. تم حقن أول مريض في الولايات المتحدة عند مستوى جرعة متوسط حيث لوحظت استجابات متعددة، بينما يستمر التصعيد في الجرعات في الصين.

تمتلك NextCure ترخيصاً عالمياً حصرياً (باستثناء منطقة الصين الكبرى) لـ SIM0505. تقيم التجربة السلامة والتحمل الدوائي والتوافر الحيوي والفعالية في الأورام الصلبة المتقدمة؛ تُوصف البيانات الحالية بأنها متسامحة جيداً بملف أمان إيجابي. وتتوقع الشركتان تسريع التسجيل ويهدفان إلى تقديم بيانات إثبات المفهوم في النصف الأول من 2026.

NextCure (纳斯达克:NXTC) 与 Simcere Zaiming 宣布将正在进行的 SIM0505 (CDH6 ADC) 的1期试验扩展至美国,时间为 2025年10月16日。美国首名受试者在中等剂量水平被给药,在该剂量水平观察到多种应答,而中国仍在进行剂量递增。

NextCure 拥有 SIM0505 的< b>全球独家许可(不包括大中华区)。该试验评估晚期实体瘤的安全性、耐受性、药代动力学和疗效;目前数据描述为耐受性良好,具备有利的安全性特征。两家公司都预计加快招募,目标在2026年上半年呈现 概念验证数据

Positive
  • First U.S. patient dosed at a mid-tier level
  • Mid-tier dose where multiple responses have been observed
  • Company expects proof-of-concept data in 1H 2026
  • NextCure holds exclusive global license (ex-Greater China)
  • Reported favorable safety profile and tolerability
Negative
  • Dose escalation is still ongoing in China
  • SIM0505 rights exclude Greater China for NextCure
  • Trial remains early-stage Phase 1 with limited clinical data

Insights

First U.S. dosing at a mid-tier level with prior responses accelerates SIM0505's global Phase 1 program.

SIM0505 entered the U.S. arm of its ongoing Phase 1 study on Oct. 16, 2025, with the first patient dosed at a mid-tier dose where multiple responses have been observed. The study continues dose escalation in China while U.S. enrollment targets a dose within an observed therapeutic range.

The key dependencies are safety, tolerability, and confirmatory response data from the combined multi-regional cohort. The release states the agent has been "well tolerated with a favorable safety profile," which is a factual claim that needs corroboration by full data before changing risk views. Watch for pooled safety/efficacy readouts and a planned proof-of-concept update in 1H 2026.

U.S. expansion plus an exclusive global license (ex-Greater China) sharpens NextCure's development and commercial optionality.

NextCure now enrolls U.S. patients under its exclusive global license excluding Greater China, aligning clinical development with potential global regulatory engagement. Multi-regional enrollment should increase the speed and diversity of evidence feeding the Phase 1 proof-of-concept milestone.

Risks include reliance on ongoing dose escalation in China and the need to confirm responses at the mid-tier dose in a broader population. Monitor the combined safety and efficacy dataset and the timing of the proof-of-concept data in 1H 2026 for clearer program value signals.

  • First U.S. patient dosed at a mid-tier dose level where multiple responses have been observed
  • Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026

BELTSVILLE, Md. and SHANGHAI, Oct. 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.

SIM0505 is a novel antibody drug conjugate directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, high systemic clearance and an improved potential therapeutic window. NextCure has now expanded the ongoing Phase 1 dose escalation study, which was initiated in China, by enrolling patient(s) in the U.S. into a mid-tier dose level while dose escalation is currently advancing in China. NextCure acquired an exclusive global license, excluding Greater China, for SIM0505 from Simcere Zaiming.

“We are pleased by the significant progress achieved by our partner, which has enabled us to start U.S. enrollment at doses within a therapeutic range where clinical responses have already been observed. Based on current data, SIM0505 has been well tolerated with a favorable safety profile,” said Udayan Guha, M.D., Ph.D., NextCure’s chief medical officer. “We believe that SIM0505 has the potential to become a leading ADC targeting CDH6. We look forward to accelerating the ongoing trial and presenting proof-of-concept clinical data in the first half of 2026.”

“Enrollment of the first patient in the U.S. marks a significant milestone in global clinical development of SIM0505. This achievement reflects our ongoing commitment to advancing innovative oncology treatments for patients in China and worldwide,” said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming.”

About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com

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 dedicated to developing groundbreaking therapies to meet 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.

NextCure’s Cautionary Statement Regarding 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, 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: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. 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 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.

NextCure Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com

Simcere Zaiming Contacts
PR contacts: pr@zaiming.com
IR contacts: ir@zaiming.com


FAQ

What did NextCure (NXTC) announce about SIM0505 on October 16, 2025?

NextCure and Simcere Zaiming expanded the Phase 1 SIM0505 trial into the U.S. and dosed the first U.S. patient at a mid-tier dose.

What is the significance of dosing the first U.S. patient for NXTC SIM0505?

U.S. dosing enables multi-regional enrollment at a dose level where multiple responses were already observed, accelerating clinical data collection.

When does NextCure expect to report proof-of-concept data for SIM0505 (NXTC)?

The companies anticipate presenting proof-of-concept clinical data in the first half of 2026.

What rights does NextCure hold for SIM0505 (NXTC)?

NextCure holds an exclusive global license for SIM0505, excluding Greater China.

What endpoints is the Phase 1 SIM0505 trial (NCT06792552) evaluating?

The study is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.

Has SIM0505 shown any safety concerns in early data for NXTC?

According to the companies, current data show SIM0505 has been well tolerated with a favorable safety profile.
Nextcure

NASDAQ:NXTC

NXTC Rankings

NXTC Latest News

NXTC Latest SEC Filings

NXTC Stock Data

23.28M
2.28M
14.79%
32.58%
1.48%
Biotechnology
Pharmaceutical Preparations
Link
United States
BELTSVILLE