Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC) Phase 1 data readout to be presented at ASCO 2026  BELTSVILLE, Md., May  04, 2026  (GLOBE

NXTC

NextCure and Simcere Zaiming Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers

NextCure Initiates Key Dose Optimization Study for Cancer Drug SIM0505

<section class="insight" data-version="1">
 <section data-block="information">
 <h3>Information</h3>
 Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC) Phase 1 data readout to be presented at ASCO 2026 BELTSVILLE, Md., May 04, 2026 (GLOBE
 </section>

 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 NextCure has initiated the dose optimization phase for SIM0505, targeting platinum-resistant ovarian cancer. With Fast Track designation from FDA and upcoming Phase 1 data to be presented at ASCO 2026, this may significantly advance NXTC&#039;s market positioning and valuation.
 </section>

 <section data-block="ai-summary-bullets">
 <h3>Key Points</h3>
 <ul><li>NextCure begins dose optimization for SIM0505 in platinum-resistant ovarian cancer.</li><li>Phase 1 data expected at ASCO 2026 will focus on initial results.</li><li>Expanding clinical sites in the U.S., China, Canada, and Europe.</li><li>FDA granted Fast Track designation for SIM0505 targeting CDH6.</li><li>NextCure holds exclusive global rights to SIM0505 outside select Asian markets.</li></ul>
 </section>

 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Simcere Pharmaceutical Group Ltd. (HKEX: 2096): Simcere retains rights for SIM0505 in specific Asian markets.</li></ul>
 </section>

 <section data-block="category">
 <h3>Corporate Developments</h3>
 This news fits under &#039;Corporate Developments&#039; as it involves NextCure&#039;s advancement in clinical trials, which is crucial for investor sentiment and potential revenue streams.
 </section>

 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>Upcoming ASCO 2026 presentation could boost investor confidence and stock price.</li><li>Fast Track designation by FDA may improve market perception of NXTC.</li><li>Expansion of clinical sites indicates strategic growth and resource allocation.</li></ul>
 </section>

 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>NextCure initiated SIM0505 dose optimization on May 4, 2026.</li><li>FDA granted Fast Track designation for SIM0505.</li><li>SIM0505 targets Cadherin-6 (CDH6) in oncology treatments.</li><li>Phase 1 trial data will be presented at ASCO 2026.</li><li>NextCure has exclusive global rights to SIM0505, except in certain Asian markets.</li></ul>
 </section>

 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Buy NXTC ahead of ASCO 2026 data release for potential upside.
 </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><ul><li>Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC) </li><li style="margin-bottom:3pt;">Phase 1 data readout to be presented at ASCO 2026</li></ul> BELTSVILLE, Md., May 04, 2026 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=KoHgS0Tvm5Mfje1Jpk49YUqgPN0kPbhZuR5-sGEaNPQSlYJjj0nJj1lrQy8LOruKtTByTeKX1bnoYvGlZi1_W5MzgYpHUT8rn_jLlcz-R_k=" rel="nofollow" target="_blank">NextCure, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/NXTC">NXTC</a>), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload. "Initiation of dose optimization highlights the promise of our novel CDH6-directed ADC and our focus on bringing SIM0505 to patients as quickly as possible. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe," said Michael Richman, President and CEO of NextCure. "We look forward to presenting Phase 1 data at the upcoming 2026 American Society of Clinical Oncology (ASCO) conference as we continue to build momentum in the program." About SIM0505 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 (<a href="https://www.globenewswire.com/Tracker?data=WKuL0b7qaMtjulrQMxUANI6pOQ3QUocs10kXLAQ22Pkt9-O7pcLeWLSdo95HFEPcWh1TUMO5kcA5Ur4iDBLGt3rRsAAMRHmNtz00FfXxOvDiaF2rKuzb6vXYRUkOIoJZ" rel="nofollow" target="_blank">NCT06792552</a>) for the potential treatment of advanced solid tumors, including ovarian cancer with an emphasis on platinum resistant ovarian cancer. The Food and Drug Administration granted Fast Track to SIM0505 for platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. 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, &#34;Simcere&#34;). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&amp;D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu&#xAE;, COSELA&#xAE;, Enweida&#xAE;, Endostar&#xAE;, and Enlituo&#xAE;. The Company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&amp;D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. 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: market and other conditions; positive results in preclinical studies which 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 reliance upon collaborators and international vendors for advancing clinical programs; 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. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 <a href="https://www.globenewswire.com/Tracker?data=k8BEcXuZQCOIFA_jMpGdI8aOmWGHr0Q9lIFvg_emns-nw7O2iYW1kHG-OWgZnyU6l9enTGl5GLlbMzT0GGLGEUfjAZ_oQKgRdlmkpjvB8xw=" rel="nofollow" target="_blank">IR@nextcure.com</a> Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 <a href="https://www.globenewswire.com/Tracker?data=7KEc2--Wkxaq-TDSRw5cimmaihR6SwhEMJcZHjeJadrRScqnsGusxfEvfrU1tlSMkwh0bmhPe3_VdddyOegwXT8eH7sYTS0PgN0YonnJVcTHtBNO7frRKVazYJkj_ma-" rel="nofollow" target="_blank">mmoyer@lifesciadvisors.com</a> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTcxMTgxMCM3NTc5MDkyIzIxMjU4MzY="></img> <img alt="" src="https://ml.globenewswire.com/media/OWViZGUyZTYtYmQ2Yi00MjhlLTgzMDctZGYwODlkMzg5NWY4LTExMzc0MDctMjAyNi0wNS0wNC1lbg==/tiny/NextCure.png" referrerpolicy="no-referrer-when-downgrade"></img><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/df24cd65-0f3d-4ede-9e7a-c3f58ce6e9d4"><img src="https://ml.globenewswire.com/media/df24cd65-0f3d-4ede-9e7a-c3f58ce6e9d4/small/logo-nextcure-jpg.jpg" border="0" width="150" height="26" alt="Primary Logo"></img></a>

NextCure has initiated the dose optimization phase for SIM0505, targeting platinum-resistant ovarian cancer. With Fast Track designation from FDA and upcoming Phase 1 data to be presented at ASCO 2026, this may significantly advance NXTC's market positioning and valuation.

NextCure and Simcere Zaiming Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers

AI Summary

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Trading Thesis

Market-Moving

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Companies Mentioned

Corporate Developments

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