NextCure and Simcere Zaiming Form Partnership for CDH6-Targeting Antibody-Drug Conjugate

NextCure, Inc., a biopharmaceutical firm focused on developing cutting-edge therapies for cancer treatment, has announced a strategic partnership with Simcere Zaiming, an oncology-centered biopharmaceutical company. This collaboration aims to advance the development of SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6, known as cadherin-6 or K-cadherin. The partnership is set to expand the therapeutic options available for treating various solid tumors.

SIM0505 is currently undergoing Phase 1 clinical trials in China, with NextCure planning to initiate similar trials in the United States by the third quarter of 2025. The ADC is designed to address the promising anti-tumor target CDH6 using a specific binding epitope that enhances tumor binding compared to existing alternatives. The drug also incorporates Simcere Zaiming's proprietary topoisomerase 1 inhibitor (TOPOi) payload, which is intended to deliver broad anti-tumor effects while maintaining high systemic clearance, thereby optimizing the therapeutic window.

Preclinical studies have demonstrated significant anti-tumor activity across various solid tumor models, alongside a favorable safety profile in toxicology assessments. SIM0505 is presently undergoing Phase 1 dose escalation studies in China. Following this, a global dose expansion study is anticipated to encompass multiple tumor types. Furthermore, the U.S. Food and Drug Administration has cleared an Investigational New Drug application for the ADC.

NextCure has also secured a license to utilize Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage ADC directed toward a novel target developed by NextCure. However, Simcere Zaiming retains rights for this novel target ADC within Greater China.

Michael Richman, NextCure's president and CEO, expressed confidence in SIM0505's potential as a significant therapy for cancer patients. He emphasised the strategic partnership with Simcere Zaiming as an opportunity to advance a top-tier ADC directed towards CDH6, highlighting the potency and potentially enhanced safety and efficacy profile of the proprietary payload compared to other topoisomerase inhibitors.

Renhong Tang, CEO of Simcere Zaiming, echoed these sentiments, noting the collaboration's potential to accelerate drug development and expand treatment options for cancer patients globally. He emphasized the innovative nature of SIM0505 as a differentiated CDH6-targeting ADC candidate developed by Simcere Zaiming. The partnership underscores NextCure's recognition of Simcere Zaiming's proprietary ADC platform.

As part of the partnership agreement, Simcere Zaiming is eligible to receive payments during various development phases, including upfront payment and milestones related to development, regulatory processes, and sales. These payments could cumulatively amount to $745 million, along with tiered royalties on net sales outside of Greater China.

NextCure, Inc., headquartered in Beltsville, Maryland, is dedicated to developing innovative treatments for cancer patients who do not respond to current therapies or experience disease progression. The company leverages differentiated mechanisms of action, such as antibody-drug conjugates, to understand biological pathways and biomarkers, particularly the interactions within the tumor microenvironment.

Simcere Zaiming, based in Shanghai, is a subsidiary of Simcere Pharmaceutical Group Ltd. Founded in 2023, the company is committed to developing groundbreaking therapies to address unmet clinical needs of cancer patients worldwide. With a strong and innovative research and development pipeline, Simcere Zaiming has successfully launched several products in China and aims to deliver transformative treatment options globally through strategic collaborations and internal capabilities.