(RTTNews) - NextCure, Inc. (NXTC), announced Monday a strategic partnership with Simcere Zaiming to develop SIM0505, a novel antibody-drug conjugate or ADC targeting CDH6 or cadherin-6 for the treatment of solid tumors.
SIM0505 is currently being evaluated in Phase 1 trials in China, with a U.S. Phase 1 trial expected to begin in the third quarter 2025.
Under the agreement, NextCure gains global rights to SIM0505, excluding Greater China, where Simcere Zaiming will retain development and commercialization rights.
Additionally, NextCure licensed access to Simcere Zaiming's proprietary ADC payload and linker technology for a second ADC directed to a NextCure-discovered target.
Simcere Zaiming will retain Greater China rights to that program as well.
SIM0505 utilizes Simcere's proprietary topoisomerase I inhibitor or TOPOi payload with enhanced tumor specificity and high systemic clearance, aiming for a wider therapeutic window and improved safety.
Preclinical models demonstrated strong anti-tumor activity and a favorable safety profile.
The ongoing Phase 1 dose escalation study in China will be followed by a global dose expansion in multiple solid tumor types.
Initial Phase 1 clinical data is expected in the first half of 2026, and an IND application has been cleared by the U.S. FDA for U.S. development.
Simcere Zaiming is eligible to receive up to $745 million in development, regulatory, and commercial milestone payments, plus tiered double-digit royalties on net sales outside Greater China.
Leadership from both companies emphasized the strategic value of the collaboration. Michael Richman, CEO of NextCure, said the partnership enables them to advance a "class-leading ADC" using Simcere's potent cytotoxic platform.
Renhong Tang, CEO of Simcere Zaiming, called SIM0505 a "significantly differentiated ADC candidate" and highlighted the global development potential enabled by the alliance.
The partnership marks NextCure's entry into the ADC space, strengthening its position in targeted cancer therapy and expanding its clinical pipeline into solid tumors using cutting-edge biologic technology.
Currently, NXTC is trading at $0.56, down by 16.91 percent on the Nasdaq.
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