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NextCure (NXTC) investor relations material
NextCure H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline overview and development focus
Two key antibody-drug conjugate (ADC) assets are in phase one, targeting women's health and other tumors.
B7H4 ADC uses a proprietary beta-glucuronidase linker, co-developed with LigaChemBio, with proof-of-concept data expected in the first half of next year.
CDH6 ADC, in-licensed from Simcere Zaiming, uses a topoisomerase inhibitor and is also in phase one, with parallel trials in China and the U.S.
Both ADCs target ovarian, breast, and endometrial cancers, with potential for combination or sequencing strategies.
Simcere Zaiming partnership includes a $12M upfront payment, drug supply, and a $2M equity investment.
Differentiation and competitive landscape
B7H4 ADC features a unique linker system and tubulin inhibitor payload, aiming for higher specificity and reduced toxicity.
High-affinity antibody and well-internalized construct distinguish the asset from competitors using different linkers and payloads.
Patient selection uses immunohistochemistry to identify high B7H4 expressors, aiming to maximize response rates.
Competitive benchmarks for response rates are set at 20–25%, with a goal to exceed 25% for superiority.
No dose-limiting toxicities observed so far in the highest dose cohort of the B7H4 ADC phase one trial.
Clinical trial design and timelines
B7H4 ADC phase one is in the fourth dose cohort, focusing on safety and response rates, with backfilling planned for high-expressing ovarian and endometrial cancer patients.
Initial phase one data for B7H4 ADC expected in the first half of 2026, with an update before year-end.
CDH6 ADC phase one is enrolling in China and will soon start in the U.S., focusing on ovarian, endometrial, kidney, and select lung cancers.
Simcere Zaiming’s China trial has shown partial responses, and U.S. enrollment is set to begin by the end of the current quarter.
Both ADCs may be used in combination or sequencing, with preclinical studies underway to optimize regimens.
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