
Lepu sees pancreatic cancer promise for tissue factor

With tissue factor slowly gaining favour as a target for ADCs, this field will shortly have three pivotal-stage projects. That's because Lepu's contender, MRG004A, is to go into a phase 3 study in January, a new listing on clinicaltrials.gov reveals. The other similarly advanced anti-TF ADCs are Pfizer/Genmab's approved cervical cancer drug Tivdak, and Evopoint's XNW28012; meanwhile, the early-stage pipeline has seen the entry into the clinic of Exelixis's XB371, and a licensing deal between Adcendo and Multitude Therapeutics over ADCE-T02. A key difference between the pivotal trials of MRG004A and XNW28012, and the approved setting of Tivdak, is that the Lepu and Evopoint studies concern pancreatic cancer – a tumour type in which Tivdak doesn't even appear to have been investigated. One reason for pursuing such a tough cancer type could be the data Lepu put up at ASCO in 2024 from a first-in-human solid tumour trial. Here six of 38 patients had partial responses to MRG004A, and zeroing in on 12 subjects with pancreatic ductal adenocarcinoma given 2mg/kg yielded four PRs. All four of these responders had TF expression at 50% or above, Lepu said, though curiously its phase 3 study doesn't mandate expression of this antigen.
Anti-TF ADCs in pivotal development
Project | Company | Status |
---|---|---|
Tivdak | Pfizer (ex Seagen)/ Genmab | Approved for second-line cervical cancer (InnovaTV-301 study) |
XNW28012 | Evopoint | Ph3 in 3rd-line pancreatic cancer (CTR20252545) |
MRG004A | Lepu Biopharma | Ph3 in 2rd-line pancreatic cancer starts Jan 2026 |
Source: OncologyPipeline.
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