There’s no stopping CDH17
No fewer than four ADCs with this target start human testing.
No fewer than four ADCs with this target start human testing.
There should by now be no remaining doubts that CDH17 is a hot target for companies developing antibody-drug conjugates, with recent listings on the clinicaltrials.gov registry revealing the entry into first-in-human studies of four more anti-CDH17 ADCs, from Jiangsu Simcere, Mabwell, Huadong Medicine and Duality Biologics.
When ApexOnco last analysed this space, in July, there were 11 such projects in development, six of which were in clinical trials. Huadong’s HDM2017 was among several preclinical anti-CDH17 ADCs that at the time had recently had their IND accepted, and HDM2017 as well as Simcere’s SIM0609 and Mabwell’s 7MW4911 had all featured in preclinical posters at AACR.
Of the other projects that were preclinical at the time, LaNova’s LM-350 entered human testing shortly afterwards, while IND filings for Nanjing Leads’ LBL-054-ADC and Sotio’s SOT109 are expected next year. The latest entries bring the total number of clinical-stage anti-CDH17 ADCs to 11 (there are additional projects that hit this target but use a different modality).
Big pharma buy-in
Perhaps the most interesting among the new entrants is Duality’s DB-1324, given that ex-China rights to this project were a year ago optioned to GSK for $30m up front. At the time it hadn’t been disclosed that DB-1324 targeted CDH17.
It was a little while later that the target was disclosed, and similar secrecy surrounded a MAb that Sotio licensed from Biocytogen for development as the ADC now coded SOT109. The biggest big pharma endorsement of CDH17 so far appears to have come from Roche, which in October paid Hansoh Pharma (ironically a separate ADC partner of GSK’s) $80m for rights to HS-20110.
It was at this year’s AACR conference that CDH17, a protein said to be overexpressed in GI cancers but to be inaccessible in normal tissues, really burst onto the scene as a target for potential oncology drugs. If the sums being paid in licensing deals still seem relatively undemanding this might be a reflection of the supply of Chinese anti-CDH17 ADCs outstripping demand.
It won’t go unnoticed that three of the new clinical entrants, SIM0609, 7MW4911 and HDM2017, are still unpartnered.
Recently disclosed first-in-human studies*
| Project | Mechanism | Company | Trial | Scheduled start |
|---|---|---|---|---|
| CEL001 | NK cells | Guangzhou Xiling | Solid tumours | 16 Jun 2025 |
| VSV-02 | PD-L1 T-cell engager-expressing oncolytic virus | Joint Biosciences | Solid tumours | 22 Sep 2025 |
| JMT106 | GPC3 x IFN bispecific fusion protein | CSPC Pharmaceutical | Solid tumours | 25 Sep 2025 |
| SIM0609 | CDH17 ADC | Jiangsu Simcere | Solid tumours | 7 Nov 2025 |
| 7MW4911 | CDH17 ADC | Mabwell | Solid tumours | 12 Nov 2025 |
| CC-38 | TILs | Curacell | Probetility study, in colorectal & prostate cancers | 13 Nov 2025 |
| HDM2017 | CDH17 ADC | Huadong Medicine | Solid tumours | 18 Nov 2025 |
| DB-1324 | CDH17 ADC | DualityBio/ GSK | GI tumours | Dec 2025 |
Note: *these projects were first listed on the clinicaltrials.gov database between 1 and 10 Dec 2025.
Away from CDH17, recent human trial entrants include NK cell and TIL (tumour-infiltrating lymphocyte) therapies from Guangzhou Xiling and Curacell respectively, showing that interest in such approaches remains in spite of their undistinguished clinical history.
GPC3 remains a hot target for treating solid tumours, though CSPC’s JMT106 uses not a Car-T or T-cell engager format but rather a fusion protein where GPC3 binding is combined with interferon receptor activation to achieve immune system stimulation. JMT106 was granted a Chinese IND in May.
And the most scientifically intriguing approach entering the clinic is Joint Biosciences’ oncolytic virus VSV-02. However, this is no ordinary oncolytic virus, being additionally engineered to express a bispecific MAb – in this case an anti-PD-L1 T-cell engager – something the company claims it does “only in tumour cells”.
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