The 2025 European Society for Medical Oncology (ESMO) Annual Congress was held in Oct 17-19, Berlin, Germany. CanWell presented preliminary safety and efficacy data from its Phase 1b/2a clinical trial of CAN1012, a first-in-class IFNα-biased TLR7 agonist, in combination with toripalimab for advanced solid tumors, in a poster presentation format.
- CAN1012 is an IFNα-biased TLR7 agonist
CAN1012 preferentially inducing IFN-α but inducing minimal pro-inflammatory cytokines such as IL-6, contributing to the favorable safety profile.
- CAN1012 plus toripalimab demonstrates superior safety
Among enrolled subjects, Grade 3 treatment-related adverse events (TRAEs) occurred in only 3.5% (with no Grade >3 TRAEs), and all other adverse events were mild (Grade 1–2). No cytokine release syndrome (CRS) or DLT events were observed,
- CAN1012 plus toripalimab may address unmet needs in PD-1-resistant advanced melanoma
In patients with advanced melanoma who relapsed or metastasized after PD-1 inhibitor treatment, the combination therapy achieved an objective response rate (ORR) of 37.5% and a disease control rate (DCR) of 100%.
- CAN1012 plus toripalimab could become a first-line option for dedifferentiated liposarcoma (DDLPS), addressing a lack of effective therapies
In patients with DDLPS, the combination therapy yielded an ORR of 25%, significantly higher than the ORR of doxorubicin monotherapy (2.9%) – the current treatment standard. Given that DDLPS is insensitive to conventional radiotherapy and chemotherapy, there is an urgent unmet clinical need.
The expansion part of the trial is on-going to generate additional data on safety and efficacy in DDLPS and melanoma.