FF-10502 is a nucleoside analog targeting DNA damage repair and replication polymerases. Non-clinical studies have demonstrated anti-tumor activities with monotherapy and synergistic effects in combination with various DNA damaging agents (Publication).

FF-10502 has been granted FDA orphan drug designation for cholangiocarcinoma based on a phase 1/2a monotherapy study in the US (NCT02661542). Retrospective analyses of the phase 1/2a study data indicate BAP1 and PBRM1 mutations as potential patient stratification markers (Publication).

FF-10832 is a hydrogenated soybean phosphatidylcholine (HSPC)-based PEGylated liposomal gemcitabine. Non-clinical studies have demonstrated prolonged plasma half-life and superior anti-tumor activities and safety compared to non-liposomal gemcitabine via preferential accumulation in the tumor microenvironment (2019, 2021 publications). Synergistic anti-tumor activities and immune cell modulations are also demonstrated in combination with immune checkpoint inhibitors in animal models (Poster).

Phase 1 dose-escalation part has been completed (Poster). Expansion is ongoing for biliary tract cancer with monotherapy in the US (NCT03440450). A phase 2a study is also ongoing for monotherapy and pembrolizumab combination in urothelial and non-small cell lung cancers in collaboration with MSD (NCT05318573).

FF-10850 is a dihydrosphingomyelin (DHSM)-based PEGylated liposomal topotecan. DHSM and our proprietary liposomal formulation allow efficient payload loading and stable encapsulation (Publication). Non-clinical studies have demonstrated prolonged plasma half-life and superior anti-tumor activities and safety compared to non-liposomal topotecan via preferential accumulation and payload release in the tumor microenvironment (Publication). Enhanced activities were also observed in combination with platinum, PARP, and immune checkpoint inhibitors in animal models (Publication).

Phase 1 dose-escalation part has been completed (Poster). Expansion is ongoing for Merkel cell carcinoma with monotherapy in the US (NCT04047251). FF-10850 has been granted FDA orphan drug designation for Merkel cell carcinoma based on ongoing phase 1 data.