Accanito Inc is strategically assessing GIST as a lead indication for Phase II study
Accanito’s lead asset GAM-05 has a unique mechanism of action – dysfunctioning mitochondria, triggering irreversible tumor cells death without adversely impacting healthy cells.
GAM-05 has been proven effective against NCI 60 different cancer lines and has shown efficacy across multiple indications in both xenographic and transgenic animal models.
Phase I is progressing at Fox Chase Cancer Center, Philadelphia in patients with solid tumors or Lymphoma – across multiple indications. 18 patients (multiple indications) have completed the trial with 5 level dose escalation to 85 mg/QW, and 336 plasma samples have been analyzed for human PK. No dose limiting toxicity observed, human PK is tracking as expected and early efficacy signals in a heavily pretreated patient population are noticed. Trial is still open and enrolling (Target: 36-42 patients with max dose 320mg/QW).
𝗧𝗿𝗶𝗮𝗹 𝗶𝗻 𝗽𝗿𝗼𝗴𝗿𝗲𝘀𝘀 (𝗧𝗜𝗣) 𝘄𝗮𝘀 𝗽𝗿𝗲𝘀𝗲𝗻𝘁 𝗮𝘁 𝗔𝗦𝗖𝗢.
𝗡𝗲𝘄𝘀-𝗠𝗲𝗱𝗶𝗰𝗮𝗹 (𝗝𝘂𝗻𝗲 𝟮, 𝟮𝟬𝟮𝟲)
(https://lnkd.in/d9ynag8p)
𝗝𝗼𝘂𝗿𝗻𝗮𝗹 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗔𝗦𝗖𝗢 𝗔𝗯𝘀𝘁𝗿𝗮𝗰𝘁 (𝗧𝗣𝗦𝟯𝟭𝟴𝟬)
(https://lnkd.in/dQ4wG9NR)
𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗫𝗽𝗿𝗲𝘀𝘀 (𝗝𝘂𝗻𝗲 𝟮, 𝟮𝟬𝟮𝟲)
(https://lnkd.in/du4DymbQ)
Looking at preclinical and early phase I efficacy signal, Accanito is considering Gastrointestinal Stromal Tumor (GIST) as a lead indication for Phase II. Key factors are highly likelihood of clinical success, short/small clinical studies, accelerate approval (breakthrough, fast track or ODD etc designation), and early commercialization – compassionate use or early access.
