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LEAD PROGRAM: PIKTOR

serabelisib + sapanisertib

(FTH-001 + FTH-003) aka PIKTOR
Mechanism of Action
PI3Kɑ inhibitor     |    mTORC1/2 inhibitor
Lead Indication
Endometrial cancer

Potential to be transformative in endometrial cancer and beyond.

The PIKTOR program shuts down the PI3K/AKT/mTOR pathway, which is the most frequently mutated pathway and the major mammalian metabolic hub in cancer. This pathway is key to the proliferation of cells, especially cancer cells.

Together, serabelisib and sapanisertib slow cancer growth and may increase overall survival in combination with cytotoxic drugs. Our approach provides true pathway blockade to finally realize the potential of inhibiting the PI3K/AKT/mTOR pathway.

PI3K/AKT/mTOR is one of most important oncogenic pathways

PIKTOR targets multiple pathway components to completely shut down the PI3K/mTOR pathway. The program also includes an insulin suppressing diet, designed to mitigate the toxicities commonly associated with the drug class.
AN3CA Human Endometrial Cancer Cell Xenograft Study

Preclinical data

  • PIKTOR inhibits the PI3K/AKT/mTOR pathway more effectively than approved drugs
  • PIKTOR + paclitaxel suppresses tumor growth more than paclitaxel alone in a variety of solid tumors, both pathway-mutated and non-pathway-mutated
  • Adding an insulin-suppressing diet prevents pathway initiation, further contributing to pathway shutdown
AN3CA Human Endometrial Cancer Cell Xenograft Study

Preclinical data

  • PIKTOR inhibits the PI3K/AKT/mTOR pathway more effectively than approved drugs
  • PIKTOR + paclitaxel suppresses tumor growth more than paclitaxel alone in a variety of solid tumors, both pathway-mutated and non-pathway-mutated
  • Adding an insulin-suppressing diet prevents pathway initiation, further contributing to pathway shutdown

Clinical data

PIKTOR has demonstrated outstanding efficacy in our Ph1b study of PIKTOR + paclitaxel in PI3K mutated solid tumors.

Sapanisertib and serabelisib have been very well tolerated by patients across multiple clinical studies.
Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors - PubMed
View the published paper
47%
ORR in Phase 1b dose escalation study in advanced, disease-recurrent patients
71%
ORR in PI3K/AKT/mTOR mutated patients in Phase 1b dose escalation study in advanced, disease-recurrent patients
3
CRs from 15 evaluable patients in Phase 1b dose escalation study in advanced, disease-recurrent patients

PIKTOR for the treatment of endometrial cancer.

Our goal is to transform the treatment of endometrial cancer while maintaining quality of life for patients. There are a handful of approved PI3K and mTOR inhibitors on the market, but we believe the combination of serabelisib and sapanisertib can achieve better outcomes with decreased toxicity.

In endometrial cancer, PIKTOR in combination with paclitaxel has the potential for best-in-class oral performance, with greater efficacy and decreased toxicity vs. other approved agents.
Target Value Propositions
Primary endpoint:
To see how many patients have their tumors shrink or disappear with the treatment.
Upside includes improvements in:
• Increased tumor response to chemotherapy
• Progression-free survival
• Overall survival rates

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