Pipeline

Our Pipeline

Pursuing first-in-class therapies targeting the PAM (PI3K/AKT/mTOR) pathway

The PAM (PI3K/AKT/mTOR) pathway has been implicated in breast, prostate, endometrial, ovarian and hematological cancers, among others. We are currently developing REVTORPYK, an inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, to treat advanced breast cancer and metastatic castration resistant prostate cancer.

REVTORPYK (Gedatolisib) Clinical Pipeline

HR+/HER2- Breast Cancer – Advanced or Metastatic
Tumor Type/indication
Gedatolisib Combination
  • Phase 1 PH 1
  • Phase 2 PH 2
  • Phase 3 PH 3
  • Approved Approved
2L PIK3CA Wild-type
palbociclib + fulvestrant
VIKTORIA-1
2L PIK3CA Wild-Type
fulvestrant
VIKTORIA-1
2L PIK3CA Mutant-Type
palbociclib + fulvestrant
VIKTORIA-1
2L PIK3CA Mutant-Type
fulvestrant
VIKTORIA-1
1L Endocrine Resistant
palbociclib + fulvestrant
VIKTORIA-2
1L Endocrine Sensitive
palbociclib + letrozole
VIKTORIA-2
Prostate Cancer – Metastatic Castration-Resistant
Tumor Type/indication
Gedatolisib Combination
  • Phase 1 PH 1
  • Phase 2 PH 2
  • Phase 3 PH 3
  • Approved Approved
2L mCRPC
darolutamide
CELC-G201
HR+/HER2- Breast Cancer – Advanced or Metastatic
Tumor Type/indication
2L PIK3CA Wild-type
Gedatolisib Combination
palbociclib + fulvestrant
  • PH 1
  • PH 2
  • PH 3
  • Approved
Tumor Type/indication
2L PIK3CA Wild-Type
Gedatolisib Combination
fulvestrant
  • PH 1
  • PH 2
  • PH 3
  • Approved
Tumor Type/indication
2L PIK3CA Mutant-Type
Gedatolisib Combination
palbociclib + fulvestrant
  • PH 1
  • PH 2
  • PH 3
  • Approved
Tumor Type/indication
2L PIK3CA Mutant-Type
Gedatolisib Combination
fulvestrant
  • PH 1
  • PH 2
  • PH 3
  • Approved
Tumor Type/indication
1L Endocrine Resistant
Gedatolisib Combination
palbociclib + fulvestrant
  • PH 1
  • PH 2
  • PH 3
  • Approved
Tumor Type/indication
1L Endocrine Sensitive
Gedatolisib Combination
palbociclib + letrozole
  • PH 1
  • PH 2
  • PH 3
  • Approved
Prostate Cancer – Metastatic Castration-Resistant
Tumor Type/indication
2L mCRPC
Gedatolisib Combination
darolutamide
  • PH 1
  • PH 2
  • PH 3
  • Approved

The safety and efficacy of REVTORPYK has only been established in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

2L, second line; HR, hormone receptor; HER2, human epidermal growth factor receptor 2; PIK3CA, phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha; 1L, first line; mCRPC, metastatic castration-resistant prostate cancer