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Details:
PKI-587 (gedatolisib) is an investigational, intravenously administered pan-class I isoform PI3K and mTOR inhibitor. It is being evaluated in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PKI-587
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2024
Details:
Under the agreement, Bayer will provide Nubeqa to Celcuity for its Phase 1b/2 trial of PKI-587 (gedatolisib), a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, in combination with darolutamide in metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PF-05212384
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 22, 2023
Details:
PKI-587 (gedatolisib) is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, and investigating in ombination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer.
Lead Product(s): Gedatolisib,Darolutamide
Therapeutic Area: Oncology Product Name: PF-05212384
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2023
Details:
PKI-587 (Gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. Its in Phase 1b clinical trial in combination with palbociclib and endocrine therapy for patients with HR+/HER2- advanced breast cancer.
Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: PKI-587
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Details:
Gedatolisib for the treatment of HR+/HER2- advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.
Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant
Therapeutic Area: Oncology Product Name: PKI-587
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
PKI-587 (gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its MOA and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR.
Lead Product(s): Gedatolisib,Palbociclib,Undisclosed
Therapeutic Area: Oncology Product Name: PKI-587
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
Under the terms of collaboration with Pfizer will provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial to evaluate gedatolisib, in combination with palbociclib, and Faslodex® (fulvestrant), in patients with ER+/HER2- advanced breast cancer.
Lead Product(s): Gedatolisib,Palbociclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 15, 2021
Details:
Gedatolisib is a Phase 1b pan-PI3K/mTOR inhibitor. Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib.
Lead Product(s): Gedatolisib
Therapeutic Area: Oncology Product Name: PF-05212384
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Celcuity
Deal Size: $340.0 million Upfront Cash: $5.0 million
Deal Type: Licensing Agreement April 08, 2021
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