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Details:
The two companies will jointly conduct Phase III of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca's BTK inhibitor, Calquence (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma.
Lead Product(s): Lisaftoclax,Acalabrutinib
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 15, 2023
Details:
APG-2575 (lisaftoclax) is a novel, orally administered small molecule Bcl-2 selective inhibitor developed by Ascentage Pharma to treat a range of malignancies by selectively blocking the antiapoptotic protein Bcl-2, thus restoring the normal apoptosis process in cancer cells.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2023
Details:
Lisaftoclax (APG-2575) is a Novel BCL-2 Inhibitor, selectively binds BCL-2 (Ki < 0.1 nM), disrupts BCL-2:BIM complexes, and compromises mitochondrial outer membrane potential, culminating in BAX/BAK-dependent, caspase-mediated apoptosis.
Lead Product(s): Lisaftoclax,Acalabrutinib
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
Study demonstrated that Alrizomadlin combined with APG-2575 (lisaftoclax) synergistically inhibited the proliferation of RS4:11-BCL-2 mutant cell lines and the growth of cell-derived xenografts in vivo.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2022
Details:
APG-2575 (lisaftoclax), a small-molecule Bcl-2 selective inhibitor treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 and hence restoring normal apoptosis process in cancer cells.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
Details:
Results from 6 preclinical studies of drug candidates: Bcl-2 inhibitor lisaftoclax (APG-2575) and MDM2-p53 inhibitor alrizomadlin (APG-115), two key products of pipeline - FAK inhibitor APG-2449, EED inhibitor APG-5918 and KRAS Inhibitor APG-1842, will be presented.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
Under terms of the agreement, Ascentage Pharma is responsible for conducting the trial and Pfizer is responsible for supplying study drug for Phase Ib/II dose-escalation and expansion study, to evaluate the anticancer activity of lisaftoclax in combination with palbociclib.
Lead Product(s): Lisaftoclax,Palbociclib
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ascentage Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 08, 2021
Details:
This first-in-human global Phase I study assessed the safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and MTD/recommended Phase II dose (RP2D) of lisaftoclax in patients with R/R CLL and other HMs.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
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 June 08, 2021
Details:
Updated data on lisaftoclax have demonstrated favorable preliminary safety and efficacy, including an objective response rate (ORR) of 80% and a favorable tolerability profile, with manageable adverse events (AEs) in patients with R/R CLL/SLL.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
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 June 07, 2021
Details:
APG-2575 is a novel, orally administered small-molecule Bcl-2‒selective inhibitor. APG-2575 is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
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 January 28, 2021
Details:
APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
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 November 23, 2020
Details:
This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).
Lead Product(s): Lisaftoclax,Rituximab
Therapeutic Area: Oncology Product Name: APG-2575
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 September 07, 2020
Details:
The U.s FDA has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM).
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: APG-2575
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 July 15, 2020
Details:
Companies will study the combination of Ascentage's APG-2575 and Acerta's CALQUENCE® (acalabrutinib), evaluating the efficacy and safety of this combination therapy in patients with relapsed/refractory (r/r) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Lead Product(s): Lisaftoclax,Acalabrutinib
Therapeutic Area: Oncology Product Name: APG-2575
Highest Development Status: Phase I/ Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Ascentage Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 21, 2020
Details:
Phase Ib/II study will evaluate the safety, tolerability, and preliminary anticancer activity of APG-2575 as a single agent or in combination therapies for the treatment of patients with r/r CLL/SLL.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: Undisclosed
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 April 07, 2020
Details:
The study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with rituximab or acalabrutinib in patients with r/r CLL/SLL.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: Undisclosed
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 March 23, 2020
Details:
The company will initiate a Phase Ib study of APG-2575 as a single agent or in combination for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML) in China.
Lead Product(s): Lisaftoclax
Therapeutic Area: Oncology Product Name: Undisclosed
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 March 09, 2020
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