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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:
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). It has been approved in China for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2023
Details:
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). It has been granted first regulatory approval in china for adults with previously treated mantle cell lymphoma.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Details:
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Its tablet formulation has been approved in the EU for patients with chronic lymphocytic leukaemia.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
Calquence (acalabrutinib), a next-generation, selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2022
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:
In the trials, results showed the CALQUENCE capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Details:
Updated data from ELEVATE-TN Phase III trial at five years, will highlight longer-term safety, PFS efficacy results and OS rates for Calquence (Acalabrutinib) in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with CLL.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 June 09, 2022
Details:
Updated results from ELEVATE-TN trial showed CALQUENCE (acalabrutinib) maintained significant PFS versus chlorambucil plus obinutuzumab and safety and tolerability profile consistent with known profile for CALQUENCE at median follow up of five years in combination.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 June 04, 2022
Details:
At a median follow-up of 58.2 months, Calquence (Acalabrutinib) plus obinutuzumab reduced risk of disease progression or death by 89% and as a monotherapy by 79% (based on a HR of 0.21, 95% CI 0.15-0.30), compared with chlorambucil plus obinutuzumab.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 June 04, 2022
Details:
The filing is based on results including Phase III ELEVATE-TN study evaluating efficacy and safety of Gazyva (obinutuzumab), a glycoengineered type II anti-CD20 monoclonal antibody and acalabrutinib bruton's tyrosine kinase inhibitor in patients with untreated CLL.
Lead Product(s): Obinutuzumab,Acalabrutinib
Therapeutic Area: Oncology Product Name: Gazyva
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Nippon Shinyaku
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
Long-term follow up from ELEVATE-TN trial in front-line setting showed Calquence maintained progression-free survival and favourable tolerability at four years.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence met the primary endpoint showing non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukaemia compared to ibrutinib.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Details:
Pooled analysis of cardiovascular safety data from 762 patients treated with Calquence for chronic lymphocytic leukaemia, the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events leading to discontinuation.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
The addition of Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the trials.
Lead Product(s): Acalabrutinib
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Calquence
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 12, 2020
Details:
Calquence demonstrated superior progression-free survival and favorable tolerability in both previously untreated and relapsed or refractory patients.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
AstraZeneca Pharma India will launch Calquence (acalabrutinib) in India. Calquence (Acalabrutinib), intended for the treatment of chronic lymphocytic leukaemia (CLL).
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 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:
ACE-CL-001 trial showed an overall response rate of 97% with a sustained safety profile for previously untreated patients after more than four years.
Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
AstraZeneca says new analysis shows that its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) cut markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease.
Lead Product(s): Acalabrutinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Calquence
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 June 05, 2020
Details:
The trial design is based upon strong scientific evidence supporting the role of the Bruton’s tyrosine kinase pathway in the production of inflammatory cytokines.
Lead Product(s): Acalabrutinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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, 2020
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