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Details:
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2022
Details:
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, potential therapeutic option for patients with B-cell malignancies.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
ME-401 (zandelisib), an orally administered investigational phosphatidylinositol 3- kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
Clinical trials are investigating the efficacy and safety of ME-401 (zandelisib) as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (ID) and in a time-limited manner when dosed in combination.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2022
Details:
ME-401 (Zandelisib), an oral and selective inhibitor of PI3Kδ, is being evaluated in multiple clinical studies, including COASTAL, a Phase 3 study, and TIDAL, a Phase 2 study, in patients with relapsed and refractory follicular and marginal zone lymphomas.
Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Clinical and preclinical data suggest that ME-401 (zandelisib) distinct characteristics include prolonged target binding, preferential cellular accumulation, high volume of distribution throughout body tissues, and an approx, 28-hour half-life suitable for oral administration.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Data from preclinical studies with ME-401 (zandelisib), a selective PI3Kδ inhibitor, ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells.
Lead Product(s): Zandelisib,Ibrutinib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
ME-401 (zandelisib), a selective phosphatidylinositol-3-kinase inhibitor, an investigational cancer treatment for patients with B-cell malignancies, demonstrated a 70.3% objective response rate in Phase 2 TIDAL study.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
ME-401 (zandelisib), an oral and selective inhibitor of PI3K delta, is being evaluated in multiple clinical studies, including COASTAL and TIDAL study, in patients with follicular and marginal zone lymphomas and other B-cell malignancies.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
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 March 08, 2022
Details:
Company announced that the study evaluating zandelisib as a single agent for follicular lymphoma patients received at least two prior systemic therapies demonstrated a 70.3% objective response rate and 35.2% Achieved Complete Response.
Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2021
Details:
MEI Pharma's portfolio of drug candidates contains four clinical-stage assets, including zandelisib, currently in an ongoing Phase 2 clinical trial which may support accelerated approval applications with the U.S. Food and Drug Administration.
Lead Product(s): Zandelisib,Rituximab
Therapeutic Area: Oncology Product Name: ME-401
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, 2021
Details:
Combination of PI3K-Delta Inhibitor Zandelisib (ME-401) and BTK Inhibitor Zanubrutinib in Patients with Relapsed or Refractory (R R) B-cell Malignancies data presented at the European Hematology Association 2021.
Lead Product(s): Zandelisib,Zanubrutinib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.
Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
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