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Details:
APL-106 (uproleselan) is an investigational, first-in-class E-selectin antagonist, which is under phase 3 clinical development for the treatment of of adults with relapsed or refractory acute myeloid leukemia (relapsed/refractory AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 January 03, 2024
Details:
GMI-1271 (uproleselan) is designed to bind to E-selection and block the normal processes controlled by E-selectin. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: GMI-1271
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 15, 2023
Details:
Patients on study of Actimab-A (Lintuzumab-Ac225) received a median of 2 lines of prior therapy with 57% receiving prior treatment with venetoclax and 67% had adverse cytogenetics with 52% of patients having a TP53 mutation.
Lead Product(s): Lintuzumab-Ac225,Cladribine,Mitoxantrone
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
The primary endpoint of APL-106 is overall survival and Secondary outcome measures the rate and duration of remission, and whether APL-106 can reduce the rate of oral mucositis, a chemotherapy-related side effect.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 November 22, 2021
Details:
Rafael Pharmaceuticals' lead compound devimistat (CPI-613®) is designed to selectively target the tumor mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival.
Lead Product(s): Devimistat,Cytarabine,Mitoxantrone
Therapeutic Area: Oncology Product Name: CPI-613
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 October 28, 2021
Details:
The multicenter, open-label, randomized pivotal trial is assessing the efficacy and safety of Rafael’s lead compound CPI-613® (devimistat) in combination with high dose cytarabine and mitoxantrone compared to high dose cytarabine and mitoxantrone therapy in older patients.
Lead Product(s): Devimistat,Cytarabine,Mitoxantrone
Therapeutic Area: Oncology Product Name: CPI-613
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 March 30, 2021
Details:
APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 January 07, 2021
Details:
This announcement comes on the heels of the Company receiving Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer, in November. FDA has granted Fast Track designation for the Company’s lead compound, CPI-613®, for the treatment of AML.
Lead Product(s): Devimistat,Cytarabine,Mitoxantrone
Therapeutic Area: Oncology Product Name: CPI-613
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 15, 2020
Details:
Zella 201 is a biomarker-driven study of alvocidib followed by cytarabine and mitoxantrone in patients with relapsed/refractory MCL-1 dependent acute myeloid leukemia. Data presented will include findings from an exploratory cohort of newly diagnosed, high-risk patients.
Lead Product(s): Alvocidib,Mitoxantrone,Cytarabine
Therapeutic Area: Oncology Product Name: Flavopiridol
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 06, 2020
Details:
Across all three cohorts, 67% or 10/15 patients treated with 0.25, 0.50 and 0.75 uCi/kg of Actimab-A and the standard regimen of CLAG-M achieved a Complete Remission (CR) or Complete Remission with inadequate hematopoietic recovery (CRi).
Lead Product(s): Lintuzumab-Ac225,Cladribine,Mitoxantrone
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
The multicenter, open-label, randomized pivotal trial is assessing the efficacy and safety of Rafael’s lead compound CPI-613® (devimistat) in combination with high dose cytarabine and mitoxantrone compared to high dose cytarabine and mitoxantrone therapy in older patients.
Lead Product(s): Devimistat,Cytarabine,Mitoxantrone
Therapeutic Area: Oncology Product Name: CPI-613
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 October 27, 2020
Details:
This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GlycoMimetics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2020
Details:
The multicenter, open-label, randomized pivotal trial is evaluating the efficacy and safety of its lead compound devimistat in combination with high dose cytarabine and mitoxantrone (CHAM) in older patients.
Lead Product(s): Devimistat,Cytarabine,Mitoxantrone
Therapeutic Area: Oncology Product Name: CPI-613
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 July 21, 2020
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