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Details:
The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).
Lead Product(s): Venetoclax,Cytarabine
Therapeutic Area: Oncology Product Name: Venclexta
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
Iran Expo
Not Confirmed
Contact SupplierDetails:
AbbVie and Roche’s Venclexta has failed to significantly improve overall survival in an acute myeloid leukaemia (AML) trial that was supposed to confirm its efficacy.
Lead Product(s): Venetoclax,Cytarabine
Therapeutic Area: Oncology Product Name: Undisclosed
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 03, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product.
Lead Product(s): K-NK cells,Cytarabine,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: K-NK003
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
A poster presentation demonstrates results of multiple FC21-NK infusions in R/R AML patients with CNS disease, treated in an investigator-initiated Phase I/II study.
Lead Product(s): Interleukin-21-Expanded Haploidentical NK Cells,Cytarabine,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product.
Lead Product(s): K-NK003,Cytarabine,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
Annamycin is a next-generation anthracycline, which is being evaluated in combination with cytarabine for the treatment of subjects with acute myeloid leukemia.
Lead Product(s): Annamycin,Cytarabine
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 25, 2024
Details:
Liposomal-Annamycin is a Topoisomerase II inhibitor small molecule drug which is currently being evaluated in phase 1/2 clinical trials in combination with Cytarabine for the treatment of Acute Myeloid Leukemia.
Lead Product(s): Annamycin,Cytarabine
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 January 24, 2024
Details:
AnnAraC (annamycin), is a next-generation anthracycline, topioisomerase II inhibitor, designed to avoid multidrug resistance mechanisms and to have little to no cardiotoxicity. It is being investigated for soft tissue sarcoma and AML.
Lead Product(s): Annamycin,Cytarabine
Therapeutic Area: Oncology Product Name: AnnAraC
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 13, 2023
Details:
VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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, 2023
Details:
Ara-C (Annamycin) forms complexes with DNA by intercalation between base pairs and inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex. It is being developed in combination with cytarabine for AML and soft tissue sarcoma lung metastases.
Lead Product(s): Annamycin,Cytarabine
Therapeutic Area: Oncology Product Name: Ara-C
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 October 02, 2023
Details:
AnnAraC (annamycin), is a next-generation anthracycline, topioisomerase II inhibitor, designed to avoid multidrug resistance mechanisms and to have little to no cardiotoxicity. It is being investigated for soft tissue sarcoma.
Lead Product(s): Annamycin,Cytarabine
Therapeutic Area: Oncology Product Name: AnnAraC
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 18, 2023
Details:
Vanflyta (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine
Therapeutic Area: Oncology Product Name: Vanflyta
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 15, 2023
Details:
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, which is investigated for the treatment of relapsed and/or refractory acute myelogenous leukemia.
Lead Product(s): FHD-286,Cytarabine
Therapeutic Area: Oncology Product Name: FHD-286
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 August 31, 2023
Details:
VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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 09, 2023
Details:
VANFLYTA® (quizartinib) is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine
Therapeutic Area: Oncology Product Name: Vanflyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2023
Details:
Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Product Name: Vanflyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
Details:
Annamycin forms complexes with DNA by intercalation between base pairs and inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex. It is being developed in combination with cytarabine for AML and soft tissue sarcoma lung metastases..
Lead Product(s): Annamycin,Cytarabine
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 May 02, 2023
Details:
Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2023
Details:
Vyxeos (daunorubicin and cytarabine) have synergistic effects at killing leukemia cells by inhibiting DNA polymerase activity, is indicated as a chemotherapy treatment option specifically indicated for the treatment of adults with newly diagnosed t-AML or AML-MRC.
Lead Product(s): Daunorubicin,Cytarabine
Therapeutic Area: Oncology Product Name: Vyxeos
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 08, 2023
Details:
Annamycin forms complexes with DNA by intercalation between base pairs and inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex. It is being developed in combination with cytarabine for AML.
Lead Product(s): Annamycin,Cytarabine
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 01, 2023
Details:
BLINCYTO is a BiTE® (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells.
Lead Product(s): Blinatumomab,Cyclophosphamide,Cytarabine
Therapeutic Area: Oncology Product Name: Blincyto
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
Actimab-A (lintuzumab-Ac-225) is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target that is expressed in virtually all patients with AML. Actimab-A due to its radiation modality is agnostic to cytogenetics.
Lead Product(s): Lintuzumab-Ac225,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: Actimab-A
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Columbia University
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 08, 2022
Details:
Submission based on QuANTUM-First results showing Vanflyta (quizartinib) an oral, highly potent and selective type II FLT3 inhibitor plus chemotherapy significantly improved overall survival compared to chemotherapy alone.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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 24, 2022
Details:
Submission based on QuANTUM-First results showing Vanflyta (quizartinib) plus chemotherapy significantly improved overall survival compared to chemotherapy alone.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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 23, 2022
Details:
Under the terms of the agreement, Rigel Pharmaceuticals will develop, manufacture and commercialize FT-2102 (olutasidenib), an oral, small molecule inhibitor of mIDH1 being investigated for the treatment of relapsed/refractory acute myeloid leukemia and other malignancies.
Lead Product(s): Olutasidenib,Cytarabine
Therapeutic Area: Oncology Product Name: FT-2102
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rigel Pharmaceuticals
Deal Size: $235.0 million Upfront Cash: $2.0 million
Deal Type: Licensing Agreement August 02, 2022
Details:
Positive results from Vanflyta (quizartinib) combined with standard induction and chemotherapy demonstrated statistically significant and meaningful improvement in OS in adult patients with newly diagnosed FLT3-ITD positive AML compared to standard chemotherapy alone.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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 11, 2022
Details:
First poster describes the analysis of mutational and gene expression signatures from bone marrow and peripheral blood samples of patients with NPM1-mutated AML, with or without co-mutation of FLT3, is a strong predictor of GS-9973 (entospletinib) anti-leukemic activity.
Lead Product(s): Entospletinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: GS-9973
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 10, 2022
Details:
GS-9973 (entospletinib) is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1.
Lead Product(s): Entospletinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: GS-9973
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 May 12, 2022
Details:
Completion of enrollment of GMI-1271 (Uproleselan), sets the stage for planned interim analysis evaluating potential for regulatory filings, improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia.
Lead Product(s): Uproleselan,Daunorubicin,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
Under the terms of co-development agreement, CicloMed holds the responsibility for executing clinical trial operations while Notable is focused on optimizing Notable’s predictive precision medicine platform with the goal of assessing patient responsiveness to fosciclopirox.
Lead Product(s): Fosciclopirox,Cytarabine
Therapeutic Area: Oncology Product Name: CPX-POM
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CicloMed LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 01, 2021
Details:
Vanflyta (quizartinib), an oral, highly potent and selective type II FLT3 inhibitor, is in phase 1/2 clinical development in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America.
Lead Product(s): Quizartinib,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Vanflyta
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 18, 2021
Details:
Volasertib is a Polo-like kinase 1 (PLK-1) inhibitor with demonstrated activity in AML and other tumor types with significant unmet medical need. Company plan to fast-track volasertib’s development with phase 2/3 clinical trials in AML and other cancers.
Lead Product(s): Volasertib,Cytarabine
Therapeutic Area: Oncology Product Name: NBL-001
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 11, 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 combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
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 23, 2021
Details:
The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The University of Texas MD Anderson Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
Lead Product(s): Bemcentinib,Cytarabine
Therapeutic Area: Oncology Product Name: BGBC003
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 11, 2021
Details:
Annamycin is a "next generation" anthracycline, that has been shown to be less cardiotoxic compared to other anthracycline, such as doxorubicin, and to avoid multidrug resistance, so the use of Annamycin may not face the same dose limitations imposed on doxorubicin.
Lead Product(s): Annamycin,Cytarabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Polish National Center for Research and Development
Deal Size: $6.7 million Upfront Cash: Undisclosed
Deal Type: Funding May 11, 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:
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:
The data indicates that treatment with the bemcentinib-LDAC combination shows promising efficacy in relapsed patients who are unfit for intensive chemotherapy.
Lead Product(s): Bemcentinib,Cytarabine
Therapeutic Area: Oncology Product Name: BGB 324
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 December 06, 2020
Details:
For animals treated with the combination of Annamycin and Ara-C, median survival ranged from 56 to 76 days, thus expanding median survival by 585%, with some animals being completely cured.
Lead Product(s): Annamycin,Cytarabine
Therapeutic Area: Oncology Product Name: L-ANN
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 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:
Three abstracts selected for oral presentation, including long-term results from a Phase 3 study of Vyxeos in older adults with newly diagnosed, high-risk/secondary acute myeloid leukemia.
Lead Product(s): Daunorubicin,Cytarabine,Venetoclax
Therapeutic Area: Oncology Product Name: Vyxeos
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 05, 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:
The study shows that delaying treatment up to seven days is feasible and safe, and that patients who opted for the precision medicine approach experienced a lower early death rate and superior overall survival compared to patients who opted for standard of care.
Lead Product(s): Samalizumab,Daunorubicin,Cytarabine
Therapeutic Area: Oncology Product Name: BAML-16-001-S1
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
VIALE-A study showed Venclexta plus azacitidine significantly improved overall survival in newly diagnosed AML compared to azacitidine alone.
Lead Product(s): Venetoclax,Cytarabine
Therapeutic Area: Oncology Product Name: Venclexta
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:
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
Details:
Updated findings from the Phase 1, dose-escalation, safety and biomarker study of alvocidib followed by cytarabine and daunorubicin (7+3) induction therapy showed encouraging clinical activity and a tolerable safety profile in adults with newly diagnosed AML.
Lead Product(s): Alvocidib,Cytarabine
Therapeutic Area: Oncology 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 June 12, 2020
Details:
The decision came in line with the urgent change of clinical sites due to COVID-19, affecting the feasibility of completing the analysis during the shelf-life of the existing stock of ficlatuzumab.
Lead Product(s): Ficlatuzumab,Cytarabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2020
Details:
Study builds on recent Actimab-A plus CLAG-M combination trial results showing an 86% remission rate with 71% MRD negative rate in CD33 positive patients with relapsed or refractory AML.
Lead Product(s): Lintuzumab-Ac225,Cytarabine,Daunorubicin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2020
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