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Details:
KO-539 (ziftomenib) is a potent and selective a menin-MLL(KMT2A) inhibitor, which is being evaluated in phase 1 clinical trials in patients with NPM1-mutant & KMT2A-rearranged acute myeloid leukemia.
Lead Product(s): Ziftomenib,Gilteritinib Fumarate,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: KO-539
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
Xospata (gilteritinib) is a small molecule that inhibits multiple receptor tyrosine kinases, including FLT3. It is being evaluated in combination with venetoclax & azacitidine for the treatment of relapsed/refractory acute myeloid leukaemia with a FLT3 mutation.
Lead Product(s): Gilteritinib Fumarate,Venetoclax,Azacitidine
Therapeutic Area: Oncology Product Name: Xospata
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 30, 2024
Details:
The net proceeds will be used for the development of KO-539 (ziftomenib), a potent and selective inhibitor, being developed in combination with Xospata (gilteritinib), an inhibitor of FLT3, for the treatment of NPM1-mutated acute myeloid leukemia.
Lead Product(s): Ziftomenib,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: KO-539
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 14, 2023
Details:
The net proceeds will be used for the development of KO-539 (ziftomenib), a potent and selective inhibitor, being developed in combination with Xospata (gilteritinib), an inhibitor of FLT3, for the treatment of NPM1-mutated acute myeloid leukemia.
Lead Product(s): Ziftomenib,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: KO-539
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 13, 2023
Details:
ORY-1001 (iadademstat) is a highly selective inhibitor of the epigenetic enzyme LSD1 with powerful differentiating effect in hematologic cancer. It is being investigated in with gilteritinib for relapsed/refractory AML harboring a FMS-like tyrosine kinase mutation.
Lead Product(s): Iadademstat,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: ORY-1001
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 15, 2023
Details:
Xospata (gilteritinib) is a FLT3 inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-tyrosine kinase domain mutations.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blood and Marrow Transplant Clinical Trials Network
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2023
Details:
Lanraplenib (Lanra) has demonstrated favorable pharmacokinetic (PK), pharmacodynamic (PD) and safety in more than 250 trial participants, including healthy volunteers and patients with autoimmune diseases.
Lead Product(s): Lanraplenib,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Lanra
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 08, 2022
Details:
Lanra (lanraplenib) is the company’s next-generation spleen tyrosine kinase (SYK) inhibitor. In addition to lanraplenib, Kronos Bio is also evaluating its lead investigational SYK inhibitor, entospletinib, in the Phase 3 patients with NPM1-mutated AML.
Lead Product(s): Lanraplenib,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Lanra
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 August 22, 2022
Details:
The net proceeds will be used to evaluate efficacy and optimal dose of ORY-1001 (iadademstat), a novel, highly potent, and selective inhibitor of LSD1, plus Xospata (gilteritinib), an inhibitor of FLT3, in patients with relapsed/refractory AML with FLT3 mutations.
Lead Product(s): Iadademstat,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: ORY-1001
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Commission
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Funding June 07, 2022
Details:
ERAS-007 is a highly potent and selective small molecule ERK1/2 inhibitor. It is being evaluated in phase 1/2 clinical trials in combination with gilteritinib for the treatment of acute myeloid leukemia.
Lead Product(s): ERAS-007,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: ERAS-007
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 12, 2022
Details:
ORY-1001 (Iadademstat), small oral molecule, act as a highly selective inhibitor of the epigenetic enzyme LSD1 has a powerful differentiating effect in hematologic cancers, combination of iadademstat with gilteritinib demonstrated a very strong synergy in preclinical models.
Lead Product(s): Iadademstat,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: ORY-1001
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
The first stage will evaluate initial safety, PK and anti-leukemic activity of escalating once-daily doses of LANRA in combination with the standard approved dose of gilteritinib.
Lead Product(s): Lanraplenib,Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Lanra
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2021
Details:
Xospata (gilteritinib) is a small molecule that inhibits multiple receptor tyrosine kinases, including FLT3. It is approved for the treatment of relapsed/refractory acute myeloid leukaemia with a FLT3 mutation.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kotobuki Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
In COMMODORE, patients receiving gilteritinib lived longer than those receiving salvage chemotherapy, confirming the overall survival benefit seen in the Phase 3 ADMIRAL trial.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
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 30, 2021
Details:
The approval was based on results from the Phase 3 ADMIRAL trial, published in the New England Journal of Medicine. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
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 04, 2021
Details:
Independent Data Monitoring Committee recommended terminating XOSPATA study, concluding results are unlikely to show statistically significant increase in overall survival. Astellas has stopped enrollment in the trial & is reviewing the results for other action as needed.
Lead Product(s): Gilteritinib Fumarate,Azacitidine
Therapeutic Area: Oncology Product Name: Xospata
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 21, 2020
Details:
Oral presentations include new data on the use of gilteritinib, either as monotherapy or in combination, across the FLT3mut+ AML patient spectrum – from those newly diagnosed, to relapsed or refractory patients who have been pre-treated with other tyrosine kinase inhibitors.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
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 16, 2020
Details:
With the submission of supplementary clinical data showing that gilteritinib demonstrated superior overall survival benefit compared to chemotherapy, increasing median OS from 5.6 months to 9.3 months.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
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 16, 2020
Details:
New drug application for XOSPATA, for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation, has been accepted by the NMPA for regulatory review in China.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
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 10, 2020
Details:
Xospata (gilteritinib) is a small molecule that inhibits multiple receptor tyrosine kinases, including FLT3. It is approved for the treatment of relapsed/refractory acute myeloid leukaemia with a FLT3 mutation.
Lead Product(s): Gilteritinib Fumarate
Therapeutic Area: Oncology Product Name: Xospata
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kotobuki Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2020
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