CD135

Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

Retrieved on: 
Tuesday, May 19, 2020
Enzymes, CD135, Chemistry, Physical sciences, Assay, Lactams, Midostaurin, Gilteritinib

SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

Key Points: 
  • SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.
  • In 2017, Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe's clinical laboratory in San Diego.
  • This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay kits for in-house testing.
  • The LeukoStrat CDx FLT3 Mutation Assay may be used as an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies.

25th EHA Congress: Menarini Ricerche Discloses First Results From the Clinical Study on SEL24/MEN1703

Retrieved on: 
Thursday, May 14, 2020
Cancer, Chemical compounds, CD135, Acute myeloid leukemia, Oncology, Menarini, 7+3, Piperidines, Tyrosine kinase inhibitors, Gilteritinib

The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

Key Points: 
  • The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).
  • Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

25th EHA Congress: Menarini Ricerche Discloses First Results From the Clinical Study on SEL24/MEN1703

Retrieved on: 
Thursday, May 14, 2020
Cancer, Chemical compounds, CD135, Acute myeloid leukemia, Oncology, Menarini, 7+3, Piperidines, Tyrosine kinase inhibitors, Gilteritinib

The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

Key Points: 
  • The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).
  • Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

Aptose to Present Early CG-806 Clinical Findings at the 25th Congress of the European Hematology Association

Retrieved on: 
Thursday, May 14, 2020
Enzymes, Tyrosine kinase receptors, Tyrosine kinases, CD135, Bruton's tyrosine kinase, Tumors of the hematopoietic and lymphoid tissues, Oncology, Protein kinase inhibitor, C-Met, Oncogenes, Morpholines, ETV6

The accepted abstract is available online on the EHA conference website, ehaweb.org .

Key Points: 
  • The accepted abstract is available online on the EHA conference website, ehaweb.org .
  • CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies.
  • Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.
  • Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology.

Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners

Retrieved on: 
Tuesday, May 12, 2020
Chemical compounds, Enzymes, Chemistry, CD135, Piperidines, Tyrosine kinase inhibitors, Gilteritinib, CDX, Assay, CDX, Midostaurin

Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.

Key Points: 
  • Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.
  • Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/ refractory FLT3-mutated AML.
  • "This is an announcement of two significant milestones: Submission of our LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network into China.
  • The LeukoStrat CDx FLT3 Mutation Assay is the onlyinternationally standardized signal ratio assay that identifies both ITD and TKD mutations of the FLT3 biomarker.

Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners

Retrieved on: 
Tuesday, May 12, 2020
Chemical compounds, Enzymes, Chemistry, CD135, Piperidines, Tyrosine kinase inhibitors, Gilteritinib, CDX, Assay, CDX, Midostaurin

Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.

Key Points: 
  • Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.
  • Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/ refractory FLT3-mutated AML.
  • "This is an announcement of two significant milestones: Submission of our LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network into China.
  • The LeukoStrat CDx FLT3 Mutation Assay is the onlyinternationally standardized signal ratio assay that identifies both ITD and TKD mutations of the FLT3 biomarker.

Aptose Presents Preliminary Clinical Data on CG-806 at AACR Virtual Annual Meeting 2020

Retrieved on: 
Monday, April 27, 2020
Tyrosine kinases, Branches of biology, CD135, Bruton's tyrosine kinase, Dose, Health, Medicine

The first-in-human tests of CG-806 are being carried out in a Phase 1a/b clinical study.

Key Points: 
  • The first-in-human tests of CG-806 are being carried out in a Phase 1a/b clinical study.
  • The first patient, previously dosed at 150 mg BID was dose escalated to dose level 3 at 450 mg BID.
  • We look forward to presenting new data from higher dose cohorts at a future medical meeting.
  • CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies.

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration

Retrieved on: 
Friday, April 10, 2020
Chemical compounds, Enzymes, Organic compounds, Acute myeloid leukemia, RTT, Gilteritinib, Piperazines, Pyrazines, CD135, Leukemia, Midostaurin, ETV6

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements.

Key Points: 
  • A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements.
  • Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation.
  • Health Canada approves Astellas' XOSPATA (gilteritinib) for patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.

Ryvu Therapeutics Receives Orphan Drug Designation From FDA for SEL120 to Treat Acute Myeloid Leukemia

Retrieved on: 
Saturday, March 28, 2020
Chemical compounds, Enzymes, Cancer, Tyrosine kinase inhibitors, Acute myeloid leukemia, Leukemia, CD135, Cyclin-dependent kinase 8, Oncology, Tumors of the hematopoietic and lymphoid tissues, Myeloid leukemia, Entospletinib

KRAKOW, Poland, March 28, 2020 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).

Key Points: 
  • KRAKOW, Poland, March 28, 2020 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).
  • SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors.
  • Orphan drug status (ODD) is intended to advance drug development for rare diseases.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.

Ryvu Therapeutics to Present Recent Data From Multiple Oncology Programs at AACR 2020 Annual Meeting

Retrieved on: 
Thursday, February 27, 2020
Enzymes, Chemical compounds, CD135, Acute myeloid leukemia, Oncology, Cancer, Tyrosine kinase inhibitors, Protein kinase inhibitors, Bemcentinib

Presentations will be held at the San Diego Convention Center, Exhibit Halls A-F, in respective Poster Sections.

Key Points: 
  • Presentations will be held at the San Diego Convention Center, Exhibit Halls A-F, in respective Poster Sections.
  • Additional information is available at on the AACR conference website http://www.aacr.org .
  • Ryvu Therapeutics is a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.