CD135

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Thursday, January 7, 2021 - 11:10am

The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.

Key Points: 
  • The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.
  • Rivipansel, a pan-selectin antagonist, is being explored for use in treatment of acute VOC in sickle cell disease.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Thursday, January 7, 2021 - 12:10pm

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.

Key Points: 
  • Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.

Allogene Therapeutics and Overland Pharmaceuticals Form Joint Venture in Greater China to Develop and Commercialize AlloCAR T™ Cell Therapies

Tuesday, December 15, 2020 - 11:00am

The joint venture will focus on the development, manufacturing and commercialization of AlloCAR T therapies for patients in greater China, Taiwan, South Korea and Singapore.

Key Points: 
  • The joint venture will focus on the development, manufacturing and commercialization of AlloCAR T therapies for patients in greater China, Taiwan, South Korea and Singapore.
  • Allogene Overland will have an exclusive license to develop, manufacture and commercialize specific Allogene candidates targeting BCMA, CD70, FLT3, and DLL3 in the licensed territories.
  • The joint venture will also seek opportunities to advance the global development of AlloCAR T therapies against these targets.
  • Allogene Overland will be governed by a Board of Directors with equal representation from Overland and Allogene.

Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting

Monday, November 16, 2020 - 1:00pm

TOKYO, Nov. 16, 2020 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.

Key Points: 
  • TOKYO, Nov. 16, 2020 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.
  • "Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation.
  • Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.

Rubius Therapeutics Announces Dosing of First Patient with Relapsed/Refractory Acute Myeloid Leukemia in the Ongoing Phase 1/2 Clinical Trial of RTX-240

Thursday, November 5, 2020 - 1:00pm

The ongoing clinical study of RTX-240 has two Phase 1 arms, one in all solid tumors and the other in relapsed/refractory AML.

Key Points: 
  • The ongoing clinical study of RTX-240 has two Phase 1 arms, one in all solid tumors and the other in relapsed/refractory AML.
  • When NK cells are restored to their full anti-tumor potential, their cytolytic activity predicts a better long-term outcome for patients with AML.
  • AML is a rare and aggressive cancer of the blood and bone marrow, and is the most common form of acute leukemia in adults.
  • Rubius Therapeutics is enrolling patients in a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study of RTX-240.

Actinium Announces Actimab-A Venetoclax First-in-Human Data Accepted for Poster Presentation at the 62nd American Society of Hematology Annual Meeting

Wednesday, November 4, 2020 - 5:00pm

All 3 patients had poor risk with adverse cytogenetics, and each patient has an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation).

Key Points: 
  • All 3 patients had poor risk with adverse cytogenetics, and each patient has an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation).
  • There have been no Actimab-A related dose limiting toxicities (DLT) or nonhematologic Grade 3 or greater related AEs.
  • This preliminary first-in-human data is encouraging, particularly the reported patient response after a single cycle of venetoclax with a subtherapeutic dose level of Actimab-A.
  • Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/
    Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

Aptose Initiates Dosing of CG-806 in Patients with Acute Myeloid Leukemia

Monday, October 19, 2020 - 12:00pm

The investigational drug is the only known clinical agent that potently inhibits both FLT3 and BTK, giving it broad therapeutic potential across the spectrum of lymphoid and myeloid hematologic malignancies.

Key Points: 
  • The investigational drug is the only known clinical agent that potently inhibits both FLT3 and BTK, giving it broad therapeutic potential across the spectrum of lymphoid and myeloid hematologic malignancies.
  • Separate from the AML trial, Aptose is conducting a Phase 1 a/b dose escalation study with CG-806 in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphomas (NHL), who have failed or are intolerant to current therapies.
  • Acute myeloid leukemia, or AML, is a heterogeneous and aggressive cancer of the bone marrow and blood that occurs in people of all ages, but is most common in adults older than 65.
  • 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.

Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia

Friday, October 16, 2020 - 9:01pm

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Key Points: 
  • Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.
  • In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
  • Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO.

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-106 to Initiate a Phase 3 Bridging Study in Acute Myeloid Leukemia

Monday, September 28, 2020 - 1:05am

This approval enables the initiation of a Phase 1 pharmacokinetics (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).

Key Points: 
  • This approval enables the initiation of a Phase 1 pharmacokinetics (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).
  • AML is one of the most common leukemias in adults, and there is a strong demand for an effective breakthrough treatment for relapsed/refractory AML.
  • We look forward to initiating our clinical trials in China as we strive to offer a new and effective treatment option for AML patients.
  • A comprehensive Phase 3 development program in AML is currently ongoing with uproleselan in the United States by GlycoMimetics.

Precipio Launches its Proprietary HemeScreen™ AML (Acute Myeloid Leukemia) Molecular Panel

Tuesday, September 22, 2020 - 3:30pm

This new panel expands the HemeScreen offering for reference laboratories and physician office laboratories, enabling them to provide improved patient care through faster turnaround time.

Key Points: 
  • This new panel expands the HemeScreen offering for reference laboratories and physician office laboratories, enabling them to provide improved patient care through faster turnaround time.
  • Among the key genes that comprise the molecular testing for AML and are part of Precipios HemeScreen AML Panel are IDH1, IDH2, FLT3 and KIT mutations.
  • However a survey conducted by Precipio found that some of the largest reference laboratories in the US took 7-14 days to deliver results for molecular testing for AML.
  • As part of the HemeScreen product line of assays, HemeScreen AML joins our current HemeScreen MPN panel which includes the important JAK2, MPL and CALR genes.