Acute myeloid leukemia

MD Anderson Cancer Center Publication Shows How Bionano’s Saphyr System Can Significantly Reduce Time to Actionable Results for Myelodysplastic Syndrome Patients

Tuesday, January 19, 2021 - 1:00pm

MDS is a precursor to Acute Myeloid Leukemia and structural variation analysis is important for clinical management of patients with MDS.

Key Points: 
  • MDS is a precursor to Acute Myeloid Leukemia and structural variation analysis is important for clinical management of patients with MDS.
  • Several tests are run sequentially after initial data analysis to confirm gene-specific variants, leading to a diagnostic process that can span several weeks.
  • In this study, Dr. Kanagal-Shamanna evaluated the performance of OGM in a series of 12 previously well-characterized MDS cases using clinical bone marrow samples.
  • Erik Holmlin, PhD, CEO of Bionano Genomics, commented: The MD Anderson Cancer Center is one of the worlds most important cancer research and treatment centers.

GT Biopharma Announces Eighth Patient Begins Treatment Of GTB-3550

Tuesday, January 12, 2021 - 3:00pm

The GTB-3550 TriKE clinical trial commenced patient enrollment in February 2020 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).

Key Points: 
  • The GTB-3550 TriKE clinical trial commenced patient enrollment in February 2020 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).
  • The only treatment with curative intent for a majority of elderly HR-MDS or relapsed/refractory AML patients is allogeneic hematopoietic stem cell transplant (HSCT).
  • GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE NK cell engager platform.
  • GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology.

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.

BerGenBio (BGBIO): Progressing towards key inflection points

Thursday, December 17, 2020 - 8:05am

BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020.

Key Points: 
  • BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020.
  • We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted).
  • We continue to value BerGenBio at NOK5.16bn or NOK59.1 per share based on a risk-adjusted NPV analysis.
  • The key drivers are bemcentinib in second-line NSCLC (peak sales $1.2bn, NOK40.7/share) and AML (peak sales $588m, NOK13.3/share) plus COVID-19 opportunity (NOK5.9/share).

Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Acute Myeloid Leukemia (AML)

Tuesday, December 15, 2020 - 2:00pm

While one of the most common types of leukemia in adults, AML accounts for only 1% of all cancers .

Key Points: 
  • While one of the most common types of leukemia in adults, AML accounts for only 1% of all cancers .
  • This announcement comes on the heels of the Company receiving Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer , in November.
  • The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.
  • Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Burkitts,peripheral T-cell lymphomas and soft tissue sarcoma.

AIkido Pharma Announces Publication of Artificial Intelligence-Machine Learning Sponsored Research Program for Pancreatic Cancer

Wednesday, December 9, 2020 - 3:00pm

NEW YORK, Dec. 9, 2020 /PRNewswire/ --AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today announced the publication of positive results from its Artificial Intelligence/Machine Learning Sponsored Research Program in the field of Pancreatic Cancer.

Key Points: 
  • NEW YORK, Dec. 9, 2020 /PRNewswire/ --AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today announced the publication of positive results from its Artificial Intelligence/Machine Learning Sponsored Research Program in the field of Pancreatic Cancer.
  • Pancreatic ductal adenocarcinoma (PDA) is the third leading cause of cancer-related deaths in the US.
  • PDA is increasing in frequency owing to its association with obesity, smoking, and type 2 diabetes.
  • Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

Curis Announces Positive Preliminary Data from Ongoing Phase 1 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes

Tuesday, December 8, 2020 - 12:00pm

"We also have been pleased by the pace at which our trial partners have been able to enroll patients.

Key Points: 
  • "We also have been pleased by the pace at which our trial partners have been able to enroll patients.
  • We look forward to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021."
  • The reported preliminary data are from Curis's ongoing open-label, single arm Phase 1 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS.
  • CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin's lymphoma and in a Phase 1 trial in patients with acute myeloid leukemia and myelodysplastic syndromes.

Treadwell Announces Two Presentations at the 2020 ASH Annual Meeting Featuring Clinical Trial Updates on Lead Product Candidate, CFI-400945

Monday, December 7, 2020 - 9:01pm

The first presentation described the efficacy results from an investigator-initiated Phase 1 dose escalation study in AML/MDS.

Key Points: 
  • The first presentation described the efficacy results from an investigator-initiated Phase 1 dose escalation study in AML/MDS.
  • We are very encouraged by the promising preliminary Phase 1 study results which included single agent, durable remissions.
  • This compelling early data supports the continued investigation of CFI-400945 for the potential treatment of patients with acute myeloid leukemia (AML), said Principal Investigator, Karen W.L.
  • Yee, Leukemia Program, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.

MacroGenics Presents Flotetuzumab Data in Patients with Refractory Acute Myeloid Leukemia at the 2020 ASH Annual Meeting

Sunday, December 6, 2020 - 6:00pm

Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.

Key Points: 
  • Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT.
  • More detailed flotetuzumab clinical data in the TP53MUT AML population is available via a separate poster presentation at ASH (see TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia, Session 617).
  • The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), which occurred in all patients.
  • In addition to the above data provided in an oral presentation, five additional presentations related to flotetuzumab and AML have or will be presented at ASH.