FDA grants RMAT designation to HSCT adjunct

Print Friendly, PDF & Email


T cells
Image from NIAID
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATIR101™, which is intended to be used as an adjunct to haploidentical hematopoietic stem cell transplant (HSCT). ATIR101 is a personalized T-cell immunotherapy—a donor lymphocyte preparation selectively depleted of host-alloreactive T cells through... [Read Article]
Print Friendly, PDF & Email

Antibody shows early promise in AML/MDS trial

Print Friendly, PDF & Email


Micrograph showing MDS
Interim results of a phase 1 study suggest flotetuzumab, a CD123 and CD3 bispecific antibody, may be a feasible treatment option for relapsed or refractory acute myeloid leukemia (AML) or intermediate/high-risk myelodysplastic syndromes (MDS). Researchers said flotetuzumab demonstrated acceptable tolerability in the dose-escalation portion of the study, with infusion-related reactions... [Read Article]
Print Friendly, PDF & Email

VSTs can treat 5 different viral infections after HSCT

Print Friendly, PDF & Email


Ifigeneia Tzannou
(left) and Bilal Omer
Photo from Baylor
College of Medicine
New research suggests virus-specific T cells (VSTs) can protect patients from severe viral infections that sometimes occur after hematopoietic stem cell transplant (HSCT). The VSTs proved effective against 5 different viruses—Epstein-Barr virus (EBV), adenovirus (AdV), cytomegalovirus (CMV), BK virus (BKV), and... [Read Article]
Print Friendly, PDF & Email

Predicting response to azacitidine in MDS

Print Friendly, PDF & Email


Micrograph showing MDS
Research published in Cell Reports helps explain why some patients with myelodysplastic syndrome (MDS) do not respond to treatment with azacitidine. The study showed that patients who were resistant to the drug had relatively quiescent hematopoietic progenitor cells (HPCs). A smaller proportion of their HPCs were undergoing active cell-cycle progression when... [Read Article]
Print Friendly, PDF & Email

Vaccine granted orphan designation for MDS

Print Friendly, PDF & Email


Micrograph showing MDS
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndromes (MDS). DSP-7888 contains peptides to induce Wilms' tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in... [Read Article]
Print Friendly, PDF & Email

Company discontinues phase 3 trial of vadastuximab talirine in AML

Print Friendly, PDF & Email


AML cells
On the advice of the Independent Data Monitoring Committee, Seattle Genetics is discontinuing the phase 3 CASCADE clinical trial of vadastuximab talirine as frontline treatment in older patients with acute myeloid leukemia (AML). The company is also suspending patient enrollment and treatment in all its vadastuximab trials, including the ongoing phase 1/2 trial... [Read Article]
Print Friendly, PDF & Email

Azacitidine alone comparable to AZA combos for most MDS patients

Print Friendly, PDF & Email


Micrograph showing MDS
A 3-arm phase 2 study of azacitidine alone or in combination with lenalidomide or vorinostat in patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) has shown the combination therapies to have similar overall response rates (ORR) to azacitidine monotherapy. Based on these findings, investigators did not choose either... [Read Article]
Print Friendly, PDF & Email