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The companies will jointly develop CAR T-cell therapies designed to inhibit HPK1 gene expression, which has been shown to lead to T-cell exhaustion.
In heavily pretreated adults with Hodgkin's lymphoma, the therapy resulted in mostly grade 1 adverse events and no neurologic toxicities.
The FDA has accepted an investigational new drug application for the long-acting human interleukin-7, NT-17, combined with standard-of-care CD19 CAR T-cell therapy.
Awaiting data from the Phase II SOLAR trial, miRagen is looking to potentially advance cobomarsen into registration-enabling studies for miR-155 elevated CTCL and ATLL.
Therapy was most effective in patients with a diverse baseline repertoire of T cell receptors and an associated expansion of singleton clones during treatment.
Following positive Phase II results, the company plans to seek US and EU approval for the CAR T-cell therapy in relapsed or refractory follicular lymphoma in 2021.
The company will provide proprietary algorithms for analyzing omics and imaging data to define predictors of drug response and identify new biomarkers.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The goal of the LLS PedAI study is to investigate the efficacy and safety of multiple precision oncology drugs at once for children with relapsed acute leukemia.
The genetic classifications determined by the LymphGen tool could help shed light on the heterogenous responses of DLBCL to chemotherapy and molecularly targeted therapies.