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The company announced the FDA has cleared its IND for ATA2271, allowing it to start a Phase I study of the autologous CAR T-cell therapy in advanced mesothelioma.
The biopharma company is evaluating its experimental immunotherapy against HPV-positive cancers alone and in combination with a bifunctional fusion protein.
In the dose expansion portion of the trial, CFI-402257 will be evaluated in three arms, including estrogen receptor-positive, HER2-negative breast cancer, TNBC, and solid tumor patients.
The first-in-human trial will evaluate the safety, tolerability, and anti-tumor activity of SBT6050, a TLR8 agonist conjugated to a HER2-directed monoclonal antibody.
The company is hoping that ACE1702 will validate its antibody cell conjugation technology and show that its proprietary NK cells are more effective than current cell-based therapies.
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.
The Phase Ib trial will include exploratory analyses of patients' serum biomarkers and the correlation between HIF2a gene expression and response to ARO-HIF2.
Strata will use its StrataNGS profiling test to identify patients with advanced solid tumors harboring KRAS G12C mutations for enrollment into Mirati's KRYSTAL-1 trial.
Patients on the combo regimen had similar outcomes to those on monotherapy, but researchers said that the benefit seen in certain groups should be explored in randomized trials.
The trial will assess patients' blood samples to determine DSP107's effect on T-cells, B-cells, NK cells, and monocytes and their expression of activation markers.