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The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
The program is in its third year monitoring individuals with these mutations to try to detect disease early, understand their risk, and develop preventive treatments.
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.
Fred Hutchinson Cancer Research Center investigators engineered T cells to recognize a protein expressed by acute myeloid leukemia cells with a CBFB-MYH11 gene fusion.
The global license extends to all indications under evaluation, though Rain will focus on exploring the activity of milademetan in MDM2-amplified or -overexpressing cancers.
The company said it is evaluating the full data from the IDHENTIFY trial and will present the analysis at an upcoming medical conference.
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.
The agreement will facilitate key proof-of-concept studies for Hemogenyx's HEMO-CAR-T product in AML, where there is an unmet need for new safe and effective treatments.
The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.
Chi-Med subsidiary Hutchison Medipharma has kicked off the Phase I trial in China and has dosed its first patient with the investigational IDH inhibitor.