ONCT - FDA clears Oncternal to proceed with dose escalation study for lymphoma car-T therapy

• Clinical-stage biopharma Oncternal Therapeutics ( NASDAQ: ONCT ) on Monday said the U.S. FDA had cleared it to proceed with a phase 1/2 dose escalation study of its car T-cell therapy ONCT-808 for the treatment of aggressive B cell non-Hodgkin’s lymphoma ((B NHL)).
• The company said it had got a 'Study May Proceed' letter from the FDA, 30 days after it submitted its investigational new drug application for the study.
• "Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today," ONCT CEO James Breitmeyer said in a statement .
• The company expects to start the trial in the coming months and anticipates presenting interim results at a scientific conference next year.
• ONCT stock +4.1% to $1.01 after hours.

For further details see: