Immutep surges 25% after 'positive' FDA meeting for...

Immutep surges 25% after 'positive' FDA meeting for eftilagimod's trial in breast cancerDec. 23, 2022 9:01 AM ETImmutep Limited (IMMP),

PRRUFBy: Ravikash, SA News Editor Sarah Silbiger Immutep (NASDAQ:IMMP) (OTCPKRRUF) said it had a positive follow-up Type C meeting with the U.S. Food and Drug Administration (FDA) regarding late-stage clinical development plans for eftilagimod alpha (efti), with standard-of-care chemotherapy, to treat metastatic breast cancer (MBC). The company and the FDA agreed to an integrated phase 2/3I trial design that will help back a biologics license application (BLA), Immutep noted. In addition, the patient population has been expanded to include patients with triple-negative breast cancer (TNBC). The phase 2 portion of the MBC trial is expected to start in Q1 2023. The company said that the FDA agreed to test 90mg efti dosing in combination with paclitaxel mainly due to the safety profile of a phase 2b trial, dubbed AIPAC, and the FDA's Project Optimus initiative in oncology. Immutep added that late-stage clinical development efforts remain focused on frontline non-small cell lung cancer (NSCLC) in combination with anti-PD-1 therapy Immutep noted that the phase 2 portion of the MBC trial and the start of the study in 1st line NSCLC are included in its budget and have no impact on its expected cash runway to the end of H1 2024. IMMP +25.93% to $2.38 premarket Dec. 23