Immutep Limited ( IMMP ) announces safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase 2/3 trial.

Updated safety data from patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC) treated with this immuno-oncology (IO)-chemotherapy combination reveal no treatment-emergent serious adverse events. 

Also Read: Immutep Touts Encouraging Data From Efti Triple Combination Therapy In Lung Cancer Setting.

Additionally, all treatment-emergent adverse events during the safety observation period have been mild to date.

Initial efficacy reports show these six MBC patients exhibited encouraging results, achieving a 50% overall response rate, including one complete response and two partial responses, and a 100% disease control rate overall, with the remaining three patients having stable disease as the best response.

Efti with paclitaxel historically has shown a dose-dependent effect in MBC and has, in some cases, also led to stable disease patients becoming partial responders after six months. 

The biologically active 30mg efti dose, previously the highest dose of efti ever tested, has demonstrated a stronger immune response and greater efficacy than lower dosing levels (1mg, 6mg) in multiple clinical trials.

The ongoing randomized Phase 2 portion of the trial, which will include up to 58 evaluable patients, is focused on whether 90mg efti dosing is safe and more efficacious than 30mg dosing. 

This portion of the trial has enrolled 23 patients to date. 

Price Action: IMMP shares are up 11.90% at $2.63 on the last check Tuesday.