Ann: Immutep receives EMA scientific advice for Phase 3 in MBC, page-2

Immutep receives positive EMA scientific advice for
further clinical development of efti in MBC including Phase III
• Positive feedback for the general clinical development program including the planned registrational
Phase III trial in metastatic breast cancer (MBC)
• Other regulatory engagement ongoing, including with the US Food and Drug Administration (FDA)
SYDNEY, AUSTRALIA – 29 October 2021 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or
“the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments
for cancer and autoimmune disease, is pleased to announce it has received positive feedback from the
European Medicines Agency (EMA) regarding its clinical development program for lead product candidate,
eftilagimod alpha (efti), including the planned Phase III trial in MBC.
In its scientific advice the EMA has supported the Company’s view to continue the development of efti in
MBC in a Phase III clinical trial, based on clinical data presented in December 2020 at SABCS. The trial will
be built on the Company’s ongoing Phase IIb AIPAC trial, which reported encouraging interim results in
key patient subgroup populations. Final overall survival data from the Phase IIb AIPAC trial will be reported
in mid November at SITC 2021 as a late breaker poster presentation.
As the planned Phase III trial is intended to take place across multiple countries, additional interactions
with the EMA and other regulators, including with the US FDA to generate a final study design are ongoing.
Immutep CEO, Marc Voigt, noted: “Receiving positive and constructive EMA advice on our clinical
development program for efti, including the planned Phase III trial in metastatic breast cancer is an
exciting achievement for Immutep. We now look forward to further engagement with the EMA and other
regulators, including the US FDA to solidify our trial plans.”
About Scientific Advice
Scientific Advice is a procedure offered by the EMA to medicine developers for clarification of questions
arising during development of medicinal products. The EMA provides scientific advice to support the
timely and sound development of high-quality, effective and safe medicines, for the benefit of patients.
Scientific Advice is prospective in nature and focuses on development strategies rather than preevaluation of data to support a Marketing Authorisation Application (MAA). Scientific Advice is legally
nonbinding and is based on the current scientific knowledge which may be subject to future changes.
Nevertheless, the advice provided is taken into consideration during MAA and any deviations from the
advice given need to be well justified.