Benzinga | Oct 29, 2021 06:24AM EDT

Immutep Filing Shows Co. Received European Medicines Agency Advice For Further Clinical Development Of Efti In Metastatic Breast Cancer, Including Phase 3 Trial

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."