Positive EMA advice for development of Immutep's eftilagimod in MBC

Market reaction was positive for Immutep (ASK: IMM), with the Australian biotech announcing progress for its lead candidate, a novel LAG-3 related immunotherapy treatment for cancer and autoimmune disease, with its shares rising 2.6% to A$0.58.

Immutep announced 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 metastatic breast cancer (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 the Society for Immunotherapy of Cancer (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 Food and Drug Administration to generate a final study design are ongoing.

Immutep chief executive 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.”

Prospects for LAG-3 targeted therapies and efti