- Shares in Immutep (IMM) open green after the company announced positive feedback from European regulators around its lead anti-cancer drug candidate
- Immutep says the European Medicines Agency (EMA) supported IMM’s continued development of efti, including for a third-phase clinical trial for metastatic breast cancer
- Immutep plans to build the phase three trial on its ongoing phase two Active Immunotherapy PAClitaxel (AIPAC) trial
- The planned third-phase trial will be taken on across several different countries, meaning Immutep will need to engage with multiple international regulators
- Shares in Immutep were up 1.77 per cent and trading at 57.5 cents each
Shares in Immutep (IMM) have opened green today after the company announced positive feedback from European regulators around its lead anti-cancer drug candidate.
Immutep said the European Medicines Agency (EMA) supported IMM’s continued development of efti, including for a third-phase clinical trial for metastatic breast cancer.
In light of the EMA feedback, Immutep said it would build the phase three trial on its ongoing phase two Active Immunotherapy PAClitaxel (AIPAC) trial, from which the company has reported “encouraging” interim results.
Immutep is slated to release the final survival data for the AIPAC trial in mid-November.
Immutep CEO Marc Voigt said the company planned to continue engaging with the EMA and other regulators, including the US Food and Drug Administration (FDA), to solidify its clinical trial plans.
“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,” Mr Voigt said.
The planned third-phase trial will be taken on across several different countries, hence the need for engagement with other international regulators.
The EMA’s scientific advice is designed to clarify questions and concerns from drugmakers during their drug development process.
It’s important to note, however, that the advice is centred more around development strategies rather than the pre-evaluation of data.
Immutep’s anti-cancer treatments are based on using a protein found in the human body, known as Lymphocyte Activation Gene-3 (LAG-3), to boost the immune system.
Eftilagimod alpha, known as efti, is being developed to manipulate and activate this LAG-3 protein to increase the body’s immune response to cancer antigens.
Shares in Immutep were up 1.77 per cent and trading at 57.5 cents each at 10:47 am AEDT. The company has a $482.4 million market cap.