Immutep (ASX:IMM) receives fast track designation from FDA

Immutep Limited (ASX:IMM) CEO and Executive Director Marc Voigt discusses the FDA fast track designation received in first-line non-small cell lung cancer, the company's new Phase 2 trial in soft tissue sarcoma and the outlook ahead.

Tim McGowen: We're talking with Immutep (ASX:IMM) today, market cap of $227m. If you don't know the company, it's leading the development of immunotherapy for cancer and autoimmune diseases. We have with us the Executive Director and CEO, Marc Voigt. Marc, thanks for the time. Nice to see you again.

Marc Voigt: Tim, thank you for having me. Pleasure to be here.

Tim McGowen: Can we start by talking, Marc, about some of the recent announcements you've released to the ASX, in one of which you were recently granted fast track designation by the US FDA. What's the significance of this recent fast track status for first-line non-small cell lung cancer?

Marc Voigt: Yes, thank you, Tim. It's indeed very significant because the US FDA has been granting us fast track designation for first-line non-small lung cancer, so the most important cancer indication in immuno-oncology. Now, this enables us to have more frequent interactions with the FDA to, if the opportunity presents itself, apply for accelerated approval or priority review. So, it's very important to receive it, and it's based on the data we have been presenting at ASCO in June this year. And, of course, we are very happy. It's actually our second fast track designation for Eftilagimod. First one has been in first-line head and neck cancer. And it's, of course, good to be recognised that way and shows that we are in a good contact and in a good progress and process with the competent authorities.

Tim McGowen: And, Marc, can you talk a little bit in more detail about your new Phase 2 trial in soft tissue sarcoma as well?

Marc Voigt: Yes, so we have been approached from a group of Center of Excellence in Warsaw, the Marie Curie Center in Poland. And they have the idea to test Eftilagimod and anti-PD-1 plus radiotherapy. So, a new setting which has never been explored before, in soft tissue sarcoma in a so-called neoadjuvant settings. So, before surgery. And this is, of course, very exciting and is the first example of the increased inbound interest we saw since ASCO last year turning into new clinical trials, new collaborations. And we hope that the study starts in first quarter next year. And then, of course, we keep our fingers crossed for good results, especially as this clinical trial is fully funded by the Polish government. So, it's the grant which the investigators have been applying for and which was obviously given from the Polish government. So, I think it's a pretty good example of the way you can detect new signals and new indications, new combinations, without using your own cash.

Tim McGowen: And, Marc, of course the biotech sector has been quite depressed here in Australia and it has been globally. Is there any signs of life that you're seeing in European and US markets?

Marc Voigt: Yes, first of all, I believe your statement is right — the markets are depressed in terms of healthcare in general, also in terms of tech and many other industries. We see a number of challenges from the macroeconomic environment. But we also see that, for instance in the United States, some new funds are positioning themselves. They actually take this as an opportunity to buy, as many titles have been absolutely oversold. And it's a good opportunity, especially if you look at the quality of some of the companies — the quality in terms of data, the quality in terms of the overall development. So there are also good chances. So, you will position yourself best if it's relatively cheap, I believe. But this is my personal opinion here. So, I hope that in the next year and end of this year we see some more life in the healthcare sector specifically and in the US. Even though there's still a great deal of volatility, I believe it's starting here and there cautiously and carefully to see some, let's say, good signs of life. And, of course, that should transpire also to Australia.

Tim McGowen: And, Marc, looking forward, say perhaps to the end of the year, what should investors look out for in regards to Immutep news?

Marc Voigt: Yes, we have a very busy quarter and a very busy end of the year. We announced that at SITC, it's a big conference in the United States in Boston this time, we will present data. On the one hand side, in first-line non-small cell lung cancer in regard to the triple combination. So, anti-PD-1 plus Eftilagimod plus chemotherapy. So, this will be very important. We have a trial in progress poster regarding TACTI-003, the trial in head and neck cancer. And we mentioned that there will be a late-breaking abstract coming. These are abstracts which typically contain significant data and will be announced 2 November. The abstract is such, and then presented at the conference. So, this is about data. We also would like to qualify, actually, how TACTI-003 is going. And there will be other updates and news potentially in terms of manufacturing, in terms of expansion of the pipeline, maybe a new clinical trial. So, there's a lot to expect. We will be very busy, very active, and the start of next year will be not much different.

Tim McGowen: Marc, thank you for your time. Always good to talk to you.

Marc Voigt: Thank you so much.

Source: Finance News Network