Immutep (ASX:IMM) reports positive discussions with the FDA and strong survival data

Immutep Limited (ASX:IMM) Executive Director and CEO Marc Voigt discusses the significance of recent announcements on the back of a recent surge in trading volume.

Paul Sanger: We're talking today with Immutep (ASX:IMM). The company is a leading biotechnology company. The stock has a code of "IMM" and a market cap of $215m. We're joined today by Marc Voigt, who is the Executive Director and CEO.

Marc, it has been a busy week newswise for Immutep. You have made a couple announcements to the market this week, which resulted in a modest reaction from Australian investors and traders. Overnight in the US, your Nasdaq listing had a huge positive move on extraordinary volume, which I believe even got the attention of Nasdaq, who gave Immutep a special mention at the close of trading. It was great to see this momentum carried into the Australian market today.

Firstly, can you talk about both announcements that you released this week and why they are so significant for Immutep?

Marc Voigt: Yeah, Paul. First of all, thank you very much. Great to be here. And, indeed, we had two very important announcements during this week. First of all, we have been press releasing that we had a good discussion with the FDA in the United States regarding our most important centre of gravity, which is non-small cell lung cancer, first line, with our lead product, Eftilagimod. And, of course, to discuss with the FDA and to get their support is a critical step when you develop a program and when you plan for late-stage development. So, this has been a very important announcement. The FDA is, of course, the regulatory authority in the most important pharma and healthcare market in the world, quite frankly speaking. As simple as that, if you like.

And we have been declaring and publishing our priorities, I believe roundabout October last year, where we set first-line non-small cell lung cancer is a priority. So why is that? It is because we saw very good data last year presented at ASCO and also then at SITC in Chicago and Boston. It's one of the largest cancer indications. It's causing most death caused by cancer. So, it's a terrible disease. So, to make a difference there is ethically very relevant and also commercially very relevant. Now, if you look at this disease, and what is most important for patients, for regulators, for reimbursement, that's typically overall survival. So, how long does the patient live?

And the second announcement this week has been providing our data, the initial median overall survival data for Eftilagimod, plus Keytruda, the top-selling drug in oncology. And this data has been very, very strong. It was 25 months median overall survival.

So, two very important announcements in our key focus, and hence it has been a very significant stream of news, if you like, and has been leading to, I believe, a good market reaction so far.

Paul Sanger: Marc, can you enlighten us on what the US investors saw that Australian investors did not? Or is it more of the case that US investors and traders have a better appreciation of what a nod from the FDA followed by good data means to Immutep?

Marc Voigt: Also a good question. First of all, I believe in both markets we saw a positive reaction. In the US, I have to admit, that reaction has been stronger, but both have been pointing into the right direction, and the Australian market has then been following up, practically stronger a day later. But that's entirely fine.

Of course, when you discuss with the FDA and when you are dealing with the pharmaceutical and biotech industry, there is a broader pool in the United States, broader than anywhere else in the world, quite frankly speaking. So, the appreciation of the data in context of regulatory interactions and in context maybe also of benchmarking has been providing maybe a little bit a stronger start. But I believe the data has been understood in both markets and also globally and also by the industry. And then it's the amplitude of the reaction which made a difference.

Paul Sanger: And finally, what should the investors be looking out for news flow wise over the coming months?

Marc Voigt: We don't even need to talk about months, actually. We can talk about weeks because we will present final data in second-line head and neck cancer beginning of June. So, in about two-and-a-half weeks or so at ASCO in Chicago. So, the world's largest clinical oncology conference.

And we will certainly have in the second half of the year a more mature overall survival data from TACTI-002. So, related to the announcement, where we said at the major upcoming medical conference second half of the year. We are adequately excited about it, as you will understand.

We are also currently recruiting our TACTI-003 clinical trial in first-line head and neck cancer. Top-line data could be expected also in the second half of this year. We have other clinical trials like INSIGHT-003 and also started AIPAC-003. We started also a trial together with Merck and Pfizer, as well as another one in soft tissue sarcoma.

So, there will be no shortage of news flow and data points. And we have just been discussing here our main product, Eftilagimod, but we have also IMP761, one should not forget that, as well as our collaborations with Novartis and GlaxoSmithKline.

So, in other words, and I said it before, a lot to expect in the short term, in the mid term and also in the long term. So, we won't have much of a quiet time, I believe.

Paul Sanger: Marc Voigt, thanks for your time.