Immutep Limited (ASX:IMM) CEO and Executive Director Marc Voigt provides an update on the company's pipeline of clinical trials, focusing on results in head and neck cancer, lung cancer and breast cancer.

Manny Anton: Hello. I'm Manny Anton from the Finance News Network, and today we're talking to Immutep (ASX:IMM). Immutep is a leading biotechnology company focused on developing treatments for autoimmune disease and cancer. Joining us is Immutep's Chief Executive Officer, Marc Voigt. Marc, welcome back to the network.

Marc Voigt: Thank you so much, Manny.

Manny Anton: Great to have you. All right, well, why don't we get started? The company is involved in around half a dozen clinical trials in a number of cancer indications, including head and neck cancer, lung cancer, breast cancer and melanoma. Why don't we start with perhaps you talking us through the status of some of these trials, perhaps starting with your trial called TACTI-003? And just to remind our viewers, "TACTI" stands for "two active immunotherapies". So, the trial is looking at the combination of Immutep's lead drug candidate, efti, with Merck's drug called Keytruda, as a first-line therapy for patients diagnosed with head and neck cancers.

Marc Voigt: Yeah, thank you, Manny, for that question. First of all, indeed, as you said, our lead product candidate, eftilagimod, which I will call "efti", that's simpler, is tested together with Keytruda, top-selling drug in the world, which has been changing day-to-day clinical care in different oncology indications in a variety of different clinical trials. And you have been asking about TACTI-003. That's our trial in first-line head and neck cancer, so for patients which are exposed for the first time to a systemic therapy against cancer and which have metastasised disease. So, it's a difficult target to treat. We are very excited that we have the chance to do that. The trial is now fully recruited with 171 patients, thereof 138 in a so-called randomised -- so it's a controlled -- part of the trial, and 33 patients in a not-controlled part of the trial, simply because Keytruda is not approved there. And we hope to make a difference across the board of all different segments. And the first data, if I can add that, the first data is expected actually first half of this year. So we have to wait not for a very long time.

Manny Anton: Great. All right, so those announcements will be coming out in due course.

Marc Voigt: Definitely.

Manny Anton: Great. All right, well how about we move on to your trial called TACTI-002, which is looking at both head and neck cancer and lung cancer. What is the difference between TACTI-003 and TACTI-002, and what's the status of the TACTI-002 trial?

Marc Voigt: First of all, TACTI-002 is coming to an end. Indeed, we have been publishing a number of different data points in different indications. So, a key difference is that TACTI-003 is looking at first-line head and neck cancer, so at one cancer indication. In TACTI-002, we have been looking at three different settings, first-line non-small cell lung cancer, second-line non-small cell lung cancer, and second-line head and neck cancer, not first, but second-line head and neck cancer.

The trial has been fully recruited already back in 2021. I believe it's fair to say that we have been publishing amazing results, fantastic results across the board, especially in first-line non-small cell lung cancer. Those have been getting greatest attention. We presented the results in top clinical oncology conferences, such as ASCO, SITC, or ESMO, in oral presentations, which is very rare, and a top-ranking form to present the data.

So, we are currently in follow-up for patients in first-line non-small cell lung cancer. Those patients have been getting very good benefit, especially in terms of median overall survival. So, we are following up the patients for three years after treatment practically. But that's the final part of the study. So, all the other parts, including second-line head and neck cancer, have been published and announced, predominantly last year.

Manny Anton: Great. And the results are looking, by the sounds of it, very encouraging.

Marc Voigt: Extremely encouraging. Again, it's a trial which is looking at the combination of Keytruda together with efti, and we, for instance, doubled the median overall survival for patients in first-line non-small cell lung cancer. So, they take the most powerful top-selling drug in the world, and, in our clinical trial, we doubled the median overall survival, which is obviously a very good outcome for the patients. That's number one. But also a very strong statement for our drug. Those results have been presented in November last year. And we have been able to link also the overall survival to the underlying immune function, because eftilagimod is an immune booster and we can measure that in patients.

Manny Anton: All right. You're also running a trial called INSIGHT-003 in lung cancer. Could you remind our listeners and our viewers of the difference between INSIGHT-003 and the TACTI trials? And could you comment on the results in INSIGHT-003?

Marc Voigt: Yeah. INSIGHT-003 is a second trial in first-line non-small cell lung cancer. We look there at a different standard of care. That standard of care includes Keytruda, so an anti-PD-1, plus chemotherapy plus eftilagimod, because a number of patients are being treated in combination with chemotherapy that's established, and we wanted to see if we can position eftilagimod also in that setting on the one hand side from a safety point of view. Because when you combine different drugs, safety is, of course, a very important aspect. And B, how the efficacy trends. And we saw very good results. First results, we have been presenting in last quarter last year, and we saw actually 70 per cent of patients reacting with tumour shrinkage to the treatment, which compares to 30, 40 per cent what you would typically expect. It's currently a smaller number of patients, 21 patients. But the results are so far very exciting and we didn't see any complications on the safety side of things.

Manny Anton: Okay, fantastic. And the last trial I want to touch on is your trial in breast cancer called AIPAC-003. Could you comment on AIPAC and on the results that you're seeing?

Marc Voigt: Yeah, AIPAC is a slightly different setting. First of all, we are not looking at first-line, but practically second- or third-line patients. What does it mean? It means that patients are coming to the second or third therapy. So they failed, unfortunately, on the first two treatments, so they are coming at later stage into the trial. We are looking here not at a combination with Keytruda or other anti-PD-1s. We are looking at the combination with chemotherapy where efti is the only active immunotherapy.

We have been releasing first results a few weeks ago, and these first results, six patients only, so one has to be careful, but those results are looking very encouraging. We actually saw also a complete response, so complete disappearance of the tumour, which is relatively rare, especially if you have been pre-treated. Overall, we are testing there two different dosages of efti, 30 mg, well established, and one higher dose, 90 mg, as we discussed this with the FDA and which will be also relevant from a dose perspective for the whole program. So, it's exciting that we have overall three different indications, first-line head and neck cancer, which we discussed a few minutes ago, first-line non-small cell lung cancer, and also metastatic breast cancer.

Manny Anton: Yeah, okay. Well, I mean, the company's clearly... the pipeline is pretty full for Immutep. So, with that in mind, how is the balance sheet currently positioned? I mean, is it in a position to deliver the funding requirements that you'll demand from it over the next year or two?

Marc Voigt: Yeah, we have a very strong balance sheet end of last quarter. More than A$100m cash on bank. That's a very good position to be in, because we can address our different clinical trials from a position of strength, and we feel very comfortable about that.

Manny Anton: Just to round it up, let me ask you, what news flow can investors and shareholders expect from the company in the coming months?

Marc Voigt: You pointed to a number of different clinical trials. So, the news flow will be hopefully very exciting, very rich in the nearer term. So, till end of second quarter this year, we are going to see data from first-line head and neck cancer. We will be also more precise about a very exciting next step in first-line non-small cell lung cancer, a Phase III. You can expect more data in lung cancer. You can maybe expect also data from other clinical trials we haven't had the chance to discuss -- soft tissue sarcoma, for instance, a trial called EFTISARC-NEO. Maybe updates in terms of urothelial cancer. And I should not leave out also our newest member of the LAG-3 family, which is another product in autoimmune diseases, IMP761, which we intend to bring to clinical development first-in-man mid of this year. And of course, in second half of this year and beyond, a lot of additional data, different other updates. So, there are a lot of reasons to be excited.

Manny Anton: You've got a lot going on. And, yeah, so it sounds like shareholders and investors will have plenty to look at over the coming months. So, Marc, thank you for your time today. It's been great having you in here. And we look forward to getting you back in here again and hearing about the progress, which sounds pretty exciting so far.

Marc Voigt: Manny, thank you so much. It's been a pleasure.

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