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Immutep Limited (ASX:IMM) Executive Director and CEO Marc Voigt discusses data from SITC, the strategy to take Efti to market and milestones for 2023.
Tim McGowen: 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, thanks for your time
Marc Voigt: Tim, nice to see you
Tim McGowen: Marc, and for those investors who don't know Immutep, we might start with you giving us an overview of where Immutep's positioned in the biotech industry?
Marc Voigt: So, we have a portfolio, different assets and I think this is quite good from a risk perspective but also from an opportunity perspective. So, we are active in oncology, a key driver of growth for the industry, as well as autoimmune diseases. Four core products, two in oncology, two in autoimmune diseases, two of the four out-licensed exclusively worldwide, one to Novartis, the other one to GlaxoSmithKline. And we move forward with Eftilagimod Alpha as well as IMP 761. And we do it from a position of strength because we are well-funded. We have been updating our guidance in terms of cash life till mid of next year or end of financial year 2024. That's important to address your development from a position of strength.
Tim McGowen: Now, Marc, Immutep's clinical trials from Efti have been delivering some strong results. Can you give us a short overview of those results?
Marc Voigt: Yeah, indeed. First of all, we presented data in November last year in Boston in the States, conference called SITC. So, very important immunotherapy conference in oncology. And we presented, I believe, one of the strongest data sets in the most important cancer indication, first-line non-small cell lung cancer. And we doubled practically the overall response rate, so, the tumour shrinkage of patients, taking standard of care Keytruda. So, very significant results, and we have been presenting strong results in the past. So, at ASCO for instance. Both SITC and ASCO in oral presentations, so the highest standards you can have at those conferences.
Tim McGowen: Now, you've also recently announced a strategy to take Efti to market. Can you give us an outline of that strategy?
Marc Voigt: We have multiple different avenues to reach the market and to move forward. So, we are engaged in late-stage clinical trials. For instance, in first-line head and neck cancer. This is a trial called TACTI-003, which is actually recruiting. And we announced in December that we recruited now more than 50 per cent of patients already. Hope to have it fully recruited mid of this year. And then, of course, data second half of the year. This is a randomised, so a controlled clinical trial. We have in non-small cell lung cancer also the plans to move forward. Given the strong data, I believe it's almost a must. And we are preparing a Phase II/III clinical trial — this is likely the way to go — for some time towards end of this year. So, there will be interactions with the FDA, interactions with other key opinion leaders, stakeholders. And then let's see when we can kick off that potential trial. And also in metastatic breast cancer, we would like to move forward, potentially in a Phase II/III clinical trial, a little bit smaller size in terms of the Phase II part, to be kicked off hopefully soon. In other words, we are active in very important cancer indications with high unmet medical need. And we also pursue the strategy of having multiple shots on goal if you like. And if we prioritise one thing, then it's definitely non-small cell lung cancer first-line.
Tim McGowen: Marc, so part of Immutep's strategy is to progress Efti in combination with already approved drugs, such as Keytruda. Can you tell us why that's such an attractive route to market?
Marc Voigt: Indeed. Combination therapies are the way to go. I think this is what we see across the board in a number of different cancer indications. Cancer is very aggressive, it's very differentiated. So, you need to have different attacking points for the optimal benefit for the patients. Of course, we have also some monotherapy data, but we very early on concentrated on so-called combination clinical trials where you take approved standard of care drug, combine it with something new, which makes it more powerful, which makes more patients eligible to treatment. And if you take the example for instance of Keytruda from Merck, top-selling drug in oncology, we double or triple the market potential of that very powerful drug if you look at our results, for instance in first-line non-small cell lung cancer or head and neck cancer. So, at the end of the day, it's about benefit for the patients, and this you can achieve if you combine two or more different drugs, and this you see across the board of different indications.
Tim McGowen: And, Marc, you've touched on cancer drugs, but you're also focused in that autoimmune area. Can you give us some more colour on that?
Marc Voigt: Yeah, autoimmune diseases are also a very, very interesting field. We have two approaches there. On the one hand side, GSK'781. That's a depleting antibody exclusively worldwide out-licensed to GlaxoSmithKline. And we are concentrating on the world's first agonist to LAG-3. So, I don't go into any scientific detail, but at the end of the day what we try to achieve is to bring the immune system back into the right balance. So, your own immune system has been running wild. And now you give a therapy which brings your immune system into the balance. And, therefore, you get rid of the root cause of more than 90 per cent of autoimmune diseases, which are the auto-reactive effect of T-cells.
IMP761 is at preclinical stage. We press released late last year that we finished a GMP-compliant 200 litre manufacturing run. Why is that important? Because you need to complete your preclinical development with a consistently manufactured product. And if you would like to go into first-on-man, which we hopefully can do in about a year from now, that you have the right material at hand, that you have a completed preclinical package, so that you can hopefully safely administer the drug to the first patients. And that's a very exciting period of time in this cutting edge science approach.
Tim McGowen: And, Marc, we're just at the early stages of 2023. What are the milestones you're looking to achieve for Immutep this year?
Marc Voigt: Quite a lot. Last quarter has been a phenomenal quarter for the company. Very strong at now 2023. We are hopefully going to see more of that. So, we will see data hopefully in the not-too-distant future across the board of a variety of different cancer indications. So, in first-line non-small cell lung cancer, we will see some data. Hopefully, we will see data from TACTI-003, the randomised clinical trial. It's on track for second half of this year. We will see data in terms of head and neck cancer, second-line potentially. So, a lot of data. Regulatory milestones can be expected as well. Partnering updates can be expected, and a number of other important progress points for the company.
Tim McGowen: Marc, thanks for your time.
Marc Voigt: Thank you so much.
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