Immutep Limited (ASX:IMM) Executive Director and CEO Marc Voigt provides an overview of the company, discussing the LAG-3 immune checkpoint, Immutep's LAG-3 pipeline, eftilagimod alpha's potential, and ongoing clinical trials.Immutep
(ASX:IMM) is a biotech company. We are active in two very large disease areas. On the one hand side, oncology, and on the other hand side, autoimmune diseases. We are globally active, with our headquarters in Sydney, at Australia Square, and subsidiaries in Germany, France, and a legal entity also in the United States. We have late-stage clinical trials, either started or planned. We have been presenting a lot of exciting data. A little bit, I will show you here during the presentation, and new data is coming up very, very soon. Also as a part of our DNA, we have been teaming up with big pharmaceutical industry. You can see a few of the names on the left hand side, like Novartis or Merck or Pfizer and others.
Now, the most important characteristic is that we are leading the LAG-3 space, a validated immune checkpoint. There are different immune checkpoints, and many of you know, PD-1, you'll see here, mid of this page. On PD-1 multi-billion-dollar blockbuster drugs are based, and it is a paradigm shift the way you treat cancer patients today, and it started back in 2011, it was anti-CTLA-4, then PD-1 in '13, '14. And now in '21, '22, LAG-3, when the first product has been approved, a product from Bristol Myers Squibb.
So, there are immune checkpoints. Some of those are validated, and LAG-3 is the newest one. And it took actually more than seven years to have this very, very important event. So, it's commercially very relevant. It's clinically very relevant. And we are leading, actually, regarding the LAG-3 space. You see also that the LAG-3 space is characterised by an increased number of patients and clinical trials, scientific publications. So, an increased interest from the clinical community, scientific community, pharmaceutical and biotech community. And there are a few players around LAG-3, including the big pharmaceutical industry, but no company has that many programs as Immutep. And Immutep is also the only LAG-3 pure play.
First part of our pipeline. We have four different programs, two in oncology and two in autoimmune diseases. You see here, eftilagimod alpha on the top mid of this page, which we have in different clinical trials in metastatic breast cancer, head and neck cancer, non-small-cell lung cancer, partly in collaboration with the industry. So, with Merck US, Merck Germany or Pfizer. And we out-licensed eftilagimod years ago to EOC Pharma in China. So, the full arm of Chinese development is funded by EOC Pharma. We are collecting milestone payments and royalties.
Then, at the bottom of this page, you'll see a program called IMP761, positioned in autoimmune diseases. It's at preclinical stage. There was a very good publication in Journal of Immunology a while ago. And in October last year, also a publication about IMP761 in juvenile arthritis. You see also that we are addressing very, very large markets.
Second part of the pipeline, everything you see here is fully paid for by our licensees Novartis, Glaxo Smith Kline. Novartis is running five clinical trials. We hope for data updates throughout this year. GSK successfully completed two Phase I clinical trials, but had to stop about a year ago a Phase II trial in ulcerative colitis. And we are waiting for next steps from Glaxo Smith Kline.
Now, the main program is eftilagimod alpha. This is, I believe, dominating our value, and it's about antigen-presenting cell activation in oncology. In other words, we have an immune booster. We provide the patient's immune system with a broader push and enable the patient's immune system to actively fight cancer. We do this in a unique way with an MHC II agonist. So, we use LAG-3 as a tool to activate the immune system. We have a very good safety profile, encouraging data, low cost of goods, very important in terms of the pharmacoeconomical debate, drug pricing, etc. Of course, we have intellectual property and clinical experience.
Here's an overview slide. You'll see that we conduct and partly finished a number of different clinical trials. And I believe it's important to have multiple different clinical trials addressing different indications, different forms of the cancer disease, and also in different combinations.
A bit of data from this clinical trial here in collaboration with Merck, TACTI-002, a Phase II clinical trial. The keynote designation from Merck is 798. Three different indications. First-line non-small-cell lung cancer. Second-line non-small-cell lung cancer. And second-line head and neck cancer unselected for PD-L1. PD-L1 is a biomarker which is important to assess if a patient is likely to respond to anti-PD-1 therapies, such as Keytruda, or if a patient is not responding, suboptimally responding or responding potentially very well. And we, in this clinical trial here, recruited all patients.
It's a combination of efti plus Keytruda in the US and Australia and different European countries. Fully recruited. 189 patients with centre of gravity on first-line non-small-cell lung cancer. This is what we showed at ASCO last year. Overall response rate was 36 patients between 35 and 40 per cent, PD-L1 all-comer. And now at this year's ASCO -- so, in early June, in practically in a few days from now -- we will show the data set from 114 patients. So, extremely important. We publicly said that we enlarged the trial with Merck in order to see if the data holds or if it was by chance. So good. So, we double here, by and large, the response rate you would expect with Keytruda monotherapy, and to be in a position, if that's the case, to plan for late stage clinical trials.
We presented data at the ESMO lung cancer conference earlier this year. Also a very encouraging signal. First cut of the data with two responses, which is okay, but a very good disease control rate. And for patients, most importantly, promising overall survival signals. So, at the six months landmark, more than 70 per cent of patients have been alive. You could compare that to the toxic option of chemotherapy. For instance, Docetaxel, in this case. There is more to come from this part of the trial.
Second-line head and neck cancer. We have been showing an overall response rate of 30 per cent. So, again, we doubled what you would typically expect was Keytruda. Long-term, deep and durable responses, very promising overall. And this prompted us and Merck to go into the next clinical trial in head and neck cancer. Here a first-line randomised trial, which is recruiting, actively recruiting. So we test here Keytruda versus Keytruda plus eftilagimod in a small satellite cohort which is not randomised. 154 patients. We hope that this trial will be recruited till about early next year. And of course data is coming as well. You would expect that from second half of this year ongoing. And if the data is very good, it's a registration-relevant clinical trial.
IMP761. So, we are switching our fields to autoimmune diseases. IMP761 being a preclinical stage is addressing potentially the root cause of more than 90 per cent of autoimmune diseases. So, these are the autoimmune effect or T-cell. So practically in autoimmune diseases, our own immune system is attacking our own organs. So, it's out of balance. And, with IMP761, we specifically silence the troublemakers, these autoimmune effect T cells, where they are expressing LAG-3. And we use conceptually LAG-3 as a marker to bring the immune system under control and back to the right balance. We are currently GMP-manufacturing IMP761, and hope that this will be finished in a few months from now so that we can go to toxicology studies and be ready for clinical development some time next year.
The outlook? First of all, the LAG-3 space has been clinically validated at ASCO last year. It has been commercially validated by the FDA approval in March this year. I expect the BMS drug to be approved in Europe mid of this year, maybe in July, maybe in August. And, more importantly, Immutep continues to deliver very exciting data out of our ongoing clinical trials. Next stop is ASCO, the world's largest clinical oncology conference. We have an oral presentation, so it's super important. And if this goes well, and if what we are presenting is positive, I believe this will open up a variety of different options. Other points will come as well. Also the second half of this year, we are going to present data. We are working on the manufacturing scale up. So we have also exciting times ahead there.
So, Immutep is the leader in this space, validated immune checkpoint. We have four LAG-3 programs, multiple big pharma partnerships. We are very well funded, with more than 87 million Australian dollars cash on bank, end of last quarter. So, we are in a strong position, no need for short-term financing. And we are here to deliver. We approach drug development in a very fundamental way. And with that, I can thank you a lot. Thanks, Tim. And back to you.
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