Immutep (ASX:IMM) (NASDAQ:IMMP) LAG-3 validated in Bristol Myers Squibb trial


by Rachael Jones

Immutep Limited (ASX:IMM) CEO and Executive Director Marc Voigt talks about the Bristol Myers Squibb trial evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in patients with previously untreated metastatic or unresectable melanoma, meeting its primary endpoint of progression-free survival and what it means for Immutep.

Rachael Jones: Hello, I'm Rachel Jones for the Finance News Network. Joining me from Immutep is CEO, Marc Voigt. Marc, good to see you again.

Marc Voigt: Hi, Rachel. Good to see you.

Rachael Jones: Now, Marc, firstly, can you briefly describe what Immutep is currently doing?

Marc Voigt: Yeah, Immutep is a biotech company. We have four programs, two of them out-licensed, one to Novartis, the other one to GlaxoSmithKline. And we are a leading company in terms of LAG3, lymphocyte activation gene three, which is a specific immune checkpoint, a little trigger in the immune system which can up or down-regulate your immune system.

Rachael Jones: Now, we learned last week that LAG3 has been validated. Can you please describe what happened and what the relevance for Immutep is?

Marc Voigt: Yes, this is indeed a very big event, also for the industry. Last week, a major pharmaceutical company called Bristol Myers Squibb has announced that their phase three, a registration relevant study, had a positive readout, has been meeting the primary end point, progression-free survival in first-line metastatic or unresectable melanoma.

The study was more than 700 patients actually. And this study has been conducted with a combination of anti-PD-1 and anti-LAG3 versus anti-PD-1. So, this is actually now the very first time that, beyond CTLA-4 and PD-1, where you have multi-billion dollar blockbuster drugs based upon, like Opdivo, like Keytruda, like Yervoy, and this is LAG3. And as we are a LAG3 Pure Play, a leading company in that space actually, it's pretty big for us.

So, it is a validation, not only of LAG3, that's too narrow, it's a validation of the LAG3/MHC class-II, that's a major ligand and if you like, the playing partner, of that interaction. Our portfolio of different drugs, we have four of them, is directly affected by that. Our partner Novartis, our licensee, is doing exactly the same, like Bristol Myers Squibb. Also, they have an anti-LAG3 in five clinical trials for phase two, one phase one, well above a thousand patients. And our Eftilagimod also positioned in immuno oncology, a unique drug is addressing MHC class-II.

So, we are active on both sides of that interaction. For us, it's pretty big, especially as there has not been a lot of data in the past regarding LAG3, a lot of clinical trials, thousands of patients, but not a lot of published data. Actually, the biggest data contributor, if you like, has been Immutep. And of course, we will add to that also in the future. I think for the whole medical actually, this has been a big day. The precise data of course needs to be announced. Bristol Myers said they will do it at a major clinical conference. I assume it might be ESCO, but it is pretty big because since actually six, seven years, there was no new approval based on the checkpoint after PD-1 and Keytruda and Opdivo. So, this really has big potential, a very big catalyst and this is why I explained it in a little bit more detail.

Rachael Jones: That's fantastic news, Marc. How is Immutep now positioned and where could it be in a year from now?

Marc Voigt: Yeah, we are very well positioned I believe. And this involves, on the one hand side, the financial sphere. We have a cash runway into calendar year, 2023. On the other hand side, also our operations, with Eftilagimod in a variety of different clinical trials. Actually, we announced that we have a new partnership, second one with Merck from the US. We will start a new clinical trial mid of this year in first-line head a neck cancer, a randomised clinical trial, actually. That's the plan.

And of course, we have now with this validation of LAG3, a lot of support and LAG3 is now more widely discussed and people see and feel that during the coming months. And in a year from now, I believe we will be in a very good position, of course, always subject to the data, but we have many readouts coming during the course of this year, and then of course also next year.

Rachael Jones: And what are the next potential data points and events, especially regarding Efti?

Marc Voigt: Yes, the next important catalyst will be, on the one hand side, data from our ongoing clinical trials. We have, on the one hand side, TACTI-002 in first-line non-small cell lung cancer, second-line non-small cell lung cancer and second-line head and neck cancer. We expect an update in terms of data around mid of this year. Same applies to APEC where we will actually face final overall survival data. This is also a double blind randomised clinical trial with, I believe, very good data we showed in terms of overall survival in last December. This will come around mid of this year.

Then we will see also final data from the Pfizer study, INSIGHT-004. It's a phase one clinical trial. And then, beyond Eftilagimod and beyond clinical development, of course also manufacturing. We are moving up to commercial scale with Eftilagimod manufacturing, up to 2000 litre. And then, IMP761, our preclinical candidate should deliver some more data during the course of this year. And of course, we hope also from updates from our partners, meaning Novartis, Glaxo, CYTLIMIC, EOC and so on and so forth.

Also, Labcorp potentially. They have actually own some abstract at AACR conference in April in the US together with Bristol-Myers Squibb, addressing expression of LAG3 in different tumor types. So, a lot to expect during the course of a year. Also in terms of regulatory interaction, we prioritized those given the data we saw in the last year and given our development plan. We are quite excited here. I think we are very well positioned and there is a lot to come in 2021.

Rachael Jones: Marc Voigt, great to talk to you today. Thanks for your time and thanks for the updates.

Marc Voigt: Rachel, thank you so much.


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