Adaptimmune Therapeutics Q1 2023 Earnings Call Transcript

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May 12, 2023

There are 11 speakers on the call.

Operator

Hello, and welcome to Adaptimmune's First Quarter Call and Business Update. I would now like to turn the call over to Julie Miller. Julie, please go ahead. Good morning, and welcome to Adaptimmune's conference call to discuss our 1st quarter 2023 financial results and business updates. I would ask you to review the full text of our forward looking statements from this morning's press release.

Operator

We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call. Other members of our management team will be available for Q and A. With that, I'll turn it over to Adrian Rockliff. Ad?

Speaker 1

Thank you, Judy, and thanks to everyone for joining the call. My comments today will be brief and we can go directly to questions. We started 2023 at pace and it promises to be a year of change for Adaptimmune. We completed the prioritization of restructuring in Q1, cutting costs whilst remaining focused on our priorities, the epamacell BLA, the CD8 program in ovarian, bladder and head and neck cancers, PRAME and our allogeneic platform, a strong pipeline of cell therapies for a wide range of solid tumors. Adding to that strength, we announced that we entered into a strategic combination with TCR2.

Speaker 1

We are 2 companies that have spent our entire histories focused on solid tumors with experienced teams who have advanced strong clinical pipelines with significant value creating near term catalysts. Add to that the compatibility of our technology platforms, including an innovative next generation toolbox and a cash runway into 2026. When taken together, it's clear that this combination will create a preeminent cell therapy company to treat solid tumors. We expect the transaction to close in Q2 2023, subject of course to shareholder approval at the end of this month. Both companies are very actively planning for integration and we will update further once the transaction is closed.

Speaker 1

We are also on track to have a commercial product, Afamicel, which would be the 1st engineered T cell product on the market for a treatment of a solid tumor. We announced that we completed Part 2 of the BLA submission in Q1 and Part 3 is in progress for completion in mid-twenty 23. Afampasal is an incredibly exciting drug and the need for new marketed treatments for synovial sarcoma compelling. Recently, we had the privilege of hosting a young woman who is surviving synovial sarcoma at an internal meeting. Hearing her personal account of misdiagnosis, harsh treatments and are pleased with new and innovative therapies is inspirational for all of us here and highlights further how important AflanaCell is to this patient population.

Speaker 1

She also described the loss of young lives to this cancer and the experiences of her peers in the sarcoma community. We hope to share stories like hers in the future and continue to raise awareness for synovial sarcoma and the high unmet need in this cancer. Continuing with the Famicel news, we will present updated overall survival analysis for a Famicel in June at ASCO. It's clear that this is a powerful treatment for this rare and deadly cancer. Beyond the famicel, we remain focused on developing our MAGE A 4 franchise with our next gen CDA therapy and progressing more products to market.

Speaker 1

To that end, we are initiating the Phase 2 SURPASS III trial in combination with nivolumab for platinum resistant ovarian cancer. This trial has the potential to become registrational and is supported by RMAT designation with the FDA. We are also initiating additional cohorts in the Phase 1 SURPASS trial in combination with pembrolizumab to treat patients in early aligned settings for head and neck in urothelial cancer. Last year, we announced we have PRAME back from GSK and we believe this is another powerful target for solid tumors with increasing validation across the industry. We are progressing PRAME to be IND ready by the end of this year and plan to initiate trials next year.

Speaker 1

We also announced in Q1 that we are in process of transitioning Letticell back and we will receive approximately $37,000,000 from GSK in relation to the transition of the ongoing clinical trial. We anticipate letiselle data in synovial sarcoma and MRCLS later this year and will evaluate this opportunity accordingly. In closing, this has been a significant Q1 for us and will undoubtedly prove to be a year of change as we move towards our first BLA and marketed product. Behind that, we have an unparalleled pipeline of cell therapies for solid tumors that will continue to prioritize development in a thoughtful, data driven fashion. I look forward to reporting out on future progress.

Speaker 1

And with that, I'll turn the call over to Q and A. Operator?

Operator

Thank Our first question comes from Mark Frahm of TD Cowen. Please go ahead.

Speaker 2

Hi, guys. Thanks for taking my questions and congrats on the progress. Adrian, you made the update of Part 2 being in of the BLA. On the Part 3 there, do you now have everything you need in house and it's a question of packaging it all up appropriately and submitting it or are there still data points that you need to gather for that portion?

Speaker 1

There's still a lot of work going on to complete the BLA on time. I'll ask Dennis, who's leading that program to comment a bit further.

Speaker 3

Yes. Hi. As Adrian said, I mean, we're in the final stages of method validation and some of the other activities related to the dossier preparation, but we continue to look forward towards our goal. And we're excited to have 2 thirds of the application already down at the FDA.

Speaker 2

Okay. That's helpful. And then maybe just on the pipeline, the MAGE A 4 CD8 program, just any data presentations we should be looking forward to maybe in the second half of the year?

Speaker 1

We said that we will provide an update on the monotherapy cohort in late line patients and the patients that we've dosed in combination with nivolumab at an appropriate congress later on this year. Okay, great. Thanks. Thanks.

Operator

Our next question comes from Tony Butler of E. S. Hutton. Please go ahead.

Speaker 4

Thanks very much. Adrian, I just wanted to

Speaker 5

discuss some

Speaker 4

of the trials with checkpoint inhibitors. I want to make sure that is Adaptimmune paying for the checkpoint inhibitor? That's point 1. And number 2 is, is the notion here that the combinations I mean, let's be clear, the combinations may evolve greater activity. But I guess in the absence of a total control arm, how do you actually separate the 2 when you're simply, if you will, doing a Phase II study or at least a study that's exploring the combination?

Speaker 4

How do you think through that if you were to move to a regulatory trial? Thank you.

Speaker 1

So the short answer on the question of who's paying for the checkpoint inhibitors, The answer is that the Adaptimmune is currently paying for the checkpoint inhibitors. And then on the question of the trial design, I think we focus on the SURPASS III trials since that's the one that we are that is a Phase II trial progressing, particularly towards registration. I'll ask Dennis to comment on that trial design and how we consider that in platinum resistant ovarian cancer.

Speaker 3

Yes. Sure. So in SURPASS-three, it's a randomized trial in that there's a monotherapy arm and then there's another combination arm with nivolumab. Both arms are compared against historical response rates for non platinum based chemotherapy in platinum resistant disease. Your point is well taken.

Speaker 3

But in the checkpoint inhibitor space, both as monotherapy and in combination with chemotherapy and platinum resistant disease, the efficacy is very well described. So for us, it will be very obvious that if the combination arm shows something, it will allow us to compare that against the monotherapy arm to make some inferences if we see perhaps greater depth and durability. But we certainly will be able to determine that that's not solely due to the checkpoint alone because as we know checkpoints alone don't have appreciable activity in that disease. So we feel very confident that we'll be able the results of that trial will be quite interpretable.

Speaker 4

And if I could just ask one follow-up, Dennis, on this topic. Thank you very much for the commentary. But the other is, do you limit the number of previous therapies that a patient may undergo in part because it seems that at least the response rates in a number of tumors were better when it was I think 2 or less at least for monotherapy. So I'm just curious how you may balance that in combination also with the checkpoint inhibitor? Thank you.

Speaker 3

Yes. For SURPASS-three, we do limit the number of prior lines of treatment. The data we presented about baseline characteristics and how they relate to response, among them being the number of lines of prior therapy, That's across the basket experience we have in the Phase I SURPASS trial. And of course, some of those prior lines of therapies differs notably depending on which cancer that patient has. In the platinum resistant space, since platinum based therapy is quite effective until they become resistant, we do allow a number of prior platinum treatments.

Speaker 3

We would expect patients to receive bevacizumab unless they were otherwise enabled to receive that. And we would also expect patients to have received a prior PARP, if that was indicated. But we do intend to, have a more homogeneous Phase II population and among that to limit the number of prior lines in this trial.

Speaker 1

Our

Operator

next question comes from Mara Gold Steyn of Mizuho. Please go ahead. Hi.

Speaker 5

Thank you for taking our questions. This is the call for Mara. Two small ones first. When are you going to get that $37,000,000 payment from GSK? And it says on the release that there will be the vote on the 30th.

Speaker 5

Is that TCR or is that Adaptimmune's vote?

Speaker 1

So I will comment on the vote and I will ask Helen to comment on the payments received from GSK. The payment the votes on the 30th both the TCR Squared and the Adaptimmune votes happened on the same day. And subject, of course, to that vote, we plan to close the transaction very shortly thereafter. Helen?

Speaker 6

Yes. Thanks for the question. This is Helen Tatum, Martin. In relation to the money, the income from the GSK transition, the majority of that will be in line with the transition of the program, which is anticipated the lessor program, which is anticipated during the course of 2023. There is some very small amount which will come in 2020 4, but we haven't disclosed it.

Speaker 6

It will come in stages basically, but the majority of it will be during this year and hence it being sold into our runway and projection.

Speaker 5

Got it. And then just a follow-up on Afamiselt launch. I was wondering if you can if there's anything you can share regarding the payer discussion, how is that going? And any color on the pricing strategy would be helpful. Thank you.

Speaker 1

I think the discussions with payers are going well at this point in time. We are obviously a year or so away from launch and we will have more to say on pricing strategy as we approach approval.

Operator

Our next question comes from Michael Schmidt of Guggenheim. Please go ahead.

Speaker 2

Hey, this is Paul on

Speaker 7

for Michael. Thanks for taking our questions. My first one is on frame. As you look towards a future Phase 1, how are you currently thinking about expression thresholds for PRAME and potentially enriching for certain tumors upfront versus sort of a broader signal finding approach? And maybe just a read through from the recent frame updates across the landscape.

Speaker 7

It seems like some of the responses have mostly been in particular tumor types in the melanoma, ovarian. So as you're moving towards the IND, what gives you confidence in the broader opportunity? And are there any sort of particular indications and focus for you?

Speaker 1

So I would ask Joe Brewer to comment on that and our thinking as regards frame expression, our TCR and what indications we are considering.

Speaker 8

Thanks, Thad. So it's a great question. And I think we're really excited about having PRAME back in our hands because it's a fantastic target and we are very excited about the opportunity that this will give us. So you're right, we'll likely look at more than one indication. We are making informed decisions about our kind of There are obviously synergies in ovarian with our other trials, as There are obviously synergies in ovarian with our other trials as we're looking working with the right people in that area.

Speaker 8

But there are great expression profiles in other tumor types as well. And PRAME is a large opportunity for us. So I think we will use some of our learnings from MAGE A 4 most definitely. We'll look at working with sites that we know well. And we will see we're still in the preclinical phase here, getting ready for IND.

Speaker 8

And obviously, we're discussing those right now. But I think in terms of PRAME out there, it's obviously a well validated target. There's been some great data recently from Imastics, and we're very mindful of that. Our TCR is engineered, as you would expect. So we have a higher affinity engineered TCR where we've been optimizing the TCR for binding and function.

Speaker 8

And so we're quite confident that this is going to give an edge with our Frame product. We're also looking at our next gen opportunities with PRAME as well based on work that we've done with the MAGE A 4. We're transferring that across to PRAME. And so we will be looking to make the most of PRAME as a target with products coming forward. And I think it's still early days for the PRAME space, and we intend to be in there doing the best that we can and hopefully bringing forward some great products.

Speaker 7

Great. And then maybe just a follow-up on Letticell. Just wanted to get your updated views on that program and how you might expect that program transfer in the 3rd quarter to perhaps impact your OpEx? And then for that data later this year, is there a particular response rate threshold you're hoping to see to support a potential commercialization decision? Thank you.

Speaker 1

So I think implicit in your question is the correct consideration that we're making, which is, as I've touched on before, we view letter sales return as essentially a free option on what has the potential to be quite a late stage product given that the IGNITE ESO trial was designed to support least in part, registration. So we look forward to getting those data back in house and it will be very much tail end of this year. And we will make rigorous data driven decisions. And the I think the standard for activity in this space has been set by a Famicel with response rate approaching 40%. But I think if we look historically at what we've said about the required response rates in this space, I think if we're not at 30 odd percent in this space, I think it would be challenging to think about development.

Speaker 1

So that's been our historic benchmark. It probably ends up being our future benchmark at this point in time for this particular asset

Speaker 7

too.

Operator

Our next question comes from Jonathan Chang of SVB Securities. Please go ahead.

Speaker 9

Hey, guys. It's Dylan Drakes on for Jonathan. Thanks for taking my question. First of all, I just want to ask how you guys are thinking about strategic priorities for your pipeline programs following the merger, particularly when you think about your approach to ovarian cancer and how you plan to address any overlapping MAGE or mesothelin patient populations?

Speaker 1

So let me say please just say a little about that. Obviously, we're limited in what we can say because we have yet to complete the transaction. And at the moment, TCR2 and Adaptimmune are continuing as independent companies. And the best way of thinking about our focus at the moment is that we're focused on our priorities for adaptively as a company, which I went through a Famicel, BLA, CD8, PRAME and our other genetic platform. However, clearly, we as we bring this pipeline together, we will need to address 2 angles.

Speaker 1

1 is how do you develop these programs in a synergistic fashion, a synergistic and efficient fashion And there's pros to the benefits to the fact that we have both assets in ovarian in terms of execution, clinical execution and experience in the ovarian space. And there's also considerations like overlap between the antigen that we need to think about how long we deal with. All of that is driven by data. And I think we are looking forward to the data that has been accumulated by TCR Squared of gabasal in combination with nivolumab and we look forward to making data driven decisions on the entire portfolio as we go through this year and into next year. So we are very clear that we will need to be thoughtful and rigorous about the prioritization across the portfolio in order to develop the best medicines out of what is the best pipeline with the broadest range of targets and the deepest base of assets in the cell therapy industry at this point in time.

Speaker 9

Follow-up on that. So how do you see the allogeneic pipeline progressing? And how do you guys think about prioritizing both the allogeneic and autologous programs in the future?

Speaker 1

So I'm going to touch on that just very briefly and then I'm going to invite Jo to comment as she is leading the allogeneic platform work. I think one of the things that's become clear in the industry, and in fact, I think this is why there's a resurgence of interest in the autologous space is that it's been clear to us for a long time that the allogeneic promise is definitely there. The idea of an off the shelf cell therapy product is incredibly attractive. It's also quite a long way away. And I think the next decade is in particularly in the solid tumor space is the decade of autologous solid cell therapies.

Speaker 1

And I think you can see in the investments that people are making in the CAR T space that I think this is becoming an industry perspective. Now it's unfortunate that some of that is because of the inevitable challenges that have arisen as you try to develop a new modality, I. E. Allogeneic T cells. Would mean that there's now, I think, going to be quite a gap.

Speaker 1

Oftologous is not simply a bridge to allogeneic. They will be different products. And the allogeneic products will be, I think, quite a way behind the autologous products, particularly in the solid tumor space. And as such, our focus is on developing our autologous pipeline of products, which have near term potential, near and medium term potential to benefit thousands of patients who have deadly cancers. And then I think the evolution of the allogeneic platform will then determine 2 things.

Speaker 1

1, the extent to which there is direct overlap or the extent to which there is complementarity between these platforms in due course. We're very pleased that we have a foot in both camps and in particular with the allogeneic platform with our partner Genentech. But we see a very, very significant solid business in the autologous space in solid tumors before there's any allogeneic players out there, including our own. Jo, anything that you'd like to add to that?

Speaker 8

I think you covered that pretty well, Ed. As I've said, we're still really committed to the allogeneic platform and we are making progress there. It's one of those working through unknown unknowns. It is What comes up in these programs, they're new challenges that need to be solved. And the team has been working very hard on this for a long time now, and we've made a huge amount of progress.

Speaker 8

But we have to react to whatever changing landscape around us as well. So the bar, the regulatory bar for allogeneic programs is very different to autologous. And the way that the autologous programs are progressing in terms of business model and ability to supply patients is also making that bar harder for allogeneic products as well. It's becoming we're getting better at supplying and treating patients with autologous products, which means that the allogeneic products have to try much harder to be improvements on that. We're still completely convinced that that is the long term future and we're keeping all of that in mind.

Speaker 8

So we're still putting a huge amount of effort into our allogeneic platform because we do see that as our long term play for the future. And that's why we're very happy to be partnered with Genentech who view it in a similar way to ourselves and that this is a long term play for good gains at the end of it. So I think it's we've not been talking about it much recently because we're just carrying on. And it's great. But right now, the transformative data is in the autologous space and we're committed to that as well.

Speaker 8

We're making a valid business with strong data and treating patients. Allo will come in time, but for now, there's important work to be done in autologous as well and important products that we can bring forward.

Speaker 9

Great. Thank you. I appreciate that.

Operator

Our next question comes from Peter Lawson of Barclays. Please go ahead.

Speaker 5

Hey, good morning. This is Alex on for Peter. Thank you for taking our questions. Just another question on PRAME program. I was wondering if you could clarify just the timing of the IND if that's mid-twenty 3?

Speaker 5

And then when would you be in position to start a Phase I study here? And then kind of related in terms of manufacturing for the PRAME program, are there any synergies in terms of being able to leverage your current manufacturing footprint or know how processes for manufacturing for that program? Thank you.

Speaker 1

So I will comment briefly and then I'll ask John Lunger, Chief Patient Supply Officer to comment on the manufacturing approach for the PRAME program. I think you might be confusing our BLA timing of mid-twenty 23 with the discussion that we've had on PRAME where we said we would be IND ready in 2023 with the clinical trial to follow shortly thereafter. We anticipate being in the clinic with Prane in 2024. John, would you like to just talk about the manufacturing for Frank?

Speaker 10

Yes. Thanks, Ed. Hi. Yes, absolutely, we're leveraging our capabilities that we've built in manufacturing. It's definitely one of the advantages of building the integrated capabilities that we have.

Speaker 10

So we as soon as PRAME began to come back, we started to look at our network. We have the ability to make the lentiviral vector that we would need in our facility that's in the U. K. And we have the capacity for drug product in the Navy Yard. So the flexibility that that's enabled to react is fantastic and we'll certainly leverage that.

Speaker 1

Okay.

Operator

This concludes the question and answer session. I would like to turn the conference back over to Adrian Rockliff for any closing remarks.

Speaker 1

Thanks, everyone, for your time today. We've been very pleased to share our progress with you, and we look forward to updating later on in 2023 after we have concluded our transaction with TCR2. In the meantime, please feel free to reach out with any questions. Thank you again for your time. Bye.

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Adaptimmune Therapeutics Q1 2023
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