Ladies and gentlemen, thank you for standing by, and welcome to Adaptimmune's Third Quarter 2020 Financial Results and Business Update. [Operator Instructions]. Please be advised that today's conference may be recorded. [Operator Instructions] I would now like to hand the conference over to your host, Adaptimmune's Investor Relations, Juli Miller.

Madam, please go ahead. .

Good morning, and welcome to Adaptimmune's conference call to discuss our third quarter 2020 financial results and business update. I would ask you to please review the full text of our forward-looking statements from this morning's press release.

We anticipate making projections during this call, and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer; and Elliot Norry, our Chief Medical Officer, are with me for the prepared portion of this call.

Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe.

Ad?.

Thank you, Juli, and thank you, everyone, for joining us. Before Elliot talks about the clinical updates we will be providing later this month at SITC and CTOS, I want to share a few reflections. .

This time last year, I hosted my first quarterly call as CEO. And I said then that I was committed to our focus on execution. And this remains our focus.

While the management of the pandemic continues to evolve at our clinical sites, I'm happy to report that we've seen an increase in enrollment across our early phase clinical trials over the course of the third quarter.

We are enrolling and treating patients in the ADP-A2AFP trial in HCC and our ADP-A2M4CD8 next-generation SURPASS trial in a range of solid tumors.

The numbers of patients that we see coming in for apheresis and cell manufacturing prior to being treated continue to provide us with confidence that we will be able to evaluate the initial safety and efficacy of these products in the coming months. .

As I reported last call, our Phase II SPEARHEAD-1 trial with ADP-A2M4 in sarcoma has been less affected by COVID-19. Recruitment continues to go very well and we're on track to complete enrollment in the first half of 2021, further strengthening our ambition to launch ADP-A2M4 in the U.S. in 2022. .

I want to thank the investigators, study coordinators and other health-care professionals R the centers where we conduct our clinical trials and everyone working in our clinical CMC and supply teams for their work and commitment. .

Later this month, we will have our virtual Investor Day where I will lay out the strategy and value drivers for the company over the next 5 years.

We'll present our perspective on the blockbuster market opportunities that MAGE-A4 targeted products represent; our near-term plans for bringing ADP-A2M4 to market in 2022 and the cell therapy products we are developing beyond our current clinical autologous pipeline. .

You will also hear from senior leaders who will provide more details about how we will deliver our vision for the future of the company. There will be no new data updates.

As we've said previously, we will provide new clinical data where we believe we have ample information to determine next steps, and these communications will be at medical congresses. .

I will now turn it over to Elliot to provide more perspective on our upcoming presentations at SITC and CTOS. Elliot, over to you. .

Thanks, Ad. In Q3, Dr. Bruno Sangro presented data at the International Liver Congress from our ADP-A2AFP trial. These data confirmed the safety profile of this product. We reported a complete response in one patient with hepatocellular carcinoma. This patient had disease progression with new lesions at Week 32.

As Ad said earlier, we are continuing to treat patients in the expansion phase of this trial at doses up to 10 billion cells, and I remain very encouraged about the potential of this product. .

We have a few presentations coming up in Q4. At CTOS, we will present duration of response data from the 16 patients with synovial sarcoma from the ADP-A2M4 Phase I trial.

These data further validate the potential of this product to meet the significant unmet medical need for patients with synovial sarcoma and our updated data from what we presented at ASCO earlier this year. .

At SITC, we will present the data update for the first 6 patients treated in the dose-escalation cohorts of the SURPASS trial with ADP-A2M4CD8, our first next-generation product. In every dose-escalation stage, there was a stagger between patients and cohorts for safety evaluations. .

I want to provide some additional context for the SURPASS data, particularly following the abstract being made available ahead of the scheduled date. In late May, we reported very early data with 3 out of 4 responses. And at that time, 2 of these responses were unconfirmed.

The SITC abstract with a later data cutoff in July reported that 1 of the unconfirmed responses, which was in a patient with esophagogastric junction cancer, did not confirm and 1 in a patient with head and neck cancer did. One additional patient with MRCLS was treated and, for the abstract, for a total of 5 patients.

At SITC, we will report updated and more in-depth data from these 5 patients and 1 additional patient. We'll also show a compelling waterfall plot, with initial tumor reductions in 5 out of these 6 patients. .

This plot is similar to the very early data we saw with the ADP-A2M4 synovial sarcoma and is indicative, I believe, of what is likely to be a highly active product. We will also present in vitro data with analyses of the ADP-A2M4CD8 manufacture product, supporting the increased potency of these SPEAR T-cells.

We are committed to developing these first next-gen SPEAR T-cells and see great promise, particularly in gastroesophageal cancers with all 3 patients in SURPASS demonstrating reduction in tumor size. Therefore, we plan to initiate a Phase II trial in the first half of 2021 for the treatment of these difficult-to-treat cancers. .

It is crucial that we continue to treat more patients with these and other tumor types, focusing on gastroesophageal, head and neck, bladder, and lung cancers to gain a more complete picture of the potential of this product.

We continue to look forward to identifying further signals in additional indications that we can take into later-phase trials as well [ test ] combination therapies and next-generation enhancements as the data guide us. .

Now I will open the call up to questions.

Operator?.

[Operator Instructions] Our first question comes from Tony Butler with ROTH Capital. .

Elliot, your comments around Phase II with A2M4 in gastroesophageal, bladder, and head and neck, so a little bit of a consortia, why not just pick 1 tumor and move forward? I just would love to understand your rationale to continue to look at a basket. .

So thanks, Tony. Let me just clarify. The Phase II study with ADP-A2M4CD8 that's planned is in gastroesophageal cancers only. We are continuing to explore other tumor types, including the ones that you mentioned. So gastroesophageal cancer is included, but also head and neck, and bladder cancer, and lung cancer, in particular, in the Phase I study.

So the basket is in Phase I. The Phase II study is a limited family of gastroesophageal cancers. I hope that clarifies. .

It does. So let me just be clear that you're going to continue -- you're expanding the Phase I enrollment. And then you're going to start Phase II in gastroesophageal, right? That's the way we should think about it. .

Yes. I mean Phase I is continuing in the tumor types that are in that study. And the Phase II will start in 2021 in gastroesophageal cancers. That's correct. .

Our next question comes from Michael Schmidt with Guggenheim Securities. .

This is Yige on for Michael. Maybe, just start with a quick follow-up on the SURPASS trial, given the small patient number for tumor types in the SURPASS.

Maybe can you help us understand what kind of efficacy signal in EGJ that gives you guys confidence to warrant initiation of a Phase II trial?.

Elliot, do you want to take that?.

Sure. So I want to just be clear that we've now -- well, you'll see some updated information in the SITC presentation regarding all of the 6 patients that we've treated.

But as was mentioned in the call and even before the most recent patient, we've seen compelling antitumor activity in the first 2 patients treated with esophagogastric junction cancer. And in addition to that, both of those patients were treated at a lower cell dose.

And as we said, this is really reminiscent or similar to the type of efficacy that we saw early on with the sarcoma population with the first generation program. .

And we've also now said that there's -- that all 3 patients in SURPASS have shown evidence of antitumor activity, which we think is really sufficient to guide us towards a later stage program. .

Our next question comes from Jonathan Chang with SVB Leerink. .

This is David Ruch on for Jonathan. First question around the SITC data.

So given the heterogenetic tumor types in the SURPASS study and the range of H-scores that you noted in the abstract of MAGE-A4 expression, could you provide any color on the biomarker data we might expect to see at SITC and any color on how you're thinking about moving forward?.

Elliot, do you want to take it?.

Yes. Sure. Thanks very much. So I think that what I'm really going to say is please wait for the SITC poster and rather than providing the information now in advance. It'll be very clear what the range and specifics of H-score are and the translational data that we're making public that helped guide us in this study will be present as well.

So I don't think it'll be appropriate to -- given conference rules, to provide any specific additional color around anything beyond what's in the abstract. .

Got it. Understood. Second question, just go back to the last question for a second around EJG patients.

For the patient who achieved the unconfirmed PR, is there any color you can provide on that patient's duration of treatment? And can you confirm whether they're still on-study? And -- or is this something we're going to have to wait for the SITC data for as well?.

Unfortunately, I'm going to have to say that you're going to have to wait for the SITC data, again, which is not that far away. It's not that far away. It's only a couple of weeks. .

Understood, understood. I'll try one more then.

Could you talk about the HLA-independent TCR program with Astellas and give us any update on that program? And if not, when can we expect to maybe find out some more detail on this program and the target you selected?.

So I'm going to ask Helen Tayton-Martin, our Chief Business Officer, to talk about. .

Sure. So I'm afraid I'm not going to be able to tell you too much more other than to say that the program is continuing to make good progress. [ Contracts ] are moving forward. The more we do with that program, the more confident we are. It's obviously a jointly sponsored program, and so we won't be able to reveal the focus of the target today. .

We hope at some point that we may be able to reveal that, but obviously, we have to agree with Astellas on the appropriate timing for that, which, as you can probably imagine, is somewhat related to the progress that we made. But we have got a defined research plan and it's [ massing ] forward on track.

So at this point, we remain really pleased with our sponsors for it. .

We may also feel, since we'll talk more about -- we hope to talk more about HiT program more broadly at our forthcoming Investor Day as well. It's one of the areas of the future of the company which we want to bring into investor awareness. .

Our next question comes from Gabriel Fung with Mizuho. .

This is Gabriel on for Mara Goldstein. Just a first question here.

Just surrounding the planned trial for ADP-A2M4CD8 in esophagogastric junction cancer, have any clinical trials -- sorry, clinical sites been identified and perhaps onboarded for potential enrollment yet in 2011 -- I'm sorry, 2021?.

And just one other question, if you can provide an update on the allogeneic program. .

So I'm going ask -- I'm actually -- I'm going to cover that first one myself. I'll cover both of them myself, actually. So the first one, the short answer is that trial will initiate next year. I mean clearly, we have sites ongoing in our SURPASS Phase I trial that would be eligible for the gastro esophageal cancers trial next year.

But that trial will initiate, which means sites will get recruited and initiate next year in the first half of next year. .

And secondly, on the question on allogeneic, we -- I would refer you to our Investor Day on the 20th for an update on that as a core foundational platform for our strategy over the next few years. .

And I'm showing no further questions in the queue at this time. I'd like to turn the call back to CEO, Adrian Rawcliffe, for any closing remarks. .

Thank you, everybody, for your time today on this relatively short call. We look forward to data updates at SITC and at CTOS and to hosting you for our Investor Day on November 20 for a deep dive into the long-term strategies and value drivers for the company. With that, have a great day. .

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program, and you may now disconnect..