Adaptimmune Therapeutics plc

Ladies and gentlemen, thank you for standing by and welcome to Adapt-Immune's third quarter 2020 financial results and business update. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your host, Adapt-Immune's investor relations, Julie Miller. Madam, please go ahead.

Good morning, and welcome to ADAPT Immune's conference call to discuss our third quarter 2020 financial results and business updates. 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 Rockliffe, our chief executive officer, and Elliot Norrie, 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 Rockliffe.

Thank you, Julie, and thank you, everyone, for joining us. Before Elliot talks about the clinical updates we'll be providing later this month at CITSE 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 ADPA2 AFP trial in HCC and and our ADPA2M4CD8 next-generation surpassed 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 ADPA2M4 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 ADPA2M4 in the U.S. in 2022. I want to thank the investigators, study coordinators, and other healthcare professionals at 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 five years. We will present our perspective on the blockbuster market opportunity that May J4 targeted products represent, our near-term plans for bringing ADPA2M4 to market in 2022, and the cell therapy products we are developing beyond our current clinical autologous pipelines. 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 when 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 CITSE and CITOS. Elliot, over to you.

Thanks, Ad. In Q3, Dr. Bruno Sangro presented data at the International Liver Congress from our ADP A2 AFP 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 CTAS, we will present duration of response data from the 16 patients with synovial sarcoma from the ADP A2M4 Phase 1 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 CITSE, we will present the data update for the first six patients treated in the dose escalation cohorts of the SURPASS trial with ADP A2M4 CD8, 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 surpassed data, particularly following the abstract being made available ahead of the scheduled date. In late May, we reported very early data with three out of four responses. At that time, two of these responses were unconfirmed. The CITSE abstract with a later data cutoff in July reported that one of the unconfirmed responses, which was in a patient with esophagogastric junction cancer, did not confirm, and one in a patient with head and neck cancer did. One additional patient with MR-CLS was treated, and per the abstract, for a total of five patients. At CITC, we will report updated and more in-depth data from these five patients and one additional patient. We will also show a compelling waterfall plot with initial tumor reductions in five out of these six 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 A2M4 CD8 manufactured product, supporting the increased potency of these SPIR T cells. We are committed to developing these first next-gen SPIR T cells and see great promise, particularly in gastroesophageal cancers, with all three patients in SURPASS demonstrating reduction in tumor size. Therefore, we plan to initiate a phase two 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 and additional indications that we can take into later phase trials, as well as test combination therapies and next-generation enhancements as the data guide us. Now I will open the call up to questions. Operator?

Thank you. As a reminder, if you'd like to ask a question, please press star then 1 on your touchtone telephone. To withdraw your question from the queue, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Tony Butler with Roth Capital. Your line is now open.

Good morning. Elliot, your comments around Phase 2 with A2 and 4 in gastroesophageal, bladder, and head and neck, so a little bit of a consortia, why not just pick one tumor and move forward? I just would love to understand your rationale to continue to look at a basket. Thank you very much.

So thanks, Tony, and good morning. Let me just clarify. The phase two study with ADP A2M4 CD8 that's planned is in gastroesophageal cancers only. We are continuing to explore other tumor types, including the ones that you mentioned. So gastroesophageal cancers 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 a Phase II in gastroesophageal. That's the way we should think about it.

Yes, I mean, phase one is continuing in the tumor types that are in that study, and the phase two will start in 2021 in gastroesophageal cancers. That's correct.

Thank you very much, Elliot.

Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is now open.

Hi, good morning, guys. This is Iggy for Michael. Thanks for taking our questions. Maybe to start with a quick follow-up on the SERPAS trial, given the small patient number per tumor type in the SERPAS, maybe can you help us understand, you know, what kind of efficacy signal in EGJ that gives you guys, you know, confidence to warrant initiation of a Phase II trial?

So, Elliot, do you want to take that? Sure. I want to just be clear that we've now, well, you'll see some updated information in the CITSE presentation regarding all of the six patients that we've treated, but as was mentioned in the call and even before the most recent patient, we've seen compelling anti-tumor activity in the first two 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 all three patients in SURPASS have shown evidence of anti-tumor activity, which we think is really sufficient to guide us towards a later stage program.

Got it. That's super helpful. Thank you very much.

Thank you. Our next question comes from Jonathan Chang with SBB Lee Rink. Your line is now open.

Hey, guys. Good morning. This is David Ruchon for Jonathan. Thanks for taking our questions. First question around the CITC data. So given the heterogeneity of tumor types in the SURPASS study and the range of H-scores that you noted in the abstract of an AJ4 expression, could you provide any color on the biomarker data we might expect to see at CITC and any color on how you're thinking about moving forward.

So, do you want to take it? Sure. Thanks very much. So, I think that what I'm really going to say is, you know, please wait for the CITSE poster. And, you know, rather than providing the information now in advance, it will be very clear what the range and specifics of H-score are. And the translational data that we're, you know, making public that helped guide us in this study will be present as well. So I don't think it would be appropriate to, you know, given the 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? Or is this something we're going to have to wait for the CISTI data for as well?

Unfortunately, I'm going to have to say that you're going to have to wait for the CIDC data again. It's not that far away. It's not that far away.

It's only a couple of weeks. Understood. Understood. I'll tell you 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? Thank you.

So I'm going to ask Helen first. Kate and Martin, our Chief Business Officer, should talk to that.

Sure. So I'm afraid I'm not going to tell you too much more other than to say that the program is continuing to make good progress. Constructs 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 Estella on the appropriate timing for that, which you can probably imagine is somewhat related to the progress that we made. But we have got a defined research plan and it's mapping forward on track. So at this point, we remain really pleased with our sponsors with it. We may also be able to talk more about, we hope to talk more about the HIPS 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 to investor awareness.

Got it. Thank you. And look forward to the investor day. Thanks a lot.

Thanks. Thank you. Our next question comes from Gabriel Fung with Mizuho. Your line is now open.

Hi there, guys. This is Gabriel. I'm from Goldstein. Thanks for taking the questions. Just the first question here, just surrounding the planned trial for ADP A2M4CD8 in esophageal gastric junction cancer, have any clinical sites been identified and perhaps on order for potential enrollment yet in 2021? And just one other question, if you can provide an update on the allogeneic program. Thank you.

So I'm going to ask I'm actually, I'm going to cover that first one myself. I've covered 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 one trial that would be eligible for the gastroesophageal 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 Allergenic, 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.

Great. Thanks for that.

Thank you.

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

So thank you, everybody, for your time today on this relatively short call. We look forward to data updates at CITSE and at CTOS and to hosting you for our investor day on November 20th 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.