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Adaptimmune Therapeutics plc (ADAP) Q2 2021 Earnings Call Transcript

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ADAP earnings call for the period ending June 30, 2021.

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Adaptimmune Therapeutics plc (ADAP 1.98%)
Q2 2021 Earnings Call
Aug 9, 2021, 4:20 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Adaptimmune Second Quarter Earnings Conference Call. [Operator Instructions]

I would now like to turn the conference over to Juli Miller, Investor Relations. Please go ahead.

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Juli Miller -- Senior Director, Investor Relations

Hello, and welcome to Adaptimmune's conference call to discuss our second quarter 2021 financial results and business update. Please review our forward-looking statements from this afternoon's press release as 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 with me for the prepared portion of the 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?

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Juli. And thanks everyone for joining us. So last year we set out our 2-2-5-2 strategy for the next 5 years, and at the beginning of this year, we identified the milestones in 2021 to start to deliver that strategy. From a clinical perspective, these milestones were: One, to present initial data from our pivotal SPEARHEAD-1 trial with afami-cel ASCO with a full data set to follow at CTOS. Two, present data from our AFP trial at ILCA.And three, present data from our SURPASS trial with our next-gen program targeting MAGE-A4 at ESMO. I'm pleased to say that in Q2 we delivered on the first of these with excellent afami-cel data at ASCO. And we are positioned to deliver on the next two in Q3 at ILCA and ESMO as anticipated. I would say a little bit about each of these milestones in turn.

As you can see from the press release, we had a busy Q2. In June, we presented initial data from our pivotal SPEARHEAD-1 trial at ASCO. With the disease control rate of approximately 85% and overall response rate of approximately 40% and very encouraging initial durability, these data demonstrate that afami-cel has life-changing potential, for people with synovial sarcoma and MRCLS. We plan to update data from this trial at CTOS later this year. But we're working hard to file our BLA next year and achieve the first element of our 2-2-5-2 strategy to have a product on the market targeting MAGE-A4. We're preparing for a successful commercial launch working with key industry leaders, Agilent for companion diagnostic, Miltenyi for our lentiviral vector supply as well as developing our in-house capabilities to support commercial delivery for afami-cel.

For the second and third clinical milestones this year, we are on-track to update in Q3 on our AFP and SURPASS programs at ILCA and ESMO, respectively. At ILCA, on September 5, Dr. Bruno Sangro will present data from our AFP Phase 1 trial. He will present data on 13 patients who've been treated in Cohort 3 and expansion, 11 of who have had at least one post-baseline scan. We will issue a full press release around these data and we'll update regarding this program going forward.

At ESMO, we'll present an update from the SURPASS trial with our next-gen program targeting MAGE-A4. You'll remember that last year we reported data at SITC from 6 patients in the dose escalation cohorts of this trial with two confirmed responses in patients with EGJ and head and neck cancer, as well as tumor reductions in three other patients with esophageal, ovarian and EGJ cancers. As I said in the Q1 call in May, enrollment in the first half of 2021 in this trial has gone very well. Out of the data cut for the ESMO presentations, we've treated 25 patients in this trial and 23 of these patients have at least one post-baseline scan, and we are very much looking forward to sharing this data update as planned at ESMO. The poster will be available online on September 16. Again, we'll issue a full press release and provide an update on the future for the development of this therapy.

A couple of other updates on this program. The SURPASS trial was initially in a wide range of MAGE-A4 expressing tumors, but was subsequently amended to recruit in full focus indications, lung, bladder head and neck and gastroesophageal cancers, where we have seen anti-tumor activity and responses with our MAGE-A4 targeted therapies previously. Based on emerging data in several patients with ovarian cancer treated in the SURPASS trial, we will add ovarian cancer back to the list of focus indications. So going forward, the SURPASS trial will continue to enroll patients with lung, bladder, head and neck, gastroesophageal and ovarian cancer.

In addition, our SURPASS-2 trial, which is the Phase 2 trial with the next-gen product targeting MAGE-A4 for patients with esophageal and EGJ cancers is on-track to initiate as planned in Q3. We've designed the protocol to account for the evolving standard-of-care in this setting and identify a patient population that is most likely to benefit from this type of therapy.

We are committed to identify more indications for late phase development with the 2-2-5-2 goal of having an additional MAGE-A4 marketed product in the next 5 years. Our clinical data, our translational learnings as well as our pre-clinical pipeline including our industry-leading allogeneic program move us closer every day to our goal of cell therapy products that are both curative and mainstream.

And with that, I'd like to turn it over to the operator for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] And our first question comes from Tony Butler with Roth Capital. Your line is open.

Tony Butler -- ROTH Capital Partners -- Analyst

Good afternoon. Thanks very much for taking the questions. There are two. One, with two parts. Adrian, you mentioned the companion diagnostic development with Agilent, and I'm assuming that you're going to see clear validation. So the question is, can you provide some information around the number of patients that you may need to see to provide to the FDA? And importantly, will that cause any delay, or do you think it will cause a delay in the BLA filing based on SPEARHEAD-1? And part B of that question, would you use this particular validated diagnostic in SURPASS-2 in esophageal cancer and EGJ?

Question two, is around the program that you have with Astellas. And I recall that one of the -- I believe it was one of the hit programs Astellas had taken if you will, a ownership or joint venture and they have also taken a second program. And I wondered if you could speak to that, and if you don't want to reveal the program, fine, but how far along are the development of both? Thank you.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Tony. So we have not provided details on the development power-play for the companion diagnostic. I can confirm that there won't be any delay to -- we don't anticipate any delay to the BLA file on the basis of that.

Could you repeat the question on the SURPASS-2 trial?

Tony Butler -- ROTH Capital Partners -- Analyst

Yes. So you are going to use that companion diagnostic in the SURPASS-2 trial, and therefore, that trial may actually be somewhat delayed in the rolling, even though you said it's going to be in Q3? Thanks.

Adrian Rawcliffe -- Chief Executive Officer

Yeah. So the answer is no, we're not using that diagnostic in that trial and we don't anticipate that, that will be delayed in enrolling. With respect to the Astellas collaboration, I'm going to ask Helen to comment on the status of those programs.

Helen Tayton-Martin -- Chief Business Officer

Thanks, Ad. And so, thanks for the question, Tony. Can I just repeat it back to you. I think you were double checking on the second program. The first one we named mesothelin as a target. So one of our HLA-independent or HiT TCR, and we are co-developing that one together. The second one is, has been selected, but is not named and won't be named foreseeable. Hope I got the question.

Tony Butler -- ROTH Capital Partners -- Analyst

It is, Helen and thank you. The issue was how far along has that progressed since they have decided to take that program under their wings as well?

Helen Tayton-Martin -- Chief Business Officer

I wouldn't take liberty to say exactly how far it has progressed. But it is moving along the timelines that we anticipated for in selecting the target. So I think early basically, but not that far behind the mesothelin program.

Tony Butler -- ROTH Capital Partners -- Analyst

Thanks very much.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Tony.

Operator

Our next question comes from Marc Frahm with Cowen and Company. Your line is open.

Marc Frahm -- Cowen Inc. -- Analyst

Hi, thanks for taking my questions, and congrats on getting all these patients in and ready for presentation. Maybe Adrian, your comment about adding focus on ovarian within SURPASS, just to be clear, is that based on -- I think you had a little bit of tumors, yes, some tumor shrinkage in one ovarian patient as of the last update, is it based on that or is it really that you've seen more in additional patients that have happened subsequent to that update?

Adrian Rawcliffe -- Chief Executive Officer

We are going to comment on any of the data that is in the SURPASS trial pending the ESMO data release. I think that question will be much better answered when we can all look at the same amount of data and have that discussion made.

Marc Frahm -- Cowen Inc. -- Analyst

Okay. And maybe you won't answer here, but I think I missed, but can you give us a flavor -- you gave that kind of patient numbers, but can you give a flavor kind of spread of tumors that are going to be in there? And should we be thinking about any of these tumor types starting to get to that high single-digit 10-patient-type of threshold you've historically talked about that useful for kind of establishing proof-of-concept or futility, if that were the case?

Adrian Rawcliffe -- Chief Executive Officer

You're correct. You're going to get the same answer as for the previous question, but I do admire your persistence on this. We haven't guided, and we're not going to guide. I think it's best -- it's only a month away. Everybody can look at the data set when we put it out there at ESMO. And we can talk about it from an improvement perspective at that point.

Marc Frahm -- Cowen Inc. -- Analyst

Okay. And then maybe turning to the plan BLA. You're continuing to enroll a second cohort of patients in SPEARHEAD-1. Will the filing just have the -- the first cohort that we've already have seen the response rate data, plus the couple of incremental patients or do you expect that filing to have the complete trial, including some of these patients who are enrolled into the second cohort?

Elliot Norry -- Chief Medical Officer

Yeah. Hi, Marc. It's Elliot. The plan is to file the BLA based on the data in cohort 1.

Marc Frahm -- Cowen Inc. -- Analyst

Okay. Thank you.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Marc.

Operator

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

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Hey, this is Kelsey on for Michael. I just had two quick ones. Could you just provide some color on where you stand with the launch prep and commercial readiness? And then the second one, we saw in the press release that the Radiation Sub-Study was officially closed. Maybe just a little bit of color there on why it stopped? And that's it from me. Thank you.

Adrian Rawcliffe -- Chief Executive Officer

Thanks. Thanks, Kelsey. I will ask Elliot to touch on the Radiation Sub-Study, and Helen, do you want to just pick up on where we are with commercial readiness and prep?

Helen Tayton-Martin -- Chief Business Officer

Yes, sure, I'll kick off with the answer to that one. I mean, I think we're in reasonably good shape. We've been planning for this for quite some time. We've had internal focus on the key things around market access, marketing, broad commercial planning and now we're beginning to turn our attention to dig deeper and also obviously into the the outward customer facing roles. So as you'd imagine, we are working very closely with KOLs, etc. and then getting feedback and beginning to sort of map out all kinds of materials, pathways, enrolls on that side. And then I think John could quite easily comment on the prep that's going on for our commercial manufacturing and our operations, kind of operations in place ready for a different level of delivery of products to complement what we do on the clinical side. So yeah, that we'll say more in due course, I'm sure, but at this stage, I think we're pleased with how it's tracking.

Adrian Rawcliffe -- Chief Executive Officer

John, do you want to pick up on the CMC aspects of this?

John Lunger -- Chief Patient Supply Officer

Sure. We've said before that our commercial launch will come out at the same facility here in Philadelphia that we've been using for the clinical trials and we have the capacity that we need for that launch. So supply wise we're in good shape and then we're obviously going through all of the activities that we need to prepare for the BLA filing, the process characterization work, and those types of things, which is proceeding well.

Adrian Rawcliffe -- Chief Executive Officer

And Elliot, do you want to touch on the Radiation Sub-Study?

Elliot Norry -- Chief Medical Officer

Yeah, sure. So we decided to end enrollment in the Radiation Sub-Study, really for multiple reasons. This is a single center Sub-Study of the Phase 1 afami-cel multi-tumor study and really the only part that was remaining open. The study was significantly affected from an enrollment standpoint by the COVID pandemic and really presented a very challenging enrollment scenario with the single center and also with expanding into other centers. And when we look back at the trial design as well based on how it had been organized, it was really unlikely to provide sufficient answer is as it relates to differentiating the addition of low dose radiation to cell therapy. So while there is still, I think scientific, promise to the idea of using low dose radiation to improve T cell trafficking and we'll sort of retain the option to reintroduce that at a later time, if it makes sense. This study really did not make good sense for us to continue to enroll. The real focus is for those same tumor types that are expressing MAGE-A4 to really be put into the CD8 alpha program and continue to enroll SURPASS.

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Got it. Okay. Thank you.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Kelsey.

Operator

Thank you. Our next question comes from Jonathan Chang with SVB Leerink. Your line is open.

Jonathan Chang -- SVB Leerink -- Analyst

Hi guys, thanks for taking my questions. First question, what do you see as the go, no-go bar for advancing the next-gen MAGE-A4 program into late-stage development for the different indications beyond the Phase 1 SURPASS study?

Adrian Rawcliffe -- Chief Executive Officer

So maybe I'll take stab of that. And so I think I don't want to get into speculation about individual tumor types. I think we'll let the data speak for itself at ESMO. But I think I'd just refer everybody to the discussions that we've had previously about what efficacy in cell therapy in very late stage population, such as those that we're studying in this Phase 1 trial would look like. And I think we've consistently said that three out of 10 patients responding with benefit to patients, so 6 months, give or take would probably be the ballpark we're looking to see. Now obviously that does vary depending on individual settings and tumor types, but I think we need to understand the data a little bit more before we can discuss that and look forward to doing so from ESMO onwards.

Jonathan Chang -- SVB Leerink -- Analyst

Got it. And maybe a similar question in the same vein, what do you see as the go, no-go bar for picking a particular indication to be a focus indication in the ongoing SURPASS study?

Adrian Rawcliffe -- Chief Executive Officer

That one is a bit more-- a bit simpler and that we selected those indications some time ago, the four that we have previously -- and obviously, I'm not going to comment on the rationale behind putting ovarian, and as I commented earlier, we'll talk about that when we get down to ESMO, but more generally you might recall that we had analysis of all of the patients that were treated with MAGE-A4 targeting therapies in both the dose escalation portions of the SURPASS study and then also the Phase 1 trial for afami cel. We recruited a number of non-sarcoma patients, you may recall, and the indications that we selected as focus indications then lung bladder, gastroesophageal and head and neck were indications where we had seen either confirmed responses or very substantial anti-tumor activity in the case of bladder our urothelial cancer. We didn't have any responses there, but we had seen very significant anti-tumor activity and really was a way of focusing down that trial from the sort of 10 indications that it was routinely express MAGE-A4 down to something a bit more manageable and to try to get to patient numbers where we could make development decisions.

Jonathan Chang -- SVB Leerink -- Analyst

Understood. Thanks for taking the questions.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Jonathan.

Operator

Our next question comes from Mara Goldstein with Mizuho. Your line is open.

Mara Goldstein -- Mizuho -- Analyst

Thank you. Hey, it's Mara Goldstein. Just two questions...

Adrian Rawcliffe -- Chief Executive Officer

Hi, Mara.

Mara Goldstein -- Mizuho -- Analyst

Hey. On SURPASS-2, you spoke to in your prepared comments about making some modifications to sort of conform to evolving standard-of-care. And I'm wondering if you can just speak to that at this point in time. And then the second is, I'm just curious, we've heard from a couple of companies within the cell therapy space around vector supply constraints. And you also kind of alluded to a little bit around sort of supply management. Maybe you could speak to that specifically as it relates to you guys and what you're doing?

Adrian Rawcliffe -- Chief Executive Officer

Certainly. Thanks, Mara. So I'm going to ask Elliott to talk about the SURPASS-2 study and the standard-of-care evolution there, and then I'll ask John to pick up the discussion on our strategy around back to supply.

Mara Goldstein -- Mizuho -- Analyst

Thank you.

Elliot Norry -- Chief Medical Officer

Yeah, hi, Mara. Just very briefly, the standard-of-care for really the gastroesophageal cancers has evolved from being chemotherapy approach in first-line followed by PD-1 inhibitor in most scenarios. There are some other drugs that play in, in specific settings, but those drugs are now being used fairly commonly as a combination first-line approach, which does two things. I mean, first of all, it improves the standard-of-care for those patients, but it also opens up the space for second-line therapy in many patients and that the patients don't just receive -- they don't receive first chemotherapy progress then PD-1 inhibitor, then progress, then be open to third-line treatments. They're really compressing those two treatments still into first-line. That being said, there is still tremendous unmet need in this population and that the response rate and duration of response with that combination, although better and an advancement for patients, there is still quite a long way to go to help us really devastating tumor type, the patients with those diseases.

Mara Goldstein -- Mizuho -- Analyst

So the modification you'll expect to make will be essentially to move sort of closer to a second-line therapy? Is that what I'm understanding?

Elliot Norry -- Chief Medical Officer

The study does allow for the drug to be used in second line beyond...

Mara Goldstein -- Mizuho -- Analyst

Okay.

Elliot Norry -- Chief Medical Officer

Behind combination chemotherapy. We've made some other changes with respect to patient selection and whatnot based on what we've learned in the Phase 1 program, but that's the most significant change.

Mara Goldstein -- Mizuho -- Analyst

Okay. All right. Thank you.

Adrian Rawcliffe -- Chief Executive Officer

John?

John Lunger -- Chief Patient Supply Officer

Yeah. And on the vector probably, you'd probably recall back in 2017, we made the decision to pursue a vector strategy that had two main elements. One was an external partner that could work with us through commercial and Ad mentioned Miltenyi earlier, which we've worked with Miltenyi for the vector supply for our SPEARHEAD trial and other trials. So that's the material that we'll use going into commercial. But secondly, we decided to also develop the internal capability. So we have done that and we're supplying our other trials with material produced internally from our facilities. It's a new Cell and Gene Therapy Catapult center in the U.K. So we've kind of executed on the plan to have two sources of vector available to us, one internal and one external.

Mara Goldstein -- Mizuho -- Analyst

Okay. All right. Thanks a lot.

Adrian Rawcliffe -- Chief Executive Officer

Thanks, Mara.

Operator

Thank you. And there are no other questions in the queue, I'd like to turn it back to Adrian Rawcliffe for closing remarks.

Adrian Rawcliffe -- Chief Executive Officer

Thank you, everyone, for your questions and your continued support for the company. We look forward to updating everyone on the data in September and keeping you up-to-date with continued progress.

With that, we'll close the call. Thanks a lot.

Operator

[Operator Closing Remarks]

Duration: 25 minutes

Call participants:

Juli Miller -- Senior Director, Investor Relations

Adrian Rawcliffe -- Chief Executive Officer

Helen Tayton-Martin -- Chief Business Officer

Elliot Norry -- Chief Medical Officer

John Lunger -- Chief Patient Supply Officer

Tony Butler -- ROTH Capital Partners -- Analyst

Marc Frahm -- Cowen Inc. -- Analyst

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Jonathan Chang -- SVB Leerink -- Analyst

Mara Goldstein -- Mizuho -- Analyst

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