Q2 2021 Adaptimmune Therapeutics PLC Earnings Call

August 9, 2021

Operator: At the end of this presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Juli Miller, Investor Relations. Please go ahead. Hello, and welcome to Adapt Immune's conference call to discuss our second quarter, 2021 results.

Presentation there'll be a question and answer session to ask a question. During this session you will need to press star 1 on your telephone.

Please be advised that today's conference is being recorded I would now.

I'd like to turn the conference over to Juli Miller Investor Relations. Please go ahead.

Right.

Hello, and welcome to adapt <unk> 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, and we anticipate making projections during this call and actual results could differ materially due to several factors including.

Juli P. Miller: 2021 Financial Results and Business Updates. 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 FTC. 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.

<unk> those outlined in our latest filings with the SEC Adrian Roslyn, 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 ballclub at.

Adrian G. Rawcliffe: Thanks Juli, and thanks everyone for joining us. So last year we set out our 2-2-5-2 strategy for the next five 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 famosella ASCO, with a fuller data set to follow at CETA, and to present data from our AFP trial at ILCA.

Thanks Judy.

Thanks, everyone for joining us.

So last year, we set out with our 2252 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 1 to present initial data from our pivotal spearhead 1 trial with a famous Sala ask Scott.

With a full data set to follow sito's.

Data from our AFP trial Ilkka.

Adrian G. Rawcliffe: And three, present data from our SURPASS trial with our NextGen program targeting MAYJ4 at ESM. I'm pleased to say that in Q2 we delivered on the first of these with excellent ephamisole data at us, and we're positioned to deliver on the next two in Q3 at ILCA and ESMO as anticipated. I want to say a little bit about each of these milestones in turn. As you can see from the press release... We had a busy queue too.

And 3 presented data from our surpass trial with our next Gen program targeting MAGE <unk>.

I am pleased to say that in Q2, we delivered on the first of these with excellent pharma sales data at scale.

And we are positioned to deliver on the next 2 in Q3 at <unk> and ESMO as anticipated.

I won't say a little bit about each of these milestones and tests.

As you can see from the press release, we had a busy Q2.

Adrian G. Rawcliffe: In June, we presented initial data from our pivotal Spearhead1 trial at us, with a disease control rate of approximately 85%, an overall response rate of approximately 40%, and very encouraging initial durability. These data demonstrate that FAMICEL has life-changing potential for people with synovial sarcoma and MR-CLS. We plan to update data from this trial at CETOS later this year, but we're working hard to file our BLA next year and achieve the first element of our 2252 strategy to have a product on the market targeting Mage A4.

In June we presented initial data from our pivotal spearhead 1 trial at <unk>.

With a disease control rate of approximately 85% and overall response rate of approximately 40% I'm very encouraging initial durability.

These data demonstrate that <unk> has life changing potential, but people with synovial sarcoma and MLR CLS.

We plan to update data from this trial at Sito is later this year.

But we're working hard to file a BLA next year and achieved the first element of our $2.5 2 strategy to have a product on the market targeting major for.

Adrian G. Rawcliffe: We're preparing for a successful commercial launch, working with key industry leaders, Agilent for companion diagnostics, Miltenny for our lentiviral vector supply, as well as developing our in-house capabilities to support commercial delivery for our pharmaceuticals. For the second and third clinical milestones this year, we are on track to update our AFP and SURPASS programs at ILCA and ESMO, respectively. At ILCA, on September 5th, Dr. Bruno Sangreau will present data from our AFP Phase 1 trial. He'll present data on 13 patients who have been treated in Cohort 3 and expansion. 11 of whom have had at least one post-baseline scan.

We're preparing for a successful commercial launch working with key industry leaders.

Sheila for companion diagnostic mill <unk> for our limited viral vector supply as well as developing our in house capabilities to support commercial delivery for our pharma so.

For the second and third clinical milestones. This year, we're on track to update in Q3 on our AFP and to past programs at <unk> and <unk>, respectively.

Ilkka on September 5th Dr. <unk> will present data from our AFP phase 1 trial.

<unk> will present data on 13 patients who've been treated in cohort 3 and expansion at.

11 of whom have had at least 1 post baseline scan.

We'll issue a full press release around lease data and we'll update regarding this program going forward.

Adrian G. Rawcliffe: We'll issue a full press release around these data, and we'll update this program regarding this programme 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 six patients in the dose escalation cohort of this trial, with two confirmed responses in patients with EGJ and head and neck as well as tumor reductions in three other patients with esophageal, ovarian, and EGJ tumors. As I said in the Q1 call in May... Enrollment in the first half of 2021 in this trial has gone very well.

At ESMO, we presented update from the surpass trial with our next Gem program targeting MAGE <unk>.

Youll remember that last year, we reported data from 6 patients in the dose escalation cohorts of this trial.

With 2 confirmed responses in patients with EG, Jay and head and neck cancer.

As well as tumor reductions in 3 other patients with a sofa, Gilles ovarian and AG J, Kansas.

As I said in the Q1 call in May.

Enrollment in the first half of 2021 in this trial has gone very well.

Adrian G. Rawcliffe: As of the data cut for the ESMO presentations, we've treated 25 patients in this trial, and 23 of these patients have had 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 6th.

As of the data cut for the ESMO presentations, we've treated 25 patients in this trial in 23 of these patients have at least 1 post baseline scan.

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.

Couple of other updates on this program.

The <unk> was initially in a wide range of MAGE <unk> expressing tumors.

Adrian G. Rawcliffe: Again, we'll issue a full press release and provide an update on the future of the development of this therapy. And a couple of other updates on this program. The surpassed trial was initially in a wide range of MAYJ4-expressing tumors but was subsequently amended to recruit in four focus indications: lung, bladder, head and neck, and gastroesophageal, where we have seen anti-tumour activity and responses with our MAJ-4 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.

But was subsequently amended to recruit and full focus indications lung bladder head and neck and gastroesophageal cancers.

Where we have seen antitumor activity and responses with a major <unk> targeted therapies previously.

Based on emerging data in several patients with ovarian cancer treated in the <unk> 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 <unk> 2 trial, which is the phase II trial with the Nexgen product targeting MAGE <unk> for patients with a soft Gilles and EG J, Kansas.

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.

Adrian G. Rawcliffe: 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 NextGen product targeting MAI-J4 for patients with esophageal and EGJ cancer, is on track to initiate, as planned, in Q3. We've designed a 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 a $225.2 goal of having an additional major <unk> marketed product in the next 5 years.

Our clinical data, our translational learnings as well as our preclinical pipeline, including our industry, leading our generic program move us closer every day to our goal of cell therapy products that are both curative or mainstream.

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

Thank you.

Ask a question you'll need to press star 1 on your telephone to withdraw your question press the pound key.

Our first question comes from Tony Butler with Roth Capital. Your line is open.

Good afternoon, and thanks very much for taking the questions.

Or 2.1 with 2 parts.

Adrian G. Rawcliffe: We are committed to identifying more indications for late-phase development with the 2.2.5.2 goal of having an additional MAI-J4 marketed product in the next five years. Our clinical data, our translational learnings, as well as our preclinical 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.

You mentioned the companion diagnostic development with adjuvant.

Im assuming that youre going to see CLIA validation. So the question is.

Tom.

Can you provide some information around the number of patients that you may need to see.

Provide to the FDA.

And importantly.

Will that cause any delay or do you think it will cause a delay in the BLA.

Filling based on spearhead 1.

<unk> B of that question would you use this particular validated.

Operator: Thank you. To ask a question, you'll need to press star 1 on your telephone. To withdraw your question,

Diagnostic and surpassed 2.

Operator: To withdraw your question, press the pound key. And our first question comes from Tony Butler with Roth Capital. Your line is open.

And as profit Joe cancer <unk>.

T J.

<unk> 2 is around.

The program that you have with Astellas and I recall that.

Tony Butler: Good afternoon. Thanks very much for taking the questions. There are two, one with two parts.

1 of the.

It was 1 of the hit programs.

Adrian G. Rawcliffe: Adrian, you mentioned the companion diagnostic development with Agilent, and I'm assuming that you're going to seek CLIA 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 any delay in the BLA filing based on Spearhead 1? And Part B of that question, would you use this particular validated diagnostic and proceed to an esophageal cancer in EGJ? Question two is around the program that you have with Stellus. And I recall that one of the, I believe it was one of the HIT programs.

Astellas Astellas had taken.

If you will.

<unk> 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's fine, but how far along are the development of both thank you.

Thanks, Tony.

So.

We have not provided details on the development pathway for the companion diagnostic I can confirm that there won't be any delay.

2 we don't anticipate any delay to the BLA file on the basis of that.

Could you repeat the question on the width from the <unk>.

<unk> II trial.

Yes are you going to use that companion diagnostic and surpassed 2 trial and therefore that from may actually be somewhat delayed in enrolling even though you said, it's going to be in Q3.

Adrian G. Rawcliffe: Estellas had taken, if you will, a ownership or joint venture in, they'd also taken a second program. And I wondered if you would speak to that, and if you don't want to reveal the program, fine, but how far along are the developments of both? Thank you. Thanks, Tony.

Got it so the answer is no we're not using that diagnostic in that trial, and we don't anticipate that that will be delayed and enrolling.

With respect to the Astellas collaboration I am going to ask Helena to comment on the status of those programs.

Got it.

Good question Toni can I just repeat it back to you I think you will double checking on the second program. The first 1 we named Mr. Seaton at target.

Adrian G. Rawcliffe: We have not provided details on the development pathway for the companion diagnostic, but I can confirm that there won't be any delay. We don't anticipate any delay in the BLA file on the basis of that. Could you repeat the question about the SURPASS II trial? Yes, so you're going to use that companion diagnostic in the CERPAS-2 trial, and therefore that trial may actually be somewhat delayed in enrolling, even though you said it was going to be in Q3.

HLA independent TCR.

Tcs and we're developing that 1 to get the second 1 is <unk>.

Has been selected.

Not named it will be named <unk>.

For example.

Ask your question.

It is Helen and thank you.

The issue was how far along is that progress since.

They have.

Decided to take that program under their wings as well.

At Liberty to say exactly how far progressed.

It is moving along.

Adrian G. Rawcliffe: Thanks. So the answer is no, we're not using that diagnostic in that trial, and we don't anticipate that it will be delayed in enrollment. With respect to the Estelas collaboration, I'm going to ask Helen to comment on the status of those programs.

And along the timelines that we anticipated for initially came to target so I think.

Early basically but not that far behind me.

Mesothelin program.

Thanks very much.

Thanks, Tony.

Our next question comes from Marc Frahm with Cowen <unk> Company. Your line is open.

Helen Katrina Tayton: Thanks for the question, Tony. Can I just repeat it back to you? I think you were double-checking...

Hi, Thanks for taking my questions and congrats on getting all these patients.

Helen Katrina Tayton: Can I just repeat it back to you? The first one, we named mesothelin as a target for one of our HLA-independent or HIT TCRs, and we are co-developing that one together. The second one has been selected but is not named and won't be named for the foreseeable future, if that's the question. It is, Helen, and thank you.

And ready for presentation.

Maybe Adrian your comment about adding a focus on ovarian.

Within surpassed.

Is that based on I think you had a little bit of a tumor you have some tumor shrinkage in 1 ovarian patients as of the last update is it based off of that or is it really that you've seen more than an additional patients that have happened.

Thanks for that update.

We can't comment on any of the data.

In the surpass trial pending the.

<unk> data release.

That question will be much better answer when we when we can all look at the same amount of data.

Helen Katrina Tayton: The issue was, how far along has that progressed since they decided to take that program under their wings as well. I wouldn't give it the liberty to say exactly how far it's progressed, but it is moving along the timelines that we anticipated for, you know, selecting the target. So I think, you know. Early, basically, but not that far behind the

And have that discussion net.

Okay.

And Meg as Arnaud answer here, but but.

But can you give us a flavor you gave that per patient numbers, but can you give a flavor kind of spread of tumors that are going to be in there.

And are you should we be thinking about any of these tumor types starting to get to that okay.

High single digit 10 patient type of threshold, you've historically talked about that useful for establishing proof of concept or or futility.

Operator: Our next question comes from Marc Frahm with Cowen & Company. Your line is open.

That was the case.

Youre correct Youre going to get the same answer as from.

The previous question, but I do admire your persistence on this.

We haven't we haven't guided and we're not going to guide.

I think.

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 informed perspective at that point.

Okay, and then maybe turning to the planned BLA.

Operator: For Marc Frahm, with Cowan & Company, your line is open. Thanks for taking my questions and congrats on getting all these patients in and ready for presentation. Maybe, Adrian, your comment about adding a focus on ovarian cancer within surpassed... Just to be clear, is that based on, I think that you had a little bit of tumors, you had 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?

You keep you are continuing to enroll.

A second cohort of patients in the <unk>.

In spearhead 1.

The filing just have the first cohort that we've already can see response rate data plus 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.

Yes, hi markets, it's Elliot.

The planet.

To file the BLA based on the data in cohort 1.

Okay. Thank you.

Thanks Ross.

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

Operator: We aren't 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 then. Okay. Um, and maybe we'll get a similar answer here, but, but, um, but can you give us a flavor, you know, you gave the kind of patient numbers, but can you give us a flavor of the kind of spread of tumors that are going to be in there?

Hey, this is kelsey on for Michael.

2 quick ones could.

Could you just provide some color on where you stand with the launch prep and commercial readiness and then the second 1.

And the <unk>.

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.

Thanks Catherine.

I will ask.

Elliott to touch on the radiation sub study.

And Helen do you want to just pick up on where we are with the commercial readiness and prep.

Operator: Um, you know, in our, should we be thinking about any of these tumor types starting to get to that kind of high single-digit 10 patient type of threshold you've historically talked about that useful for kind of establishing proof of concept?

Sure.

Yes.

Yeah sure Joel ill kick off with the answer to that 1 I mean, I think we're in reasonably good shape, we've been planning for this.

For quite some time.

Heading channel.

Marc Alan Frahm: Proof of Concept, or futility, if that were the case.

The key things around market access marketing.

Adrian G. Rawcliffe: You're correct, you're going to get the same answer as for the previous question, but I do admire your perseverance in this. We haven't guided you, and we're not going to guide you. 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 informed perspective at that point. And then maybe turning to the planned BLA, you're continuing to enroll a second cohort of patients in Spearhead 1.

Book.

<unk> commercial planning and now we are beginning to turn our attention today.

If you dig deeper and wholesale will be seen to be the outlet customer.

Well, so as you would imagine.

Working very closely with Kols et cetera, and then getting feedback and beginning to sort of map out all kinds of materials pathways involved.

That side and then.

My name is John <unk> comment on the profit going on T put out commercial manufacturing and our operations technical growth.

Operations and in place ready for.

Adrian G. Rawcliffe: Will the filing just have the first cohort that we've already seen the response rate data for plus a couple of incremental patients, or do you expect that filing to have the complete trial, including some of these patients who are enrolled in the second cohort?

So a different level of delivery.

Our next comes from that what we do on the clinical side. So, yes that will say more LNG calls I'm sure, but at this stage I think we're pleased with how it's tracking.

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

We've said before that our commercial loans 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 so supply wise. We're in good shape and then we're obviously going through the all of the activities that you need to prepare for the BLA filing the process characterization work and those type of things which is proceeding.

Well.

Okay.

Elliot Norry: enrolled into the second cohort. Yeah

Total radiation sub study, yes sure so.

We decided to <unk>.

Elliot Norry: Hi Marc, it's Elliot. The plan is to file the BLA based on the data in Cohort 1.

And enrollment in the radiation sub study.

Really for multiple reasons.

This is a thing was a single center sub study of the phase 1.

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

Our family sell multi tumor study.

And really the only part that was remaining open.

The study was significantly affected from an enrollment standpoint by.

Operator: With Guggenheim, your line is open.

By the Covid pandemic.

Kelsey Beatrice Goodwin: Hey, this is Kelsey on behalf of 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 for me. Thank you.

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.

It 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.

Adrian G. Rawcliffe: 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? Yes, sure. I'll kick off with the answer to that one. I mean, I think we're in reasonably good shape.

Well 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, a 4 to really be put into the <unk> Alpha program and.

And continue to enroll surpassed.

Helen Katrina Tayton: We've been planning for this for quite some time. We've had internal folks focus on the key things around market access and marketing. Broad Commercial Planning And now we're beginning to turn our attention to the, and also obviously into the outward, customer-facing roles, working very closely with KOLs, et cetera, and then getting feedback and beginning to sort of map out all kinds of materials, pathways, and roles on that side. And then, you know, John could quite easily comment on the prep that's going on to put our commercial manufacturing and our operations, and technical operations in So yeah, that will say more in due course, I'm sure, but at this stage, I think we're pleased with how it's tracking. John, do you want to pick up on the CMC aspects of this? Sure.

Got it okay. Thank you.

Thanks Catherine.

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

Hi, guys. Thanks for taking my questions.

Other question, what do you see as the go no go bar for advancing the Nexgen <unk> 4 program into late stage development for the different indications.

The phase 1 surpassed study.

Okay.

Sure.

Yes sure.

Maybe I'll take a stab at that.

So the I.

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 just refer everybody to the discussions that we've had previously about what efficacy in cell therapy.

In very late stage populations such as those that we are studying in this phase 1 trial would look like.

I think we've consistently said that.

3 out of 10 patients responding with benefit to patients. So 6 months give or take would be would probably be the ballpark that we're looking to say.

John Lunger: Sure. We've said before that our commercial launch will come out of 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 you need to prepare for the BLA filing, the process characterization work, and those type of things, which are proceeding well.

Now, obviously that does vary depending on individual settings and tumor types.

And but I think we need to understand the data a little bit more before we.

Before we can discuss that and look forward to doing so.

From my own words.

Got it and maybe.

Similar question in the same vein.

What do you see as the go no go bar for picking it.

Particular indication to be a focus indication and the ongoing surpass study.

Elliot Norry: Elliot, do you want to touch on the radiation sub-study? Yes, sure.

Yeah.

But that 1 was a bit more simpler.

Elliot Norry: So we decided to end enrollment in the radiation sub-study, you know, really for multiple reasons. This was a single center sub-study of the Phase 1 Afamacel 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. When we look back at the trial design as well, based on how it had been organized, it was really unlikely to provide sufficient answers as it relates to differentiating the addition of low-dose radiation to cell therapy.

We we selected those indications some time ago. The 4 that we have previously.

I'm not going to comment on the rationale behind putting ovarian and Thats as I commented earlier, we will 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 <unk> targeting therapies.

<unk>.

Both.

Dose escalation portions of the surpass study and then also the phase 1 trial for <unk> recruited a number of non soft kind of operations. So you may recall and the indications that we selected as focused indications day in lung bladder gastro esophageal and head and neck in the.

<unk>, where we had seen.

Either confirmed responses.

Elliot Norry: So while there's 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 successfully.

For very substantial antitumor activity in the case of bladder cancer.

So we didn't have any responses that but we have seen very significant.

Antitumor activity and really was a way of focusing down that trial from the sort of 10 indications that it was.

Routinely express Magi, 4 down to something a bit more manageable and to try to get to patient numbers, where we could make development decisions.

Operator: Got it. Okay, thank you. Thanks Kelsey. Thank you. Our next question comes from Jonathan Chang with...

Understood. Thanks for taking the questions.

Thanks, Jonathan.

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

Operator: Jonathan Chang with SVB Lyric. Your line is open.

Jonathan Chang: Hi guys, thanks for taking my questions. There is a question. What do you see as the go, no-go bar for advancing the next CHIP and AJ-4 program into later stage development for the different indications beyond the Phase I surpassed?

Thank you Mara Goldstein.

Hi, Mario 2 question.

Surpass 2 you spoke to in your in your prepared comments about making some modifications.

Can you sort of conform to evolving standard of care and I'm wondering if you can.

Speak to that.

Adrian G. Rawcliffe: So maybe I'll take a stab at that. So the, I think...

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 and maybe you could speak to that specifically as it relates to you guys and what Youre doing.

Adrian G. Rawcliffe: 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 populations, such as those that we're studying in this phase one trial, would look like. And, you know, I think we've consistently said that three out of ten patients responding with benefit to patients of six months, give or take, would probably be the ballpark that we're looking to see.

Suddenly thanks, a lot so I'm going to ask Elliott to talk about.

Past 2 study.

And the standard of care evolution, there and then I'll ask Jon to pick up the discussion on our strategy around back to supply.

Thank you.

Yes, Hi, Mara just very briefly the standard of care for really the gastroesophageal cancers has evolved from.

From being chemotherapy approach in first line, followed by PD, 1 inhibitor and most in most scenarios. There are some other drugs did play in in specific settings.

But those those those drugs are now being used.

Adrian G. Rawcliffe: 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 onward.

Fairly commonly.

As a combination first line approach.

Which.

It does.

2 things I mean first of all it improves the standard of care for those patients, but it also.

Adrian G. Rawcliffe: 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?

Opens up the space for second line therapy in many patients in that.

The patients don't.

Adrian G. Rawcliffe: That one is a bit simpler in that we selected those indications some time ago, the four that we had previously, and obviously, I'm not going to comment on the rationale behind putting ovarian in. As I commented earlier, we'll talk about that when we get down to ESMO.

Just receive they don't receive.

<unk> chemotherapy progress than PD..1 inhibitor. Then progressed then be open to third line treatment there really compressing those 2 treatments still into first line.

That being said.

There is still tremendous unmet need in this population.

Adrian G. Rawcliffe: But more generally, you might recall that we did an analysis of all of the patients that were treated with MAJ-4 targeting therapies in both the dose escalation portions of the SURPASS study and then also the Phase 1 trial for FAMICEL, which recruited a number of non-sarcoma patients. 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 or urethelial cancer.

And that the response rate and duration of response windows comment with that combination.

Although better than an advancement for patients there's still quite a long way to go to help this really.

Devastating tumor type.

Patients with that disease those diseases.

Okay.

So yes.

We'll expect to make will be essentially.

Closer to second line therapy is that what I'm understanding.

The study does allow for the.

Drug to be used in second line beyond 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 thats the most significant change.

Adrian G. Rawcliffe: We didn't have any responses there, but we had seen very significant anti-tumor activity, and it really was a way of focusing down that trial from the sort of 10 indications that it routinely expressed MAJ-A4 down to something a bit more manageable in trying to get to patient numbers where we could make development decisions.

Okay alright, thank you.

Okay.

Yes, and on the vector you probably recall back in 2017, we made the decision to.

Pursue a vector strategy that had 2 main elements.

1 was.

An external partner that can work with us through commercial and Ed mentioned military earlier, which we've used worked with military 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 capabilities. So we have done that and we're supplying our other trials with materials.

Operator: Understood. Thanks for taking the questions.

Operator: Our next question comes from Mara Gladstein with Mizzou. Your line is open. Thank you.

Mara Goldstein: Thank you. Hey, it's Mara Goldstein.

Produced internally.

Mara Goldstein: Just two questions. On SRPAS2, you spoke in your prepared comments about making some modifications to sort of conform to evolving standards of care, and I'm wondering if you could just speak to that at this point in time. And then the second question is, I'm just curious, we've heard from a couple 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.

From our facilities, it's a new cell and gene therapy catapult center in the UK. So.

We're kind of executed on the plan to have 2 sources of vector available to us 1 internal and external.

Okay, alright, thanks, a lot thanks.

Thanks, Ron.

Thank you and there are no other questions in the queue I would like to turn it back to.

Andrea and Rockford for closing remarks.

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.

Adrian G. Rawcliffe: Thanks, Mara. So I'm going to ask Elliot to talk about the PASS2 study and the standard of care evolution there, and then I'll ask John to pick up the discussion on our strategy around vector supply. Thank you.

This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.

Yeah.

[music].

Elliot Norry: Hi Mara, just very briefly, the standard of care for really gastroesophageal cancers has evolved from being a chemotherapy approach in first line, followed by PD-1 inhibitors. 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... 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, so they don't just receive first chemotherapy, progress, then PD-1 inhibitor, then progress, then be open to third-line treatments.

Elliot Norry: They're really compressing those two treatments still into first line. That being said, there's still tremendous unmet need in this population, and the response rate and duration of response with that combination, although better and an advancement for patients, there's still quite a long way to go to help this really devastating tumor type and the patients with those diseases.

Mara Goldstein: So the modifications you'll expect to make will be essentially to move sort of closer to second-line therapy. Is that what I'm understanding?

Elliot Norry: The study does allow for the drug to be used as second line 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 I program, but that's the most significant change.

Mara Goldstein: Okay. All right. Thank you.

[music].

John Lunger: So that's the material that we'll use going into commercial. But secondly, we decided to also develop internal capabilities. So we have done that, and we're supplying our other trials with material produced internally from our facility that's in the 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.

Operator: Thank you. And there are no other questions in the queue. I'd like to turn it back to Adrian Rawcliffe.

Adrian G. Rawcliffe: Adrian Rawcliffe for closing remarks. 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.

Operator: With that, we'll close the call. Thanks a lot. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day. www.cdc.gov.au

Operator: [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

Operator: Good day, and thank you for standing by. Welcome to the Aptimume 2nd Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone.

Juli P. Miller: Please be advised that today's conference is being recorded. I would now like to turn the conference over to Juli Miller, Director of Industrial Relations. Please go ahead.

Juli P. Miller: Hello, and welcome to Adapt Immune's conference call to discuss our second quarter 2021 financial results and business updates. 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 preparedness portion of the call. Other members of our management team

Adrian G. Rawcliffe: will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe.

Adrian G. Rawcliffe: Adrian Rawcliffe. Thanks Juli and thanks everyone for joining us. So last year, we set out our 2-2-5-2 strategy for the next five 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 famosella ASCO, with a fuller data set to follow at CETA, and to present data from our AFP trial at ILCA.

Adrian G. Rawcliffe: In June, we presented initial data from our pivotal Spearhead1 trial at us, with a disease control rate of approximately 85%, an overall response rate of approximately 40%, and very encouraging initial durability. These data demonstrate that FAMICEL has life-changing potential for people with synovial sarcoma and MR-CLS. We plan to update data from this trial at CETOS later this year and say 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 major A4.

Adrian G. Rawcliffe: We're preparing for a successful commercial launch, working with key industry leaders, Agilent for companion diagnostics, Miltenny for our lentiviral vector supply, as well as developing our in-house capabilities to support commercial delivery for a pharmaceutical. For the second and third clinical milestones this year, we are on track to update our AFP and SURPASS programs at ILCA and ESMO, respectively. At ILCA, on September 5th, Dr. Bruno Sangreau will present data from our AFP Phase 1 trial. He'll present data on 13 patients who have been treated in Cohort 3 and expanded. 11 of whom have had at least one post-baseline scan.

Adrian G. Rawcliffe: We'll issue a full press release around these data, and we'll update this program regarding this programme 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 six patients in the dose escalation cohorts of this trial, with two confirmed responses in patients with EGJ and head and neck as well as tumor reductions in three other patients with esophageal, ovarian, and EGJ tumors. As I said in the Q1 call in May... Enrolment in the first half of 2021 in this trial has gone very well

[music].

Good day, and thank you for standing by and welcome to the <unk> second quarter earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you'll need to press star 1 on your telephone.

Please be advised that today's conference is being recorded other now like turn the conference over to Juli Miller Investor Relations. Please go ahead.

Adrian G. Rawcliffe: Again, we'll issue a full press release and provide an update on the future of the development of this therapy. And a couple of other updates on this program. The SURPASS trial was initially in a wide range of MAYJ4-expressing tumors, but it was subsequently amended to recruit in four focus indications: lung, bladder, head and neck, and gastroesophageal, where we have seen anti-tumour activity and responses with our MAI-J4 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.

Due to several factors, including those outlined in our latest filings with the SEC Adrian Roberts, 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 Ballclub ad.

Thanks Julie.

Well, thanks, everyone for joining us.

So last year, we set out with our 2252 strategy for the next 5 years and at the beginning of this year, we identified the milestones in 2021 day.

To deliver that strategy.

From a clinical perspective these milestones 1 to present initial data from our pivotal spearhead 1 trial with a famous I'll ask Scott with a fuller data set to follow sito's.

To present data from our AFP trial Ilkka.

And 3 presented data from our surplus trial with our next Gen program targeting MAGE I thought as much.

I'm pleased to say that in Q2, we delivered on the first of these with excellent pharma sales data at our Sky.

And we are positioned to deliver on the next 2 in Q3.

Adrian G. Rawcliffe: 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 NextGen product targeting MAYJ4 for patients with esophageal and EGJ cancer, is on track to initiate, as planned, in Q3. We've designed a 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.

And as much as anticipated.

I would say a little bit about each of these milestones interest.

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 that's ask Scott.

With a disease control rate of approximately 85% and overall response rate of approximately 40% I'm very encouraging initial durability.

These data demonstrate that <unk> myself as life changing potential, but people with synovial sarcoma and <unk> CLS.

We plan to update data from this trial at <unk> later this year.

But we're working hard to file a BLA next year and achieved the first element of our 2252 strategy to have a product on the market targeting major for.

We're preparing for a successful commercial launch working with key industry leaders.

Julian for companion diagnostic mill <unk> for our limited viral vector supply as well as developing our in house capabilities to support commercial delivery for our fiber cell.

For the second the third clinical milestones. This year, we're on track to update in Q3 on our AFP and to past programs at Ilkka and as my respectively.

Ilkka on September 5th Dr. Brenner, Sangre will present data from our AFP phase 1 trial.

We will present data from 13 patients who have been treated in cohort 3 and expansion.

Operator: Our next question comes from Tony Butler with Roth Capital. Your line is open.

Several of whom have had at least 1 post baseline scan.

We'll issue a full press release around these data and we'll update regarding this program going forward.

Tony Butler: Good afternoon. Thanks very much for taking the questions. There are two, one with two parts.

At ESMO, we presented update from the surpass trial with our next Gen program targeting MAGE <unk>.

You'll remember that last year, we reported data from 6 patients in the dose escalation cohorts of this trial.

Adrian G. Rawcliffe: Adrian, you mentioned the companion diagnostic development with Agilent, and I'm assuming that you're going to seek CLIA 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 any delay in the BLA filing based on Spearhead 1? And Part B of that question, would you use this particular validated diagnostic and proceed to an esophageal cancer in EGJ? Question two is around the program that you have with Stellis. And I recall that one of the, I believe it was one of the HIT programs.

With 2 confirmed responses in patients with <unk> and head and neck cancer.

As well as tumor reductions in 3 other patients with a soft Gilles ovarian and AG J, Kansas.

As I said in the Q1 call in May.

Enrollment in the first half of 2021 and this trial has gone very well.

As of the data cut for the ESMO presentations, we've treated 25 patients in this trial and 23 of these patients have at least 1 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.

Couple of other updates on this program.

Adrian G. Rawcliffe: Estellas had taken, if you will, a ownership or joint venture in, they'd also taken a second program, and I wondered if you would speak to that, and if you don't want to reveal the program, fine, but how far along are the developments of both? Thank you. Thanks, Tony.

The surpass trial was initially in a wide range of MAGE <unk> expressing tumors, but was subsequently amended to recruit and full focus indications lung bladder head and neck and gastroesophageal cancers, where we have seen antitumor activity and responses with a major <unk> targeted therapies previously.

Adrian G. Rawcliffe: We have not provided details on the development pathway for the companion diagnostic. However, I can confirm that there won't be any delay in, or we don't anticipate any delay in, the BLA file on the basis of that. Could you repeat the question on the SURPASS II trial? Yes, sir, you're going to use that companion diagnostic in the CERPAS2 trial, and therefore that trial may actually be somewhat delayed in enrolling, even though you said it would be in Q3.

Ovarian cancer.

In addition, our surpassed 2 trial, which is the phase II trial with the nexgen product targeting MAGE <unk> for patients with a softer GL and EG J, Kansas.

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 a $235.2 goal of having an additional major <unk> marketed product in the next 5 years.

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

Thank you.

Ask a question you'll need to press star 1 on your telephone to withdraw your question press the pound key.

Helen Katrina Tayton: Thanks. Thanks for the question, Tony. Can I just repeat it back to you? I think you will double check.

Our first question comes from Tony Butler with Roth Capital. Your line is open.

Helen Katrina Tayton: Thanks for the question, Tony. Can I just repeat it back to you?

Good afternoon, and thanks very much for taking the questions there or 2.1 with 2 parts.

Helen Katrina Tayton: I think you were double-checking on the second program, but the first one we named mesothelin as a target for one of our HLA-independent or HIT TCRs, and we are co-developing that one together. The second one has been selected but is not named and won't be named for the foreseeable future, if that's the question. It is Helen, and thank you.

You mentioned the companion diagnostic development with adjuvant.

Im assuming that youre going to see CLIA validation. So the question is.

Can you provide some information around the number of patients that you may need to see to <unk>.

Helen Katrina Tayton: The issue was how far along that has progressed since... They have decided to take that program under their wings as well. I wouldn't be at liberty to say exactly how far it's progressed, but it is moving along the timelines that we anticipated for, you know, selecting the target. So I think, you know, early basically, but not that far behind the measles healing program.

<unk> 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 and surpassed 2.

Any thoughts Joe cancer and EG Jay.

Operator: Our next question comes from Marc Frahm.

Question 2 is around the.

The program that you have with Astellas and I recall that.

Operator: This presentation comes from Marc Frahm with Cowan and Company. Your line is open.

Wanted to I believe it was 1 of the hit programs.

Marc Alan Frahm: Thanks for taking my questions and congrats on getting all these patients in and ready for presentation. Maybe Adrian, your comment about adding a focus on ovarian cancer within surpassed... Just to be clear, is that based on, I think that you had a little bit of tumor, you had 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?

Astellas Astellas had taken if you will.

Our ship, our joint venture and they have also taken a.

<unk> program and I wondered if you could speak to that and if you don't want to reveal the program's fine, but how far along are the development of both thank you.

Thanks, Tony.

So.

We have not provided details on the development pathway for the companion diagnostic I can confirm that there won't be any delay.

2 we don't anticipate any delay to the BLA file on the basis of that.

Marc Alan Frahm: We aren't going to comment on any of the data that is in the surpassed trial pending the ESMO data release. I think that question will be much better answered when we've, when we can all look at the same amount of data and have that discussion then. Okay. Um, and maybe we'll get a similar answer here, but, but, um, but can you give us a flavor, you know, you gave the kind of patient numbers, but can you give us a flavor of the kind of spread of tumors that are going to be in there?

Could you repeat the question on the word from the.

The <unk> II trial.

Yes. So are you going to use that companion diagnostic and surpassed 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.

Got it so 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 am going to ask Helena to comment on the status of those programs.

Marc Alan Frahm: Um, should we be thinking about any of these tumor types starting to get to that kind of high single-digit 10 patient type of threshold you've historically talked about that would be useful for kind of establishing proof of concept or, or utility, if that were the case? You're correct, you're going to get the same answer as for the previous question, but I do admire your perseverance on this. We haven't guided them, and we're not going to guide them.

Okay.

Thanks, guys.

Thanks for the question Toni can I can I just repeat it back to you I think you will double checking on the second program. The first 1.

Mr. Stephen other targets.

HLA independent will hit.

<unk> and we're developing that 1 together the second 1 is <unk>.

Has been selected.

Named it unlikely to be named force.

Adrian G. Rawcliffe: 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 informed perspective at that point. And then maybe turning to the planned BLA, you're continuing to enroll a second cohort of patients in SPIR-HEAD1. Will the filing just have the first cohort, you know, that we've already kind of seen the response rate data plus the couple incremental patients, or do you expect that filing to kind of have the complete trial, including some of these patients who are enrolled in the second cohort? Hi Marc, it's Elliot.

Examples.

Perhaps a question.

It is Helen and thank you the issue was how far along is that progressed since.

They have.

Decided to take that program under their wings as well.

At Liberty to say exactly how far progressed.

It is it is moving.

And along the timelines that we anticipated for interest came to target. So I think.

Early basically but not that far behind the day.

The major training program.

Thanks very much.

Thanks, Tony.

Our next question comes from Marc Frahm with Cowen <unk> Company. Your line is open.

Elliot Norry: The plan is to file the BLA based on the data in Cohort 1.

Operator: Thank you. Our next question comes from Michael Schmidt with Guggenheim.

Hi, Thanks for taking my questions and congrats on getting all these patients.

Operator: With Guggenheim, your line is open.

Kelsey Beatrice Goodwin: Hey, this is Kelsey on behalf of 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 for me. Thank you.

And ready for presentation.

No.

Maybe Adrian your comment about adding a focus on ovarian.

Within surpassed just to be clear is that based on I think you had a little bit of a tumor you have some tumor shrinkage in 1 ovarian patients as of the last update is it based off of that or is it really that you've seen more than an additional patients that have happened.

Sequencers to that update.

We can't comment on any of the data.

As in the surpass trial pending the.

ESMO data release.

That question will be much better answer when we when we can all look at the same amount of data.

And have that discussion net.

Okay.

And Meg as Arnaud answer here, but but.

But can you give us a flavor you gave that kind of patient numbers, but can you give a flavor of kind of spread of tumors that are going to be in there.

Helen Katrina Tayton: We've been planning for this for quite some time. We've had internal folks focus on the key things around market access and marketing. Broad commercial planning, and now we're beginning to turn our attention to the, and also obviously into the outward, customer-facing roles. Working very closely with KOLs, et cetera, and then getting feedback and beginning to sort of map out all kinds of materials, pathways, and roles on that side. And then, you know, John could quite easily comment on the preparation that's going on to put our commercial manufacturing and our operations, and technical operations in place ready for a different level of delivery of products to complement what we do on the clinical side. So yeah, we'll say more in due course, I'm sure, but at this stage, I think we're pleased with how it's tracking. John, do you want to pick up on the CMC aspects of this? Sure.

And are you should we be thinking about any of these tumor types starting to get to that cash.

High single digit 10 patient type of threshold, you've historically talked about that useful for establishing proof of concept or or futility.

That was the case.

Youre correct youre going to get to say about <unk> is from the <unk>.

Previous question.

I do admire your persistence on this.

We haven't we haven't guided and we're not going to guide I think it's best it's.

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 important perspective at that point.

Okay, and then maybe turning to the planned BLA.

You keep your continuing to enroll.

A second cohort of patients in the.

Spearhead 1 will the filing just have the first cohort that we've already seen response rate data plus a 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.

Yeah, Hi markets, it's Elliot.

The planet is.

To file the BLA based on the data in cohort 1.

Okay. Thank you.

Thanks Ross.

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

Yes.

Hey, this is kelsey on for Michael.

2 quick ones could.

Could you just provide some color on where you stand with the launch prep and commercial readiness and then the second 1.

John Lunger: Sure. We've said before that our commercial launch will come out of 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 you need to prepare for the BLA filing, the process characterization work, and those type of things, which are proceeding well.

And the <unk>.

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.

Thanks Catherine.

I will ask.

Elliott to touch on the radiation sub study.

And Helen do you want to just pick up on where we are with the commercial readiness and prep.

<unk>.

Yes.

Yeah sure Joel I'll I'll kick off with the answer to that 1 I mean, I think we're in reasonably good shape, we've been planning for this.

Elliot Norry: Elliot, do you want to touch on the radiation sub-study? Yeah, sure.

Elliot Norry: So we decided to end enrollment in the radiation sub-study, you know, for really multiple reasons. This was a single center sub-study of the Phase 1 Afamacel 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. When we look back at the trial design as well, based on how it had been organized, it was really unlikely to provide sufficient answers as it relates to differentiating the addition of low-dose radiation to cell therapy.

For quite some time.

Heading channel from the key things around market access marketing.

Broad commercial planning and now we are beginning to turn our attention today.

If you dig deeper annual sales machine today, the outlet customer facing roles so much EBITDA.

Imagine that.

Working very closely with Kols et cetera, and then getting feedback and beginning to sort of map out all kinds of materials pathways involved.

On that side and then.

And then John <unk> comment on the profit going on the team put out commercial manufacturing and our operations.

And in place ready for them.

So a different level of delivery.

<unk> can come from that what we do on the clinical side. So yes that will say more LNG calls I'm sure but at that at this stage I think we're pleased with how it's tracking.

John do you want to pick up on the CMC aspects of this share.

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

Well.

Okay.

And then John touch on radiation sub study, yes sure so.

We decided to.

Operator: Got it. Okay, thank you. Thanks Kelsey. Thank you. Our next question comes from Jonathan Chang with SVB.

And enrollment in the radiation sub study.

Really for multiple reasons.

This is a thing was a single center sub study of the phase 1.

Operator: Wei Chang with SVB Lyric: Your line is open.

Our family sell multi tumor study.

And really the only part that was remaining open.

Jonathan Chang: Hi guys, thanks for taking my questions. There's a question: what do you see as the go, no-go bar for advancing the next CHIP MAJ-4 program into late-stage development for the different indications beyond phase one?

The study was significantly affected from an enrollment standpoint by.

By the Covid pandemic.

And really presented a very challenging enrollment scenario with the single center and also with expanding into other centers.

And.

Adrian G. Rawcliffe: So maybe I'll take a stab at that. So, I think.

When we look back at the trial design as well based on how it had been organized it was.

Adrian G. Rawcliffe: 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 and cell therapy in very late stage populations, such as those that we're studying in this phase one trial, would look like. And, you know, I think we've consistently said that three out of 10 patients responding with benefit to patients of six months, give or take, would probably be the ballpark that we're looking to see.

It 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.

Well 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, a 4 to really be put into the <unk> Alpha program and.

<unk> continued to enroll surpassed.

Got it okay. Thank you.

Thanks Catherine.

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

Hi, guys. Thanks for taking my questions.

Other question, what do you see as the go no go bar for advancing the Nexgen <unk> 4 program into late stage development for the different indications.

The phase 1 surpassed study.

Okay.

Sure.

Yes sure.

Take a stab at that.

So the I.

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 just drift.

The body to the discussions that we've had previously about what efficacy in cell therapy.

In very late stage populations such as those that we are studying in this phase 1 trial.

It would look like.

I think we've consistently said that.

3 out of 10 patients responding with benefit to patients of 6 months give or take would be would probably be the ballpark, we're looking to say.

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.

Before we can discuss that and look forward to doing so.

From my own words.

Got it and maybe.

Q2 2021 Adaptimmune Therapeutics PLC Earnings Call

Request a DemoDemo

ADAP

Adaptimmune Therapeutics

Earnings