ATRA - Earnings call transcript Q3 2021 | Atara Biotherapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to Atara Biotherapeutics Quarter Three 2021 Financial Results Conference Call. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host Eric Hyllengren, VP, Investor Relations and Finance. Sir, the floor is yours.

Eric Hyllengren

Thank you, operator. Good morning, everyone, and welcome to Atara's third quarter 2021 results conference call. a operational announcing progress. issued financial third we and results today, press our release quarter Earlier section This slide in Media deck release are atarabio.com. press and available the an Investors updated corporate at and from On our our on and upcoming the today's milestones results call, Atara team objectives. an financial also will and progress and executive operational key update provide review members

of Utpal Executive Joining Executive Officer; Chief Chief Touchon, President Vice and Dr. Chief me President and AJ on Development; Chief today's Dr. Medical call are Officer. Research Global Officer; Financial Officer; Head Jakob Koppikar, Kristin Dr. Dupont, and Commercial Pascal Joshi, Dr. Yarema, and

and the We will will be the forward-looking open questions. forward-looking then for or Company's statements. begin Jakob are statements press the these business. the no making uncertainties your differ as our in could by Actual undertakes Company's stated today's prepared SEC associated statements release the during with their We those would due date today's of update cautionary made Pascal remind contained obligation materially call, and Company the These filings. in the statements. implied to from call to by Company's from qualified to management risks statements with up like statements are and results comments that listeners forward-looking and These entirety

Pascal? Now, call I'd the like turn to Pascal. over to

Pascal Touchon

you and for us joining thank Eric all Thank you, this morning.

for in extended three PTLD, These our X BLA next new will with ATAXXX time line tab-cel strategic to These XX% first safety we basis PTLD. positive additional with CAR which be tab-cel, prior line response results. for for confirm the the demonstrating while multiple at Today, up. of survival a submission all XX% submission of and Phase continue data ALLELE data in one in and positive year patients with objective tolerated progress plan analysis, top generation profile and priorities, in of announced durability across in positive strong pivotal for our EU patients overall allogeneic programs. and imminent includes responders, EBV We EBV MAA data clear year T follow make meaningful study for still sclerosis, in rate next response well more a the U.S. the

We the few and are of Europe half granted for in we've approval accelerated the second excited very XXXX. assessment, all tab-cel to recently submit a anticipate next in on days we regarding of approval EU in decision filing

October, Africa these Fabre exclusive in Europe, to believe for select cancers. Pierre potentially value this reinforces Middle strategic opportunity for markets We partnership and Additionally, maximizes therapy. for and tab-cel emerging EBV financial in in we commercialization our extremely were positive the of agreement announce transformative this tab-cel commercial with East, pleased and the other markets

front a tab-cel, in the including in EU. meaningful meetings believe the from and other the continuing the Enrollment in in of QX EBV including on analysis further make proliferative work could study is regulatory aligned the U.S. In particular, immunodeficiency additional approach EBV this tab-cel the our XXXX to statistical FDA. on on and items for comparability recent for will the outstanding with study we driven continue and we with to new have Concurrently, which to have pursuing IALPD is FDA QX the of we review on and evaluating label expansion BLA provide U.S. patient expected opportunity. data additional XXXX. primary in data six in continue agency patient within step-wise multi-cohort submitted. IALPD. CMC resolve be in progress expect four development the The submission we Based disease CMC disease is have request associated label to populations, multi plan at On type methodology. the expansion population focus B a with in We for the the leasehold team FDA following cohort XXXX interactions, with complete we the tab-cel to already interactions we two

ATAXXX, to multiple fitted ATAXXX our a presented XX OLE patients months. progressive transformative we Turning label Phase at Last sclerosis. therapy month, with potentially data ACTRIMS in to patients up for with for with open or decade X progressive MS extension

expected progression. disability we achieved sustained the demonstrate data As that that presented patients patients higher improvement majority a MS rate driven is Phase is be improvement with seen in our primary which natural and in X disability endpoint randomizes or reminder, progressive this The the based history EMBOLD The duration naturally so-called story. of our by longer sustained at the EDSS continuous presented have SDI study. of of OLE would on SDI data is

This EDSS the pre-the-nation for These biomarker statistically MTR improvement ATAXXX Additionally, making clinical biological in central build significant and increase of in nation evidence we medical community state Transfer presented the parallels partners. the with continues significant interest for Magnetization to and with clinically ATAXXX transformative observed maybe improvement awareness provide MTR than considered in EDSS potential the potential and potential the data to Ratio reflect system. and driver improvement. basis of in nervous observed the the

we while maintaining with investors Bayer data portfolio, program. for to progressing regarding the will assess are in the mesothelin efficacy analysis decision or our IA rationale and conduct this the reminder, product candidate will regard the for on based disclose of next CAR-T strategic study. potential ATAXXXX to partnered the IA to And the of first and safety well. or With and we important partners. these our company, of milestone ATAXXXX for integrity IA steps a an an plan and still from XXXX half As We the interim believe the be decision

ATAXXXX continue to in oral December clinical at Meanwhile auto Sloan-Kettering Memorial clinical lowest mini Phase X signaling present of and and PD dominant ESMO using to the half IND the therapy and domain at on targeting in CAR second receptor we technologies of for translational co-stimulatory single-arm allogeneic make and ATAXXXX we targeting from CAR-T anticipate which IO for study the mesothelin of next another XXXX. 'XX. negative dose collaboration preclinical, enabling label, filing presentation data Our generation will studies progress cohorts therapy open shelf IND X an a mesothelin XXX

we November. preclinical Additionally, in ATAXXXX data benefits at new tumors present SITC I to plan for mean potential both in solid

B-cell ATAXXXX, our malignancies. for targeted patients Turning to CDXX with allogeneic CAR-T

new that an our actually We potential gene a translational support platform. XXX editing submit drive or ATAXXXX or ARC in analytical science, or science further not require capabilities platform support of TCR of house in platform pipeline off cell and XXXX, have domain targeted further process T invested to key we therapy the we co-stimulatory To QX by is to is which a CAR further in signaling our Research expect next-generation innovation to north opening on CDXX CAR and and product and defaulted and allogeneic IND new believe our leverages differentiator, Center does allogeneic teams. Atara preclinical best-in-class development

talented differentiated innovation our further facility Our platform. drive cell will our and allogeneic and product pipeline support this therapy unique by leveraging new team at

of with runway, this and in payment second the of our This XX regard cash. to to commercialization for XXXX and XXX are includes the our sufficiently million now quarter ended facility. million position financials, cash third million the of we with the funded in We of we in with Moving the agreement. common go to ATM shares cash XXXX [indiscernible] quarter stock received of believe $XX pump sales

the XXXX, I'm months of we serious into of head of lives partners diseases. and staff proud in final improving the progress As the with Atara patients of steady

could We world. allogeneic cell clinical And filing the of weeks. to our truly study are in very providing the forward in to MS call transformational tab-cel, the We patients. first will I the EU progress the in close turn bring the therapy a over for you application to now Jakob? therapy NDA update look an coming in T for to ATAXXX Jakob. more to

Jakob Dupont

during further three we on third I quarter like the to in color Pascal. you. add our progress priorities. Thank strategic advancing made the

PTLD session response SOT at both presentation new continued both and pivotal American of the Phase the the at support This plan Meeting at safety In submission Hematology imminent these tolerated which rate we Society M&A the or be following of positive HCT. partial European announced from today positive and response ORR by and mentioned, XX% complete will month. data ALLELE includes well an of a objective and responses. Pascal independent response observe X, we ORR as first following oral a EBV XX% profile adjudication data confirming with durability As tab-cel study response PTLD in next response Annual BLA of These presented the data, strong PTLD measured submission. oncologic

as treatment. need XX at months X of which SOT, for months, one-year X.X Safety are was host and response and confirmed a previously The OS survival duration this yet only reports of findings HCT. of versus more rate no they to where few in non-responders have flare have not were with lasting response, of with urgent tab-cell response responders reached. no to point XX% critical time months not to data median median XX graft for Those treatment patients XX% Of longer reach live. a with related tumor responded a rate a in had XX% than setting overall overall, time, XX% duration Importantly one-year survival of published is non-responders. to with who disease in compared in compared median consistent of this XX% to reaction was survival evidence

data second CR and studies XX X showing long-term on in Next or presentation PR. Phase EBV responders patients a will PTLD month on multicenter OS abstracts, oral months positive at and several relapsed-refractory present of we survival survival in at additional tab-cel reaching overall XX% years, ASH, median experience including from or over through EAP X

for for historical progressed reminder, a our today tab-cel around data filings tab-cel. included a the the a truly to to patients therapy positive and prior be a We benefit just EBV the with data who tab-cel patients. believe of have regulatory on ALLELE study the of conviction one therapy have deepen PTLD can As the will from line these is months and pivotal is potential we survival patients data bring with shown serves median transformational both in the few

held the make design the October in commercial tab-cel including and a We as the Regarding achieved approach Pascal progress mentioned, CMC the good Type comparability to on meeting the statistical with FDA. and team B FDA's agreement review discussions to we assess products. we with pivotal comparability in between regulatory continue U.S. tab-cel

Importantly, new lots. has not the studies manufacturing or requested FDA additional

to the with pivotal regarding 'XX along of of the these with submitted to for We Phase historical from received their request. data also comparability the are analysis additional studies. agreement to at planning help will plan to first filing. FDA analysis submit We clinical pivotal We've ALLELE data on X to quarter feedback FDA the the tab-cel. supportive We and that BLA and shared interact already in from the productive to data structure from study agency the our guide gain

meeting for tab-cel BLA Following quarter have agreements to to in the the XXXX. PTLD we on a in of the prior second comparability, plan positive submitting pre-BLA EBV

ATAXXX the data from progressive month, to open study candidate for Moving sclerosis. and MS. encouraging extension ACTRIMS we multiple last in At X clinical ATAXXX from translational the label our Phase MTR presented Phase data X new product of X-year

level it have over a impact treatment current to progresses. possibility the progressive these there that lives. continue offer worsen as who was unfortunately maintaining function, the a MS If of tremendous of patients' on patients have context, only the would will disease physical As time

be normal sustained unassisted. saw walking no treatment improvement in there or clinical with a data, at showed of of X chronic X was OLE the needed sustained The measure in at transformational In were extension patients that for improving SDI in those step been a as MTR function brain and who MTR assessing who Taking is in more to key up data in is patients seen TX of label favorably a XX to the been were regard did all ACTRIMS which PPMS most brain presented using SPMS for data months. we points X seen would open With ACTRIMS also remyelination body that at the evidence that I'd achieved may trend them patients at time the XX their of treated Phase X brain versus or even has appearing at was highlight not, watch compares increased similar of data X indicative further, with in A months and patients to appearing ATAXXX a our patients scientific MS. tissue. to presented trend in with and EDSS data This from aid be Phase improvement like increasing a MTR never new of remyelination. achieved has significance significant Slide statistical As X increase made This increase meters disability prospect lesions MTR multiple longer following. we Phase progression-free. non-enhancing XX of for before. locations presentation SPMS. to MTR hundred they presentation the MTR corporate of maintained comparison to Siponimod The the few able tissue SDI enough months an ATAXXX subsequent on regaining disability study normal updated a

declined or course We demyelination. expect this of MS progressive in MTR is

slowing showed NCR placebo. on the seen of Siponimod the placebo the X based in decrease demyelination Siponimod data, in group in versus As small Phase study

remyelination uniquely starting months time and Slide at a in those EDSS relatively base of On course increased improvement. stable the brain hand, treatment increase is without. MTR. the other XX after on MTR Lesions six parallels normal tissue in EDSS in and relatively clinical large Unenhancing ATAXXX magnitude TX On with This improvement indicates patients appearing ATAXXX in

analysis improvements excitement data and first support half Moreover, first clinical the the these improvement MTR and MTR with patients analysis this EDSS randomized, and be basis patients biological the MS, probability time observes as EDSS EDSS ATAXXX. increased remyelination in improvement statistically where MTR enroll a for may placebo-controlled observed the towards both significant success unique the for of of Unenhancing new study. for Phase provides This we Lesions demonstrated remyelination generated continue with investigator interim course improvement. driver time potential treated TX as has ATAXXX suggesting a clinical we inquiries that EDSS head in XXXX. increase MTR to in further with For We of evidence parallels in upcoming the finding believe improvement the supports progressive the ATAXXX in X in

Turning into CAR best-in-class T portfolio. our potentially

enables the of like our bioreactors. to staff, extend or And scaling receptor. our and reminder we in manufacturing tank that EBV the and the EBV that been of back academic in durability been The require TCR a shown I presents HLA increased in studies tolerability trafficking. allogeneic that has that and involved evidence closing, to patients and As gene the In endogenous studies the together, approach the - retains studies. in now XXX our our will patients operator hopeful therapies persistence, various platform entire therapies collaborators the stirred I safety now to would my disease approximately T-cell our T-cell approach This are by need. supported clinical to in platform we in call areas Working to not and and gratitude Operator? patients bring transformative begin does a has differentiated of portion editing. call. to turn and Q&A will our

Operator

Go our Instructions] Salim comes question Mizuho. [Operator Syed from from ahead. first And

Salim Syed

the for thanks color and congrats the all on progress. guys hi Yes,

driven that it's So, couple need pretty multiple progressive sclerosis historically ATAXXX in Pascal, on so we is I me need and I less sort unmet they've less disclosure more trial a the if remind limit to will and thinking understand you're the reason more sclerosis disclose first only increase the more you or But this is, us there or you're say you you of where how by folks about to more hey, that also question, generally increase? file argue get I than I need increase second smaller when X.XX that think the by to if of a the give wondering, disclosure around us entire just that? a I'm if P XXXX. data if regulatory the you the think something a going first the we're when actually of asked P value, is Can from X.XX you. this an the interpret a going limited one - you companies an going that know is ask XXXX this or increase decision trials it's half it's half that Thank would way value like think get value conceptually get and us to can just investors and you to there two - and multiple to guys then just you of and FDA, is seeing And this large is P the data? you're in the think large being let I'm in that fair you just we're just have curious trial smaller can to you wondering to why capital for efficient approval. some Jakob And is a and data established here here a is disclose

Pascal Touchon

answering you and Salim ask one AJ. question AJ will I first with the to because there. to start starting question, your color give thank will second there the that I’m for Yes,

AJ Joshi

thanks this. for an question, can Salim. of starting give your on you question overall just the Sure by Again maybe kind view second

study from around a do higher you we this, So, beyond additional safety have know, placebo-controlled both we're three-month range well as criteria going a year of as efficacy when as well know people X timeframe. with will who or the IA randomized data and to the for study, results, been hit people Phase have for biomarkers. everything you IA And with some the as

depending at adapt to and on to the it we be to FDA. we're set size, it's is of And XX, to could incorporate as but objective, a going which And there. fairly discussions form. alluded for stage is with what the So the possibly trend is, in kind us sample data is plan the large adapt seeing this we're seeing - the larger we are a an size, potentially certainly to you

is size in We provide that and sample we're will of both as after on adjustments detail communicate done to what based IA results. on rationale terms do the we those well IA publicly as that using plan the

we there. some detailed additional to are rationale going So provide

IA for can't clear. study get But actual in today, share going going of the extent results, into have of the we're we’d of integrity still - last made we rationale we but maintain study the that depend EMBOLD asking. actual we won't will leads will to any double-blind Now to we're IA-based our specifics because the some on that into to share that that you're be data data emphasize that that make adjustments kind to the in question the

So maybe won’t what to be to and what a so will just provide. providing example able add an give to can this, I we little color

that So, for but in expected at a EDSS of see active the similar Xa that's placebo of say then see trend we our the the much in let's improvement we to pretty modeling. we what observed in the ATAXXX And time what IA trend Phase we a arm, study.

point disclosing so the integrity course the At no into likely it without larger decision FDA can make point our discussion decide of of we’d a minimal give publicly study we disclose change that if detailed that a we’d could data, be at rationale sample the we Phase once then, or have X, transform either around will which the the we study. that So except we to in size, that preserve specific we believe of the expansion. with much

control, as what again, – fully X, maintain So to so to and as this strong setting robust oncology that’s can it's a with - about, study. we really, much the an that entire this happen is its like placebo going Phase still is really

behind the the main but the rationale itself. not the that's So details rationale, on data details on giving

that be second that. values. this not statistical So we your or P disclosing of to and wouldn't we kind specific the at point study question values into P we’ll methodology about be going disclosing leads be for We're discussing the

Salim Syed

it. Got

Pascal Touchon

plan cannot and specifics you share, And on our give again information there from this there. the to with enough investor milestone analyze that All this a do specifics depending time. the related that will to meaningful specifics. FDA, is will make that is we study be sure communicate particular at discussion how about because that the We aspects the but clear results of understanding particular the is actually community the to in interim

Operator

Phipps comes Blair. question And ahead, from Matt. our from William next Go Matt

Matt Phipps

want question. to taking my I for just thanks

on the regulatory Just on clarify you CMC the wanted color call this because what to focused around that discussions of CMC on some any you're the comparability so team approach. regarding aligned QX point, is said

you’re for. And QX? kind requested the so submit be what additional correctly, that or to additional a sequence will and and just informal that then you're B And hold meeting events in going QX I discuss to make of then analysis information pre-BLA sure meeting this curious looking understand just the another Type then again, in something of that FDA

Pascal Touchon

Matt I on maybe have compatibility needed we new there. if This is we on said, this B you October we agreement QX. start chime the you and during XX Atara analysis as reached remember, in in Thank said the based Type all new batch there recent the presented analyzing a and this batches by manufactured Jakob can you in and may methodology analysis

the FDA And study difference in I we've may shown data process that of there. of set is data process minimum we process really between in mind believe the with process data amount they these But between presented analyze as of an you the these batches all course there. keeping immense the a of all should reality demonstrate minimum sent these our data this and the are there Internet that's we FDA. comparability to remember we manufacturing that So say, should commercial and lot that in pivotal analyzes

provide us they the because but has to data a we ask have data analysis. analyses them few data the is will there the and related what asked additional they FDA do So to attributes already, additional

the I further then provide plan once for with we’ll already analyses with analyses for submitted. do FDA FDA we’ll which discussion. analyses data the additional we So And this

for where, and then the of file agreement of plan type to of commenting that Type and we make will discussion but sure an to all other FDA then the pre-BLA once to not we've are sense discussion, would level to the stuff And able with yet on then be B go got there. on all We the we'll to to be for that's including BLA. then submit what comparability, present meeting we a able clinical alignment and

sequence question. this the that Does are with events that's the your on it So of there answer we based FDA. planning discussion

Matt Phipps

then on I data, switch And maybe was we'll you received can on asked included the just. of maybe maybe you me if kind many that say rates that? see these yet, the a like kind way cell but can of can remind the if in how of you think study, line. patients in response don't And

Pascal Touchon

one. answer you to Jakob want Yes that

Jakob Dupont

Thanks question. so, the for Matt. Yes

So abstract and is included with but presentation. current the But in by a of abstract a so response at particular we we're But is here, what what we rate the these point that and first slots, in of have in this included of that SOT, we those the and this in the can HCT you independently this I reviewed. will XX% assessments really obviously haven't independent time. patients that both radiographic XX% rate responses detail on all not were course reporting were and is and is oncologic this response see course therapy. PTLD details say can most switch in And

Pascal Touchon

all can an it’s But presentation ASH. you at expect

much you ASH. more So at detail expect can

Operator

from Go John ahead, next John. And Newman Canaccord. from comes question our

John Newman

follow some the for question your products. I Europe me, Thanks CAR case at median very the look at is asking then may the want my the long. just the the The durability taking data regarding congrats they could have T-cell ask about that would that I study question to FDA I the have for because comment I tended assuming durability but the But all products my is the or with FDA study. you this point at progress, to this - you perhaps data FDA, especially And if in tab-cel. a Thanks. months provided follow-up is that for excuse very, the for reason the six and past all - durability. I'm wanted bit at to T In just in I'm think on has just wondered up understanding additional point

Pascal Touchon

for Thank do you, want question. your one. to you Jakob, that John take

Jakob Dupont

sure absolutely. Thanks, Yes, John.

the last of the cut data is as that the October of patients, number with provided we last you So, agency a that was disclosed in year, recall, year this we reasonable FDA But this number for this duration did months is from why data, approval, the wanted data cut. response recent six of again most regulatory perspective. required is we which which they

have again of do we durability so And this data. response

As comments mentioned XX% I encouraging. quite is earlier in think my at think the encouraging. I are year And quite responders one that we of survival

again we our months median now. have study these supportive And historical patients. ALLELE which presentation have studies. the very also that on is for of result survival again is that profound XX of that's mentioned there I So we in a a of oral circumstance, second which overall and for at course ASH,

and high durable a disease. be a that rates, then really long-term data on response again of response, will also where for for that totality patients, the have data the lethal at shows these the response rapid get a you study think between additional I these supportive So and ASH patients presented the benefit an impact a overall ALLELE survival

John Newman

ATAXXX. question of on I have additional general sort just a one question,

decline. wondering you you EDSS EDSS slowing the versus way for comment the regarding improvement the have the could on Just if simply potential agency about thinks understanding that

thinks been progressive could EDSS slowing the are curious if decline. simply like I improvements? that approved how have on something or about therapies think you perhaps just I'm the MS the color MS agency provide some

Pascal Touchon

was he of end and it align develop was XX-month yet up points EDSS one [ph] start with have product on consecutive A.J improvement the dialogue it failing we take being we’ll this has one Thank EDSS study there question which the approved not But having last because been so for that FDA time mean, in. and primary important, there. to study year try that's last and chime improvement only with - X these there. improvement, Phase months why a where our knowledge John criteria is you say, for on unfortunately That us for the you two has your important I'll MDA the to to at want was might the very to was no for XX - for I sustained as at that

that EDSS probably important criteria an there sustainability EDSS important very say that's sustained for is EMBOLD with them was in primary to improvement primary was PMS. talk it they with did we be and FDA we And endpoint change improvement. why that our the So align the and third study we the improvement

first nobody are now that. PMS, few to trying to even look nobody else improvement. the trying the that done do in the sustaining that's at go nobody - to Because that is has trying EDSS else So is studies

been that's it has John? answer your but question, in line - So, first that the with FDA. Does

Operator

our question comes next from Tessa from And Go JPMorgan. ahead. Romero

Tessa Romero

from in here about point? T the are gating in A morning IO second also you that could updates Thanks about from and just at your me your And What know program ATAXXXX my the here? this at couple program, much. And ahead CAR is data what given what of a program? IND data this MSK would scenario the on to ATAXXXX so programs the little thinking questions this allogeneic are ESMO T factors on win what be we a coming bit December. allogeneic submission view so update then prior understand looking and mesothelin to of up CAR the if I in question

Pascal Touchon

one? Thank you to you for Jakob, want very do take the your question. first much

Jakob Dupont

so Tessa, your absolutely question. Yes, thanks for

Sloan-Kettering at an excited allo oral again presentation and autologous collaborators platform a for costimulatory until for of our following CAR announce program performance EBV one of the risk we're generation PD-X the gene we again, for our one XXX - mentioned, the really editing. domain as like and because dominant T limit we negative do our study and potentially really are to And mesothelin And sales with that that we important first have then we think have best-in-class program technology next is and we the allogeneic leveraging of well. Memorial auto So don't mini cell as exciting T this receptor. is And that think course the that's using we platform.

but will So Sloan-Kettering at patients. clinical collaborators, program, also low for present ESMO data the data IO from dose preclinical our

really as would will there as important. we these into you'll are really of I also think, low-dose move then, persistence cohorts. safety as CAR see say, these you is efficacy know, potential these the questions solid But I again, well tumors. is I are data And therapies for of here of course early T So course, cells important some safety translational say,

SITC the just program Turning on a having allo shortly allogeneic with XXXX data we data, presentation here one very that program. mesothelin comment, at updated for are to preclinical

this be type be course the at SITC in are filing we preceding IND here could for our CAR IND IND with year. aspects much of half manufacturing including track we're will well then moving again for partner everything for you which Bayer know, and that very will or And get that all of I which the of say, again think XXXX we this a will to ready second filing IND your and targeting of T, the filing poster QX is be next any a say year. best-in-class studies with type IND, very presented So ahead, will But you the and with on have as of is the CDXX program. next of allogeneic I with therapy,

Pascal Touchon

are There this so point, additional excited maybe two very about we program.

very that one aspect in - And aspects. in so to particular two XXXX unique fact to is

that's because efficiency this allogeneic have big believe, First made bioreactor first, taking together think why which is manufacturing. is that's stirred-tank some in that already CAR first early the allogeneic a a in into T T I but the we that's to general time change stage is being big bioreactor growing, manufacturing stirred-tank made XXXX for there. to CAR And this CAR an allogeneic be right to radically put we therapy T or make it's of cell can that one is we at evidence going now

So what's the pace there.

are only have maintaining process. example point EBV efficacy there very important of XXXX maintaining we’re safety shown. not believe that aspect We a But in we TCR an view the recent of the from from point as our believe fact been other a view. The is also we TCR in that's manufacturing

cells to using XX a In PD-X the fact, the that others in in And mesothelin TCR T and the recently the detect published were cells patients patients. study, T clinical the X interesting were which very edited positive lose a patient CAR T three I think only few detect study been gene could XX expression that they just what present CAR in a that has TCR Nigeria we Phase was could of there. not we're after three TCR patients only and cells they for not CAR in where were editing. weeks which the in And fact that few

not is for Ts if have delete But maintain a us terms for it your clear only does the gene allogeneic for few you a you modify addition TCR will editing stay for limit gene in CAR TCR that weeks, the more answer all create evidence having you additional terms [indiscernible] safety. also if you persistent TCR you So of a risk T question. in that of CAR the only the

Operator

next our from question ahead, Cowen. Phil. from comes Nadeau Go And Phil

Phil Nadeau

not confident QX. request a how add that appreciate real for to CMC does the be that there therapies from on in How cell first me that is FDA know so - the guess I'm A with newer are guidance tab-cel and you complete the agency on and the in It dealing when QX. FDA division evolving exactly on are on FDA of BLA its you going us the requirements wants data. you like have kind particular that what are to you congratulations filing for my QX curious seem questions can confident is alignment. you few Let the fly talk and you the in

Pascal Touchon

you, to so Thank are of say few mean like next are great start have in very in the full we we've of in and all, we in. go that days as Jakob mean a the I filing going we're and high all product. product I have we we I file I'll and are I we file, first Phil ready to this to and next ready said and is data and that Europe confident few chim aspects develop will in to believe file there invested a quality of days. We on Europe

in a Now discussion mean, U.S. and a I the FDA the type terms of it's of process. true it's that step-wise the,

have are lot could are discussing we that. of level study we're they have review making often I think also we progress that progress are increased coming So and there. BLA with mean far, questions we the there and more [Sadelain] we there step-wise is of that data and team we that do that a lot doing value in a the meeting

questions have together we and exists but all anything it's So the analyses will we new Jakob, this and trying they on add. stage. product the put the are for. we think given that understandings data than at new them create around analyses data them, really they we're new predict have that asking more interactions to And their to whether to this other certainly all we question, ask with are going cannot

Jakob Dupont

amplify we're maybe making you that as this step-wise to do just as and think well. I Yes, see, progress.

were agreement commercial announced clarity that comparability do we the quarterly and we've determination and wanted that see of the material we manufactured this order the that between can make great that. call, of got in this in lots is all the to FDA pivotal at last So, to news

those all lots. have We

statistical this get with that we've approach, was further to step-wise with from call, now October on now come that we that the announce So quarterly FDA where the can B to meeting agreement the we've Type progress comparability clarity including and great methodology. made agency at

further want much this we on an certain now analysis have of points QX of data them the which in providing was to agreement came agency to advance then and they now focus in discussion year. our agency additional again, next interaction we So the next with and area here, there of and said

filing incredible there of it's that pretty I in Pascal here So progress confident mentioned the we are next think have and a that's regulatory of completed I implications here full documents. think and filing small our again, regulatory we the in and is and couple that first really we within here that submitting that, as Pascal company leverage clear progress of we completing a those But says, been Europe of all evidence are as can days. is

of ready of any a of shared we're from helps would that gotten actually those BLA feedback pre-BLA the and data clinical supportive in in go and the well to BLA really us so data from course study information other analyses that also to filing in type of and the in filing data All that so as studies all meeting. you position the the get clinical ALLELE we've the with FDA FDA the guidance that

think filing So Atara And again on so progress here. hard worked of here again at I very regulatory team very nice getting proud that's together. the this

Phil Nadeau

pre-BLA on was point And you without meeting. past you you the FDA you pre-BLA able maybe the there clarity your think you a a to follow-up for like need to might if meeting. to filing be the necessary a had that perfect in progress second what filing, management Today, suggested thought sounds it

that B do all already you haven't the that learn the So expect what to curious, at meetings you from established you've we’re had? I Type guess meeting pre-BLA other

Pascal Touchon

answer maybe that can one. Yes I

as the file different to and align different EMA. on because go aspects type the we have analysis so a of comparability then free. FDA to really And be terms said, that of to pre-BLA need it's on in think also will is of and we step-wise But on. lead there ready have I model the the content to agreement just asking file that content, the of the will we aspect final some that the

plan file put the there. we aligned to file So the for want to the the together is put that we BLA the or make FDA with together way sure

part, I make So what that with necessary a is that's data we to the will is their we them administrative maybe we which together be, have would pre-BLA with put more expectations. we way why and meeting, that discuss the believe that sure call aligned the

Phil Nadeau

possible long think on that the therapies was or patient of you last then that IND than the of sounds lag T CAR to prior there is XXXX It from IND question maybe for from in is And Perfect. track so dosing us to actually you quarter next think or somewhat first do like it a is months take a apply sooner six will on XXXX. I for year. the How to that? that dose patient, could will it first

Pascal Touchon

Yes, stage. that at going to we're not Phil this comment on

the later lot make to of about company say do we at sure that the that in expense is patient can the there. the CDXX of stage best But accelerate we CAR have to to about way a when a reaching will T comment and learnings first we study get the point. from that and timing are trying patient all total are we T with type to suffice that that right to So CAR we and IND

So that. sorry, speak, we're working on that too for activity but we cannot early details as we is but give

Operator

comes And question Go Jonathan from next Miller ahead. our from Evercore.

Jonathan Miller

a But little question on in guys bit associated I taking MCR my and - sort data with call been associated one disease went this One with the How the thought have obviously declines there? you it much MCR broadly, we I of in is shared has inverse increase today. that decline associated clinical that the I understand directions has or stabilization on do question. being interesting Thanks MTR confidence but stabilization my mean improvement. very is biomarker MS demonstrated, of but in XXX, predictive ACTRIMS disease again, for ever guess both are MTR through is with I the

Pascal Touchon

AJ, no you you one. your that much take very question. thank Yes, for do want to

AJ Joshi

Sure, yes question. thanks for the

to symptoms best look the looking in this thinking myelination remitting when has about about correlations been is or the it space utilized improvement of biomarker make in the Remember way to right. and trying relapsing all you're resolution think those is at I when at MS. this disability you're most

are lesions So when that active. remitting relapsing at you look

shouldn't resolve. will those decline MTR You I and when say having significant substantial see decline. then lesions

with the getting definition that's that You will disability that lesion is that MTR associated right. see the better, increase by

remyelination you there progressive in ever that's that's has you progressive not So to you've progressive the improvement improvement see and know, disability patients. disability It's utilization of has improvement in as hasn't no MS evidence questions seem In as and the the at in in take and and MS, look RMS we're and lesions. been seeing are very having for MTR that's almost really the it presumably patients remyelination RMS connections just importantly between been chronic in been asked. clinical status data of significant seen why those you the increase TX shown statistically Because the those there MTR that are many remyelination where old who ones you unique. we Those dead in example, for have lesions considered they're when and lesions a the had why where are lesions consider if see the remyelination that disability of generally associated who so we improvement. in

progressive that So the and are progressive people in showing this powerful here, of but important because really remitting, MS. time data is seeing the are we're something first that hints it why in the And so relapsing is MS. this

Jonathan Miller

so thanks, that And a much of sense. makes lot

that's I franchise. on one and So guess more

the you of being going not bunch that's the that to data by you're following is in in-house be amount to earlier with is the out limited is call. like from analysis? about part IA the here what blind pulled study, integrity data It smaller we you color are the up is even to amount the study limited you're that blinding more to study the run on maintaining a a fair? interim us. going to in maintained double-blind, be talk randomized, prespecified of have of maintaining Just is of DSMB data about Salim going that And throughout and the the a gave the obviously actually of the When assume the provides you you analysis hiring the you're the – of not, therefore, have

Pascal Touchon

AJ in. I’ll and will chime start

AJ Joshi

trial is, as it blind work best a to to as stronger maintain in really we many for you controls sure might robust make Sure, any the putting way as controlled imagine I think possible. look possible at we are, as randomized

safety the limited data all DSMB the the the exposure committee internally. all will will committee course to see be So of data at those monitoring monitoring see very the data. There'll

hide specific this is, any So best like looking it's the conducted at look to be again, But way will to robustly. we're not information.

the that as the we of can we at way. The power maintain we will as much as So blind strong result end can. so a be the

Pascal Touchon

that, specifics again, we best on I of to Yes Could at say time Jon be can of I clarified and That with depends say it very confirm mean, of but a the discussion following of be but to many extent not that the these the we only there decided in very What valuables only say of why say, what depends as while the important can not we trans-communication status that what be we very the FDA. milestone, going the today deciding study the integrity to be able based of on are are will the to much are detail. terms the we'll data. are the certain much of from preserving we think, is because IA, there.

Jonathan Miller

many what Pascal Maybe second dose ESMO much forward gears at Thanks expand early patients there is understand make it how to so us of just from some that a you But previously, data in IO cohorts. sense. I to this total. said for lower the you on seeing XXXX, can tell looking to switching just

these as going it we and have IO? to ESMO You're meaningful continue cohorts we to should there expect beyond response whether see dose

Pascal Touchon

on. so this and we think are patients stage I many commenting at Yes, the on not

You was give lowest said at wait that dose really time weeks to will last we’ll have details for you but time, it the there cohort. few we the

on So X and cohort one only. the

step-wise. are [indiscernible] was are X X cohort mean X the it per key cohort for these and these million per low for So I Remember kick there. dose

So are safety focusing there. why on we really transnational that's and

both XXX that. the are [indiscernible] level be no against and T on role be costimulatory aspects able think different play lower and seen this expansion. having exhaust, the CAR that of of immunosuppressive DNR could key but And starts or showing be to proof will type T the of there is a and for least and if PK there CAR something more one see of difference there CAR to that we PDX that show domain data mechanism we a much persistence then from as if concept because for be some we so and could see think could to having us I mean them I I we’ll we T really at and great really

Operator

And our Sachs. from Richter next Salveen. comes Goldman from question Salveen ahead Go

Unidentified Analyst

for remind you for tariffs you of competitors? the Ts on mesothelin compared us the Salveen. This targeting is Tommy of points key Can to taking just Thank the CAR differentiation on you. question. other Thank

Pascal Touchon

want Jakob that Yes do you to take one.

Jakob Dupont

Yes sure absolutely.

that the for an there is we IO presentation partnered in here autologous There So is half there the going reminder that's the are is programs is franchise. the a XXXX allogeneic where that towards the T the of IND filing program year. ESMO program, then heading the And second which December. occur is we're in next CAR to and a currently that two XXXX, is in our with mesothelin in and program clinic, Bayer program which this just

these of what is firstly both in have binder common So programs the mesothelin. against

a Memorial that's this at been by So program academic is binder first generation an Sloan-Kettering. already derisked

from is end at we'll So first share we at of again ESMO the know this the IO. binder program and that coming gen safe this data year here a

programs in our are Additionally, what we costimulatory XXX have domain.

you developed enhance persistence domain Sadelain next cells. So idea Sloan-Kettering, the vivo co-stimulation exhaustion this expansion is generation costimulatory so those in where is to reduce in Memorial of innovate Dr and by that Michel T-cells, the at

again this important So domain. is costimulatory an

constructed tumor are risk you expression. dominant where not have suppression into LX receptor the Additionally, for - where not both negative from at cells cells, programs do PD PDX also tumor the the

also well. And that so again could feature vivo as exhaustion prevent this and enhance is in a unique persistence

T the feature experience clinical I those EBV using that XXX A lot EBV our good from a of the cells here programs where intrinsic a ago in actually with T-cells as a really you with we the program a T today few CAR there's those performance have in allo that had important receptor vivo knock those great persistence cell side that for CRISPR blood receptor out And cell that profile cells. you patients. T. those important receptor retain because so, Pascal shows from those platform they you and T-cells, allo if the cellular limiting publication the vivo our cell really as foundation our of cells safety I the the cell performance allogeneic that's knock the yes, that mentioned additional as cells what's patients treated nearly and you're the as in with is T minutes as The And is if we we the great cells those EBV think cell EBV allogeneic receptor. in T those ago mentioned that and is so months function we're out evidence and - intrinsic importantly, in of allo this really CasX of of T intrinsic T And have German retain toxicity the will also not few say. these

liabilities We editing gene feature do important gene gene safety can not approach. we our CAR our T here issues critical do really and editing that in in editing know is the probably programs. do have Another and not we do

a further? differentiating that factor Pascal that as anything be And so also us well. we for could think

Pascal Touchon

No, platform I burden very indeed. allogeneic sort very on think and there and very not think also exciting there following you it's called the It's and differentiated only all a the unique fast. aspect I

Operator

can't I'm Yigal Nochomovitz I name, Nochomovitz, comes your sorry question last Yigal. last from Our pronounce

Yigal Nochomovitz

Pascal Hi the Thanks worries. questions. no and Hi, team. for taking

could the or in necessarily interim study the there continuing? with the is are for going study scenarios to be overwhelming curious, size analysis either ATAXXX. interim efficacy result where Just for stopped either or the analysis adjustment at sample The futility

Pascal Touchon

question your for you thank Yes AJ?

AJ Joshi

stock there There's intent kind for robust always week. interim possibility unlikely that not, of And Yes, you amazing always - you with We've you utility. that on efficacy possibility start. that our an as is other a any there's round. these event would a highly got would

you analysis our where So the be here size a is adjustment primary possibilities, really expectation. sample in have would but it's interim those intent standard that

Yigal Nochomovitz

going when an Match to are Okay. question, update just this and a And be then the trial we get would separate where on presented?

Pascal Touchon

have two got. study that that the one became is few merger into think pivotal study When Match ALLELE, the and SOT study both we think don't pivotal we trial merged now We about only years trial ALLELE one only number I I three so not when merge the HCT ago. we anymore.

Operator

at further questions no time. this And

Pascal Touchon

Thank you.

Operator

conference At this time, the has concluded. now appreciate attendance. We your

may You day. wonderful your have now a lines and disconnect

Atara Biotherapeutics (ATRA) 4 Nov 212021 Q3 Earnings call transcript