ALLO - Earnings call transcript Q1 2020 | Allogene Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Allogene Therapeutics First Quarter 2020 Conference Call. [Operator instructions] Please be aware that today’s conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. ahead. go please Cassiano,

Christine Cassiano

and sincerely We doing hope operator us well. you today and you good you, appreciate morning. joining Thank are all

for provides will our ended call on March Before press XXXX. that This replay. financial Allogene today’s today, is XX, be www.allogene.com. for a available our We release that listeners on results quarter market webcast and at corporate website is first issued the available being press and update website opened release a remind

the Vice on Dr. and Chang, Research me Dr. are Joining call Dr. David Officer. and Development President today Officer; Eric Executive Rafael and Financial Schmidt, Chief Officer; and President Chief Medical Amado, Chief Executive of

your we note we are difficulties. any should conducting that technical we have different Please appreciate and patience today understanding call from our locations, so

and filed Form March upcoming cause Form Securities March the ended Form XX-K manufacturing Exchange capabilities results on those made our current Commission, ended development the based among research certain trials, XX, in we described subject XXXX, that X-K for quarter and today’s expectations include and XX, on our and as involve These regarding assumptions the for may and materially call, During other to uncertainties are and year our presentations, are and be data as the XX-Q are the things. planned regulatory risks XX, statements XXXX, will guidance, efforts, ongoing contained statements. differ XXXX. These may of statements information, statements well our December future including forward-looking timing from that forward-looking and success clinical XXXX financial actual These to in risks change. These filings statements. forward-looking our with making periodic filings, other

forward-looking You not reliance these to obligation place update are these and statements. on to disclaims statements Allogene any undue cautioned

over to Chang. the turn Dr. I will David now call

David Chang

quarter our join hope conference been just time the seems everyone, our place. you, over safe thank Thank world call. taking since and for but two you loved Christine. you has and us different call, ones for months first a to Good morning, your are earnings well. It and last We

many to thanks our ask of the Across joined it relatively positive profoundly everyone are fully about and, he same fortunate all dynamic were have he scientific lives a recovered. which feel how after has vaccine. Arie identify that announced for for to reached of that industry, sorry has potential tested so way regulatory created Belldegrun, in his our out the communities has COVID-XX. sincerest he and Our who mild, the hopefully, many see We you At treatments time, to inspiring we globally. very and hardship to current have claimed and is together symptoms

handling One business in maintain and the of our and the challenges. our medical is community, on biotech of some time: we protect toughest calls, true lines, momentum talents pharmaceutical clear the are Allogene, possible. industry employees, to prior At our thing our as The patients including heard On those we priorities have and the health much of to are fortunate the speak as have innovation during cornerstone our north. been support at fighting to serve front Allogene. caliber is the us this do of and have our about of best business you scientific

business. path organization, the of the and the policy to some our on activities been employees and and resourcefulness our COVID-XX of directed workforce local to maintaining ever, effects quickly to focus, lab employees small our on statewide in Now advance great acted values, matters. work-from-home innovate, lead for demonstrate protect implementing of of of majority of ability mitigate able more the a than presence shutdowns. have our critical our we By to relying at collaborate We

As key a milestones five XXXX. for track achieve we result, remain to our on

two, the combination momentum Phase This non-Hodgkin’s number nirogacestat suspended data; been the ALLO-XXX reporting gamma clinical Phase ALLO-XXX has candidate, that our quarter; in recruitment number is with and initiating our diligently four, Servier, X multiple IND secretase in it working due by in related year-end. ALLO-XXX initiating initial lymphoma ALLO-XXXA the the our submitting COVID-XX Phase T partner, ALLO-XXX trials trial of we Number studies half; are in to X in ALLO-XXX our relapsed/refractory quarter; to a fourth myeloma. as our reporting relapsed/refractory second trial, initial inhibitor, much ALLO-XXX in X March. of AlloCAR not five, one, to number our number usual, the both say three, and data this exceptional business circumstances UCARTXX And to maintain anti-CDXX in

pandemic. our recognize or not treatments supply defer a with along clinical We many the risk by patients investigators, complicated delays are to that position that could further in be chain

for in open patients who rapidly unanimous to lack keep desire or options. the disease treatment these were investigators alternative Our their trials progressing had

more provide T which deliver and the overburdened, proven in technical to supply of we and logistics schedulings more and therapy hospitals on-demand to vigilant have become oversight are operations therapy Our benefits time. a even acute. can be In have sites AlloCAR to able ensure an challenging, maintain even being can world allogeneic to in

we conduct. each adjusted sharing need practice and work We site as best to challenges COVID-XX-related facilitated for through of sites between the study

track developed trial remain remote well data We point-of-care as the and local while utilizing this of exposure. tumor rigorous patient’s to assessments maintain monitoring follow-up entry, ALLO-XXXA sample X quarter. reduce integrity initiate also Phase trial or as collection to to and the We using on ALPHAX process travel

have recall, a allows used which broader Rituxan to eliminated lymphoma may in we ALLO-XXXA ALLO-XXXA, recognition be in population. you the domain As patient non-Hodgkin’s

and launching X of study, pivotal trial. we the ALPHA the Phase the ALLO-XXX of ahead to ALPHAX current Phase The to ALLO-XXX safety X work the as has including the of the efficacy informed and of potentially ALPHAX optimize ALLO-XXXA, design confirm dose the study of seek ongoing portion

differences the CAR-T AlloCAR T, autologous at and therapy we questions the between As be must foundational addressed. look

therapy rejection? us making and administer effectively We lymphodepletion of which create causing disease? present demonstrating and responses. can the lymphodepletion we period industry focus graft allows without cell products dose versus as are an depth length questions can a manufacture these of we to on toward critical cell early work and from safely two durable optimal normal First, to genetically on ALLO-XXX host we progress goal of CAR-T donor optimal edited cell and utilize allogeneic Second, as safely

and variety allows Last of been at believe optimal Clinical cell Society ALLO-XXX the Virtual of had data announced week, and that explore clinical in lymphodepletion We strategy meeting on our us presentation the our window to persistence we the a for to an Oncology settings. oral of AlloCAR determine T ALLO-XXX American later this expansion use continue based month. selected initial for

escalation, safety of ALPHA began vary regimens three evaluate plus Our a dose ALLO-XXX. efficacy three designed X different the doses, to a with lymphodepletion the range as of of cell and that dose trial Phase as well

step on of Rafael time, Exactly allogeneic additional on with that what expect as be provide an benefits From years ago from consistent will data additional as to ASCO therapy, in note would Allogene has While the We to data have details I which May follow will our ASCO while like abstract, week, released January presentation, to we call realizing be released patients will launched to scale. initial day, of will that on see therapy. CAR-T a May toward you. data The the been important therapy ASCO host major we virtual potential will XX, this conference ALLO-XXX. dose presentation, CAR-T goal operations. the allogeneic XX. autologous the include providing higher with the and of beginning, including this On two a which those review convenience, of in treated cell during have success reliability

strategy make goal been and development trial Our structured have design reality. this a to

experimentation only will ASCO. we outstanding the forward some pleased date we to at steady made are you our answer, with that progress have there progress with questions look are While and and to sharing time

I working the own Allogene, during through how I of Before to have Rafael, times allogeneic commitment challenges all their their over to XXX-plus cell personal would to unwavering I say like at in call despite who remained turn employees proud these am therapy.

update on and now you the research further will activities. development Rafael

Rafael Amado

and David, you, Thank morning. good

for As to forward continued XX. ALPHA we’re data X trial from to our on ALLO-XXX David looking sharing this enroll has patients, and initial Phase trial May noted, at ASCO

that Phase of dose an allows from opportunity our TXX trial customize focus ALLO-XXX, on with continue the to and X field. anti-CD differentiation any using appropriately we others trial bodies escalation unique this to lymphodepletion provides us us While translational clinical outcomes safety, to the in is as use and optimize

the patient new when awaited in be XX-day a patient with to Those enrolled. DLT has took a dose window. to while lower of enrolled window safely the the must and to limit followed cohort ALPHA treated cohorts every additional trial, move cohorts. for cell been a can patients followed we level toxicity in patients our familiar opportunity DLT those conduct in backfill next for higher the into advance As to before be In dose less XX-day doses, the clearance we therapy that can or each to cell the cohort dose trial, reminder, at

included we XX-milligram phase the ALLO-XXX, enrolled which data portion ASCO Initial escalation XX of a the escalation doses abstract. study, such, the three-by-three the our cell in initial of prospect of As dose of total study. was and from patients utilized dose

cell dose escalation phase, of began higher ALLO-XXX, milligrams. to initial Upon doses we completion the namely of explore XX

trial dose initial into set from As trial, the ALLO-XXX. of XX-milligram the this ASCO the of who enroll also data continue we the to a received higher of portion first patients include patients will

expect on will data assessment While very only have patients with ALLO-XXX. data treated those we of these limited milligrams to we, have patients, XX one-month tumor understandably, on follow-up

of the good a one at a that ability manageable this purpose AlloCAR demonstrate program, activity control ability look not hoping this cells. the graft of a an over of success lymphodepletion the stage to disease, would understanding are including win, though demonstrate I this is the believe can fields the at but Phase even of not achieve and, be safety allogeneic self-expansion X T field, profile, We to how in for persistence optimized be a and study just large, as host to like. anti-tumor trial, for

and of cellular markers, including the patient’s of T prior regimen pharmacokinetics will ascertain to kinetics infusion. proprietary Other are of to the durability correlative the critical response. of cells recovery cell ALLO-XXX, the of to follow-up to time ALLO-XXX lymphodepletion, optimize Longer any required depth be

to we is plan presentation. for ASCO Our as evaluate translational other these oncology our and parameters team collecting data

Our also explored the intensive efforts role to Phase and ALLO-XXXA in and doses play a X biomarker pivotal trials. evaluation ALPHAX the optimizing potential be will ALLO-XXX X Phase in

to is studies. the in it variables scientist, physician different investigate we playing see a ongoing as really gratifying out science As ALPHAX itself

study. X We we finalize Phase on as design will leverage hand the the flexibility of we have the ALPHAX

clinical cell an T second treatment myeloma. relapsed/refractory of is focus anti-BCMA for Our multiple AlloCAR the therapy

have use regimen, created address cyclophosphamide. robust fludarabine the actively clinical to will continues X explore around trial including patients. the center Phase also components lymphodepletion all and trial treat of of We ALLO-XXX. ALLO-XXX accrue optimal a This and our to strategy this ALLO-XXX, doses field of with Universal,

endpoints duration and cell We will tolerability, for be of assessing determinants activity key success such safety, of anti-tumor lymphodepletion, and ALLO-XXX. expansion as as depth

in We trial fourth this are track on year. of to report quarter this data from initial the

will anti-BCMA Our investigational in in the secretase investigate nirogacestat combination program SpringWorks. inhibitor gamma ALLO-XXX collaboration also with with

for we issued currently findings the preclinical of week, of finalized and XX. the our release and that Society TurboCAR it the May American have half would technology discussion We support combination regulatory Therapy study Annual Virtual Last a protocol Cell announcing on that second initiating we Gene press at before year. submitted present this for planned Meeting the

domains be TurboCAR also administration, signaling signally certain anticipate models, of The TurboCAR which the not cytokine the technology, risk many exemplifies only cytokine ways, exogenous CAR-T innovation can BCMA in this developed preclinical immune cells the efficacy, ALLO-XXX, expansion, cells introduce technology, which submitting greater minimize AlloCAR to engineered stimulate candidate, directed advance look we are ALLO-XXX for enhanced we multiple gene and far of receptors designed We the results selectively different our safety approach cytokine present also As with internally for activation CAR-T We from leg cell’s continuing first with to in therapy the allows strategy delay T technology, numbers. TurboCARs requirements. endogenous which starting and study would potential cell persistence. to TurboCAR this unlike technology to AlloCAR enhance T with therapy. T into associated forward dose our cell XXXX. In will BCMA T tailored reduced IND can TurboCAR this in but that preclinical a with involves In the engineering recently demonstrate an exhaustion unveiled, be myeloma. have cells. engineered TurboCAR our

technology anti-myeloma the effect. of excited very to this about are potential We enhance

ALLO-XXX, we AlloCAR as tumors. work from Lastly, candidate. able critical have look solid progress our preclinical T bridging to anti-CDXX program into continue our cell This clinical therapy as on hematologic of to toward work been is we next our use malignancies

As tumors need. in and great we unmet most high advances all know, of they therapeutics, represent solid cancer medical despite curable, not are metastatic areas

clinical that ALLO-XXX is Our by for the very lead of of initial we programs, planned results very of momentum with remain soon. will IND this look end strong planned forward renal I our and other in cell treatment excited the be with the the carcinoma providing year future. malignancies to both

review to I our call to now to financials. Eric the would like turn over

Eric Schmidt

good Rafael you, Thank morning. and

I you the will the today read issued additional on XX-K, financial on our SEC. press In our provide can in with release overview, addition be and our earlier detail which the will first today, to call filed in brief quarter

continue position with non-cash includes March totaling strong We $XXX expenses and a were XX, compensation of investments expense. maintain which cash, research development of XXXX. million, quarter, to In stock-based equivalents million first our as $XX the financial $X.X cash million and

for General $XX.X administrative the non-cash of quarter and $X.X million expenses million XXXX, compensation stock-based of which expense. includes were first

to due we pandemic. to quarter COVID-XX for able am we I $XX.X filing loss stock-based late per the California reinitiate of SEC our of In GMP first was million. an compensation to been work. or expense pleased had interrupted net $XX.X million in share, Our report non-cash including XXXX $X.XX of the stated manufacturing that in been the facility Newark, construction have construction cell March,

XXXX. to to situation, this our continuing to do in the evaluate not are facility plans currently online manufacturing bring expect the disruption significantly we we While temporary affect

XXXX with our well research expect million our losses $XXX business we As million activities. estimated build-out that between and the of $XX and to any facility, continue compensation $XXX as as able have will $XX stock-based be our manufacturing expense an full-year to plans, includes been to development potential development from This continue Newark million. of and excludes million we non-cash impact net

open will the call With that, now your to we questions.

Operator

comes from Goldman [Operator instructions] Our question Salveen with Richter first Sachs.

is line Your open. now

Salveen Richter

Good question. thanks for morning taking and my

those XX the could about preliminary So across XXX by that’s with to I go just the numbers then you presented and again? ASCO, regard you data mean, the patients going be nine to talked three. three over first for at data

data So month how And seen one your how that data have the I comparing and about of should set we per here on then a follow-up. think to think about the do totality have we patients up data? two months, with autologous regard versus And programs or we to to-date? seeing durability cohort

David Chang

morning doing and you This are Salveen. Alright, Dave is Good I Chang. well. hope

details So as we about are information into trying question. the as possible. let questions first lot to one much And the of is the certainly, me take without provide a your asked of much we what This expect at ASCO. get to going that presentation,

have been that have in dose nine escalation, included So the is we said what patients minimum previously treated. that a February that completed and have we

recruiting the the patients the we become the and dose while as trying this as there opportunity available put additional escalation, site While on we previously are dose levels. were is cleared patient address well were treated really to to conducting who need, And study.

will There patients from at nine cutoff. will treated, terms So come who of that couple a couple the to included out data patients sorry, nine the of first nine that and the treated weeks I’m in waiting were first – more were of the in still what are a be is than in time be patients is enrolled. of abstract patients

essentially nine answers were escalation your cells dose as the – patients initial dose that as third first of in testing So who beginning question. and the as people will two Hopefully, that treated be of plan. final we design were that levels, well the initial the the

Salveen Richter

this how data? about and the then And per context autologous How getting Yes. about to should month months in the just we of here cohort? data comparing two think to one existing we overall, of durability should think

David Chang

Yes.

So X carried durability question have a a get the longer-term is patients that will out, study who But Phase is been have that at that durability question follow-up. really a forward. the cell asked obviously, we that the be dose lymphodepletion Phase were treated early we This lot. I comparison so should real on remind should real the as the the X. will go and around That the finalize for we another be

As earlier much is of well doses I the as that of ALLO-XXX. the of that lymphodepletion we studied the XX the were as lymphodepletion. mean, the essentially cell with milligrams exploration, beginning doses

you milligrams. on the XXX up gone XX know, have the we dose As to

in when level sometime early cohort, the you’ll think this you really So treated follow-up, the at. of data year. has context about have some to all a be longer of Yes, the these the dose looked been relevant

terms follow-up, we short. said follow-up one-month will that in prepared that of be has of the include So as will in presentation. limits certainly, his the will statement, case And relatively the be data, but Rafael in

Salveen Richter

follow-up and David playing then are can other in those too lymphodepletion versus there regard the maybe programs And using question whether one you with? are you with to talk regimen levers just maybe optimization other your about XXX programs, you

David Chang

Yes.

the we think we Phase really is Rituxan can we XXXA optimizing So much X The potentially but dose the that and it lymphodepletion, will be that haven’t re-dosing. the with with. cell program prepare play that we switch three way the about and as XXX the into lacks about the talked done levers then

rejection can that T In and with and the terms immune keep anti-tumor somewhat to allow persist we at out carry the as early really dealing activity. the this AlloCAR-T cells system potentially to of AlloCAR lead patients’ to expand cells is of cells bay lymphodepletion, to immune try

at a So bit indications, about system, think the there variability different different one there they down trying line. we so in overall, is But the each patient narrow that further indications. and in get are myeloma leverage than time. that to the affects overall are patient’s consider first, XXX and how we on program a then non-Hodgkin’s we bit the components, is as little immune study treated lymphoma learnings second of little depending as XXX now, are from of we we Obviously, have a more multiple to and doing lymphodepletion. Right both we the try to studying

is study once maybe as between programs. to lymphodepletion. all some try we we get the the there different the data decision to uniform there course, or a final of know how So we of optimize lymphodeplete the comparison will whether lymphodepletion, lot exactly in be different indications And differences we will point, for

Salveen Richter

you. Thank

Operator

Thank you.

from Our question Biren comes Jefferies. next Amin with

Your now line open. is

Biren Amin

Thanks Yes. and staying you are safe. taking Hi, I my guys. for questions hope all

the Just try might on understand doses remarks, the the guess doses, or what the in want cell more the I this. you had so the dose? XXX drove events XX-milligram to are there lower some drove just which else? dose-limiting – in to couple lower the something have patients higher I see patients of administering And what a I was data you Did with required XXX mentioned you at also lower the then three it prepared doses, in tox some lymphodepletion on you in some that you any was that the lower doses. ASCO, David, than backfilled mention more And patients that think think,

David Chang

because are that same you asking question. different in things take me many question let Biren, Okay. the

process we completes again, which have then clear wait findings, last toxicity therapy I the And dose on DLT dose escalation, will In were is the of to patients And or accommodated you that who the just any close starts XX without we move become same person patient may dose-limiting level. simple which a dose start the again, when level that And that when can slots. for there tested dose study, terms some is logistical when dose make once may patients for take in sure clears process issues be the means available, you especially go can multiple site sites that the the next patient is the dose window open putting but the to as we window, level thing you in We terms on not of and in open, clear as are level those level, that where study, we about up need, when And Phase eligible who patient days. in dose were very of that the levels we X any the during one the the is next just site cleared. cell the days escalation had and I the study. that any remainder escalation study by well in before so-called the patients standard those would a doing dose to met safety this for and patients patient say each of dose treat needs the treatment want XX patient. been practice already to ensure the the receive

around So that’s second we your And carried phase questions question then asked. that out how the of study. some are and others. these the safety the get we

Let due Very out but really defer to I me any Phase important all we for later to carry presentation at regimen as safety to question, the different well other enough sure window to of your the lymphodepletion X this coming can our a study close would And expand make as as the lymphodepletion safety respect, and things testing that study, are than up some evaluate the presentation. was around point, the that cell, well with we the ASCO of the anti-tumor so questions month. effect. actual of this and PhaseX as to purpose the reiterate cells regimen, allow

Biren Amin

product? where And translational donors guess your you for ALPHAX? cell maybe informed incorporate study I data, I from lymphodepletion been ALPHA is on ALPHAX, to cell and supposed through optimize what if imminently, you better design have I on you the follow-up to guess has to could which learnings ALPHAX, And start able dose for that can a Okay. then have identify so able are

David Chang

and is in allows So be population the to one XXX difference to patient indication. the which of remind wider XXXA Rituxan XXXA, just removal much between lymphoma everybody, switch, a the the in XXXA potentially used

So that changed. of CAR really sequence the the from perspective, hasn’t itself

that indicates products, construct, that as should the two preclinical So and almost the essentially, well we we as done that XXX these have all nature before behave XXXA, IND, of identical cleared way. studies in

as and However, and the find XXXA in clinical saw preclinical want in you find know, different. situation of in we well the just as the studies be little what what part And we the we normal in may bit the a program. what conduct confirm we controlled to XXX, study

the of cells. that and So me time, do as And ahead just of study provide you range. so bit gets to activated, not tiny said being that study the But release of we doses on stop tested, me more to the sort can also be outside need said information test that’s the have second have we to the asked? there. cognizant you the conduct more And not a let or and that at less design. we’ll previously certainly, to other little we question quarter, I want the XXX just of details just XXX XXXA then, of the Biren, remind any it. will sort have we that range And million just abbreviated cell adding we from that, said million see in And that XX cell bookend from XX X. doses tested we to we also that an Phase XXX, this

Biren Amin

cell on treated identify translational data to whether the whether for able patients optimize better you were are Yes, product or from the donors ALPHA that ALPHAX?

David Chang

that is an Yes, ongoing effort.

and some can variability So different some I have others, and was are process. that how the during slightly understandable. between in definitely different that’s time some is and the differences. manufacturing be ago, there question, we think cells that is probably there really, expand this Everyone’s donors, cells And noticed

Our to process. some fundamental the kind toward is adjust the can understand we of of approach variability characteristics that so that trying manufacturing

the or that’s that all talking whether in And requires have potentially different and variability the And you’re of process age a more before they comes have the the may more anybody infections are it. these themselves, I about from person and So trend donor, you the the the are at sex the addresses you differences things donate I samples. manufacturing less would individuals. that donor than factor analysis very think, of itself normally may of get looking we how guessed had as complex mean, in. few this donors, approaching of kind

it is a but will well are take characterizing So the at an way, effort process. that under manufacturing of parameters we these each time,

is not that some what out simple in point to endeavor a really a see. it to So – differences leads we

Biren Amin

Okay, great. Thanks for taking my questions.

Operator

Thank you.

question next Our comes Kasimov from JPMorgan. with Cory

line now Your is open.

Matthew Holt

Cory. Thanks my for taking This for questions. is guys. Hey, Matthew on

NHL should you So the say the subtypes understand ALPHA different study that of thinking I the into guess how enrolled how affect we but I results? initial trial, the that about much in might regard to and can’t be the about details interpretation of from read-out, a

David Chang

thanks that So, Matt, for question.

or of in have progression I of non-Hodgkin’s the within so-called to who lymphoma, fact there are aggressive lymphoma think differences. your sort question the or patients who chemotherapy. line last transplantation refractory one, after the And that the patients large early underlies two cell are

have over there that But mean, that And period in I So, we a I to also that just the are especially with our responses, differences. the much isn’t are some of study, of after cell I who patients the but lymphoma from indolent multiple therapy, large learnings we Phase lymphoma just coming CAR-T given autologous lines X there therapy. also time, add learning relapsed/refractory initial also when not included relapsed comes should so-called the think difference. it that’s

I subtypes in Phase belong to subtypes perspective, think early the don’t purpose be in impact I mind, lymphodepletion and of the on terms our of that patients, be non-Hodgkin’s will much that some this lymphoma. keep will tumor of So ability in But from of said, there is, there efficacy. previously who safety, patient’s But lines X information. as analyze key

Matthew Holt

Great. any to then abstracts, into we will patients guess helpful. get And of the in nine super get re-dosing should terms That’s expect I that data?

David Chang

later was and made the we we prepared is have abstract before on for came an data study. amendment the is in statement, cutoff said the that the that in effect. January, the And as Re-dosing amendment

be first re-dosing won’t instance. in any re-dosing There won’t there So be the in any information the abstract.

Matthew Holt

CAR Okay, too. to about a last just clinical just got then the it. question pandemic will from more level, for That’s helpful, COVID-XX me, think but the high this development near thinking one maybe guess in how change do I term? medium you And T

David Chang

Great question.

the essentially, COVID-XX phase, and mean, of to all, now we of will of early sort you’re May. out. is I talking of the I what pandemic end are First play since trying think part early about lived how till just through understand February we

as the but – things including react so can pretty I the this that Things surge we external we have know studies what we to Within I interrupted. sometimes prepare is we activities, case, think the what do limited clinical the how of about, fortunately, happens use way clinical making experience, the of that to an CAR studies, the do luxury do, the inventory over supply our what, so hospitals hospital the T-cells And two in not do, a the is patients. can are to is of shape. internal So chain we sure going controlling control, this from which we have in building of beyond good what environment, up investigators that months may that we little for experience. is have own can on you mean, they our

So variables. there of lot different is a

that hoping are by the things the based the not planning play have. not The if have be that we as on as as part as – information last more this out, studies that we two way or through will – are affected less hoping well months, in we large I’m experienced be will the COVID. over well is However, affected

Matthew Holt

That’s questions. helpful. taking for Thanks my

David Chang

Thanks for that.

Operator

Thank Our [Operator instructions] from you. Company. next comes Frahm Cowen with Marc question &

Your line is now open.

Marc Frahm

auto of an kind from product. and Thanks kind you’ve – who patients an questions. kind your driving just move for finding of of the been and an building offered COVID enroll, Maybe my on course the rituximab need highlighting the David, over ALLO-XXXA on that’s enough struggles long for answers, of on early – of now some to mentioned of ALLO to trial and for potentially this auto had to one taking the prior force

the shifting things disease think should that baseline think that? how of like over time, patient like or other mentioned that characteristics and or tumor about burden efficacy, like we do of baseline, should earlier, terms populations some of things type, either we safety kind you – in the So impact

David Chang

So question. let me understand the

patient the So COVID sort of are of because will asking pandemic? the shift whether population you

Marc Frahm

that might later, able pandemic kind think being to the now is T be in rituximab COVID broader about also then sick of space? you’re but follicular very initial because we impacting population, CAR very your getting of should those on, be patients later Well, or maybe high as early off patients the maybe more just more burden, enrollment

David Chang

Yes.

becoming diffuse it’s think CAR life of lymphoma benefits autologous population. I cell in view but I’ve patient terms mean, X, said, limited experience of other I But there T, the will larger much as whether just differences it Phase So in in patients, apparent, our you enrolling the on indolent of of doesn’t not well. subtypes in number also as very the be give

also by So from issue, if perspective, study that shifting the is that but occurs, the patient this population, see it the could be that really addressed becoming an of a don’t topic design. I

get Obviously, the study population. of single-arm as But range with in Phase toward as XXX, pivotal Phase doing there as want study to X information refinement will with We’re that’s of the limited of we a especially possible. some conducting study. of XX number as further be to the patient we a study, pivotal a much X small move current in plan study, patients,

So we study. data a the properly single-arm interpret can from

Marc Frahm

duration doses of X manufacturing terms the BCMA of what construction, that about in-house to the and also comments Newark, into facility for And for us and need your facility in some CDXX readiness interruption to trials manufacturing advance can you where of X? kind in the you – for? Phase manufacturing can remind then the the of in the And just stand Okay. you kind you Phase of do

David Chang

Yes.

to now, XXXX. physical control the construction supply we come that timeline in So is essentially, the contract facility structure we can that dependence And dependent done to toward facility the there’s needs we materials to shift toward to be are – in manufacturing Newark. online by manufacturer done. completing produce planned clinical the it be work of is that the of and manufacturing after previously are the and clinical on clear is own we done, But a our getting we the sort working to lot are something And the that sometime that manufacturing working our bringing plan have of for very made in-house, clinical still that right is supply. in

time after as occurred has period we pandemic, that disruption to expect the materials. affect producing plans don’t significantly start to that to site of clinical bring a So the Eric for our COVID the the short commented,

Marc Frahm

Thank you.

Operator

Thank you.

Mark Your Oppenheimer. next with comes from question Breidenbach

open. now is line Your

Mark Breidenbach

good at and as baseline if Very of variability limit trend you. expecting with patients morning, rituximab Rafael. and reported dataset? of I’ll the to be break I’m And ALPHA part substantial myself be will wondering quick maybe the Thank here you’re parameter a one guys. ASCO directed trial and Hey, actually levels question. in in try the this that one will

Rafael Amado

question. thanks question only first the the an that for Mark important been XXX. it’s pertains And to

As won’t issue. an be obviously XXXA, on you that know,

months is have been [indiscernible] actually had allow and have should they a would rituximab patients We above was either greater these that really a or many that kinds allowed that the been that of level We patients. we which one than for getting haven’t below the patient to it for rituximab level. patients, if get have microgram, to In enough not level on bring the too sooner. have other problems three, X were on X fortunate received and they patients had to those

months rituximab before, to the came that course, those Of got to therapy X XX have and some and wasn’t wait, patients then we levels the patients going knew have and bring that it doing later.

other select patients, freeze And problem. though able important on But fact, appear went we’ve this I in able this must been to to were be therapies. too patients. overcome hurdle, say the many to right and even an to Some investigators to we haven’t had

been hindrance relatively been a mild it’s but it’s So one. –

Mark Breidenbach

taking helpful. That’s question. the very for Thanks

Operator

you. Thank

next comes Duncan from Sandler. with Our question Piper Alexander

now is line Your open.

Alexander Duncan

for to questions. the hear thanks well, everyone doing Hey, glad and is

in follow-on on at develop strategy, so myeloma solid lot runs First, even on potential as or clinical much. for follow-up treated? from ALLO-XXX first information candidate will tumors? in in given was the could you this questions, to a on which thought Thanks as TurboCAR previous in renal the patient TurboCAR manufacturing a program process ASCO, which each providing the a candidate lead be you XXX as the the advancing behind explain technology ALPHA quick RCC opposed to Then

David Chang

me I’ll Rafael the So Alex, ask the let answer take and question. first to question, second

I getting I of we’re terms to very In said, as ASCO. think, previously inflammation, close lot

So probably presentation. the Rafael, to to actual it’s question? defer best second

Rafael Amado

It we TurboCAR the have sales tells in long less we’ve about so promise. can excited has TurboCAR’s. lot BCMA. tested preclinical a antigen, encountering going we be it’s in mean, They working course, can optimal we upon are can promise are indeed, And a that a it really time. think that lot solid the And exhausted the of I the to work of tumors. on may What of seen unexhausted Yes. in of first really They remain for period proliferate or technology. divide. the us

I if And without DLL to behind. trigger initial depend, we one at the solid will on the [indiscernible] programs, are into different X. technology expect we will obviously, you would to allows use lag in containing optimal be it, that will particularly IND the CARs will durable on the it excited pre-clinically, not our much with CDXX As cytokine working so cytokines, insert what to gates and but but signed what we’re tumors. all pretty of do potential be different moment upside signal, us The the one

Operator

Thank you.

with from Newman comes Canaccord. John question next Our

is open. now line Your

John Newman

taking thanks question. morning Good my there. Hi for and

ALLO-XXX. So to forward And question initial chemotherapy. test regarding dosing you the curious, the as I’m in ALLO-XXX agent, on have lymphodepletion going a just with own will lymphodepletion its is opportunity here, after my perhaps, combination

that Thanks. Just if strategy that’s here you’re curious considering forward. going a

David Chang

John, good morning.

their we strength leveraging from ALLO-XXX great Let mean, I added and the me are antibody, a own CAR-T is creation uniqueness we speed selective allow certainly our lymphodepletion take for that that cells CDXX. And is question. lymphodepletion. comes as also of based that that the ALLO-XXX because anti-CDXX

of the necessary that then making is whether lymphodepletion chemotherapy that? think do really is first, a great get to your nonspecific lymphodepletion. discuss to stepwise we we’ll question. question process something And that the that sure that adequate alone, do can terms whether it we of be taking, In that How is testing frequently. that certainly, is I for internally and XXX a start

little answer something But time, it’s plan. interested that So the it but the the – a very take definitely, is question are in in. will we

John Newman

Thank you.

Operator

you. Thank

comes question Michael from next Guggenheim. Our with Schmidt

is open. line Your now

Michael Schmidt

taking Hey, guys. Thanks questions. for my

know you don’t one But right the this David, gives Just that here what you dosing at that guess, further ALLO-XXX, optimizing lymphodepletion. of more work main that that on on need I the on some focus around you I actually is have point dose front? and comfort cell

David Chang

Yes.

B-cell very time back. definition mean, or of the talking that time been early starts lymphodepletion that’s to look as well before count, of on T lymphodepletion, cell duration we that terms the of cells at lymphocyte the coming of things I NK I or have in the cells and can essentially in absolute as we recovery about. So or one is lymphodepletion mean, the the the reduction

that how looking So that changes from are get what introduced we different into for. aspect, lymphodepletion pretty can we can into on the translate early read actually we

target the that’s to Essentially, the question. expansion. how context of lymphodepletion that allows In density, put as density burden the process, in the of and how therapy cells T a tumor expand dose, well very is therapy. or conduct cell cells, CAR is cell autologous the cell terms learned therapy during homeostatic of ways. a The into of the of as that patients, many promote antigen quality a cytokines that in the the multifactorial the the dynamic of great changes sort We

cell having parameters worked optimizing from on as that all that’s range one and that in experience two the defined T looking said, cell dose are XX dose. parameters, and different we That’s some reasons comes also moving the are that deciding with and this to will have the dose So range And at final factor as emphasize is the things forward the autologous CAR has and lock right and certainly, we we at. many are looking lymphodepletion now. there in something of that make regimen XXX. we that The that this translational between decision. we And namely experiences you been the in playing

Michael Schmidt

gamma XXX, I Okay. the ALLO-XXX, you Thanks. programs least that now I Or think should moving about strategy a guess X planning on study after you’re just programs those inhibitor data longer-term we of parallel? myeloma, multiple for working how have one in pick high-level on, the then secretase the question you over and in then about at also example, And strategy for planning combination a programs pivotal to you, several are Are those think here? Phase across programs? three comparing

David Chang

Rafael question. ask very with is we Rafael that answer strategy multiple passionate taking great – I’ll are the your question. And Yes, myeloma. about in to

Rafael Amado

Michael. you, thank and David, you, Thank

privilege Lanza be are and GSK. the therapies field, we will at of on that as be I the blossoming, products that you approved. are directive BCMA And in other So this advance lab there know, had will an working there know

of well. job year, to which most by that’s with benefit come to said accelerated, up collaboration of going it’s if to dose SpringWorks the why so that track nirogacestat, We we’re the and is escalation to initiated a is such, our that try cornerstone The and end with three-pronged for drive that how disclose very will, and XXX. submitted. we data the doing the trial would is the We’ve through product, is been already on patients, movement you going we the As essentially that’s that. approach

combination. So patients combination, is and the also with we have preclinical the that data as stunning in treated some well should

next not come between XXX so we a then and it’s be trial, XXX with randomized nirogacestat. even would though the XXX differences And will year. see, combination in to able And

the and benefits we are them but and try CARs with to curative. lot move before, to even is said autologous there will hope And reason are with hard when, able three-pronged working of live do haven’t I a we’re CAR said to none – as though of TurboCAR, this understand We that would to strategies, one approach so. allogeneic the the therapies, of field, we be for anti-BCMA these of

three So BCMA these we will, the myeloma the passionate you with if in one allogeneic with setting really strategies. of multiple needle, about remain moving in

Michael Schmidt

you much. Thank Great. so

Operator

you. Thank

comes question Tony Butler Capital Partners. ROTH next Our with from

Your line is now open.

Tony Butler

very much. Thanks

questions. brief two Just

could really But that the stick CAR The here satisfied first, I cytokine cytokines. finally, antibody notion do the you’re constructs? think XXX. lymphodepletion to it’s theory, goal see really to could safer you at would the think you there? the was assumption? the it’s me please, that obviously safety incredibly you TME same you’re in with actually why to and T other And to anti-CDXX I it systemically do am happy with I safer Am appropriate in or microenvironment. strikes clever. be be correct with you tumor an need question How theme, do move And actually for that you XXX one about and nine XXX to then safety want Part delivering for simply that example, of of of, on necessarily say than the addresses in be that some able do getting receptor in inducible the to it that durability with incorrect wouldn’t strikes that dose? have than, or fight milligrams Or the construct, compound it I notion that me see B through around the is the to BCMA binder. it But

David Chang

ask see will the this I for at on questions the you have mean, mean, good questions to TurboCAR, are autonomous but we I we certainly, us. questions, morning. interesting TurboCAR. Great introduced promise that there of many lot answer signaling Rafael that a Yes, I to Tony, cytokine

So, Rafael?

Rafael Amado

We CAR we’re think, voice. TurboCARs. for benefit as from your more a looking There Yes. in targeting therapy. with a are may I anti-tumor questions to effect rapid of Tony, also this know and that tumors is T it’s solid this upfront. nice clever to David mentioned, But interesting test brisker, what which hear robust technology. May, is realized allogeneic has really lot BCMA, I is a

rejected. cells be eventually, So the will

younger cells want be sales. to it we anti-tumor replicate they surrounding see exerting a fitter the it that they are to and and affect while antigen So do doesn’t when the to activity in manner

to with there from and do that, those a an that to we proven, work lower want to don’t be is growth, aren’t don’t to And In question. the be I’m to very much that any these with possibility, terms the but sure of hypotheticals if in using actual this there cytokine I go other TurboCARs important I humans, that knowledge, cell other be doing issues fully all And our not which released in year. is lymphodepletion or the soluble know, there systems been we are safety, that obviously allow perhaps my has you There that’s But IND is your never to cells. not the no having lower autonomous unique. question is into a dose But the us toxicology cell believe theory, level, to product are an system, much selling are more. at hypotheticals, the understood in all dose, could terms than that next where chance of may more actually but growth, cytokine and is issue. needs preclinical going as toward

question. answers flavor So thinking your I a of you hope gives and how we’re this

Tony Butler

much. very thanks Rafael

Rafael Amado

Thank you.

Operator

Goonewardene our Thank And Asthika with from SunTrust. you. final comes question

now is line open. Your

Asthika Goonewardene

on a for get cells little NHL repressing key data do the cells Hi. Rafael, want this, in. on I couple T a cells how important want you the for then XX bit next keep have is days? is endogenous quick thoughts – suppressed the endogenous it these a follow-ups. days the bit lymphodepletion to the the Good your about for on of expansion. T in does first aggressive please, patients think your here. And to just T morning, XX I guys I thoughts suggest to and more thanks And me little squeezing that talk in

Rafael Amado

allogeneic and studies. between would we TV, say we all cells, at That’s and it’s keep better. T can very corollary outstanding the longer T But can suppressed, our lymphodepletion, an cells a I certainly, have be follow in statement we exploring this question, NK of need viral little that to balance the to in days, terms ability toxicities you and and And to are longer obviously made the the to is about actually point one of closely other for length lead suppressed may cells CAR the true which the goal expand. than XX reactivation may cells longer. that that I the think We that our strike is the the

come asked you the and part cell hope to what have study all happens pharmacokinetics an but in of the exploring to really dose each What happens with to for answer just of T-cell of the they chemotherapy, these role to Phase these resurgence when in Phase What study. midst very in reason doing play not parameters, NK supression? lymphodepletion, question the at did by back? we’re and with regards So that that of look and one that the is just that’s with elements a ALLO-XXX the XXX with resurgence so the end X X

Asthika Goonewardene

of a to mind. have don’t memory at the expansion? I and And the question T to CAR analysis and about do color phenotypes hope then on the peak upcoming at some cells to I ask on have ASCO. at you you provide infusion data Excellent. Did then time the guys look

Rafael Amado

part make is the as at cells well the X Phase panel do, a obviously, it’s it’s the we I’ll take of I number with we in to those patients. important cells able Yes. study to exogenous endogenous as one answer And before, David of multiple test the in the experimentation moment, as both that to that But administered. would mean, question, said yes, need question. answer cells, able limited to more that And of are graphs a is conclusions make and comparisons. on more it. it be to to space, multiple time have and really be a sources this just certainly,

Asthika Goonewardene

the backfill that finally And completely am right assuming – in Got I agree. I it.

might the million would it that by see more just the But dose XX opportunistic driven here. or backfilled dose, maybe toxicity and not level? more be was lowest backfill million XXX guys i.e., you have that in that You

Rafael Amado

ASCO I see wait think is proximity you I the that presentation for of to and prefer yourself the data. such let the

Asthika Goonewardene

the for so you call Thank much okay. today. it. Appreciate it, Got

Operator

remarks. the gentlemen, and concludes over now closing any this Ladies like to David back our for would turn session. call to you. I Thank question-and-answer Chang

David Chang

again be We Thank you for look we today Allogene cell support call soon, for an to ahead may us look will with allogeneic the know joining in we forward to what therapy. ASCO. Operator, exciting of you forward continued on and your you speaking and now year disconnect.

Operator

and for you gentlemen, today’s participating. conference call. this Ladies Thank concludes

You may disconnect. now

Allogene Therapeutics (ALLO) 9 May 202020 Q1 Earnings call transcript