IOVA - Earnings call transcript Q3 2020 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to the Iovance Third Quarter and Year-to-date 2020 Financial Results Conference Call. [Operator Instructions].

Now I would like to turn the call over to Sara Pellegrino, Vice President, Investor and Public Relations at Iovance. Please go ahead.

Sara Pellegrino

Thank you, Operator. you us. thank and afternoon, for joining Good

update. Finance Speaking President Finckenstein, and call, This we afternoon, President our Accounting Financial Fardis, our have Maria of Vice our on well Chief results we Swartzburg, Medical and X for press on on Interim Officer. and can September which as iovance.com, X be Officer; that a Principal at and today's corporate includes Chief ended Michael XX, the and as XXXX, issued found Executive Officer; Friedrich months release website the financial

remind Before position call that technologies, manufacturing we updates. future and start, regarding business I cash would plans, forward-looking trial regulatory future include capabilities, activities, made like Iovance's conference potential and to plans this pre-commercial of business guidance, results, collaboration, focus, everyone expense plans, applications during our statements feedback and goals, statements guidance will clinical and

risks control, uncertainties which subject of and to many statements time from filings. described the Forward-looking including our to time numerous are SEC uncertainties, in our risks beyond are and

call. Our today's those the With I over turn differ from no update Maria. undertake forward-looking projected to materially that, will to during statements. call may any obligation results publicly We

Maria Fardis

afternoon, good you, Sara, pleased during our to highlight quarter I Thank and progress conference everyone. am call. third today's Iovance at

broadening reflect Our while multiple or potential its lymphocyte, patients recent our to across accomplishments efforts to tumor-infiltrating bring TIL, our indications.

melanoma, head in cell for upcoming of process our plan look application, TIL cancer we An license pursuit For registration-directed refining submit in lung in combination XXXX. and additional that data our in have lifileucel forward in indication, developing neck existing metastatic BLA, we are cancer. to well of our lead or study as of in assays assays to clinical KEYTRUDA initiated new product LN-XXX in non-small candidate, with FDA the of the LN-XXX to as biologics presentation and we

I manufacturing clinical, will highlighting in including needs our for would begin to and Friedrich of Metastatic our few and annually execute the like furthering our a year toward updates States for skin diagnosed I melanoma. patients. CMC, We and key cell commitment in all continue cancer, head each a to melanoma I lifileucel common cancer then with let pre-commercial our non-small approximately and spend to lung critical XX,XXX will priorities, indications, address United advanced type activities, lead of cancers. deaths is neck and highlight of and the alone. accounting X,XXX patients minutes

population therapeutic need. is We only Chemo duration are X% a currently short unmet response. response to the rate patient that focused a melanoma and serious on of is metastatic available a option, offering XX%

pivotal B announced, reached previously a we X the our the clinical with BLA. on data As cohort of follow-up where we for duration U.S. support agreement to the meeting held Type FDA,

further refine have do assays to assays. work We existing to potency new and develop

actively to Iovance. FDA are on to top a assays the TIL. matrix on of working potency is offer priority We with agreement better a assay for define Reaching to FDA

updates we may plan submission length the submission future dialogue and on until XXXX of depends the agency, While the when on BLA BLA provide time in with available.

line patient quarter, program and with X with pending in pivotal this patients We anticipate mid-XXXX, metastatic as pivotal in FDA indication. future cervical second C-XXX-XX the Cohort approximately Our data study the for dosed investigating the third also lifileucel, discussions during data LN-XXX, now clinical in is last cancer. the on known we follow-up in top pivotal

breakthrough Fast both the has previously As and for designations lifileucel FDA therapy for Track cancer. a and cervical granted reminder,

Turning to our manufacturing ICTC. or facility

track of scalable We GMP end a manufactured initiated XXXX. TIL to employees with to these shorter, patients. has to the first ready on be process patients. clinical in address capacity are rooms To thousands for patients in a move rate be for first XXXX. of of is lengthy received the transformed than in rooms demand manufacturing to yielding XX%. XXXX of clean anticipate Iovance of of The half set by expected XXX have a continuing date, activities Commercial meet for Iovance manufacturing cryopreserved process, from more at the with product TIL cancer need academic a centralized thousands above Iovance which can to success

U.S. process, also augment built to the is X granted and surrounding or continue Gen by which We our allowed property intellectual patents. XX covered have

Turning to preparation. our commercial launch

therapy on gated service activities. leading to or HCPs, the recognize build TIL prior intend as remain awareness, the BLA focused training melanoma. access with submission. team and A engagement positive scale commercial to readiness line and professionals, a and health U.S. centers A high onboarding feedback we metastatic commercial TIL to head The capabilities, with patient and BLA need approach care very to or experience in cell upon unmet our expenses partner taking are core site continues count currently training, We is readiness team extensive to submission. core other the

Our to have that or patients the potential lifileucel. patients market Medicaid We benefit the CMS payers need and appropriate access recognize meet and with as lifileucel well metastatic as CMS, ensure Medicare Services, continues timely of private and team and and with believe melanoma. for clinical for value payers the to to unmet Centers access

development We IOVANCECares and are with progress the of program. also pleased our

assists best-in-class the a and support cell patient the to have patient deliver process. that system is they goal and Our reached ordering

available assure HCPs medical Our information of advocacy treating TIL team to patient network is works that about groups interested affairs organizations. and a to with

TIL technology. at the in non-small pass data in work IL-X some preclinical I Friedrich? neck modification new our presented TALEN as study cancer clinical our the our TIL to lung in well of to head cancer. XXXX. will outline Our and to Friedrich as now ESMO developing continues analog, call novel opportunity cell and We highlight of IOV-XXXX, genetic our using

Friedrich Finckenstein

Cohort for a who LN-XXX, who Thank patient checkpoint non-small non-small start of activating on therapy progressed metastatic basket cancer is need, LUN-XXX Patients ongoing non-small in In in clear Phase line investigate who finalized Review finally, X%, treatment by a response overview less who X X%. rate Cohort first-line neck PD-LX began score response cell have X or by look evaluable study The our our anti-PD-X TPS will our study, our without previously patients. and cancer of our prior cell the that with populations the durable retreatment an to cell neck in of believe had proof-of-concept approved at X lung the IRC. approximately X IOV-LUN-XXX TPS progress from enroll. important with year-end. tumors, IOV-COM-XXX overall two-stage to is in a will systemic X showing score an will We Iovance that docetaxel Cohort achieve lung single indication lung needs and partial checkpoint XX%, study data, Committee, X%. in an did express patients infuse use advances cancer, pembrolizumab end for therapy. basket of distinct would protocol than Cohort assessed established including strength also ongoing cancer response I chemotherapy for evaluating we X. population less like study for used with allowing patients This in different TPS in are grow preparation expansion LUN-XXX or significant in complete chemotherapy. Despite non-small greater X there rate Head will if is tumors responses in objective cohorts therapy, our primary Simon's through efficacy head solid offer lung you, cohorts. study have patients. progress are or express for signal of with study cohorts Maria. include inhibitor ORR, TIL studies. and to X that in that. not II in received confirmed X of registration-directed in cancer. and The to XX study through the cell ongoing provide is of well than rate, unmet core to be a LN-XXX X in and biopsies patient study from back cancer. Independent will was whose which in Cohorts we And of X%. in sites supports overall the Within in in to after recurrent inhibitor TIL remains patients score with Cohort they We the and patients expected PD-LX than response Iovance X unmet Moffitt tumors the is also driver TIL XA mutations significant will point patients this TIL design combination the in IOV-COM-XXX The

as week are Society in Cancer, meeting upcoming this are clinical time We KEYTRUDA patients first or of SITC, the any with excited for in Immunotherapy presenting data the in annual next indication. particularly the at is checkpoint-inhibitor-naive TIL combination about we presentation

by so with who presentation have not other neck tumors. see squamous or We study carcinoma, far chemotherapy. may combination patients prior what neck highlights from received have inhibitors with head X for treatment are The we in head encouraged and in basket the as of as same our received abstract cancer IOV-COM-XXX poster well HNSCC, solid cell previously checkpoint but the potential the highly and

in of in ORR, as XX%, response Following median been the reached combination of or median rate, pembrolizumab, with not had LN-XXX follow-up, months overall X.X abstract. and duration noted response was at study

the results therapies presenting very hand at over results. XX% to While patients call to cancer from are quarter and now approved patient to with updated to checkpoint-naive I to XX% these discuss forward the the next head find promising ranges financial data XXXX clinical year-to-date be neck and in third week. numbers, we ORR our look will and SITC Michael head literature. neck We cancer small since in

Michael Swartzburg

you, third will year-to-date quarter from and results Thank our the comments reflect Friedrich. high-level XXXX. My financial

can XX-Q with be report afternoon's the quarterly well our with be on SEC. begin this I'll release cash found position. Additional shortly Form as details filed press our as in in to

held As XX, to million of $XXX.X XX, Iovance on XXXX, in investments million and equivalents, cash, short-term December cash compared September $XXX.X XXXX. restricted cash

offering. includes position stock our million $XXX cash proceeds net Our XXXX from common of June public

support Our financial strength the cash cancer. in cash, commercial year-end of programs, short-term pipeline investments lung study be and balances including anticipate launch $XXX cash over is may non-small expected million. cell We and IOV-LUN-XXX to restricted equivalents,

income the statement. to Moving

of loss per loss $X.XX for XXXX, to partially of X the to $XX.X compensation compared and XXXX, expenses. XX, net ended quarter loss compared XX, growth quarter compared ended ended offset development period expenses $XXX the X attributable months third $X.XX ended million and periods quarter and was September million XXXX. patient prior to $XX.X per $X.XX million third was decrease or same administrative period expenses were or of XX, for share quarter stock-based XXXX, Net loss the in stock-based of September $XX.X third of of XXXX first or Research research the for ended net XX, attributable an $XX.X $XX XXXX. a share quarter in growth million Our $XXX.X net to increase months $X.XX XXXX. share XX, September XX, share for period prior the administrative the XX, million million million $XX.X compared was compared internal primarily the increase higher a team General expenses. licensing The for expenses expenses the ended administrative primarily September to for trials, XXXX. development XXXX, prior ended million for the $X.X to first million per or period increase the attributable and months and year $XX.X for increase $XX.X increase the of of per third were costs. and September million million XXXX, September for $XXX.X of an increase in XXXX, same expenses September general XX, compared XX, third the the growth by The and to for Research of internal $X.X the ended compared quarter and million prior research months the $XX.X General the an to development were internal higher of in X and team for were million ended development compensation XX, of for million expenses third quarter XXXX higher internal the XXXX XXXX. million and quarter an The The higher in for expenses same X and to third general third period a attributable general team team. year and ended was increase primarily September period to fees third were in over September XXXX. and stock-based quarter the $XX primarily was in over increase development and $XXX.X XXXX the development growth compensation, and X over the clinical enrollment the administrative million September research in administrative to and the research months manufacturing the

approximately outstanding. As common XXX.X XX, of September shares there million were XXXX,

Looking and fourth to ahead, compared lung dose XXXX to we quarter and prepare cancer we readiness cash above we I expect hand are as operating employing to expenses session. the gated year-end Q&A balance higher and At approach be third off XXXX patients continue time, study. now and sites a in expenses a activate the anticipate our same $XXX in of quarter the more the operator to kick to back measured will call the commercial to million. the

Operator

of with our from the [Operator Peter first question comes line And Instructions]. Lawson Barclays.

Peter Lawson

kind understanding that the space. you of they almost do of take? Just there entry how into like way and again barrier of a any creates those is And on new if -- of complexity the the think assays, long

Maria Fardis

Peter, your thank you question. for

it specific given to with because obviously haven't discussion is subject guidelines We FDA.

have existing the been assays information data providing and have to agency. we refining that agency, We to the that provided and the are

we providing additional also also that have first the have those, We assays in to or further we that assays. what call And have combination the in we the don't we of validation, addition are or a are we we that we are two second developing some developed, data, on to compiling and have with agency the including additional case and FDA. those of aspects agreement assays

are with a frame. not of have. working questions number but any a assure that we time fronts dialogue different to further So to on that you requires we are we address FDA, able they give specific might It

Peter Lawson

any it requires -- of external there is would the long And of complexity way they to to explaining of kind develop assays? more level if those resources How those.

Maria Fardis

the develop have do them. to We resources

it's of resources. an lack not issue of So

have in the are has additional we very is known to to has of done. provided and a been characterizing standard data. that we and has that the provided in agency, the FDA. to well we And there's lot There's of work the been gold additional validating provided It's again, Validation assays. assay a stage provide data then assay TIL. -- Our has cytokine are And agency. of the assays to to provided again refinement agency one assay been been

is that They of one appropriate So time waves on each we to frames. there's different X of FDA's that assays for assure are working request. them have

more Some our for sort are that commercial are very research developing advanced, release and assays some are of assay. we

Peter Lawson

other need And IL-X, timing just what's to new for kind on the around move a analog IL-X? And that into will of settings? you

Maria Fardis

Are you IOV-XXXX? referring to

Peter Lawson

Yes.

Maria Fardis

on in of had we be remain target for We IOV-XXXX disclosed you. you and Okay. is IL-X a graft, Novartis. targeting, IL-X from we IOV-XXXX, novel analog we recall, we have product, beta-gamma is receptors. Thank IND-enabling as GMP focusing XXXX, which IL-X CDR to that an particular manufacturing in Yes, are might licensed those. It anticipate this previously binding on to activities XXXX, initiating and early

Operator

the our Goldstein of Mizuho. with line next And Mara question comes from

Mara Goldstein

Maybe XXXX. and you're the the the respect cancer the expected work the filing cervical sort of activities What, assays current cervical from could potency if filing? in is discussions also just around and to doing, with for required ask that cancer I

Maria Fardis

you, Thank Mara.

that both the manufacturing We lifileucel that assays products same same We products. for both used for the melanoma. the the expect had same will have is given the They release. be and -- anticipated as process same cervical potency for lifileucel

Mara Goldstein

just Okay, separate? but able filing leverage this, be other? will the but will you you they into curious one Or are be to required? I'm about

Maria Fardis

Yes. Great question.

do being to to agreement them to certainly the discretion be able They would be an just reach may perspective, whichever would can discussion separate to a each one reword We be sBLA, side. operational have feasible supplement the them subject -- question be Iovance's From to whether would separate ask very for the both is BLA, one each It So independent original we of one have there whether or if other to of or from with to is would filing BLAs. one. subsequent them. FDA. your an a I which one are

Mara Goldstein

know that likelihood like would the is you when something And that?

Maria Fardis

is meeting pre-BLA a good Typically, time be this. to discussing a

be a the discuss example, cervical, meeting would So venue good for a pre-BLA for to topic.

Operator

Mark comes the of And with line from Oppenheimer. our next Breidenbach question

Mark Breidenbach

would where in the hasn't work smaller I on the study? would patient a lung populations the those patients in heard expect in little think overlap those that give cohorts. differences LN-XXX between currently basket bit on why first XXX some you study population in who you study I tested Maybe with mention Friedrich confidence enrolled maybe it not been to and are on a elaborate us could a

Maria Fardis

will just these thought make unmet about I how turn about I needs. The the that Friedrich. to patients wanted make way over comment LUN-XXX. possible Sure. to is we sure this yet Mark, the earliest population patient are a thought we to about want we medical

So that's can how to I we difference COM-XXX and the But about maybe it. thought cohorts. ask about Friedrich LUN-XXX between talk

Friedrich Finckenstein

Yes. the question. Good Thanks question. for

Maria really said. it's based think on what I just

number setting to, we for Our population actually cohort. up so registration-directed the define goal potential one, are was that for ourselves

in study. more cohort narrowly we the doing more LUN COM a study numbers the than of are in The is is of defined. prior study, the lower So signal-finding therapies where

So after a study population. this better more is COM-XXX narrow and defined the and narrowly really, the better with step defined follow-up

the rate say shown after of also concept I it. inhibitor XX think the The failure proof Moffitt patients that as evaluable concept checkpoint of of activity best that's the on probably XX% out in response in the where was the is had confidence with a I in based laid for to way really proof study, therapy study.

is where the driven that's from. So confidence

Mark Breidenbach

studies, also patients saw of who had in in that some we proof-of-concept And mutation. responses it. Okay. Got driver sort Moffitt

this new you talk cohorts why maybe be of from bit you can that the being tell the outlined? what X estimated us And they're would each a also, study? little cohort size can kind excluded for of about So you

Friedrich Finckenstein

Sure.

it again Maria. of set Another good with questions, starts and

available goal the said, basically identify mutation-positive patients unmet medical that at they have, need is limited undergo from TKI And is Maria -- depending platinum these to with limited prior of with they challenge diagnosis. they with the history therapy chemotherapy. our as therapy. which patients was round on have with least then X a high therapy, So will a driver population doublet The mutation therapy,

exhausted approved prior having history. extensive an all probably population we what for to options, therapy, options TKI we have to study. therapy would which doublet and stay So leads quite wanted as the define from all That's away platinum to TKI this

The second the was cohort sizes. about question

either the generation sample So a those signal registration-directed cohort, which the a -- currently at cohorts are X two direction who fail is and of sized that Cohort core size defined on an Then really Cohorts Cohort we size are or XX proof-of-concept X, of XX. X is the with subject equal because X And then have sized is biopsy through with these not objective a X. patients each

So enrolled hope and study. that are really affair. again that's searching the from basically sense. I a coming is that from makes not signal statistically This powered patients

Operator

And question from comes with our next Boris the Cowen. line of Peaker

Boris Peaker

first data? going your mean seeing to lung on when cancer I comment maybe we're you Can lung. the be

Maria Fardis

data time Yes, to a not Boris, committed have our we released. line be specific to lung for

Boris Peaker

correct your with you're the that own your with regardless So to -- pivotal to lung to then data going assume lung with the study, of trial? what data you're proceed is going see that

Maria Fardis

statement. I if the necessarily that's don't know correct

it mean haven't doesn't we seen it. we that haven't released fact the Just

study. obviously, start have So the behind the indication we enthusiasm to

Boris Peaker

Got you.

of made mistakes and were Okay. are from for there CAR-Ts. you curious make they commercial again? Maybe learned Any to making launch maybe are lastly, you've preparations what lifileucel what sure not that made the ahead I'm

Maria Fardis

I'm question to Absolutely. the to Jim. pass going

Unidentified Company Representative

Sure.

ready have as earlier continue third site preparations is along and then our major fronts: and launch is preparation ordering first three patient working year we this launch; is system onboarding; and cell system with ensuring -- payers. that second Our started IOVANCECares support for

and to we first, with continue the meet sites. on KOLs So

meet for last potential very high KOLs with XX week, on continue mentioned and for sites and and down. enthusiastic about to to the with at launch, delivering patients commercial targeting we need. we slowed not have the call, remain As sites, earnings unmet they we're we least lifileucel Every

MACs. On engagements. with payer payer over We've continue XX the or CMS administrative we payer front, meet Year-to-date, we -- had the contractors Medicare and the also our engagements.

on we very the firing it's And to we approved. approach ordering on custody, confident facing. lines, at those of won't yes, we So final very cell earnings assessment. progressing in too have recent be all then support and feel estimate and confident -- to we'll about absolutely the identity, they're once that of number of front, potential patients you approval, on the X FDA in can patient chain comment you with programs I I look the much cylinders that don't a creating again, fronts. CAR-T, and feel, competitive our for once trend barriers about the but all we chain were access of call lifileucel trends. We that do the nicely, have tell And

just other commercial So from thinking case, the in challenges but exchanging perspective. a we also not clinical we're between also their at like of competition terms from that know they're market trial -- in two, potential perspective share. CAR-T And least the about

payer level. site there's and learning patient the of at level that So lot the we're things level, a at the

Operator

Baird. comes question with Kumar of next line Madhu from Our the

Madhu Kumar

for So as being say lung we the the that What that lung well [indiscernible] composite Moffitt low as one are basket this the [indiscernible] kind first patient? of really data kind cancer. cancer the -- [indiscernible] of with [indiscernible] PD-X trial basis your relates proves data recently on

Maria Fardis

try and was to not easy hear. I'll Madhu, It question. answer very the

may be collective about off. yes. LUN-XXX. answer our is what the the of you're to as patient population basis experience what the internally whether is had You're observing was in from selection wondering of data the getting that cut as for I we Moffitt we well The believe

Madhu Kumar

[indiscernible] that basket beyond is duration Okay. non-small response And how ever TIL the a of value plus checkpoint rate, X response in low trial? of cell about [indiscernible] objective then the [indiscernible] chemo

Maria Fardis

Do in? you. time hard want try you repeat try to the hearing more question? We're do one want time you Or back to having a really to

Madhu Kumar

Sure.

Sorry.

extent to basically, setting [indiscernible] So what non-small second-line of beyond cancer lung [indiscernible] point cell response duration [indiscernible] is end in your

Maria Fardis

but able in he impact Moffitt. an terms I come I'm our of best was selection. did response on set from that to and might think what hear had of Madhu, So median The about patient durability talking data extent not have duration of to

it's encouraging two to of So XX patients in very response see had for XX continued the response one PR approximately their and months, complete months. a patients past response

that terms encouraging So of DOR. median highly for us in was

Operator

next Jefferies. comes from And our question the line of Biren with Amin

Biren Amin

so patients. Maria, SITC, much the you we about will at week? talked next data How having more abstract X have

Maria Fardis

Biren, deadline on really I released out and given bit at the Monday, so are being or to we is follow-up of just a abstract moved submission are longer present posters SITC, think was going the getting a a -- little are follow-up. what abstracts longer

Biren Amin

Okay.

you some had encouraging So responses. I pretty mean

I And think XX% X XX%, if X ORR. at of patients. out you historical it's about look pembro,

feel you would data pivotal moving this where sufficient into a So you study? when I have comfortable guess

Maria Fardis

Great Yes. question.

very certainly a think more and a a so of understanding longer DOR bit little of have additional be I would an little we median patients helpful. bit follow-up

enrolling hopefully, how we exactly and the to a we bit more little And we this can sort -- longer, cohort. So a added have into follow-up once durations of little patients continue with product. position decide

Biren Amin

it the phase? to need first a the last just see rate for type a thresholds and of lung What you terms on then And move of to it. LUN-XXX, into study. the the talk X maybe you about would Got question Cohort in second phase? Can response just X

Maria Fardis

Right.

disclose it our that we the So point estimate sort are we we typically, for stages patients crossed number have Once have of the -- traditionally, and announced we or continuing. exact it two. of for each we don't Simon’s cross of

sort has communication strategy. been that of our So

Operator

And Securities. our with question Reni line of comes JMP Benjamin next from the

Justin Walsh

This is Justin Walsh on for Reni.

have I a couple of So questions.

assay. is The first on one the

out clear in will you So lifileucel, to once like resolve similar the roadblocks for you'll that that you think TILs for you we're genetically do assuming products? that FDA expect products do later you be -- for and or how later this your if more you TILs? could encounter Or figure wants less modified resolve define this you the that

Maria Fardis

I it in ESMO fully for released thank an Justin, fully. really product haven't the data can genetically working are question. quite IND, products, sense I product developed defined know it if XXXX know that we yet. the we have and that haven't we modified for answer in ourselves you a at define the don't usually for but we we I

So I today because I of the question we don't exploratory answer knockout IND if stages modified haven't are in that filed the know the can we genetic still product. and PD-X

So I we're would that I I know whether how develop what know to the and going answer -- adequate. today. don't assays don't question quite if be can that

Justin Walsh

Yard And other one your plan guess Navy is commercial Okay. I production. on the for the and

you'll the be I it that commercially XXXX you're think in -- ready said for Navy Yard.

do get running? from transition up end how If you that you before that look and what up -- capacity have having and lifileucel you then, would much approval before like facility

Maria Fardis

secured Thank switch over and closely manufacturing our then for We our initialize date, manufacturing and ICTC. to us Excellent. with our capacity you there's WuXi, provider for CMO been to certainly question. commercial for WuXi at Thank you. very have that to working ample

number have are work we completely do we options, of all ready. we on make sure and So different that a to fronts

Operator

our next of And comes with line Jim question Fargo. from the Birchenough Wells

Nicholas Abbott

It's Nick on for James.

First question, follow-up. treatment of B your the you sorry, comments, meeting of duration noted -- the Type duration prepared defined Maria, in

So response? X an it why be months cancer? And would after is this different cervical for unconfirmed partial

Maria Fardis

Right.

to is we want to of necessarily cervical. I we that did answer that to think talked to saying not going timing because be But sure haven't we to that I'm step doesn't than saying to the with that that that it's question, take your follow-up, for any follow-up really I'm place. Nick? the would And it defined. be make that mean say Does different. necessarily meet just melanoma. on we about FDA the duration different release comment referring make the data of FDA you're sure it needs that

Nicholas Abbott

this that duration Yes, what months? after X thinking is. from meeting you data, that from PR PR? said B Is the Type melanoma defined confirmed the a or after of you've was unconfirmed the an is partially. I And follow-up

Maria Fardis

time X of months IRC. the assessed Right. PR by It's as from

did clarify are two -- something. but that we So X under melanoma, I define it products different The let for me think maybe INDs.

So different. the review teams are

the So and we to the we of review going to we with of confirm respectful are be meet sure that sort reviewing before be. we that's make follow-up just want team the would what cervical to submission FDA duration

Nicholas Abbott

a surgical Cohorts Okay. a just clarification via says LUN-XXX. description reception for clinical X and And trial sample then on biopsy. -- tumor or The X resection

like in comments, core So would Cohorts and it X. be not X sounds biopsy a from prepared the allowed

Maria Fardis

That's correct.

Cohorts X tumor. biopsy, of method core tumor. which our much allows smaller Cohort and a for of of collection biopsy, a So is is X X excisional which have amount traditional

Nicholas Abbott

And many then for in commercial many chemotherapy? question. giving the for about -- or credentialed surgical how comment is is of thinking lifileucel biopsy And with is melanoma. procedure, How I resection that, of surgeons terms how prospects guess, just in Great. are those

Maria Fardis

the you the... are surgeon For to give chemotherapy, referring to

Nicholas Abbott

are. credentialed of -- which is But sure but Credentials it one sort for medical chemotherapy. surgeon rather principal the trial of most it's I a investigators in them I'm mean the a not out in the if chemotherapy. they're same, also oncologist, dual-certified, They're of turns melanoma than

that surgeon the is interest does in the if then product? their as difference credentialed make if of in they're gatekeeper TIL chemotherapy, patients, a so And a to

Maria Fardis

Understood.

make our comment late a patients. that team just ask surgeons well. caring for and Jim sure patient involved in try and precisely some happens different There's it's involved site. are to me shed I'm at best the want Jim that When as to is This of involved. line that this of there commercial assessing number a there sites going usually, great light patient. me that. post why to ask therapy, on team Let team I to such there's a oncologists to -- is degree a becomes preparing is let clear coordination is is in how because There involved. speak But to support the support

that surgeon non-myeloablative chemotherapy to not to , this? who's is person something Jim the add required of So necessarily you is want administering chemotherapy. part do the as

Unidentified Company Representative

Maria. Thanks,

but in delivered lifileucel, surgical point a and exactly And on reason It to like Every say, team the coordinated medical procurement the or many obviously, fashion the You're we're It's also in the out, tissue that's little then as may as let's do therapies, CAR-T site process. of we're aspects multiple of in with, involves deliver other or with variations cell care our many cell that in team. therapy consult care across site, learning that you That's oncologists, is surrounds site have that different other care tumor right. targeting engagements people. the the begins slight top are the sites. why There's because many BMT the essentially cases. we're the bit community from a oncologists, this. It because these same focusing to sites there's therapy. the cases

Operator

the Our comes question from Ben next line of with Stifel. Burnett

Kailie Briza

implementing on provide new was are guys Burnett. to if of you on manufacturing was Kailie process the Briza expect wondering planning second as color clinical Ben for leverage to is first. IOV-LUN-XXX a I And if you Gen This for bit you study. then IOV-XXXX could the little question X indications which my

Maria Fardis

Thank you the much so for questions.

not be that analog been likely a to with investigated have able for to We won't our they program, today. quite so have in been and speak history they multiple at IL-X indications approved indications which bit or We IOV-XXXX of I obviously indications, have terms finalized of look there's in.

Gen subject X Cohort That we would X use Gen to be would. whether LUN-XXX, of and may we terms X. In

Operator

from And with we question line have Kumar follow-up of a the Madhu Baird.

Madhu Kumar

me you guys Can Yes. hear okay?

Maria Fardis

better. Madhu. Thank much you, Yes,

Madhu Kumar

Awesome. Great.

neck head and up So on I wanted to follow cancer.

seems have is cancer you response the really PD-X population. and a and after rate population largely neck data head in mentioned, so far be And the with in difference PD-X there's -- chemo PD-X between So after who chemo. the material frontline Biren received to as patients

TILs the So do do see make -- plus head population? Is in about latter neck positioning can PD-X you some ultimately, need it to truly of how drug? drug? PD-X think a And cancer? you additive you in untreated provide plus of TILs it's Like previously is frontline a confident that post-chemo benefit it if the kind the to what and

Maria Fardis

Madhu. -- my best you, I'll there's more question. assessment, to to then going as Friedrich Great to give share. for well Yes. and comment us to Thank if you ask I'm

sample quite larger is to exact really not product have the size done. be want we something I product, longer we We a follow-up. positioning that understand sure think and

So of given offer response prior I think median head a median including of to player very that therapies, frontline or important duration duration really of short neck, response X lot in here chemotherapy is and X immunotherapy an approximately a of months.

you So the responses want Friedrich, to important well very median how us duration as to of in add terms as response that additional anything are of seeing. position patients we would the do in confirm be setting this product? to to

Friedrich Finckenstein

the post so important approved now exploring it's EGFR which that basically chemotherapy right? patients that So plus first-line think cohort the therapy, this I chemotherapy -- NCCN is are in to are or positioning we extreme antibody. setting, the the No, mention right an and

meaningful. response that's still and would sample therapy. basically this in used rate So first and That what comparable is an to first-line encouraging size line. small, you although shows is something the approved is the And be is seeing

think regimen. what a indicating that's I in So the chemo-free is potential here

but we So meaningful. here, have where we quite right I now -- some options are think already is there's

Madhu Kumar

And Okay. and this I'm think a get and time. is all more, the you question sure about one

Given Rosenberg do PD-X there of and we upfront? to trial to do melanoma need I years Like get that frontline study. then what see kind with these neck head about like going? what of for a has know data, and wanted kind cancer that

you like that? So are thinking how about

Maria Fardis

thanks again. Madhu,

plus study KEYTRUDA It's frontline TIL COM-XXX XA Cohort in our or So our naive anti-PD-X exactly patients. that. immune patients is and

would of that their terms that, data quite next So decide and the think be be. ORR median would DOR I before in steps meaningful what we

Operator

question Goldstein Mizuho. follow-up line And have with of from another the Mara we

Mara Goldstein

patients. times to, the a of mean? the some mentioned colors thousands I thousands Would what you on just of capacity around few You manufacturing of, suppose, around sort call order care put on

Maria Fardis

question. Yes, thousands many presumably, the number asking... for think -- you're you thank giving how Mara, the what that's I exact the are we reason of not

Mara Goldstein

Yes.

Maria Fardis

Is you -- may you. thank

where internal going the for is for building talked larger And almost, facility but the the half that core will be the the manufacturing manufacturing facility, to of the remaining really we half are butterfly we recall we about design, may complete a capacity, facility. when of the You have manufacturing we ready. facility facility is itself

we increase is a give why to necessary, trying which capacity the opportunities a need. flexible have is on it depending as So lot to we because are a of specific number not number

demand. So it would and very much be supply

As go staff the we goes we up, can shifts. will to demand expand multiple to the facility add and

Operator

follow-up with the And have another line of Jim Wells we from Fargo. Birchenough

James Birchenough

Maria, on please? an trial, CLL give us update you the can

Maria Fardis

Jim, course. yes, of

year. patient dosed clinical mainly in The first was gotten part sites They Our of of reactivated, also as well. earlier program COVID. clinical one site, have our sort in the and had impacted active CLL was program which by recently added we

of sort recently information resumed. further able to has enrollment won't you give beyond be I much that. So

Operator

further no And I'm showing questions.

the call to I'll further for Maria President So CEO, that, Fardis, with and over turn any remarks. back

Maria Fardis

joining Thank year-end XXXX our free and any you, Operator. Thank follow you, good third Iovance's Please conference way. a up results quarter feel out everyone, you afternoon. to reach if to Have IR team to in call. wish for

Operator

you disconnect. may gentlemen, call. conference and Thank today's concludes now Ladies and participating, for this you

Iovance Biotherapeutics (IOVA) 6 Nov 202020 Q3 Earnings call transcript