MGNX - Earnings call transcript Q3 2019

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Operator

Good afternoon.

We will begin the MacroGenics 2019 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. [Operator Instructions] At this point, I will turn the call over to Anna Krassowska, Vice President, Investor Relations and Corporate Communications of MacroGenics.

Anna Krassowska

Thank you. Good afternoon and welcome to MacroGenics’ conference call to discuss our third quarter 2019 financial and operational results.

the not a chance outlining press which available has results, review today’s who our is issued on we release under anyone had macrogenics.com. to a our announcements, website For at tab Investors this afternoon

to archived You be call via webcast it XX is after the days beginning completed. conference on may this call website our also where hours listen for will approximately X

that XXXX. and I company’s result Risk of our today’s Actual by a that of to would listeners indicated various reports discussion the for plans those alert statements the annual, Private statements quarterly Safe important future include Factors section forward-looking and those Act materially Securities expectations, with results the may the Litigation current Harbor the factors, SEC. from prospects in under will constitute as about of these forward-looking Reform filed statements including like purposes of differ discussed provision

as our our In views any date. addition, representing any subsequent should only as as represent forward-looking of views be of upon and statements relied not today

to to these by law. may so, elect obligation if do point change, specifically disclaim update future, required we forward-looking any to some statements even views our in the While extent the except at we applicable

call I’d MacroGenics’ the now Executive And like Scott to over Koenig, Officer. Dr. to turn President and Chief

Scott Koenig

Karrels, for review everyone the us. our Officer conference call and so, via year. on call Thank I joining our programs near-term and Chief to and will participating turn prepared Financial for let first I remainder financial Senior the expected President of This afternoon, do Thank the before quarter. the welcome results Vice you, during will over like advanced the I to Jim Anna. today. who me you focus But more would milestones remarks webcast my

Jim Karrels

we have well the results progress made September highlight which quarter. This position Thank financial as financial you, reported the MacroGenics as quarter our Scott. for ended afternoon the XXXX, XX, over

described quarter for our This release, had research the partially and to MacroGenics and for expenses to decrease the September MGAXXX and by XXXX. ended clinical XXXX, September offset trial for due increased in costs related costs was compared development development million decreased XX, ended million our manufacturing As flotetuzumab, XX, quarter MGDXXX of to $XX.X $XX.X study.

XX, was XX, as to cash an our XX, administrative million, primarily XX, loss securities decrease was $XXX.X We revenue and upfront license Zai September XXXX. loss as $X.X increase for September payments million XXXX, September the September were $XX.X million under ended million to offset the and of general other of ended of revenue September This ended XXXX. held. corporate had services ended on the was license December of recognized ended other included reflected $XXX.X total our agreements the XXXX, fees. well had for supply related clinical as XX, Lab. primarily ended this of to equivalents under recognized XX, for and recorded as consulting agreement XX, performed Servier to $X.X and for recognized to our from that unrealized a quarter the and increase compared expenses quarter due with compared finally, revenue with for September million which $XX.X collaborative expenses in quarter agreements $XX both cash, consisting quarter We XXXX. to ended Incyte. expenses quarter for to loss quarter in professional Lab equity revenue net revenue, due Zai with million And decreased million $XX.X a net of net collaboration the September XXXX. the million for agreements, marketable XX, and XXXX, quarter decrease million XXXX, manufacturing The of XX, September This We collaboration securities the under compared our primarily of Note by $X.X compared from service million losses XXXX, partially $XX.X deferred

I’ll call the back And to turn now Scott.

Scott Koenig

Thank you, Jim.

our optimized metastatic SOFIA, evaluated cancer margetuximab, chemotherapy with against anti-HERX compare trastuzumab begin investigational plus to chemotherapy. designed Let’s being trial X Fc in Phase antibody plus our HERX-positive in breast margetuximab

have margetuximab the meeting survival to We study’s sequential arm, prolonged primary in previously trastuzumab progression-free the compared reported endpoint. arm was first that the

the projected planned analysis carrying XX. months. haz X.XX. median Antonio ratio was from by In trastuzumab population. major data XX.X XX.X increased was months San with months was OS margetuximab. the optimized approximately is months. events look a genetically and received the XXXF and of the prespecificed who been details XXXF allele further the and with months overall accrued, defined for forward OS analysis subpopulation the X.X in the the to of reported Symposium in is conducted we value in it The analysis final trastuzumab arm, of and carried chemotherapy population, prolongation and of to a human Cancer analysis of presenting be after low-affin in arm to months patients allele, exploratory including October, survival the median the margetuximab favor median in was interim The completed reached. of was of Breast of OS XX.X survival affinity XXX patients margetuximab had The events after X.XX prespecified a X.XX at the Margetuximab’s data chemotherapy, Fc interim OS have binds trend on In this the intent-to-treat P X.X XXX treated V second compared was to In XX% The of We hazard second prolonged showed patients in P the ratio XXXX. region CDXXA, SOFIA to X.XX. compared value XX.X December

living valuable unmet this an devastating and metastatic address expect to We believe disease. the Margetuximab, we HERX-positive by access submit year. a before the breast Therefore, FDA become cancer patients new important that end the need a therapies. patients with regulators, need for BLA to option approved if of with could will to treatment

breast unmet metastatic data address of and trastuzumab. margetuximab in HERX-positive patients for the needs therapy had our to September, with seek Congress also in with gastric received a cancer. presented in second-line prior ESMO evaluating patients with from study This cancer. cancers HERX-positive combination beyond regimen X chemotherapy-free We ongoing is pembrolizumab updated Phase we At study standard-of-care testing chemotherapy first-line who

In a HERX overall positive, months IHC-X As a median a in from of pembrolizumab months. XX.X chemotherapy who to the survival a positive of trastuzumab rate of second-line safety study. XX.X gastric survival XX% Phase X reported response are observed our in a was a median with IHC-X-plus study study patients, HERX median reference, in Furthermore, we ToGA of patients overall observed the and in our cancer XX%. the survival months reported first-line double and of overall XX.X was Notably, the similar profile approximately of margetuximab that monotherapy. response in of and PD-LX we rate pembrolizumab

promising first-line and who second-line have anti-PD-X PDL-X MAB, margetuximab we regimen double data, in on registration gastric advanced are Phase called with of chemo-free the into MAHOGANY HERX cancer and study X/X patients IHCX-plus Based those a positive. MGAXXX, our

October. we of of this A, accelerated significant may as a This the in single-arm refer patient to as a part objective response on for support HERX-positive U.S. a primary designed Module a paradigm be believe regimen gastric study, to treatment living is change approval endpoint chemotherapy-free rate. to first efficacy study in some We with there cancer. opportunity was patients metastatic based the The of dosed the which potential

trastuzumab in is control broader of component patients MAHOGANY our or MGDXXX, second designed a with HERX-positive of combination randomized we to the cancer. x of The is survival a The population PD-X B, to as primary and the DART refer study, to chemotherapy margetuximab either with gastric compared LAG-X molecule, study trial Module evaluate overall evaluate designed endpoint. plus a as as which MGAXXX chemotherapy to

We expect Lab. in coordinate greater with Zai B in to the global plan efforts our the half China, XXXX first partner of to Module and initiate

into BX-HX, the we most as Fc an our of Turning which briefly the incorporated targeting have to enoblituzumab, margetuximab. molecules is same in investigational advanced enoblituzumab MAB portfolio mutations

We cancer. head chemotherapy, first-line or are planning Phase with randomized with without MGAXXX, neck patients metastatic study a with plus enoblituzumab and X/X in

We expect coordinate in the to greater and Biopharma. study the our global partner China, with I-Mab plan efforts shortly to initiate

will I CDX. flotetuzumab, CDXXX our program discuss next is bispecific The investigational, and both recognizes DART that molecule

patients to there morning, enrolled this include treat with X AML. an X study ASH we announced the on a Phase XX challenging with flotetuzumab the based or leukemia, patients acute X ASH patients our relapsed annual be opportunity on updated represent study refractory be population to extremely myeloid monotherapy may unmet XX we that will X AML address the the be focus The at recommended believe enrolled at refractory including need. an in December. in an will there the dose, presentation. of These data from As patients or of total presentations of data, hour These meeting presentations where, Phase

likely The associated flotetuzumab second supporting molecule. an respond this describe more by presentation oral to exploited suggesting patients mechanism will immune with to data a signature being

We FDA guidance year. anticipate for providing this next and define early the have further molecule potential to initiated discussions with a path registration

on by a the flotetuzumab. means is of that we data AML refractory patients scientific initiated as on have in duration reported. We both lengthen rationale patients response study and have strong broaden of a combination combination potential based flotetuzumab or and relapsed of also supported a to previously AML MGAXXX The

and endometrial our one our is cell Incyte development globally, to potentially directed in pursuing a data PD-X retained is XXXX of MSI data and develop to combination as in to advanced in know, registration MGAXXX with in first is the Incyte most anticipated MGAXXX, program, trials, study MGAXXX. exclusively with although initial with initial Turning molecules high expected we which licensed XXXX. monotherapy in carcinoma, you the Merkel one through in Corporation rights clinical of cancer X anal pipeline cancer and initially

studies. are MGAXXX expanding combination each approximately addition, multiple Incyte a in trials. the both development total, and clinical for studying In program includes dozen MGAXXX In MacroGenics

from released meeting the As the has abstracts poster yesterday, taking this presentations place Incyte we several you may week. have at SITC annual seen

XX% terms reminder, Incyte, tiered to commercial a is to in eligible and $XXX our of from development in and agreement up to royalties on would up million If sales to approved XX% Incyte. MGAXXX is commercialized, potential potential the million future of MGAXXX eligible milestones. MacroGenics regulatory MacroGenics with and to be receive $XXX by under receive As milestones

is molecule co-blockade of checkpoint expressed molecules investigational DART provide MGDXXX, second PD-X LAG-X. and is T-cells, to checkpoint on immune first-in-class molecule a Our that X designed

XXX now have Phase dose approximately enrolled We patients types. non-tumor expansion X study in the in

from encouraging. enough long to the observed study monotherapy response. of assessment of across data very be tumor scientific the clinical been patients, conference signals plan first which at for is several some presentation of half followed early have with types, in majority for a of evaluated We not to The an have activity We MGDXXX submit however, XXXX.

In year. summary, over to most studies next registration positioned or advanced are initiate programs our complete directed the

As head questions of OS as forward that close and as XXXX, second BLA we presenting look submitting be to We in happy presenting Antonio callers the registration to detailed support have. flotetuzumab to of data results San SOFIA now would the and analysis of at from to interim breast any Operator? we well may the margetuximab ASH. address

Operator

Thank first from question with you. And Instructions] [Operator SVB Chang our Jonathan is Leerink.

open. line is Your

Jonathan Chang

for Thanks my guys. Hi, taking questions.

color First the for question, front margetuximab? development on any business

Scott Koenig

much very thanks for Jonathan the question.

are with report. have this at partners this our potential at I time. extending discussions no with point, and others continue the updates further discussions But to We

Jonathan Chang

allele be we allele still populations you the subgroup population, just the should F how about for the thinking in approval And different approval at in overall the in file Thanks. this Is plan file SOFIA would the or for it. to study? point? Got

Scott Koenig

question. the Jonathan thanks for very much

significant that are trend results for we intent-to-treat CDXXA in the statistically we As particularly in showed think a and improvement in PFS margetuximab OS both of with margetuximab, interim the population. profound you know, positive XXX arm allele in a the in population analysis the

context seeing the in So and as package will of that BLA the be included the we a primarily effect the is in we certainly of result, magnitude submit. we assume reviewed in we that the will of that be given total filing population, are that

Jonathan Chang

primary one for me, are the for as for And one population? about thinking well refractory study last how just in you as benchmarks the it. overall Got flotetuzumab, just

Scott Koenig

the saw sharing, will meeting. you abstract, today’s are we the obviously, very ASH at as about data the and we So from be upcoming results, definitive excited

was rate seeing in at noted that were X dose consistent the patients the last that to the again seeing move we were study Phase rate, at you additional response forward refractory ASH this in that out targeted XX% the in As population, intending are over we included XX% abstract, response year. we which with the CR were we reported

disease, the best are noted the you after first also with responses and they at they’re then chemotherapy, failed a then subsequent the and patients refractory teens, with As zero. chemotherapy response salvage to subsequent abstract, treated have literature in the look almost if close the suggests in low

discuss greater XX% we a move a this will where towards So to better. have to or ultimate to given will responses how to in X regard clearly, specifics on range, that over forward discussion But be a achieving that obviously, is nice we we in than registration this a are that in more, with in the attain, think treatments great if particularly we’re is I study. mean we FDA but greater the registration what were obviously number population advancing want this seeing responses, the are shape the we of With study. response to we think

Jonathan Chang

Got taking for my Thanks it. questions.

Operator

from our ahead. you. Morgan Stanley. go next Thank Lebowitz And question Please David with is

David Lebowitz

much you question. very my Thank taking for

question studied The or given that be to on specifically it population exploratory specifically? can group the that something have albeit pre-specified, it for that to a be data, primary actually included group be included endpoint something the with is was in other trial to that labeling the separately as is SOFIA or for separate – approved for that a an labeled would endpoint, be it’s subset it

Scott Koenig

response. means patients out Thank a as you again seeing correctly, had allot to have of are which alpha you we that exploratory, very correctly point and didn’t was much any question. which the where you essentially we predominant it And And that represents endpoint. XX% for we out pointed all population this predefined quite

get FDA the approvable. on sure should be additional is We it this again, but seek guidance But such of the make will be am want from a include, that will will we will an view at why here, data probably further And point to ODAC obviously, FDA the they a down to totality evaluated, clinicians. it information this will they make to a that if outside done ultimately case I is whether case. come strong defined.

overall consider an is months versus we of population, in on the which While filing population. an think will the seeing they interim that are recent survival, data, even complete, in not in we the given intent-to-treat be marg trastuzumab X.X the overall that should population we benefit data survival

David Lebowitz

my Thanks question. for taking

Operator

is Yigal Thank from you. And our next question Citi. Nochomovitz with

open. is line Your

Samantha Semenkow

this on our Yigal. analysis, Hi, enoblituzumab futility move of MGAXXX forward to group? question. in and in no-go need very for the taking Thanks also meet On that order go you combo is much curious the Phase in both chemo for the plus what the for enoblituzumab, Samantha thresholds portion X study, the the that I are or to am

Scott Koenig

Thank you question. much very for that

in in year rates population. about that given excited you we enoblituzumab were As mid-XXs prospects we an we know, where that of the very are enoblituzumab seeing at the presented last the data response molecule, in combination meeting, anti-PD-X SITC with

X Now combination enoblituzumab response the which one second enoblituzumab ultimately chemo front-line a comparing our of the and as and chemo, as as you arm, MGAXXX the of enoblituzumab had and arm, therapy we’re note to control this a know, which is as the probably design, currently plus mid-XXs. you in in anti-PD-X rate MGAXXX and comparing this standard arm, Phase

experimental one those responsiveness of precision arms, Phase of arms, the giving proceed an So be at approach we obviously experimental that to range without we’ll X or looking where endpoint would those like we head-to-head for exact to of number, primary OS. arm, about both before

Samantha Semenkow

similar potential accelerated if And there not in pathway margetuximab for in approval range, chemo for that. that a as include arm that well you that moving for be does a forward gastric have that is cancer? for the to Thanks happens

Scott Koenig

later-line very getting FDA if approved. be alternative to range see responsiveness us will would drug we was range. that did therapies, that given Well, do a exciting discuss that the of albeit of numbers approach the of small to achieve Again, patients give it that ways we clearly reason such that in

Samantha Semenkow

see any And me AML? response that. relapsed could there is And registrational flotetuzumab, suggest – in forward MGAXXX the also there more the combination rates is population? improve for path one that for for relapsed a do with Thanks to on data potential the you

Scott Koenig

Terrific questions.

to at defining registration towards study, primarily refractory as a plan population, given regard I will move the that with forward the the stated, we So population we seen we’ve rate. to look response where greatest

able However, segment there to some the on see be well who of ASH is relapsed to be that focused had may as and very to though the relapsed data of at subsequently, shown this evaluate response And that they salutary biomarker flotetuzumab. will even be initial patients a we and will of to updated have population an effect a meeting we chemotherapy. quickly, a date hope

the we’re trastuzumab more on very completely different AML. obviously are the T-cells as of excited and Getting is models which actually, with of as to AML populations flotetuzumab, preclinical AML XXX, see effective responses given up-regulation anti-PD-X an purely you in population in our be also flotetuzumab checkpoints, combining is the data given activated responsiveness both back more combination I think studies killing I with and being much leads the signal may PD-X that various anti-PD-X to blasts with of again, and with they’re combining well strong of but is that terms to, some anti-PD-X’s, that here, recently, think on enhancing on idea second your this in vitro treated in question there this populations exploring, very improved speculative, targets, of hopefully, analysis a AML with that aware a

could be that have the this patients quite to Now what the in on our used flotetuzumab therapy, the the we forward way better able tend this been longer seen these remain we going patients is at have respond. to upfront, are often that studies is but looking

And be interest outcomes, again, in these the to would the the leads of combining better prolongation if obviously flotetuzumab opportunity of so and together by two that treatment patients.

data, combination begun we So with this having dosing next forward patients to hopefully have year some the already of as recently. look very we

Samantha Semenkow

question. for the taking very Thanks much

Operator

you. our And ahead. from Thank next Miller Please is Jonathan go question Evercore. with

Jonathan Miller

for the Thanks guys. question. Hi, taking

I even label approved, a adoption put that trials. to have that you population complicated is ITT there or much for FDA to maybe margetuximab a on And the think some on the is, test about subpopulation flipside, that the is what there? potential know commercial importance they more your have the heard say I on then if I would IGT ADCOM having you an the think plan Do In bottleneck for you population? or think do docs, possibility things imply a available. get the subpopulation? how conversations with the that in on you bottleneck

Scott Koenig

Jon Okay. Thanks questions. the for

go was had But to questions. about speculating me would if said will the will by we Let The appears population, it regarding has in the approved to assume of anything ADCOM the FDA, F With over be ADCOM. just review. size that include we have allele F the from the the the BLA now to and given reviewed I response physicians there, more opportunity and at so specifics be provided to the be not was is subsequently. information this address hold out designed study them after journals the data – population, obviously decide I to an regard assess discussion we clearly they to it but obviously commercial there us the of regard If stuff the guess, certainly back the but for these I labeling major With in is I occur. for if that in this theirs too likely publishing the the that an beginning. that to like details submit the an would it’s as population. early point. given at allele that But commercially, about and available the to to data would scientifically not FDA was that population, speculating intent-to-treat would to point, to it’s

continually most test the selected that are to for commercial the important the and changing. drug vendors working benefit looking populations patients Our we now could to both know, if which, laboratory-developed be oncologists and at that is the would develop two as with that have available because approved from would landscape be so be is test margetuximab Right included. are we teams a you think potential it

I So miss was there anything Did anything? else?

Jonathan Miller

thank No, That you. was perfect.

seems that secondly, I timing like Moving expect margetuximab, details about PD-X a you why Is the specific XXXX I know LAG-X reason year? on opposed any have there the out more for do now of bit. a combo that? Do not color the this It had or PD-X and any the getting on for trial, in then X X flotetuzumab Clin from pushed have And is is to as other by half Trials. little you which it second on plus pipeline.

Scott Koenig

I’m sorry, from the flotetuzumab and PD-X, did you say?

Jonathan Miller

that which on not details on Yes, Clin trial, Trials. is

Scott Koenig

Yes, okay.

answer on first question, me which the let is molecule. PD-X bispecific So LAG-X DART

it now was multiple either What we’re up As X today fair the about mature manner. the be But few enough very remarks, prospects of very given balanced we felt are in – types. we to the this of of actually valuable provide a able tumor previously, because those I be received we have molecule seeing the think of a scan, to to have in a in of to didn’t give patients this only responses months types. different noted are said not what evaluation across We a XXX would maturation that patients being earlier And X with excited more results. significant data molecule a received LAG-X treated over the DART data scan. been we had or tumor had made first over their we to proportion decision PD-X my

we’ve conducted flotetuzumab is to and to X believe, I see year major in, outside expect you the half conferences the started clintrials.gov, the U.S. study countries of at why the it was to the but the one currently the in noted, first the being reason as submit PD-X, don’t on scientific study, of this So for point. regard presentation. we With

Jonathan Miller

much. Alright, thanks very

very think that see I are excited data. to we all PD-X LAG-X

Scott Koenig

Great, terrific. Jon. Thanks,

Operator

is you. H.C. ahead. our next question Wainwright. Debjit from Please Chattopadhyay Thank And with go

Debjit Chattopadhyay

Hey guys. good afternoon

a in why example? of the of you’re different is – terms in primarily does this refractory CDXXX patients, other clarification, this from, for seeing First, ADCs, some how the activity or the say,

Scott Koenig

Great really question, an a and observations the regard it be in to made ASH. will to And have gets Debjit core recently presentation we again, oral at that biomarker. with updated

ASH be to pointed was meeting, the out therapies, and segregation As chemotherapies a at it seems based on last to patients immune-based of to respond patients immune-based that respond that markers.

responding population seeing chemotherapy we’re to for gamma-interferon who clearly turns It other which that the immune other associated a So signature that depleted. flotetuzumab, are the respond essentially fall patients out to are very group, significant immune in parameters. with

is XXX%, clear population. in this the it’s while so not of a there segmentation And responsiveness

immune have so which flotetuzumab likely that have And current that do And ADCs, address. group to not therapies as the cannot therefore, being think given I that explored the provides in directed described, quite a include, that other of are they you other fall now action drugs, chemotherapy are right distinctly, signature. essentially therapeutics, mechanism

Debjit Chattopadhyay

X on Got the potentially stock it. year here, data, or your registration X SOFIA and Street’s you directed is of of studies the next given XX,XXX-foot prioritize over prospects and to the the the Thank reaction to you. And running how do more where then sheet moving constraints? balance question a

Scott Koenig

currently success the have greatest have of to of position. the think amounts programs that to cash time current and continue considerable prioritize prolonged chance company the a the runway is both we with Obviously, will spending

the the that advancing the margetuximab, this the going regard in signal breast with gastric to decision to and potential what given we’ve positive population study we forward be for that priority. proceed us should emphasis a prioritization, I we’ve results, put So expansion, opportunity an objective is make can metastatic next we we particularly that but that And accelerated that whether not of X-module cancer strong gastric on described only first year is enough positive can patients, strong if efficacy that so cancer given the the to subpopulation as a believe a obviously, patients afforded state a IHCX-plus given, we’re that signal from the the to meet study, a with in the is is get perspective. data cancer approval seen, as both for study in front-line safety PD-LX trial

certainly, given, will So a priority. that be

rapid conversations the cost-effective and say, you’ve executed on very very we some speaking, on Again, to and next a trials. about other flotetuzumab. And would that we in a, heard more of understanding I an fairly potential manner, get FDA flotetuzumab, relatively today, still given speak further how on have larger how the the As compared specific more, to think of to have with year way we that best forward to we registration be move forward that again, we’ll could excited in we’re studies hone population, do move a early there. can towards

gastric partnership with with have in contribute to development the that should help be programs, And study how in their some costs. to some we close to the offset which we a not participate discussing ability of obviously, relationship will accelerate data to the again, from as and I-Mabs, but expenses and, in is with now. done very have brought again, in back I that have that Zai history will in successful in to obviously, there, undertaking the coming And of that an the that head fact partnerships with opportunity there nondilutive Labs, of very study would strong initiate the these valuable. opportunities And X respect to in our if bringing about the have noted afford neck gastric obviously year, also population. of very very they they here the and With partnerships registration X population is is a that least to are the will past with I enoblituzumab. studies we other surprised that have mitigate molecule will And the is help note may years. today, capital have there enrollment the ways our some a of significant a molecule portfolio, them on come patients be to the Last luxurious year that studies very next Incyte course in us provided not we’ve will that guidance in we directed nondilutive if year. and the they’re call is milestone payments occur capital, that

And of the again, nicely the timing fits requirements forward. with programs these and keeping that moving so quite capital some for

more insight some of So hopefully, precision gives certainly evaluate in we on entire next the continue over will as we’re that months to the what portfolio depth. few course thinking. provide our We

Debjit Chattopadhyay

just independent And cancer, what you SOFIA, combination one CDKX/X margetuximab of consider with you the a estrogen follow-up, so another for were would with inhibition have an breast if to receptor in front doing on regulatory plus a do-over Great. happens inhibition? last

Scott Koenig

to these cancer, of breast LAG-X, margetuximab, nice And a that’s the drug you regulators particularly the we’ve the anti-PD-X haven’t about quite CDXK given is I cancer the and seen opportunity, and the look early-line given receptors is how this with enhanced hormone with So combinations. opportunity the gastric speculation. we in margetuximab effective. potentially quite think with anti-PD-X’s of we well. signal think of as Clearly, know, irrespective thought checkpoints or signal on on combinations in late-line ripe design, as specifically at approval, the the and anti-PD-X opine

Antonio updated of taken. there in front, work out late a think on [Technical be successes certainly And think forward include well reported responsiveness in is the difficulty] the how patients, both treatments, but on manner. recent are late-line broader and the we that of we early-line CDKX/X enhance these the in certainly, mechanistically blockade given out and TKIs, This could merit irrespective so well again, was will the to at reported discussion comes patients, could families study that to of I your on San think as molecules. points estrogen that and outcome And orthogonally to particularly be proceed regulatory as

Debjit Chattopadhyay

Thank you.

Operator

Thank you.

with Willey Our next question is from Stephen Stifel.

open. is line Your

Stephen Willey

and first. Yes, margetuximab on the questions. guess just couple good taking afternoon a thanks I for

any if to to overall of for to just So also as see you’re upcoming post that status, patients homozygous study allele? with Antonio are survival allele breaking not a the specifically and or those either, V a), the therapy out the be of respect then whether if impact, going we San going function are in curious presentation,

Scott Koenig

at final like Steve thanks a comment of ultimately have slides. by very I what obviously dataset a of in can’t although differences I the there will analysis know various not benefit in very those the get presentations. in-depth large among that of interest treatment we there would front potentially clear and subpopulations populations giving some seen so can here. have an exploratory, I this investigators, for question. we the by much the insight looking is present a package to for But that,

can’t specifics but So with to at presentation included give the to you, I you final the in what’s be this we’re point. share happy very that on going

Stephen Willey

potentially is reached, if your if that’s scenario filing fair. the guys Alright, final right would And kind major you’re decision? a filing decision the there is trend which triggered expectation that here could a regulatory end here, that event amendment on the some to in is before constitute Is continue hazard it that of you OS final direction delay the the by ratios data planning that of a before year. and with regulatory supplement BLA

Scott Koenig

an question excellent Steve. That’s

the what meeting favorably, not there, and and which we although an it the the will the population, P get that anomalous would the for, yet a OS events, crosses OS, regulatory the allele Given hazard will over that there particularly, be the be to and table where – until but to obviously final into if on if timing, at we obviously, timing rate look I statistic accumulation for results for the ratios trend review, of there for and only it certainly see information. be significance be, to to whether it an if values XXX is ODAC put you that obviously F share continues important knowing would

when exactly I is the have to know occur, will So ultimately, those right but something all I events can’t us don’t vision to consider. for now that certainly –

Stephen Willey

of primary the clarification acute secure so these on this to And are lot enrolling it logistics primary biomarker specifically the a data emergency? patient here enrich question then in maybe you in biomarker refractory what sounds patient you’re trying that forward? population And Are on of just selection are from a given criteria of medical Okay. population, an midst patients like refractory just flotetuzumab, to using the still patients.

Scott Koenig

question. Yes a great now that’s

this, quite some let treating on patients as be So but clear me we for continuing to relapsed are enroll well. patients which is are yes, patients refractory also mostly

started before, anti-PD-X. also treating we as obviously the study not As just monotherapy, we only the with combination out but pointed

to patients. However, it our a intent specifically use not these biomarker is to select

treatments. may but We treatments respond, failures populations previous pointed forward. earlier, lack shortly clear get current it But of some to for are future It’s on mechanistically to to have that FDA better of data. plans pursuing we studies, out to follow-up a will specifically with the – as be based get the or discussions in I on little of on again, definition criteria, to design clinical will move the how responsiveness more find

Stephen Willey

as And your comments be you investors, just mentioned if don’t to that, you may that repeat you in when to may but mind? a I you in communicate to have could think position prepared

Scott Koenig

Yes, it will next be the first of part year. in

very to We’re position able be a that. good do to in

Stephen Willey

taking for questions. thanks Okay my

Operator

Thank you.

Securities. Michael with question next from is Schmidt Guggenheim Our

Charles Zhu

Zhu This is guys. Schmidt. for the Thanks Hey, Michael taking for Charles questions. on

and seems ASH primary will the is better you ones whatever late-relapsed previous front? opposed as or for presentations refractory or in one The a bit why to work could first of from color to But early-relapsed this flotetuzumab. any any patients around follow-up whether insight on reason, provide on it, a not provide

Scott Koenig

it. have might missed you Charles,

of oral updated who analysis of what NanoString one on in presented XXX will – be primarily last patients chemotherapy signatures, respond markers, so-called earlier We did on patients that who gamma-interferon be will flotetuzumab. One to tends And year, with of seems respond responses at in fell are immune will were of who focused thorough immune-enriched who segregation the to a it immune-depleted looking an particularly which evaluation that it sort analysis in a to genes. is based patients the in And fact, theory, which in responsiveness. therapies very bucket. bucket, there’s year population signature with refractory in of that an to initially immune-enriched those, to chemotherapy the include in this presentation and that up-regulation been a and respond then questions fall which tend of the whereas fall was immune-based the to marker treated those in profile, associated patients the that gamma-interferon disease of majority is

environment of reason mechanistically, that’s lot of chemotherapy well. give very certainly inflammation, that And exploration. you why, an avenue can’t further an reason some a there so has I that the clearly in is working isn’t some for And but specifics

Charles Zhu

it. Got

of bispecific, given Okay, PD-X do patients, could remind you this expect how you action LAG-X just Thank you the those mechanism setting pretreated the thanks. and agent? PD-X post-PD-X in activity for And the again, patients me also naive of XXX you. particular evaluate would versus the for

Scott Koenig

come dog we To in activating was of and bispecific for as as this with PD-X I what over for target when think, on design compared able Charles, who that included combinations activity to and should LAG-X alone. that had are to a restoration, assessed And I question that restoring our we for, individual was much MAHOGANY respond believe, phase T-cell patient with treatment data note multiple that assess a refractoriness when and on therapy, we to response PD-X the that our and we activation patient experienced yet studies progressed T-cells is vitro preclinical anti-LAG-X to or populations synergy that And question based induce example, observed alone, have complete terms and to patients of strong your that we profile. are there the of gastric resolution has that a ASCO recall, analysis of exhaustion effective cancer expanding molecule immune And both lines is time including that the have at instance, what seem Thanks been regard in spoke a presented of separate clinically, of you anti-PD-X have therapy. either might for in very there on blockade which nivolumab. we lesions cells or superior study, an to his one configuration are preclinically, year. of in antibodies in more configuration, in with an

responses those will to both looking patients So particular the with patients PD-X well tumors examining at looking to PD-X and looking be anti-PD-X again, anti-PD-X naive, patients the therapies, historical the that are obviously, in look experienced naive improved of responsiveness as populations we responsiveness. for to for those as to

Charles Zhu

Understood.

your BLA based BLA. on you There willingness one. me, on Phase company up and But Yes, the OS NDA yet, know the and with the of ended that only from an a if a Okay, this was something a question was endpoint X or secondary ago. couple don’t endpoint accept up pending? last a filing And there question. these with event hit OS is PFS changed they days or pushing out view has had that NDA or to had I level PFS, another a days trial, as kept happened this FDA’s

Scott Koenig

based specific approved case probably and been citing, OS aware trends meet as responses criteria drug. you that ultimately oncology large not well list statistically but experimental quite not drugs for that there are the of PFS are are of of long OS on terms you’re in data I’m So the have aware, as data as very favorable a do there

we magnitude will review accept optimistic the review filing see will that particularly accept this by the we we effect be here, it, it they is the to and it point. but F this Ultimately and of it whether very decision are FDA to and seeing the Given we’ll it, population, are BLA think allele prudent the that file in shortly. at

Charles Zhu

for taking the questions. Thanks it. Got

Operator

you. Cowen. of we Thank Boris Peaker from with And have question the a line

mute is your line open. Boris, check Your button. your is line Mr. Peaker, open. please

can I next Doctor, to the move Okay, question?

Scott Koenig

Yes.

Operator

we Instinet. Please And ahead. have Marai Nomura go Okay. a Christopher question with from

Jackson Harvey

primary for higher on populations an is thank provide the for based data, think Thanks rates with PD-X the I color of you response, duration curious should This the for study if more you’ve was response think, with you that Do be some respond trial. on could the Christopher. response you. Harvey seen that for preclinical overall the questions. maybe taking you be looking around or enhancement? do regards what should to Jackson expansion AML flotetuzumab, longer combo with flotetuzumab durability we expectation the of of in monotherapy And just the the

Scott Koenig

weeks. response, year’s Thank What weeks. I’ll you for combination expectation the little now from speak as when I itself very the for of that regard with a longer but to presentation population, points. I’m to last Jackson. question had we is responding all presentation, a is My much high data few think that in noted ASH out that’s comes few you’ve regard the the it durability anti-PD-X, in the to With over in a to X the it coming was let responsive leave our recall With up months. I going hit population before, the

these we that In one as this, we is this, way, think responsiveness, during patients be have increased obviously, the subsequent response, in respond. the able in of to we’ll I wait we I’m have for length the and of dramatically what improve to opportunity duration the the cycles data. population. periods hoping here But that of is of or study will greater consolidation, and for expansion that therapy particularly which

Jackson Harvey

you thank Great, so much.

Operator

call the the turn back for Dr. closing to And this question-and-answer like his remarks. session. concludes I would Koenig to

Scott Koenig

everyone that I’d coming our continuing to all let for to thank programs look providing we joining you and in afternoon again and to a good Thank day. this Have you, on our know to months the just forward operator. like us progress. updates advance

Operator

call. gentlemen. Thank participating. And thank for conference you, This ladies concludes today’s and you

You disconnect. may now

MacroGenics (MGNX) 10 Nov 192019 Q3 Earnings call transcript