you, Thomas. Y-mAbs Therapeutics today. quarter us Thank have pleased to We're join call. you first that XXXX earnings And chosen to welcome
the by start the closely our monitor Let that me to on saying impact continue of COVID-XX we business.
measures steps of to chain supply to and our continue also safety our while employees of trials to and protect number a the clinical disruption our taking activities. include implemented These have We and mitigate to operations. planning health efforts advance of commercial
challenges impact changed have enrollment posed patient While trial XXXX major to we guidelines readouts. data site anticipated key not initiations by we due near-term and pandemic, trial clinical the expect our clinical COVID-XX some for on unprecedented the
our in of are with the To and critical trials. in ability ongoing support pleased business to our of cancer date, the need continuity we patients
over time. may that created has COVID-XX impact However, environment company a dynamic the
going appropriate keep updated investors as will We forward.
Thomas advance towards just we that potential mentioned, X naxitamab in March as date our ensure to lead the for neuroblastoma, BLA of awaiting and to market. PDUFA FDA. the are naxitamab and product have candidates, we submitted continued the relapsed/refractory our During now we hard the final omburtamab, portion quarter, In first rolling work the from
is neuroblastoma bone on The pivotal we is the from marrow. BLA during safety We after at inception a bone less this the demonstrate XX-XXX, XXX of year. high-risk suitable with the than in commercialization excited efficacy plans five on company. quarter suitable and present our we the submit and expect ability to in later BLA and present venue our company's that of which believe II submission first-ever BLA have execute relapsed/refractory patients to and/or are years for The results a based treatment studies to Phase – the continued to
we addition In patients combination as naxitamab, Barcelona. neuroblastoma in well trials at and for MSK first-line neuroblastoma for trials chemo refractory to have the BLA for as
During the treatment. we Phase XXXX, expect remainder frontline to II combination multicenter international both in chemo and trials of initiate in
an Now is Omburtamab turning Iodine-XXX. our to omburtamab, antibody lead immunoglobulin compound. second radiolabeled with
and we – have our by with For meeting plans very February we're in omburtamab, the FDA we having had – year, with pre-BLA confirmed the this agency. pleased the our
CNS/leptomeningeal patients We BLA treatment complete neuroblastoma. omburtamab rolling to of the expect from next with metastasis for month our submission
a after anticipated our the than in to and meeting This weeks back later is pre-BLA February activities. before started the affect just few we originally COVID-XX had
and We're three on to two to rolling another continue competence very the will the to you work the to BLA. submission of on We completing have keep pleased after posted coordinate submissions of only naxitamab progress. months BLA our in-house
the also. our In EMA we proposed making Europe Plan progress U.S. omburtamab. In for development, agreed in addition to to December, are Investigation Pediatric good
a their a pediatric the product in As regulatory new the investigation to for outlining new for the registration of of population. medicines companies Europe, process part strategy in provide required of are PIP
product for to in XXXX. in omburtamab a have We for And with CNS/leptomeningeal this now step in submit Application efforts bring This plan pediatric Authorization the vital in neuroblastoma. registration filing in Europe. Marketing of our November that market Europe. believe Marketing year a to in we PIP a is for Application we metastases prerequisite clear from for approved omburtamab to in any treatment Authorization is forward path Europe patients the An a for new Europe
at DIPG, glioma, Phase a Phase in study As DIPG in study omburtamab I for we we're II disclosed, for multicenter as XXXX. intrinsic previously to also study MSK. a are planning diffuse And open developing known pontine
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For study studies metastases radiolabeled is study with omburtamab-DTPA the IND pediatric we One our XXXX, open for December study and construct, this lutetium-XXX filed BX-HX a multicenter to the I/II positive expect year. and in basket in we neuroblastoma, other is adults. back Phase CNS/leptomeningeal in two later
omburtamab. our with indications with For patients prior treating both the to we studies, these experience utilize version hope of iodinized
our standpoint, build we believe much very commercial commercial we right-sized, organization. best-in-class Turning on to are track to From the commercial the path.
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on and optimal launch very are execution to to focused we a coverage. planning, ensure of that intend terms we drive pricing of and In reimbursement get upon uptake the rapid and products approval those
Our largely is commercial place. team in
two As many have Officer, his of building Commercial you ago, since. about know, ever we team been hired years our Phil we and Chief Herman,
we the the are medical of omburtamab In medical in in science believe group, place U.S. in we naxitamab launch so affairs addition, potential for liaisons the and the positioned have very well we
radioimmunotherapy Sloan Center entered mentioned. So to April also On the that we antibody call known Cancer also for into self-assembling/disassembling as that commercialize collaboration also the based with technology SADA, exclusive Massachusetts had on platform worldwide and Memorial we agreement XX, us license a to we Technology, we of an Kettering Institute antibody takes constructs, MIT, SADA Thomas briefly a research as and develop construct Radiation. describe Liquid and announced what as
tetramers SADA of of antibodies antibody tumor-targeted in step, a fragments strongly are first to the bispecific self-assembled a and subsequently very targeted to and binds fragments injection in a The the platform In vitro injected. two-step These operates saturating unlabeled tumor are with large dose prior linker the cells. manner. bispecific creates
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much antibody reaches at tumor, its it bispecific path. than radiolabeled DOTA organs, peak injected the finding concentration binds and pre-localized rapidly the In specifically second is of in antibody the pre-localized step compound when normal where tumors antibodies the the to the higher binds tumor-targeted to and is that a
papers three tissues, and indicate published with we data ratios, concentration the for non-tumor radiolabeled is that tumor, utilizing of been antibodies utilization in higher the limiting much similar normal radiolabeled step minimizes steps, the approaches, which it favorable but constructs damage in substantially such And which has to past. and processes believe with result therapies radiation
in centimeters be could larger a as multiple agents, impairing this of approach the that higher meaningful than injected i.e. responses improve tumors not without demonstrated toxicity. level with We in have to radiolabeled lesions therapeutics subsequently it macroscopic efficacy to hematological radioactivity to three the four radiolabeled historically tumors allows believe diameter
a MSK, HERX for use constructs breast cancers. potential number SADA-based We GPAXX created SADA and use solid GDX in intend SADA to of development initiate positive cancer, SADA by a in for including colon GDX a potential for tumors, positive HERX and cancer a other of
We proprietary a first to year And file we thereafter. targeting as IND patients of expect against our with next start exciting are treating to constructs this SADA advance shortly to and for a hope construct series technology well targets. other
they four small kilodaltons about These the bispecific of are XX tetramer, Fvs. the to consist basically two and XX constructs, single-chain of each antibodies for of arms
directing each ways, of arms the the binoside. radioactive a that's the of the many binding binding tumor. to you not is many like instead the of end But that know cells So may is obviously, in Amgen's to from pipe payload T the tumor
treatment radioimmunotherapy also but the and specialty make to The platform Y-mAbs. to contribution both further SADA the even us we potentially years. for in larger unlock SADA hope coming technology tremendous for We available indications for the it indications. of in improve the is allow antibodies in sublicensing, oncology landscape see field radiolabeled believe to could a the makes technology also sense significant potential platform definitely And in
To total the during for support of development XX commercial team employees. and addition from our the the potential growth our up due ramping team that increased is increase omburtamab. of plans, a quarter count to head well approximately XX% naxitamab primarily to to by XX is as as The the launch we
the naxitamab and SADA pipeline, programs we as GDX our on omburtamab and and to FDA continue in line are indications commercialization well increase for to candidates believe our next move naxitamab the bispecific our well positioned and including that the that XXXX to in lutetium-labeled as omburtamab, mentioned technology the We Thomas earlier-stage product just in omburtamab. GDX, and and focus vaccine late concurrently the approval
financial Bo So now quarter let results. to me on remarks share the his invite Bo? first
