the you very much, Therapeutics third quarter welcome Y-mAbs Thomas. Thank everybody. And call conference to
to that We are chosen today. us you pleased join have
our to thereafter. continued later product we to and had we the quarter, candidate make naxitamab to year third for initiate the submissions, to sure which advance omburtamab omburtamab naxitamab Over form lead plan hard rolling and work BLA of towards follow this shortly in BLA
in within PDUFA for the quarter the rolling few omburtamab. and expect for naxitamab a next the expect we portion be submitted also Actually, for and the first XXXX weeks, BLA naxitamab date of we to of first
general you have to with omburtamab, will posted week. our guidance progress. next we on keep FDA continue will On a the We meeting
XXXX, BLA commercialization products. both omburtamab be unchanged timeline We and end overall projected to that by the seems submission quarter complete to expect the our reconfirm of first for
third timeline of quarter, that year. have PDUFA of a be we planned that in quarter continued XXXX, our for to execute this demonstrate the we believe expect and in omburtamab would to also omburtamab We our for commercialization date the fourth ability
represented team increase is FDA ramping our grasp by programs total up products, DTPA, in XX third to the commercial earlier to opportunities to omburtamab of a so employees potential we that stages the the the approval and well And our and and from move line and commercialization quarter. to due omburtamab approximately positioned by continue pipeline we're Vaccine, during We widen the indications our well such naxitamab the XXXX, X%, as believe concurrently of as as two the increased growth next to the for us naxitamab launch in The omburtamab. and of our to bispecific headcount GDX-GDX products. focus bringing primarily
I needed FDA, we that in submission, promising presentations a by Memorial treatment of Sloan our SIOP, relapsed/refractory which for of Oncology on with International pre-BLA BLA for BLA conference our FDA October recruited in the total reached will a in Study Society believe At neuroblastoma. of Lyon, we provided France, six naxitamab. filing mentioned. rolling and In in exposure we with Accelerated naxitamab high-risk June Pediatric a XXXX, meeting now to an XXX, significant the Approval naxitamab And the have Kettering the along alignment in we be patients just for had with Pathway all
Let me a highlights recap from conference. the few
a Study And response at patients Study therapy receive data than have had addition, rate. we XX-XXX. our to patients subsequently in from cycles high-risk X post better-than-expected refractory primary First, a refractory response more from this Essentially, half GDX-GDX received is the second and of demonstrated to chemotherapy. subset refractory MSK. least patients in were overall on These intensive neuroblastoma also line went patients that the reflecting Patients including to patients induction XX% XX-XXX at therapy. investigational naxitamab of of outcomes, vaccine
refractory this of see or patients with disease, enrollment, survival. group still were received analysis, evaluable of patients having progression-free One relapsed continue XX neuroblastoma response XX% two Study the therapy relapses Patients this the response therapy, two to after had off In Overall, had and are rate mind, subset that a in years, be anti-GDX patients received of survival given more relapse overall XX% patients had XX%. progression-free two were an in and these XX% prior consisting XX-XXX. could the their and that XX%. years in threshold primary an progress salvage murine rate was bear it us that, be population XX or very for subset known XX% previously cut another and secondary to rapidly of in predecessor these we to please patients FDA's factory XX% of in to for of the naxitamab. patients And at in naxitamab the the in overall third could patients to with
was we substantially the what guided originally. agency more are So by reporting than
have or a know maintenance population, later try these naxitamab And patients with we therefore, We disease presented MSK second We patients from with were evidence GM-CSF relapsing at remission at also therapy. are risk as of no keep treated them neuroblastoma in data of high-risk who patients remission. XX high In our and also where of two-year to anti-GDX MSK. therapy complete again. and previously, of went patients rate survival XX% more of these GDX-GDX at and A Vaccine treatment. a naxitamab subset previously two on anti-GDX have therapy the XX% received investigational XX% have observed. with was this to progression-free lines receive than more or patients received of
progression-free bone. the are the a because set the have disease are patients that performance not for from these data nor this very evaluable not data is these the believe set, macroscopic I because survival part should no they XX-XXX, are efficacy only Study to and they response of in a encouraging. subpopulation take duration note data of rating BLA We
been data ever with the think interesting had clearing don't respective compartment, as the to the seen We I in neuroblastoma patients we also investigators And which XXX% from has that patients deemed any marrow in trial. marrow. disease bone attest very among bone before
and that and safety the II we Finally, had more know at complete administrated the a had GM-CSF data GDX MSK. are trial shows in treated enrolled Naxitamab had an naxitamab study to positive, outpatient recurrent the XX with data disease, from remissions. minimum or patients these Patients patients and and setting. the for patients osteosarcoma Phase were was we at these two in
omburtamab, And now, a Iodine-XXX. monoclonal that to is second compound. which turning radiolabeled is antibody is BX-HX Omburtamab lead our this
recall, the we Desmoplastic DIPG known Cell positive Intrinsic developing also all As are Round for and Diffuse Glioma metastasis Small leptomeningeal as this known BX-HX you are which compound Pontine indication. as from may of neuroblastoma, DSRCT, CNS Tumors
enrollment In this needed we in pre-BLA general completed In with But of FDA. year, meeting for patients the meeting. The reason BLA. omburtamab June any converted September the that a additional XXX did metastasis the regular Study a guidance late FDA of for this are not in requested year, indicate a to information. meeting October, or the of agency provide change CNS/leptomeningeal this we
November meeting our described a quarter be X-K XXXX, first December in not we SEC new we in that rescheduled of filed for begin after a that scheduled, X, intend on in Form XXXX, to expect has which we until this omburtamab, now the with been rolling pre-BLA As XXXX. and result, commence will as may the pre-BLA submission the
the We by and first submission, remain still timing end of which omburtamab FDA not for complete to disclosed believe BLA will confident with the anticipated impact our content the the meeting in this do we submission, our previously meeting quarter our of that and change pre-BLA timing expect pre-BLA complete in XXXX. of
by As previously of end of expected XXXX disclosed, a we our rolling date the flexibility our either to first via required the a components and at via to completed submission rolling quarter first our anticipated or expect file XXXX. quarter submission end of the all BLA have expect of BLA to have ahead completion
commercialization overall the lines omburtamab be time will that affected. believe for we addition, In not
to reached two alive. to readout to for not months the patients on survival first where neuroblastoma evaluable the CNS/leptomeningeal XX the at the received median XX-XXX Data updated more data turning readout SIOP, median based data This being showed the with of we metastasis patients at At final survival study. than in presented data months that, this prior with from XX.X median patients and Now had regulated half increased with XX.X an the compares Study omburtamab generated being omburtamab. MSK, yet from of of the doses omburtamab. XXX patients,
with happy very are this we So update.
with primary including with XX with received addition, injections with of omburtamab. of The eight other patients who included had melanoma. ependymoma, In cancers, were total medulloblastoma out-patient administered nine patients setting patients an with five included we with tumors, patients metastatic patients diagnosis had tumors a patients and metastatic in cancers, and sarcoma including with different CNS different XX with routinely cancers, CNS four including injections XXX primary diagnosed nine
highly of patients these of today, with are XX alive. the still disease diagnoses As lethal XX
week commercial manufacturing, Connective are also and omburtamab. radiolabeling Oncology data July trial South of Meeting designed taking agreement a we existing supply establish with entered for within commercial-scale At a omburtamab to CTOS, [indiscernible] and into clinical In study. the our Tokyo, U.S. development, at agreed secure to clinical can from has which Spectron produced. we both omburtamab Annual place in terms Indiana Under Society's to clinical its market Bend, Tissue manufacturing agreement, Spectron this be capacity year, for presenting in Y-mAbs the supply the access unit of to radiolabeled the for facilities this
as work say, at We of Spectron great we potential for in the as The launch overseas a establishing Spectron partner will antibodies of in radiolabeling begin the as progressing The our Spectron. with planned. radiolabeling expertise also a activities. omburtamab. to within believe strategy is radiopharmaceuticals monoclonal facility be we the European process and decided backup great are see And supporting necessary needless for have our to has company's collaboration to well. serve facility We
his invite me the let Now to third on quarter share financials. remarks Bo
