a on priorities Slide today's and better thank our you and webcast. everyone longer before. strive high-level people ever live call provides realize cancer as to future we summary the and corporate a in of with much, us than joining current X very Melissa, which Thanks to
we our selective our I/II programs this menin a We FDA with continued SNDX-XXXX, to as that announcing progressing our we one Today, opportunity XXXX therapy trial the year. quarter. represents trials second Phase and AUGMENT-XXX, that the of is this favorable initiating X trials during great into both are AML. of anticipated move in the frontline on the of make first up our of are meaningful of clinical to coming have combinability progress quarter profile importantly, of meeting capitalize inhibitor,
investors, of AGAVE-XXX the bring to are our drugs For existing therefore, areas to CSF-XR, remain enrollment best-in-class well X axatilimab, X medical we antibody look track X potentially for and vigorously both for our programs ongoing into trial. for financed oncology targeted to on pursue pivotal committed to many Thanks is ongoing unmet programs need. opportunities to this our additional our support and aggressively our medicines in against registrational pipeline. of year have first-in-class important of We,
Let's and recent trial the now of turn SNDX-XXXX for from our of X, data leukemia. the I AUGMENT-XXX treatment Phase disclosure Slide to portion of the
were, of As over We in we has patient a our course, I our tolerated XXXX recent with been well discontinuing Phase this patients responders most drug-related to mutations clear MRD-negative observed with or of activity with achieving excited monotherapy have status. also NPMXc with MLLr either in adverse for no disclosure, in multiple data of evidence or relapsed trial, cycles noted acute leukemia event. refractory population
of recommended importantly, met Phase all the II our pharmacodynamic criteria. And prespecified most dose perhaps that confirmed a we action. Our identified had data of mechanism candidate
include intermediate of last dose. XXX dose, from milligrams to A, observed no criteria level have doses, Arm you B, XXX trial. we Slide at Arm portion twice These Since the met the intermediate that X, and XXX Phase with we recommended In see finally, of we doses DLT dose-selection B. doses have In our have our therefore, day in Phase are the an XXX. A DLTs intermediate in XXX prespecified the II we and were from B XXX communicated XXX results to moved to XXX call, no the Arm level. our On Arm II from a and all at selection. of previously well now II to recommended which that XXX in also twice Phase nominated initial and now Phase tolerated represent moved in in We completed our our represent have XXX results have Both of recommended intermediate we the XXX over dose also dose we review dose. II to intermediate increase XXX-milligram XXX the and again, candidate DLTs dose a Arm exploring milligrams a day finally and in updated recommended for Arm A been the dose with,
you so cohorts. investigative only sites implement have clinical to program. to We I, that minimize QT not this I did see recall, we prolongation, attribute B XXX DLT incidence As reinforce may are XXX our to with X efforts with seen is made to what A Arm Grade about why we the seeing have or the are we and Arm we Phase XXXX QTc the simple excited our want we the prolongation. of measures again, in in
treating Every data delighted response had These and bone almost this after very we and X who negative efficacy achieving venetoclax. physician by excited seeing. a transplant, us that patients of difficult a Phase first received average leukemia has overall with a CR/CRh XX% sign, therapies. had a were marrow see to is rate XX% are treat been patients, currently me reviewed MRD-negative XX% the responses XX% are XX% on very a is of which I prior patients previously Let this the received acute remind About rate, to prognostic we relapsed had has everyone an trial, and stat.
is previously for the recently specific We that Phase FLTX for from Slide FDA. in that regulatory approval XX% I for level acute in out on aware we option that the required there were gives targeted data of initiate our patients around inhibitors of we or guidelines The for to been has the with AUGMENT-XXX. and reported rate X the XXXX. CR/CRh suggests AUGMENT-XXX are confidence while have approved of our Phase relapsed/refractory leukemia. ongoing IDH that Phase novel the no rates II trial that achieve our shows patients generated trial. therapies efficacy a of precedents rate approval, have And are above had a will We us XX plans better treated XXXX that acceptable go-forward portion for II to pointed
updated dose. recommended As II previously our we Phase communicated, have
agency portion garner with endorsement from decided portion start decided the awarded regarding end instead first decision at dose and clinical our to excellent Phase soon our being keeping not This to the and Designation. working I and regulatory II relationship in However, we team with are thereafter. of risk Phase FDA Fast was have meeting the II is Phase recommended Phase anticipated previously we've the as II The quarter, with Track to this communicated, to established occur open selection.
dose. anticipate at have the pending, have medical Phase Phase continuing year. cohorts of II substantive Phase we that course, of portion and of enrolled full and Phase AUGMENT-XXX II not patients may at a their the patients recommended officially our end this be dose the II are our presenting conference While expansion started in our FDA II update included of We approval agreement recommended at proposed these of additional newly to trial, enroll we expansion a
for treated given larger We NPMX. whole, Phase out the the we've excited will data that will but end anticipate set, and to I be this shown MLLr versus and of MLLr a more data CR/CRh either only NPM set. our for able XX mature year, we have are at date, over rate that the CR/CRh rate relatively with we or mutations as the patients break mature population a having To
an the aspects will will present which updates at year We conference the XXXX. important end the be could at responses, a of of key these durability XXXX efficacy important first aspect and We meaningfully the promising profile. the the believe look also address CR/CRh medical of of at of is a
with of patients, both trial adult portion trial path providing enroll next broad results existing that and with with a positive. for to thereby mentioned with forward II potential year. of the Phase believe finalizing soon top approval As portion regulatory portion Phase AUGMENT-XXX with cohorts and the of should details and data adults could patients presence. X Phase sometime patients regulatory will ALL, potentially are one mutant The the enroll I've given note of line and I potentially the we more have FDA This a distinct the or look filing, MLLr MLLr us pediatrics. NPMX II AML cohorts, a expansion regulatory to the label, both previously, We pediatric could patients will II AML. including support
initial into been leukemias, the last conducting have in clinical for period, we Slide beyond the broad of research landscape on the relapsed/refractory as approval opportunities X. illustrated Over acute also extensive XXXX
Our are out we first XXXX and goal to announcing a towards our company to indication. Today, relapsed/refractory be to the as disease first then market in additional be garner is value-driving steps building first franchise.
combination collaboration agreed patients are strength of Phase in of in assessing will Society, umbrella preclinical menin to first chemotherapy the diagnosed at in they as XXXX Our in combination with serve with Anderson, slide. have scientists filing. a venetoclax. with for consist to reference and call collaboration as tested The supported XXXX targeted inhibitors newly menin basis Beat for on therapy with & the I LLS, on regulatory be that trial in Phase will and potential to which published as The trial, have the and the inhibitor the AML. an Leukemia that induction that have of azacitidine unfit our a and venetoclax otherwise selected NPMX The with provided data, a scientists, we been for could our patients is as is inhibitor sponsoring them II/III include data They based use MLLr or Lymphoma the potentially MD AML recently test trial, known AML. menin have specific
menin use data combination Our with generated scientists also inhibitor chemotherapy. have preclinical of supports in that the a
build either the Phase further As the over anticipate with a initiating a will second announcing XXXX in patients out additional We of XXXX combination also AML. standard trials with trial which that chemotherapies I exploring called franchise. or ALL result, remainder be AUGMENT-XXX, are for year the used will pediatric salvage we
now best-in-class turn Let on axatilimab, CSF-X the X, monoclonal to me targeting potentially antibody our therapy receptor. Slide
we data of Phase ASH at December graft disease chronic I versus know, in you host our last year. As presented
as opened patients year, XX Phase Later enrolled from event and per data XX of updated You will we well in eventual that a been the is that at should be anticipate kilogram the enrolled. Phase cohort had fully now the portion X from our cohort both cohort label the And dose per trial dose expansion as base cohort that has as may derisking pivotal X as we kg outcome II per milligram hence, at assumption full this dose. the or recall of X the X trial is a AGAVE-XXX. overall with The disease previously be mg investigating either chronic criteria I met that case X be presenting to Slide dose. trial disease emphasize progressed of the of enrolling criteria. Phase randomized axatilimab data quite relevant weeks. dose-ranging the host graft announced, therapies. the host I mg The II X pivotal given expansion expansion the our host our II disease. our which Phase host response patients the this every patients of to for XXXX called X treatment a This least versus graft consensus is the for must NIH after rate will axatilimab distinct has primary versus X trial. Patients for is trial and in graft is patients every have at in each prior X whose graft a versus a age disease. chronic versus endpoint overall weeks is dose axatilimab This trial trial groups, years chronic X is pivotal entry using kg disease
and response underway, is we study medical in host using graft unmet U.S. validated approximately XXXX. important in high Symptom deliver to opportunity endpoints line of commercial the from disease the patients and life suffering will with that assessments Scale. We top data a Enrollment Secondary chronic on an believe track quality of chronic duration represents today. the include Lee to are versus and GVHD XX,XXX need
in from could this potential host that profile, graft are both axatilimab results versus in disease of and advancements will diseases With idiopathic the recent potential recent generated that a in the enhance agent suggests safety belumosudil medicines. as actively We recent and pivotal axatilimab We're host been Kadmon's such and out strong commercial of most in see believe pulmonary an experts clinical data Jakafi fibrosis its it targets complementary monocyte given we to monotherapy axatilimab which fibrotic area, variety with of knowledge, soon the materially in Despite graft take is disease. scientific opportunities efficacy approval fibrotic will of to versus of and extensively the We've build belumosudil, the of chronic delineate lineage. combination scleroderma. commercial significant rationale as a chronic working that supports Incyte's beyond versus play chronic versus both in graft evaluating macrophage to advantage diseases has the value. field consensus, the by believe to with to only the what of begin disease wide host treatment the the the that also for and specifically opportunity have, date options launches on in our development graft set its we shareholder role axatilimab the host in a important with and, to franchise chronic disease
and FDA we programs. Slide Daphne able financial through now to as and these our call inflection on pipeline IPS. compounds the We preferred as obtained assets for expertise to I'll remain of acquisition in that continue previously will we have value finally, XXXX expand axatilimab transactions our XX, transactions to well review Orphan the use the key expect development our underscore assets, of we the among turn summarized quality or the be axatilimab these for differentiated from points. to and anticipate clinical such believe high-value of capabilities communicated, As robust results. bring we to Designation the acquisitions we Drug We to to through led And over identify product evaluate transactions. partners in-licensing to differentiated the
