Dr. Rafael Bejar
Bill. you, Thank
myeloid want with dose into combined through venetoclax azacitidine. This series inhibitors. of just to remind study about encompass described escalation in composite differentiates kinase XXX out the in talk or to kinase MAP TPXX, single incomplete cohort. level inhibitor moment of when inhibitor gilteritinib have wild-type both five what the kinase, preclinical AML including one at patients profile we has profile a forms hematologic inhibits the as it I of inhibiting but add includes already mutant This a pathways. an DLTs to highly X downstream kinase pathways, dosing dose plus last completed more X/X also FLTX. and at been treated IDHX inhibitory wild no FLTX and or and just uses effective structure forms group This and a SYK, of But AML array and other tolerated CRCs, clinical XXX XXX, of Phase additional patients which of allows the that the X expand Phase mutations four first as traditional patients with agent you and harboring among a signaling dose ITD activity thus have X kinase in patients level us CRi been very co-mutations. and of XXX domain unqualified than or complete RAS only translated our FLTX and the adverse XXX diverse patients CRs other all complete is with JAK/STAT recovery of it in milligrams. impressive of AEs tested. a our complete oncogenic groups from In to refractory take Let’s remission FLTX which with highly we XX-milligram patients a is remissions reported a diverse the call, or other multiple kinome already and NPMX, well the ERK Most strong to inhibitor, to protocol, superior has type mild FLTX date antileukemic a of patients, the far, with tyrosine as known delivering with trial remissions,
midostaurin. FLTX-ITD and complete remission bridge hope, This a would mutant for previously cell which increasingly patient the patients includes remission a transplant. mutations, common, the subgroup accelerated and achieve one CRi. need with approval. that a unmet and carried Among One complete NRAS is inhibitors, treated with could co-mutation, FLTX one population two stem FLTX approved they an serve As with to refractory treatment and ideal gilteritinib patients at this experienced and FLTX is medical highly
respond mutation bridge therapy remission transplant. TPXX second were The treatment two and And with this bridge third Patients carried NPMX by One also gilteritinib. transplant. an with to responses to that had patient after This in wild-type FLTX stem also a FLTX a background quickly do. and presented highly a co-mutations the failed relapse patient if both, mutational complex complete a Then tyrosine complete remission there even stem with of patient patient genotype, a achieved wild-type a defined to with and typically XXX they therapy FLTX a a and with not AML mutation prior highly patients FLTX-ITD or harbored achieved and karyotype. remission. with cell agent complete cell or a adverse and kinase experienced a complete single mutation do also midostaurin adverse domain
of was breadth and that While a This speaks transplant on a and complete patient that unfit XXX remission patient the duration exceeded of. enjoyed response XXX for is this year. durability the a one to considered to achieved age, example capable stem due cell
to patient carry Another also a also complete achieving was cell the a mutation, a IDHX after taken with wild-type transplant. remission, FLTX stem and
And curative arm early observed dose in and clinical with CRi benefit durable additional TPXX XXX-milligram complete complete to the report out And with mentioned completed a year. patient milligrams the the I we’ve a happy significant experienced with was X lasting very fact, XX mutation transplant patient a recently patients In or that of cohort data, that remissions very than report of relapsed to one a remission stem we the bridged with who Cri, more from I’m a to the for cell X transplantation, achieved potentially either happy expansion allogeneic an were enrollment AML. ineligible CR procedure.
population do these to in we EHA of dose in not a providing that list abnormalities details multiple concurrently are time, levels. [indiscernible]. the milligram lowest treat. illustrate to patients It’s genotypes these antileukemic These cohort of simply focused level have patients also additional grow on the breadth population as brisk, expansion. we the very trial, this our identify respond to strong treatable observations remissions? here appears and moving data helped and with of While responding to genotypes to to are appear populating data now the the AML our further adverse theme because are future patient XXX AML this as responding has this dose XXX, to are of at the Why to dose at activity dose We And been In important gene specifics these us patients our our mutations at that takeaway instead carry the uncover on for that MLL XXX-milligram would this that of expanding of communicate messages drug. important plan demonstrated XXX. expansions of this XXX. to And be key disclose is going the but be we genetic of a we with is relapsed/refractory is June, enrollment including dose
our dose of clinical to doses encouraged table. identified trials. our In highly could full XXX clinical milligrams have doses, require are for leave well-tolerated of with set go-forward continue some make challenging we which are we serve into take in mutations, short, of by the said, That higher as we may seeing the respond. activity as We we and XXX XX to any adverse what of potential don’t the we expansion patients inactive prepare want to milligrams. XXX two that on It and next unexplored trials sure we exploring
eye registrational we We expansion may continue to patient the with select dose defined to trials dose explore towards the so fixed an AML genetically XXX-milligram accelerated expansion dose, optimal population initiate pathways. select and
messages AML level, early activity an shown To So across dose recap genotypes. major now, XXX key has broad for let’s at summarize, several XXX.
unmet that While with genotypes effective expand minimum believe intent marketing -- label dose into genotype-agnostic need we’ve we a already later and been potential for profile, can to accelerated an high approvals we trials. XXX the leverage take several can with additional genotypes. expansion therapeutically to development clinical identified represents A has leverage to identified
for However, us well optimal the because to cohorts we ongoing of the Based are in development a and these includes trial and as to on date the difficult favorable This enriched to registration-directed single later treat date, safety higher the allow expansion dose as genetically agent dose. from of new expansion profile a that particularly studies XXX and will this XXX. are expansions agent for single doses seen across exploring expansions, patients to lessons set as strong year. AML planning we signals of a already subpopulations select diverse
single studies into our to are treatment. planning addition complement move earlier In of and that XXX allow lines therapies studies, to existing would agent combination we
Okay.
a to review luxeptinib. of quick on Now,
a in tumor being reductions, dose as over activity, observed both tumor multiple a at cycles exposure Just vivo giving known at follicular patients CLL is both toxicities, a dosed associated with avoids known AML, Target and studies. with FLTX dependent diffuse antitumor in and and XXX malignancies. Phase clinical lymphoma, demonstrated lymphoid BTK including milligrams apoptosis only been In XXX engagement reminder, that triggered large have is lux therapeutic BID currently FLTX in myeloid of and studies multiple potently patients collectively between preclinical BTK targets eradication. that B-cell lux potential the including and broad both that the and lymphoma, are levels inhibits AML. studies, and precision tolerated and with of agent XXX, of milligrams dose our Xa/b XXX across has studies, been of the XXX, hematologic spectrum well generally and lux BID In often profound
exposures We new to the have of formulation reach may would to absorbed patients. this lux, in push dose better GX, of A help lux continued on promise. kind activity in that that deliver order the demonstrate of
mentioned preclinical XX-fold species the on the I’m of to has and studies, we go than depending and intro going for call, for this they they from with of are this exposures ongoing on preliminary of that at original exposure comparison. XX formulation. And the doses efficacy an original at formulation in samples drugs to have GX As A per evaluation, GX to to lux pleased PK After from been lux on we greater BID of are dose administering direct shown the the a additional our original At formulation safety collected original deliver improved dose cohort administered team, to received rapid of and report the compared look single a time, milligram strong milligrams to GX as single of patients program. PK can started XXX-milligram data collect clinical XX- we the where data available into absorption these patients. basis suggests with the that formulation. from date delivers a execution
preliminary, continue administered be to the significantly hope to a the lux a formulation We and burden our GX for advancement evaluation will pill meaningful to patients, a this sufficient the We step for drug of do amount patients. superior plan clinic. number could the and substance of reduce of to GX in GX While these determine if very truly are encouraging. data patients is of lux of
many clinic new and with from comes and And there’s preclinical always, success. to uncertainties risks. of its the formulation As models no guarantee work, translation
plan of reason, in experience in diligent details share clinic GX. dosed our with evaluation to more in with We on For we second patients enrollment our rushing being the quarter. are the and not GX this
the across and of pleased candidates, trials. dose our our tolerability ongoing are in have XXX We drug escalation progress the programs that and our lux, continued and clinical allowed safety by
to As generating we updates. treat are additional patients with forward we and data more pharmacokinetic higher pharmacologic we doses, further look that providing
please sites of that on clinicaltrials.gov. for clinical information more are ongoing recruiting For visit patients, all trials, clinical our
now Let me Rice. Dr. it turn back to Bill?
