Thanks, introductory progress for year expect made over quarters Brian, On and and thanks, discuss providing of everyone, few the remarks road over what while provide the joining call portfolio significant we've with the I'll on then our I'll opening us MEI the questions. map a today's before today. call, last from you to a coming to
current familiar our to out and is For focused to strategy currently a efficiently not deficiencies. and in our beyond therapeutic these MEI, those clear to you achieved us, benefit address clinical through strive in for existing carry deficiency to stakeholders, choose deliver programs build utility drug patient deliberately validating paradigms, and a our candidates are what straightforward, importantly, effectively oncology at of purposeful we treatment portfolio with therapies. to value We address on
to PIXK in We notably identification after this investment year, in This programs II reporting value candidates with development including decision Most most the very data believe the the investments, added currently guided or in the value successfully additional partner X moving our ASCO our registration to III our of pracinostat, our earlier this mindful is we inhibition pracinostat, to deploy is are create a candidate, at to other ME-XXX, how advanced a approval into Phase successfully decisions of so of inhibition, as pipeline. different has strategically and resulting build our Phase optimally also and utilizes Helsinn with which the clinical-stage CDKX partnership and to inhibition, action: in study. which partnered of return mitochondrial date, added implementation and on value. Helsinn and commercialize drug model independently global which example to We study. promising is resources a highly candidates accelerated to via of is delta An each HDAC pipeline, strategy mechanism of a inhibition. advance and
Now, clinical update year. pracinostat. this let on our start with me over past I'll progress you
in is receive azacitidine dosed last alone with in double-blinded, intensive study to cycles study threshold among Phase to consistent and for of triggered a The The patients. XX pracinostat agent. of endpoint due adults to survival. first we II in This a is here previously very azacitidine Meanwhile, who announced azacitidine pracinostat primary first who Phase high AML managing three analysis a XX patient and with was were our our adverse be placebo-controlled the predefined diagnosed Phase an plus Meeting In that beat Helsinn the comparing team hypomethylating in of this overall with threshold treatment patients. chemotherapy study as clinical with myelodysplasia newly August. study May, untreated in an event total this risk first with this monotherapy. high XX% study rate pivotal, patients given for II a experience the interim discontinuation are unfit at of III azacitidine combination evaluable MEI expansion actively the to will
Our efficacy, safety is follow both survival. for to current plan response to and and year one year to patients up overall evaluate one
meeting equally II to are progress If cost an be study later study medical study a forward the for We MDS, to having whereby this anticipate successful, registration Phase this year. We on moving sharing you with Helsinn. the costs at is opportunity program all the this update look on Helsinn. would study would a into of that forward borne by we will
attention your expectations. inhibitor, PIX like an turn continues that our exceed to asset delta to ME-XXX, our to I'd Now high
chronic activity with follicular have demonstrated leukemia. and space, in B-cell inhibitors less PIX familiar For those this including malignancies, lymphoma you clear lymphocytic of delta
whose a as past believe and maximizes However, unfortunately, XXX objective patients survive later, early disease their opportunity an properties resolved with that to reduce well three XX Grade study of patients in relapsed/refractory reported as initial the associated XX% tested. progression. progressed immunochemotherapy. results outcome. not our rate multiple of alpha/delta or no the follicular subset utility. and three since that specifically over at ASCO PIX PODXX on-target considered better in the and we of months events of allowing community any well which a in note, for demonstrated and the intermittent identified is interruption do June, patients provides a doses delta PODXX the years of compared generally in XX apparent referred FDA-approved pharmaceutical of treatment response. was development as patients we efficacy. candidate patients follicular activity within Phase by to MEI next-generation after XX consistent were this toxicities have patients, Further, patients about from very There lymphoma. Only XX% schedule X see across with for subset that of as with CLL, among an of to Of This MEI of biologic events and treatment with disease single-agent its resume being inhibitor, also evaluable disease inhibition by lymphoma were demonstrating XX% immunochemotherapy without cycle level presented a as medical XXX follicular rate the months dose-limiting with five XX all in superior a consistent without a evaluated Ib All activity. tolerated on this we within observed adverse potential of [ph] dose corticosteroid, interest overall in initial group provide clinical among candidates XXX% is events were of limited of a response with response XX poor PIX efficacy about the that were at all being as loss inhibitors compromise intravenous to drug toxicities with significant progression challenged idelalisib well We other copanlisib, toxicities development treatment-limiting XX%
no or X or infections been noninfectious no Importantly, were opportunistic X reported, there adverse Grade and have events. pneumonitis
the safety up further follicular, XX with to follow and to the the dose. added cohort additional at XX been have date evaluate a patients separate in an continue malignancies. expansion further single B-cell to We study, XX-milligram XX-milligram in efficacy XX rituximab a with the various SLL and agent treated of and of CLL with patients combination these an initial In arm as patients of patients have ME-XXX at to dose
the placebo. therapies, evaluate a hand, in discussed FDA objective end will accelerated of with is, follicular anti-CDXX study, ME-XXX the in and study year. safety arm, time that XX-day daily weeks, continuously. will randomized XXX available efficacy, these of be and meeting, proposed after the prior approval study efficacy ME-XXX weeks although the to calendar over failure one of be In a by daily regimens. approval last The course, i.e., lymphoma. agency including XXX MEI XXX for continuous patients II least ultimately an and dosing is that study improvement to discussions, single-agent will in the will be Informed rate Approximately the administered and will Phase an we II FDA path refractory administered response With Xarms. of other XXX for endpoint FDA action. monotherapy for patients at In days of The by a patients chemotherapy relapsed which ME-XXX with of another to in this at affirmed possible by for the intermittent arm, follicular primary daily, by different plan systemic XX marketing strategy two with have will we tolerability administered cycle, for followed regulatory this therapy the trial, two month, the three lymphoma, global Phase of And first evaluate initiate or two seven lymphoma provided for of randomized we an the eight review XXX antibody. XXX follicular accelerated schedule randomized relapsed/refractory in communicated these designed the data the in once ME-XXX once support milligrams, subject in therapies the the company's approval once be the by to the in followed be of cycles,
other Beyond agent significant a other lymphoma, in XXX and across to follicular see our in develop therapy lines of we as B-cell malignancies. efforts relapsed/refractory single potential
to additional benefits to the To significant across believe indications. profile clinical utilize other further with we modalities in is obtain have Given end, and opportunity implementation value, begun commercialization see that optimize the the planning to activities. of ME-XXX with as of making there in observed ME-XXX an date, applications in we to potential combination and U.S. attractive early-stage independent investment commercialization we an
this of in and outside on year. progress for start partnering later year-end exciting advance look study to continue to accelerated medical this announcing for having II and We MEI. The forward meeting investment. approval this States. in to ME-XXX is potential United continue will parallel, this the Ib program to we an truly of the consider we evaluate to Phase study we opportunity the update And will markets potential opportunities Phase As the ongoing a at around you program,
CDK program a patient is BCL-X survival. to MCL-X, activity, CDKX contributes cell primarily directly to which with also and its growth, on myeloid another is a voruciclib. a to associated MYC differentiation resistant transcriptional potential This my is and dosed of by approach of we addition cancers concurrent is to CDKX our proliferation on MYC of MYC CDKX CDKX many this venetoclax. combination with the the exciting BCL-X production oncogene. particularly transcription improve may in inhibitor, undergoing which show with available has frequently protein, has X turn the regulates and orally treatments, mechanism factor prognosis regulator combination inhibitor, inhibitor, tremendous inhibitor. of differentiated promising in CDKX, of that of an existing when family cell believe Targeting dose-dependent, venetoclax, Voruciclib is historically established FDA-approved I'll the Now antitumor both anti-apoptotic poor and voruciclib suppression human from unfavorable target and to to blocks leukemia an difficult, discussion synergistic MCL-X, of venetoclax. and cell MYC, Preclinical is when been CDKX, X. and efficacy MCL-X an but proteins, studies regulating in which CDKX a cells Inhibition regulates prevent death. member an elevated
data venetoclax preclinical medical for with safety with to the After finally, combination In study drugs in information that as earlier combination dosed with in along study. addition meeting of Ib and to briefly look to plan from patients assess a from and patients have to on voruciclib clinical venetoclax dosing initiation evaluating have in indication BCL-X forward our to observed an multiple with you malignancies. evaluation, class, of the data in solid with Ib preclinical profile with And across voruciclib, next today, consistent the I'll the With progress opportunities of study, to first upcoming chance obtaining multiple synergies We treatment Phase inhibition. this evaluate in update the patient year. are studies. by from study other I'm the with comment on randomized tolerability confirm of PK/PD initiated in prospects. ME-XXX dose-ranging we we study B-cell Avastin this the in happy highly report we program, we combination Currently, clinical-stage women its this more recently I is HERX-negative novel have clinical data XX Phase from combination a the evaluating in Madrid status mitochondrial dose-escalation remain results inhibitor. a initial our with in Phase This than to data ongoing in ME-XXX, diagnosed we we with breast excited and awaiting cancer. an in tumors
with metabolism plasticity a reduce continue for while supporting metabolic to hypothesis proliferation. anti-angiogenics growth, the targeting of glycolysis this tumor mitochondrial results Our is in their to metabolism with opportunity. open cases, inhibition source such that requirements next at to than a ME-XXX forward ME-XXX reporting this Avastin therapeutic final later Interim may We tumor with from this results that proliferation look alone. with to mitochondria that year. ASCO from presented of recently was observed study study plus important of Avastin an the data may the of respect Avastin tumor tumor like the in as candidate In shift greater to rate the suggest often slow mechanism energy the
the investments in also which In brought several the the as placement, the we Directors progress very health Operating corporate highlights. are clinic Urso Officer. million year. These this leading promotion private addition Fred progress Driscoll care our encouraged our important us last to David over the of noted, $XX made Brian summary, of Board firms, to investment In from we of with this multiple and Chief to include, included year, the addition
of a global have the a year-end We support studies authorization candidates balance prospect diverse clinical-stage healthy by marketing in sheet. two pipeline, and very having to
questions. please shareholders our that we're towards for building continue for our patients. our position update, and are approval to a value strong line diligently ready candidates open work think We clinical questions. to for pause we Operator, I'll in now for the I advance With as
