thank quarter our today. everyone RNAi us you nanoparticle our morning, joining Good innovative And platform. therapeutics. development DNAbilize continue Will. we our plans to execute through and Thanks, clinical for on second to the Throughout build
of As There cohorts I more detail study initiated amended be later will in cohorts of will of Phase X the patients. call, two our in describe we’ve prexigebersen.
of venetoclax prexigebersen, high of acute and cohorts first in and the triple and risk patient myelodysplastic venetoclax. syndrome MDS efficacy and to of AML Safety The or decitabine untreated evaluate myeloid AML will and be patients. in be prexigebersen, MDS refractory both The patients. in the or leukemia high combination with evaluated relapse the risk final second step will decitabine cohort
a technology. I will review our of platform begin with discussion my
we evidence membrane nanoparticle the is antisense of of to There RNAi use allowing incorporation of toxicity via cellular their acid the high no structure, therapeutics cells technology. integrate the our DNAbilize nucleic because platform our technology, lipid has As into into DNAbilize layers. the the with be drug with you therapeutics. for diseased unique to the been know, antisense with creation the delivered uptake proprietary which cells associated
enthusiastic are platform unmet from about DNAbilize our disease developing extremely treatments of patients We novel the suffering with high medical for potential need. for
the review for prexigebersen. has product treatment in of a Prexigebersen clinical studied been our advancing X candidate we’ve lead Phase Let's the made progress trial AML.
assess reminder, eligible a LDAC, originally or in multicenter is standard this regimen. two-stage who regimens prexigebersen with a who trial with low intensity AML for As low or prexigebersen. patients open-label profile, previously a pharmacokinetics, a novo pharmacodynamics studied efficacy cytarabine not and study elected otherwise with untreated design or the have de are combination to chemotherapy dose high trial safety is that intensity The of
patients recovery. of The primary complete achieve remission incomplete within hematologic complete remission, who and the recovery complete study is platelet endpoint including
time safety and evaluated assess survival, as overall will examination Secondary of the response, endpoints prexigebersen physical and by signs duration and laboratory efficacy tests. to of clinical response vital including events adverse findings,
study. during In showed XXXX, interim In and complete achieved interim ongoing some treatment, from of Phase pleased including results the to this -- we status, a patients had original four response analysis the additional four first our one who with including XX%, form disease, showed evaluable X marrow. bone April results one of patient to leukemia stable report our with were the study, significantly and had our reduced analysis our we patient free XX% exciting from patients X combination And study. or quarter from patients Phase presented remission interim in XXXX, who this
XX interim show a evaluable or from The to of results efficacy you update XX% where we As the XX% of quarter results study. may interim improved profile first XXXX, recall, the the updated that during had the announced CR in and two including marrow achieved XX% patients responses reduction one state, XX% than who six leukemia patients had free morphologic including greater a response, one bone and disease had including CRI blasts. who or stable X
through XX% patients these investigators an investigations class secondary AML difficult to patients, by treat. was it of extremely were Importantly, observed our that principle
therapy data in from stage of interim complete study the LDAC patients. prexigebersen potential treatment our X the profile increased X% opportunity patients combination XX% frontline study of novo the rate with decided Phase of AML of Whereas prexigebersen treat LDAC prexigebersen for of approval treatment AML was de updated showed provides The The of and confidence underscore XX%. de with CR These recent one alone novo to at for combining highly its an rate response safety this venetoclax our patients. for in treatment to profile. was in and a a class the efficacy safety venetoclax the for patients only AML benchmarked prexigebersen favorable in of with
we prexigebersen said before, as an with view As candidate we've frontline ideal combination therapy.
improve is the patients. leading treatment aim options match with for to Our to frontline therapies prexigebersen
reflects to will treatment continue changes. plans for program advances. clinical registration a we as As for the to evolves, treatment respond landscape AML these prexigebersen our those development directed The for
AML the X trial Stage now Phase The patients. of has syndrome is X MDS restructured in risk trial, inclusion study high two amended clinical patients. clinical existing amended the we’ve or II of patients myelodysplastic cohorts the Firstly, change Phase the refractory and with key relapsed
pre-amended patients. cohort as The MDS first risk risk MDS addition trial, AML refractory existed and high in of high patients being comprised AML the with relapsed of a but patients And patients. untreated second
completion milligram meter safe study of will of modify untreated two of and the add under decitabine. Phase patients cytarabine. combination amending in patients successful a evaluable The to X then now of and company who a a of both total X who assessment the study with patients per the prexigebersen assessment, trial AML study Phase trial, of venetoclax the cohorts of decitabine assuming will prexigebersen, a date, -- of prexigebersen which the combination the to in Three evaluating amended are with include to safety The combination X therapy of decitabine enrolled continue for in dose being received cohorts testing at three evaluable. To square by both the treatment. are patients study patients study prior treated amended XX patients will has
efficacy patient is over commence. the standard combination assessment statistical six this trial each venetoclax patients will the cohort therapy whether venetoclax of will the prexigebersen, XX the anticipated the significance. that decitabine, It of care the study an decitabine, or assessment segment prexigebersen, a evaluable current of would with exceeds combination, efficacy assess After at treatment of efficacy include interim
the to up be efficacy Drug U.S United Upon States. clinical to such sites Bio-Path conducted is and Food Administration in accelerated segment FDA the trial XX favorable expected at of would the for petition or approval. data, the The
on emphasis accruals. the to forward, company in intends Moving potential Europe with clinical sites evaluate patient an
untreated transformational plus prexigebersen other these of for two venetoclax. in directed One will and plus steps clinical for and refractory trial Overall, cohorts MDS, cohorts Phase our result Both the decitabine registration relapsed in study will AML X AML. MDS. AML
to pancreatic for additional of briefly hormone tumor expected is at our prexigebersen plan prexigebersen advanced and planned like is trial trial and our Before on care I'd and clinical including of Phase to each This several refractory potentially safety touch to type. standard centers cancer of in cancer. the evaluate ovarian in uterine initially conducted leading X combination programs, with turning with solid be to tumors, patient breast
initiate trial the of XXXX. to end We third this the and IND an quarter by in file expect to
Next, let's protein. BPXXXX, clinical third presented which -- the recently drug targets review STATX our preclinical from data the candidate
to penetrate Atlanta, April. We studies preclinical models a are of studying or in frontline in BPXXXX poster American successfully from Cancer Association have BPXXXX AACR a the treatments. of Annual The shown Meeting pancreatic of for tumor pancreatic model. in were at drug our the presentation enhance results highlighted of efficacy and Research the Previous in treatment the the patient derived standard tumors
We typically or distant Activator is are cells. number excited apoptosis tumor resist for targeting active proliferate and cell vascular cells in ability inactive cells invade cancer normal well-recognized transduction death, of STATX, Signal cancer. induce be formation are Transcription-X aberrantly hallmarks to reasons. to in organs and though The of uncontrollably, or a of STATX
cancer destruction in cancer capability genes tumors mediator is convergence emerged pathways point also regulator in has gained processes. a the a for recently oncologic of -- of of avoid significant has which tumor critical immune significance the a More field. levels. evade STATX, the system STATX acceptance to involved and by evasion is of immune surveillance as these many the research immune multiple at
including enhanced is of a linked considered Therefore, advanced expected STATX benefit. in resistance for gemcitabine been produce of has pancreatic poor many and STATX Activation cancer, of of STATX cancers, high correlates Activation outcome, been grade of types clinical including found has metastasis to care disease with clinical and lung in cancer. combination with with pancreatic chemotherapy chemotherapy, cell inhibition non-small to cancer. standard and AML
study on alone of with oligo patient panel using The Bio-Path cells. antisense blots nanoparticle manufactured XX the with xenografts against cancer pancreatic of to was tissue AML non-small activity poster gemcitabine. identified lung liposome antisense overall ex vivo messenger BPXXXX were performed RNA, at inhibitory western AACR determine a combination highlighted sequences An and DNAbilize in antisense directed of oligo STATX the cell Cell sensitivity effects technology. four by conducted RNAi STATX assay derived and Incorporated viability live tests that to in
Using than P than with .XX tissue less inhibition greater a criteria, a previously response. defined value was slice variability XX%
twice administered patient bearing derived for week a of were XX up with Tumor were validation tumor gemcitabine pancreatic For results, to volumes cancer ex monitored vivo days. and XX be to xenografts for BPXXXX of days. mice
xenografts. X dose xenografts assay, vivo a of XX tissue had derived tumor treatment was combination derived in in activity another live viability less derived at ceased. period. than slice cancer BPXXXX regression The significantly when .XX. pancreatic BPXXXX value even treatment in inhibited during of out variability maintained for further and a more days than a ex tissue of of day enhanced the xenograft XX gemcitabine the of XX XX%, BPXXXX BPXXXX -- at vivo the with subset pancreatic of the models, patient patient anticancer efficacy micromol combination P by This the drug In with patient gemcitabine XX In study caused
AACR positive had very a encouraging data were These in very response. well-received we where
limited We program as of to excited human be that validation in therapy has particularly cutting-edge it our this this options. treatment will especially launch cancer are in indication challenging first
AML cell the Further was as STATX expression. addition, in potent cells cell protein cells most non-small cancer STATX demonstrated lung BPXXXX decreasing viability. validation viability that sequence selected inhibited liposome-incorporated in in In BPXXXX antisense
solid proprietary excited technology BPXXXX product year. enter with this next and to candidate for forward are a human first would our these by in enabling studies IND our in with to promising look preclinical continuing very We a be data We goal tackling platform. tumors trial with XXXX
domain. for against and treatment It is has also protein Venetoclax with our BCLX. which we've plans activity in or works our Finally, patients BHX updated decitabine. BCLX the BPXXXX, by combination leukemia shown neutralizing CLL lymphocytic targets anti-apoptotic therapeutic improved in candidate chronic an also patients untreated proteins for second the AML
to patients exception disease treated transplantation, However, occurs with due the invariably relapse oftentimes domain mutation some BHX over cell time. of with
BPXXXX also protein. targets BCLX the
However, BPXXXX the is not on the BHX domain. blocking activity messenger based RNA, BCLX and
patients an to treat BPXXXX. those representing a provide could we patient relapsed. believe will alternative venetoclax AML there from BPXXXX an to additional we patients result, opportunity with be As treatments believe that venetoclax have Bio-Path Further, relapses who for
As a of believe and we in treatment patients to registration be result, the file for relapses able BPXXXX we AML both patients. of CLL for venetoclax will
anti-apoptosis clinical DNAbilize of driven prexigebersen in in indications. technology give will to as venetoclax treatments always, Phase us our oncology patients. X continue platform evaluate program early And planned with to modification to combination our other in these experience treating expand opportunities with AML include BCLX we The
we execute I'd financing quarter Finally, like enables first This the plans with in that briefly to for $XX on raised three successfully along to promising two our candidates. therapeutic highlight development clinical smaller us offerings. million our
we additional enhance With significantly a now number value. shareholder resources that key believe milestones to the these have we achieve of should funds
With along now Anthony over Anthony? our program second a of the review quarter turn for with I'll balance that, Price to highlights. financials brief sheet