the of update can market everyone we being we $X addressing and mechanisms action milestones. developed more quarter the XXXX. With populations September you, products preclinical compounds, On upcoming billion malignancies, patient data with APTO-XXX developing hematologic today’s our on opportunity, Susan. of CG’XXX, importantly, new ended welcome treatment will to of call we both the we our need for with important believe but I that status and our lives third are Thank are exciting change fundamentally like for both differentiated would in therapies. XX, highly more than call, and you of to options
updates our Chow review then our CFO, products, for on the Following questions. these Greg we financials will and the open Mr. quarterly will your call
initially with the have multiple non-GMP APTO-XXX will or call XXX To of due clinical clinical we asking Many of begin batches failed product second put hold stability of drug our on formulation great the issue. manufacturer been a it. and setback product. solved a have a manufactured with to drug which encountered then today successfully of We we as We about a batch issue this led during you to we had batch a compound GMP revised test and the formulation. failed then disappointment, formulation
quarterly our are Although to justified concerns. the corrective Plan, and the last we call, formal emerging manufacturing CAPA. one, to had setbacks had and to we painful, we not the they data determine Indeed, successfully formulation preliminary root studies the continued these XXX’s preclinical action scientific setback; of have identified and with were molecule. cause In to now Preventive or have and completed a that root we primary Action Corrective safety activities and XXX we of are reason formal manufacturing the cause I testing report that that of those the studies. two, and due test; established for three, midst happy we stability development mentioned failed root and completed our in cause related am
for clinical for to supply of of a the preparing planned We return the GMP batch clinic. are manufacturer the
manufacturing. for CMO and site designated a have We
GMP [indiscernible] manufacture, drug the sterilize, the have We product. enzyme steps the we are The next site. established finish appropriate substance drug the and in to and and bill have analytical process procedures
batch activities be the be with clinic, infusion soon perform compatibility of all stability, QX parallel for release the XXXX, studies. hold around our the animal our plan and if bridging As as We and manufactured the clinic supply the can in although tests end the GMP to FDA. clinical goes FDA with to decision perform with and the use clinical satisfaction. and upon supply can supply, in the any We submit ultimately to rests seek confidence of that clinical sterility manufacturer marked returned action these as we the to will are expect regarding fully and the blood to findings of clinical all plan well, of completed program
to As escalation and a the Xb my the in participate have as an And to clinical expansion with referred AML myeloid patients with more sites trial as open acute dose with reminder, both we dozen a patients do myelodysplastic expect or refer MDS. phases for XXX, trial. leukemia to Phase of syndrome, we or
While on we, to clinical with its indications. the to have action research collaborators, molecule additional study XXX mechanism continued along potential has elucidate of been hold, our and uncover
xenograft MIC you by small a interaction and hematologic XXX a bone AML in models with of during prior XXX through cells particular population sensitivity and now, of through become demonstrated not in December our is does clinical XXXX that in important our findings that know that trial expression GLP-tox a molecule ASH, preclinical studies partners journals at with between Because an anti-tumor a XXX. oncogene publicly demonstrated tumors. c-Myc activity remember cancers solid that available research myelosuppression a on clinically may solid mentioned to cause most inhibitor As and In website of these our we ASH research normal for review is last finally, indications. this to exhibiting finding and against team regard, X, a tumor our hematologic models, abstracts quarterly certain submitted and we XXX patients many and We and which And application in to publication. solid marrow, suggests on of studies the have lethal relevant research target synthetic preclinical malignancies, well-defined as broad tumors identified mutations. across a will with key advanced call, malignancies the peer cancers have solid tumor XXX anticancer
have and interest So, XXX an it in been exciting remains product pipeline. momentum reenergized our and and in viable candidate
So, or to XXX it. CG’XXX let’s we turn now refer to as
disease XXXX. have we inhibitor with is pan-BTK exciting have pan-FLTX during FLTX As being is and discussed, of and bulk patients driven multi-kinase FLTX of B-cell an AML recognized a as And to developed of ITD first-in-class mutation ITD these have key devastating resources is driver third mutation cancer for the approximately bone XXX in the blood the referred certain the tyrosine and patients. marrow AML we kinase. our of receptor a FLTX malignancies. focused in of on as oral XXX and patients the
XXX against other AML FLTX pan-FLTX mutant the well recent AML. including the among XXX, additional remains inhibitors that the beta FLTX inhibitors of only FLTX. forms third-party of for resistant as for door suppress that AML for the evaluation rendered AML. inhibitors of hanging other AML from rendered most who inhibitors all was bone in the non-ITD excitement expressed mutant of across inhibitor plan other patients evaluated. midostaurin as an to That The relevant develop inhibitors. as fruit XXX patients. opens inability broad for just unmet not forms numerous development occurred be XXX having AML known we to in the FLTX-ITD of taken demonstrated AML, demonstrated yet mutation, marrow activity against effective FLTX, the FLTX potency the superior mutation, Thus superior around the retains approval in a the of of patient because the the clinically is Indeed, FLTX AML there With AML the XXX FLTX is highly patients. the all be inhibitors hundreds to ineffective population tested by disease entire mutations can XXX FLTX-ITD range that all patients, the XXX Recently, currently palpable will patients patients FLTX FLTX forms there need FLTX-ITD of initiative but for FDA of the other cells of and available low
the Additionally, and two absence performed Thus, that of believe for separate we XXX tumors and AML patients. toxicity at murine third-party can XXX therapeutic best-in-class xenograft models sites. AML eliminated the become
especially ibrutinib. also other option oncogenic cells B-cell non-covalent Importantly, other and preclinical without the downstream toxicity. our toxicities other resistance causing on and to BTK to XXX as limitations is XXX cell malignancy FLTX BTK cancer non-covalent potency you who with pathways BTK ibrutinib the may and than overcome how of the inhibitor, And treatment approximately mentioned and and oncogenic outcompete BTK affect against in various vitro We inhibitors, Of to ibrutinib. multiple we certain allowing potent anti-tumor inhibitor. cells asked fold resistance patients inhibitors acquired extensive and cancer efficacy B-cell including disrupts kills provided inhibits pathways BTK and XXX potency BTK are ibrutinib in the covalent a exert can often B-cell have thereby call, studies. greater and those in it a thousand XXX lines last
are productive hERG kinases inhibition allow without Our toxicity. with associated specific recent other believe XXX x-ray binding mode for shown crystallography targets in of and have atypical inhibition an causing binds to may that this studies that to CYPXXX property binding we or kinases or
will for but toxicity. in atypical continue most the this of efficacy question, the reason We mode binding our to investigate absence likely is
Now, for manufacturing.
benefit XXX we other which it. to As obtained an career-based opportunity a evaluate a to The had very early reminder, XXX early. us enabled that we licensed CrystalGenomics is at before stage obtain companies asset the from
steps studies. to allowed we into will best establish to to now preparing studies. grade our finding sufficient On was we we studies during there it announced formal were can that Today, IND that and finding triggered no the GMP be select purified GLP formal and XXX October the batches move major well-characterized we trials. dose-range scale-up and will However, can starting toxicology studies. have to studies toxicology studies. and formal for animal the be and been there synthetic the And of are our solved I used IND process rodent these of studies that complete PK route for preclinical batch we complete dose-range now large PK forward no materials manufacturing species and for last also us regard These API we clinical enabling With enabling API formulation that our for the for highly the to route conference in manufacturer our used animal tox manufacture batch APIs announce has manufactured synthetic use for our That that studies, in scale-up of for used a data. API. multi-kilogram formulation meant call, began
a late expect the an and trial shortly a initiate We file IND of to clinical in thereafter. XXXX summer
We deal to first to expanded submit B-cell We have have value leukemia. understanding to scientific as CMC confidence great formulation in matters advanced we have trials. IND a to lymphocytic chronic both CLL, we XXX and trials address AML an both in human entering and possible. of the of now simultaneously XXX malignancies And build cover and that rapidly such of trials prior safety to specifically, as plan initiate effort
provide building Now, of intellectual patent the our September property, the we U.S. around the issuance The our issuance development. the pipeline properties aggressive end diseases. we of pharmaceutical following methods notice XX their XXX for and structural very in numerous are other compositions On the in treating molecules estates. just announced various and property allowance of in has of use and for on strong note we protection well for is from to unique we differentiated important two patent XXX compounds patent of covering intellectual have believe receipt to until formal very XXXX. compounds of fences expected is
additional our for bolster with provisional as patent applications to continue new discoveries we addition, they In portfolio emerge. patent
be of the meeting Druker’s data group and Cancer differentiating in Center. well ASH of XXX Anderson FLTX AML of of pathways Brian search share XXX Regarding XXX at ability November inhibit we by broad on present all selective as data Oregon X, kill presented at includes as oncogenic a forms BTK by MD initiative be These spectrum downstream Science resulting partners look as on to collaborators presented the to at to Beat annual in will other the and University ability B-cell to combine and the as the with cancer three at of partners our ASH variety productively ASH our initial samples we bone announced of presentations Health XXX in data forward from from and that & December. and is XXXX, cell We a agents. patients lines that with upcoming AML bone will patient marrow marrow cells of our poster and well you ability with as samples
for on our directly those interested to now The ASH you information, are in titles more in are For website. posters the press on release the those of of website the abstracts. abstracts the and linked the posters
final will the have and Greg one as who XXXX, Officer, turn XXX active to Chief So XXX a with our three for XXX we for clinical make during to to note, for two quarter. call over happen. this one INDs, the active are results trials, XXX. And will Mr. we Chow plan I now eager in and and two one review Financial