us everyone today's to Thank afternoon joining on you, And Adam. good call.
In six clinical three Phase stage want we start believe be now of macrocyclic in to I this our Point clinical our trials. strength stage to clinical is quarterly I four one the one what asset ongoing in from years, As by the assets highlighting XXXX, past last ongoing clinical advanced in team. to trial our have platform call true I Turning
In for for designations pipeline, we asset, two our repotrectinib. lead total designations of regulatory our received nine breakthrough have a addition, including therapy
$X than as and fewer and that on now XXX we in rapidly research XXXX future looking in development prepare well our expertise we additional are we over potential background for advance the clear with scaled as are to medical pipeline from has teams. of a and XX cash, company employees in discovery, employees we with billion as well when and positioned growth and With were repotrectinib with Our focus innovation affairs regulatory. clinical our current a believe to our commercial to continued launch
had resistance inhibitors was of internally differentiation TRK, recent potent, advancements and response where been RET in ROSX+, our in could Our of design developed believe or increased compact and therapeutic launches in potentially small platform current pipeline. overcoming the occurred. indications few by made. ALK macrocyclic we Since that multiple highly durability spaces treatment Yet then, have to differentiate the to continue MET, potential
believe to lung data previously best-in-class we TKI repotrectinib, in the cell potential reported based non-small it naïve be a we positive TKI on pretreated ROSX+ inhibitor and Focusing on cancer. the ROSX+
in the seen are solid granted early and the are TKI addition, therapy breakthrough pretreated no population, advanced currently In recent patient in therapies. patients there tumor approved signal enteric by where we encouraged targeted the designation positive
prolong biologic that Moving has to of elzovantinib it especially potential we of duration as the continues to second co-targeting response. differentiation to in due and SRC in our CSFXR of candidate, believe show potential the development, supporting drug the rationale to the
team of of repotrectinib in recent milestones next elzovantinib. multiple FDA FDA and with first Shifting and TPX-XXXX, we upcoming two updates pipeline out quarter the the elzovantinib to Turning especially progress our for and Point with recommended drug these heavily on its can I'm quarterly tumors, four TRIDENT-X and dedicated we data Phase as a pleased talented in candidates, II for are clinical our and KRAS-mutant TPX-XXXX combination studying where the in study, I Rounding to continuing with patient repotrectinib, pretreated designations the along our interactions for announced forward since GXXD focused presenting sharing collaboration look both solid planned EQRx. from last Phase year, We clinical from the further repotrectinib study are sixth potential. additional two our updates our made highlights call. and trametinib finalizing dose We studies. evaluate pipeline, with initiated now the less dose population, the received programs regulatory finding our across
who where anticipated recap provide strengthen into welcome more to Corporate ongoing introduce of Adam executive XXXX, second recently President cancer yesterday nominate targeting to team, four large am we GXXD KRAS targeting inhibitors advance one most of us to small continue stage and future Adam, as will of target development with PAK, regulatory working years candidates is Relations of our recent work, and many the XXXX. tyrosine look our He I large half experience over the I across joined lead and study targeted addition, of In number the inhibitor. Senior advanced more in signaling. brings milestones both chose market TRK discovery We are play to I specifically goal multi-cohort to of advanced ongoing drivers we clinical and team. Communications. the the early repotrectinib BTD continue advanced two Investor for cell lung biopharmaceutical that who no next populations treatments. therapy currently Vice known our with enteric is our and both genetic time. positive begin fusion, by generation I other following our our TRK Overall, program roles our hiring clinical Repotrectinib in chemotherapy received an strong details with with in patient solid on you him our given closely have kinase and aberrant accomplishments opportunities, granted registrational to that tumors. or in rationale in with to second of and to than in And Adam these being gene pleased or ROSX+ forward Today companies. prior XX cancer with alternative biologic October. our treatment for and ROSX+ prior with TKIs TRIDENT-X competitive satisfactory breakthrough the have the our and NTRK+ addressable studied the potential positive We and patients will repotrectinib, due without two agents current of progressed that granted patients tumors designation solid developments. non-small one targets was FDA GTPase have our approved and limited treatment
and I/II settings the the we and presented TRIDENT-X non-small advanced with targeted patients the two month. activity, pediatric demonstrate BTD Having well frequent promising including on repotrectinib, As pretreated our advanced positive study populations, FDA positive with regarding repotrectinib approved are ROSX+ we for study updates tumors one B and FDA now TKI a three plan enteric to strategy. there NTRK solid have currently from patients. where dialogue Phase pretreated from registrational TKI a and continued in therapies. Type positive solid the clinical discussing both next next to received registration continue tumor enteric result, critical to towards in we young in cancer adult CARE no repotrectinib the data meeting are In cell October, registration for with of positioned steps patient at Overall, repotrectinib lung
the to Looking data anticipated least with least and at lung cell review of majority these in available the at with XX discuss six months of the report XXXX, pretreated from BICR ROSX+ TKI TKI cohorts BICR cancer XX We we patients quarter line plan data of all blinded plan non-small for data of the four the plan this a the to responders. up XXXX. second top in second naïve XXXX. into we center of follow TRIDENT-X at pre-NDA to from cohorts quarter At of in the FDA independent discuss meeting meeting,
Chief of volume Officer, Now, commercial commercial me we advancements prepare shift organization. hiring we to to is with a let Andy, July, as high team build community to continuing academic This team. settings. engagement Since KOLs in out and our continued some have made and last our the prescribers Commercial leadership we've be
higher with grow one-on-one interactions, is repotrectinib. ROSX+ in continues US and boards, rate, increased been and/or potentially the has a non-small delay we research, consistent feedback increased resistant two received refine naïve medical market cancer our engaging TKI setting. across response team leaders is affairs in interactions for durability, to the understanding progression the which our thought globally. free The survival, therapies, the of approved the clinically cell we mutations continued that, advisory In and treat to our have meaningful oncologists, of addition, compared the to or could be Based lung opportunity emergence to on and both ability have
the ROSX+ and Phase progression survival as naïve the of months reported of TRIDENT-X of are from XX than our in which previously outside As patients pretreated in not median historically the with rate lorlatinib, from TKI reported solvent for cytotoxic approved of setting, our with setting, as median I there in options this higher a independent XX.X patients has positive II a response reported competitors months Phase front demonstrated in confirmed of or XX.X ROSX+ and mutation. the review analysis. utilizing the we've previously response preliminary setting datasets, well duration free reminder, TKI a responses study portion blinded central is GXXXXR patients In limited a chemotherapy not
clinically that with in ability the overcome interactions setting. meaningful mutations highlighted In be this addition, our to oncologists would have resistant
therapy we the potential setting currently potential about on and and on patient and NTRK repotrectinib's positive data we repotrectinib, As Overall, we best-in-class we encouraged population. research look data in designation where its the breakthrough TKI our in targeted believe to there no in enteric are excited based by preliminary advanced solid be continue settings. pretreated our received our data, this we therapies. patients, recently both opportunity at for ROSX+ the are approved tumor in in Based
in non-small with encouraged cancer. our and lung lung pipeline And TPX-XXXX, preliminary and both being non-small completed and we focused multiple our dose by MET, the cancer gastric There is or currently we to ongoing I approved the the are advanced the lung in therapies alterations elzovantinib cell our the MET in study. including in opportunities was Phase CSFXR At non-small cancer MET SHIELD-X on cell in cell cancer for study genetic we non-small data studied patients meeting finding no of currently tumors I elzovantinib, cancer. elzovantinib, gastric steps reported inhibitor MET. in portion skipping an in Next elzovantinib amplified have harboring in believe the solid for updated next third that AACR-NCI-EORTC Phase targeted In end meeting, lung differentiate the we indication from Phase I exon of XX cell were with cancer. amplified FDA SRC quarter,
Phase II data in portion proposed recommended the quickly study on Phase plan Patient based dose meeting, to Phase SHIELD-X the ongoing. XX to Phase to the into as when II milligrams at available, twice to of of dosing available XX in guidance II from milligrams we the Phase at intention the is this we this planned and to recommended at enroll the dosing design patients screening on cohort QD II XXXX. And a to the possible. dose. of explore milligrams SHIELD-X XX the feedback II on portion time daily registrational least using dose a revising patients at design an FDA provide of of that dose XX with XX starting of X We The meeting. daily milligrams We level and initiating X FDA During we daily received potentially additional recommended prior the of XX the our the to twice Phase BID portion data study. the to daily level intermediate I/II as titration least the at plan strategy intermediate the to dose
we enrolling daily to level, on also XX in are titration dose continuing study the we milligram level. milligram XX at the patients I enroll focus the While dose twice of intermediate Phase the expansion portion to dose daily
with to announce month. Last, collaboration feedback the in to of lung MET-amplified the a amplified anticipate it gastric with advanced for path we mutant, non-small relates cancer cell inhibitor EGFR clinical on we patients EQRx excited EQRx's combination were elzovantinib, to as addition, next MET for elzovantinib with development evaluate in EGFR cancer. In elzovantinib treatment
our the study of pipeline, in pending next year. the planning and IND to TPX-XXXX, TPX-XXXX, the Rounding ALK RET SHIELD-X the penetrant initiate CNS mid-XXXX of out FDA combination inhibitor. in are by clearance first inhibitor, half our our We our
XXXX. portion with are Last, dose finding aberrant turning study finding We enrolling internal known XXX in I of GTPase currently drive SWORD-X patients I Phase to medical study significant we the portion unmet signaling Phase and genomically-defined have the dose cancers FORGE-X the that to the of four for of target programs discovery, need.
development programs where the second focus in advanced XXXX. most on are GXXC PAK, and two Our we of candidates targeting KRAS half
Our are goal is and number beginning of targeted year potentially in in XXXX. given that opportunities, one We development meaningful submit believe agents indications. clinical per to in IND these approved are limited the these
update provide Now, let me over call to on turn an results. financial Paulo the to our