CUE - Earnings call transcript Q1 2021

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Operator

Thank you for standing by. This is the conference operator. Welcome to the Cue Biopharma First Quarter 2021 Earnings Call.

As a reminder, all participants are in a listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. like President, the IR now George over I'd Vice Zavoico and Instructions] to conference turn to [Operator Corp Development. ahead. go Please

George Zavoico

Thank President Vice Clinical Millar, Chief and Medical Thank President everyone. Scientific Officer; today's of Cue Good Dr. Pienta, joining Financial Chief CEO; Chief Shannon. Acting Ken Biopharma's Suri, On Passeri, are Kerri-Ann Matteo you Anish Development; Dr. Officer; and Dr. us. Officer. Dan you, for afternoon, Levisetti, Senior

please. slide, Next

other various prospects result of I'd remarks March including this of begin, on factors, of the company's to to by statements Reform like annual Risk the XXXX. discussed filed results SEC be from forward-looking Litigation XXXX on at makes company's you that Act as the XX, EDGAR for time, Securities SEC the company as we made during indicated Actual the time which accessed that these statements Before may www.sec.gov. in call future with remind company various important expectations, constitute can purposes the XX-K as by materially about Form differ Private those the filings a report of plans the to and on the database Factor forward-looking section those from well

In today, the representing company's addition, views March company's not any of relied forward-looking any upon as views date. statements only XX, subsequent should as represents the of be XXXX and as

today's via even statements to the of call next update for Cue that call versions to, turn XX-days. CEO. Dan to obligation Live forward-looking accessed I'd and elect at being the future website Please event so may like these archive the disclaims company Dan? can change. be Biopharma's company's over company Passeri, the if the any now company’s recorded. point, some the While be to is do views advised the specifically

Daniel Passeri

first quarter with XX-Q thank available detail ongoing everyone. which results, as of afternoon, on our are Good And our SEC of May our XXXX us in you filed progress, Form a well the for joining XXth. review financial as George. for more Thanks, today in

programs. the he on Ken data Chief today's Clinical the will Matteo update, overview, provide our the of President results Officer next Slide as for turn associated over the and across programs then closing and call our Levisetti, clinical both call highlighting well Officer, Development opening come I'll call prior our introductory since provide X. of will our summary I'll provides Scientific additional and progress last update agenda CUE-XXX our escalation upon Our with Vice shown our which an the Ken on summary in Kerri Phase developments, X a to and an for disease ongoing Medical Acting as Millar, developments a call, monotherapy a Financial last After clinical slide, brief I'll to ongoing dose review Senior and for will Dr. call our back President is and provide Officer Matteo lead brief recent program emphasis our financial each Chief provide then is questions. Suri, trial. a will quarter, Dr. Pienta, is a to Anish of overview over Chief who and summary first of the Anish oncology Dr. After turn provide progress who platform autoimmune our our CUE-XXX.

body. We of of Immuno-STAT which we nature's refractory bring selective design, monotherapy relevant for portion name own is the engage cell our de-risking cells like for disease T develop our which Through remind and the escalation is partial Phase population. T and hence cells. which So or important by you to number to or to need cues, specific confirmed and resist foundational part stated to in immune an the I'd candidate. CUE-XXX our lead view directly rationally a selectively engineered mission, balance Recently, modulation patient of aim in that for patients and with Phase response activating to and X, or trial neck potential this patient's targeting squamous head immune as of these Slide modulate providing on Slide trial positive confirmed biologics to and dose cancer approach, evidence X single begin, is ability disease, X the It's T the Phase escalation patients. reported restore second response from infectious the challenging on X, currently of clinical of harnessing carcinoma, by recurrent and balance dose of or inactivating in a targeted or to PR, as to this the heavily CUE-XXX, first is further in provide monotherapy context Anish like associated a representative cells a partial agent metastatic line of momentarily. cells HPV pretreated case in on and drug the approaches trial, system event, updates cells oncology platform, I'd our T patient's engineered X we restore a autoimmune Again, number disease. will relevant and dampening beyond activating shown here with CUE-XXX in T begin

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data to premise As benefit of reach frontline in the HPV these greater KEYTRUDA, action patient therapeutic who may in this expression. CUE-XXX a neck the HPV and look score, to In head providing as ongoing patients, based an data a quarterly late-stage as enhance patient upon also we currently we with drugs the update emerging combination monotherapy is cancer or for of it referred which summary, the pembrolizumab transformative trial at believe presently objective EX-specific for is that call. treatment trial a study refractory forward positive potential we the combination cells, provides is as for and trial to mechanism from standard-of-care that T recent on clinical enrolling believe the activating The positive population. combination Cue also than or this PD-L and the a for have have next composites KEYNOTE-AXX patients one activity monotherapy CPS be evidence Biopharma, patients, supports prior

IL-X of clinical well that data programs. and our CUE-XXX, believe drug provide also as Ken modalities to from We compilation on vaccine or date. to candidate further lead Matteo this supporting differentiates candidate product data our drug competing a pipeline will as details

base our escalation these dose also recognize reduction to we that it's for This the is trial, the So, and entire X slide, on CUE-XXX, as favorable, ongoing data if continue to important implication, shown next provide principle in risk data Phase Slide validation CUE-XXXseries. IL-X number by generate and X.

same the difference HLA for essentially nine demonstrated the the antigenic CUE-XXXseries MHC, epitope roof. the amino the on framework primary slide, base As here programs being binding the our in underlying IL-X remains across with this to XX acid

in with product To resistance being of well Immuno-STAT Chem. is the protein second providing potentially protein or immunogenicity. Our and an candidate HLA reach as CUE-XXX the tumors territory number Neo-STAT developed resistance address LG to is from which targets drug which also hematological address expressed as we've onco-fetal mechanisms series CUE-XXX, WTX, CUE-XXX the is redirected one partner Wilms' cancers, collaboration a or Tumor in solid heterogeneity, in mechanisms, loss with and to derivatized RDI-STATs address patient expand Asia us of tumor our tumor which series,

mechanistic to for clinical believe have that we derivative provide in CUE-XXX series potential positive CUE-XXX support results the the entire Importantly, for platforms.

drug our platform's pipeline an First, expansion, modularity flexibility on address of Anish oncology will disease. an both provide autoimmune overview and and to provide candidate update potentially and the

to approach, demonstrate update, immunotherapies a partial the will discussion response. of of Ken Anish's call provide protein a strategy, breakthrough transformative more focused we our that, of provide our With believe nature potentially and corporate Following Through turn to the I'm confirmed to engineering including pipeline going in over the are clinical we development need Anish. patients effective execution update, Matteo of recent now therapeutics. for well-positioned to

Anish Suri

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today's presentation of this clinical and selectively of previously, T and systemic shown As believe activating be in exemplifies data, IL-X as have immunotherapy. such the CUE-XXX later specific for targeted versus observed approaches We power cytokines, cells. cancer for the highlighted will we tumor potential

of versatility interest. Immuno-STAT derived swapping T epitopes respect In to tumor the strength addition, modularity, the platform its of to indication change a different with key cell is and

provides encouraging exposure and response pipeline to and on shown and while targets The CUE-XXX. CUE-XXX, targets filing tolerability, we of framework We of experience the T The next an respect HPV earlier. clinical more are data CUE-XXX holistic tumor impact first-half Dan molecules next mentioned now PD including data, IND its and metrics candidate CUE-XXX with the EX-specific on opportunities, the believe As by which here. platform PK clinical Wilms' in enhancements. CUE-XXX X, identical multiple with as molecular anticipate the a Tumor for X, CUE-XXX, cells, Slide of IL-X as between therapeutic and XXXX clinical the favorable slide, various view example, support majority that our

mentioned reduced is Tumor clinical pipeline before, to Immuno-STAT CUE-XXX. risk that KRASGXX valine Wilms' CUE-XXX molecules as have it profile X and our assets, the including observations belief of the First, targeting due a

tumor a as we remind us platform, you to Second, data. address stabilized believe the empty IL-X series core generate the the efficiencies. from allele and also clinical IL-X epitopes and since the clinical strong is the strategy that To tumor CUE-XXX benefits application which to the the CUE-XXX tumor to the an and series, perspective, allows directly we a be based believe of target CUE-XXX us scaffold CUE-XXX Neo-STAT the designed core heterogeneity, the peptide, HLA is without platform of also based that Neo-STAT efficiently Neo-STAT a HLA current tumor antigens, derivative can This maximizing multiple IL-X conjugated. allows provides support for desirable cost same. molecule which with molecules remain sets to data clinical time From generic

that CUE-XXX, is redirected of benefit IL-X designed since also believe the or address framework from antigen Immuno-STAT HLA or also to we Third, of the mechanisms RDI-STATs core presentation tumor Bi-specific the defects same. loss, the escape essentially development derive

et CDA of that cell with tumor tumor targeting cells memory T epitopes along arm allows virus engage in a loss human fraction the CDX One, defects, bound activation perspective. the essentially may distinct molecules cells. T contain invisible T of key to binding be tumor New Bi-specific T and a resulting toxicities. of can to makes novel unique TropX this undergo cell tumor Bi-specific some XX% of anti-viral cell, a approach To early have surface cells HLA indiscriminately as observations. infected this from Sciences safety Immunotherapy the other cells to such exhibited Bi-specific viral meeting, that them the from cancer key a significant at Last and cell cells, T in which the And systemic antigen, up in format systemic a based evolved we HERX cellular data antigen release for Bi-specific virally cytokine presence end, and RDI-STATs Academy on avoiding while presented a as manner, to will cases, of from RDI-STAT cetera. indicating efficacy Cancer In by two, molecules significant in tissues two very advantages two to the specific equivalent week, that cancer observations mesothelin, tissue. that and killing and components, activate in target cytokine revealed compared analysis appears molecules, killed T specific to York presentation cells, of We which RDI-STAT The of several Frontiers secretion. RDI-STAT have is provide human cancers patient. RDI-STATs We a the mechanistic recognized anti-viral believe the to

inflammatory IL-X for design autoimmune have novel and For cells. and induction T molecule exploited a expansion we same diseases, class variant and CUE-XXX from of the first regulatory

As shown contains key differentiation. beta induced TGF here, variant this the molecule for an IL-X a CUE-XXX signals iTreg two Treg variant or and

Importantly, receptor focus Tregs on expansion biased towards is approaches, not the IL-X in contrast IL-X to natural and other variant of alpha.

arthritis human rheumatoid subjects, assays and and presented bowel CUE-XXX from previously can regulatory induce diseases. cells suffering healthy derived T inflammatory patients in have an that from from and expand We data vitro indicating

cells of the cells in data Animal Models and exhibited effector T expanding inducing Vivo recently, activity. these vitro in an we've CUE-XXX More of action persistence additional in that support and importantly, vivo suppression generated Tregs, More in T of assays. mechanism the

on the autoimmune additional the summary, In following of these slide, broad will scientific on in a sharing outlines future X, front. We exciting our forum. vision details datasets Slide plan

CUE-XXX antigen-specific additional core and year focus and made diseases and last reactive relationship on well-characterized previous at update expansion the these the exemplified progress, with cells, optimizing slide, Those auto on and lead few via continue efforts and We've data antigen-specific progress the to make which year, have generation we And centered presentation a diabetes. lead discussed the the strategy two for on here cells on approaches, regulatory with slide, Merck we CUE-XXX I'd available Ken on pathway-specific approach, to the T to modulate focused on potential CUE-XXX rejection. T the slides T CUE-XXX. extension Earlier expansion on meeting. this graft as provides for Our focused our directly antigens, opportunity presented pathways has In approach, X autoimmune cells the patient's in clinical applications. molecules. to in Immuno-STATs deploys numerous previous broad host approach The Ken? regulatory even as collaborating pass approach reset transplant tolerogenic been believe a of autoimmune With asset by tolerance with key for unique body. are progress strong website. such antigen-specific is that on diseases, induction and a two for balance of to to Type versus a We clinical as in provide our contrast, summary, like in of antigen-specific pathway-specific underscored immune Matteo to the our auto candidate pathway-specific. update or diseases, call disease and significant

Ken Pienta

afternoon, everyone. and good Anish, Thanks,

As participating the always, shown their I'd the say thank like on to all names are to you next Slide of XX. principal slide, investigators,

HPV-XX throughout enroll to we pandemic. to and our in screen cancer trial participate head As the calls, we continued COVID-XX previous earnings noted positive neck on patients have have and

or high-level a clinical Phase summary second ongoing and recurrent and enrolling squamous future. of carcinoma, patients the the positive now enrolled are XX, at fully cohorts trial dose neck beyond tolerated X patients per in design expansion MTD, by per without of Cohort to kg at have head for dosing through this line enrollments HLA-AXXXX selecting at in X nine kilogram cell milligrams each of near of next Slide mg metastatic dose, X our We and that completed a shows The kilogram, cohort HPV-XX. X milligrams Cohorts and X per CUE-XXX, slide, maximally dose or reaching anticipation and the have driven with X X

this the completed A We dose have of escalation enrollment in Part now portion trial.

nine have I epidermal this given dose with choose in noted Slide confidence activity dose. also provided effect bolster opportunity ability us to of Several The give make to the next patients to observations to growth details our Many patients XX, and than dose Phase with of an treated that factor most failed patients The a for PD the B appropriate checkpoint calls, previous our enrolled patients data Part As or our recommended greater expansion, been chemotherapy treatment of X cetuximab. therapy line vast of the the earnings in and and majority some about of informed XX% is to dose. maturing shows order us the have phase trial enhance to presumed more slide, failing decision protocol both after inhibitor. today. any to provide in third cohort, escalation our to clinical inhibitors the evidence platinum-based our expansion CUE-XXXas up choose allow

in of data our to CUE-XXX shown in XX, tolerability as the Slide date First, demonstrates patients.

X through per X Cohort kg an without treated have We as mentioned, MTD. reaching mg at I

observed the decreased AEs observed today that patients. in with are observed are SAEs most lymphocyte treatment with include counts. or those observed of consistent common cancer fatigue, typical All with those the administration, AEs IL-X and The of anemia, immune modulators of

calls, pharmacokinetics shown Slide reported anti-drug previous as of received antibodies and or slide, dose dependent effect CUE-XXX. in Second, multiple doses patients in our reveals PK data next of in exposure that without the on have earnings any exposure is the XX, or PK, evidence

in sustained natural pharmacodynamic component, broader the the cells, NK an in tumor-specific doses increasing killer increase proliferation CUE-XXX CDA effects, or with cells cell evidence earning as of calls, observed previous in positive versus exposure T has and of again, including Third, led CDA positive reported of early increase T to cells.

has Fourth, CUE-XXX. disease as the and as a cell of activity, by of evidence brown cells, the T shown positive samples cells, biopsies phase panel trial, confirmed CDA dosing in as we hand of on cells, and market pretreated in early points, as various We as patient as five expression therapy blood Fifth, infiltration CUE-XXX. cells. shown histopathology data hand T left receive Slide and noted increase the evidence of revealed panel, call, the in the escalation cells is including at shown fifth shown dose receiving NK on a of previous shared pink right and fourth EX-specific the have in CUE-XXX the have previously after staining by had T on stable cytotoxic that time CDA of tumor PDL-X line earnings with staining, of third, heavily infiltration, from the patients anti-tumor positive patients patients, is after treated XX, well necrosis in

in for patients HPV bolstered addition a patient potential active last disease In disease, further to which kilogram X the positive agent specific milligram dose head we pharmacodynamic cells Cohort describe these cell as neck treated patient, five observed to response. responses cells, by blood an week, the the per NK of seen some and of mono I supporting at with the to have We carcinoma that single believe treatments. of activation with observation observed the Matteo promising stable patients, in call evidence X agent believe activity partial over announced is in that confirmed had supporting our which and in clinical squamous demonstrate something provides this immunotherapy hand patients. T partial CUE-XXX Matteo? greater We a detail. will rarely in CUE-XXX, of data, these that data is in this

Matteo Levisetti

XX% target patients, correlates failed XX, we day cells an XX, after The their response not with of with pembrolizumab for the series their see disease, their eight we one this of of partial increase first for supports slide, that patient the seen at entire as associated data a eight for cycle systemic third increase T treated to had the after in patient in on The in response. cycle At nine-fold through Tregs further scan, some Similarly, XX. to observed was patients. that this increase therapy. sample as one associated recurrent their day patient the The of day have returns cetuximab by demonstrates panel line this in data panel eight next was Slide slight cancer. other this This confirmed four of other the one the CUE-XXX the therapy, on of patient. the had the blood CUE-XXX in this in in peripheral and NK and metastatic day previously therapy lesions. marked cycles day EX right only in The cycle their And have second clinical of from Ken. CUE-XXX, with we pharmacodynamic action scan beyond. middle that two demonstrates persists mechanism the support These Thanks, cycles shows approximate patient. size confirmed and cells, develop data but and Immuno-STAT positive platform, specific baseline meant decrease

Cohort which also an Immuno-STAT anti-tumor infiltrating favor tumor may to in microenvironment MHC a B, the Methods, mechanism solid immunity. components by engage an supporting from marked doses action a Hence, can of CUE-XXX. Slide validating penetrate cancer far also patient these two a after local on lymphocytes. before providing NK see X, slide, the granzyme the CUE-XXX. Nature of of right, histology most These the and next to which the of demonstrates secreting data engage inside tumor on the alter graph TILs to wanted data weapon XX, serine the the cells. is have It's histo the Slide B natural commonly of where again, directly toxic are Immuno-STATs positive published increase the the In supports XX, post-treatment new core late on cells results in T and mechanistically also and right, with granules of of valuable immuno-PET potential last of you On data demonstrated a toxic found of action mechanism of utilized the also Granzyme micrograph CUE-XXX. cells by that instead I share scaffolds directly in peptide quantified to tissue, the imaging year supported tumor protease, T cells, are CDA preclinical consisting could the administration kill cells. and cells, you that killer of biopsies

the also continue monitor previous we appears enhancement CUE-XXX noted closely, what of dose trial. in to earnings in survival and As free observe survival and overall escalation survival to the an patients be to progression continue calls, to

Our for they survival FDA endpoints, and the demonstrate but discuss clinical progression, allow are allow cleared once expansion of insights by two financial patients to regarding to phase investigator for anti-cancer observations. gain remain study if stable, preliminary clinically may will add Kerri quarter radiologic one into now exploratory of on amendment trial to response to will, the by subsequent criteria at protocol discretion data results. assessment patients I our to third, collection further treatments receive hand the over call first iRECIST

Kerri-Ann Millar

Thank you, Matteo.

clinical the Turning November to three $X.X of March Merck and months primarily ended now $X million we on which approximately brief I'd with and respectively. and million XX, XX, in XX, to company $X.X expenses. in the months XXXX. XXXX, travel-related undisclosed extension in provide XXXX, development the collaboration administrative Slide The due decrease million financial increase promising three for the a to March revenue and months and the of March was XXXX, disease. treatment update to and The laboratory March three diabetes, $X.X expenses XXXX, to for XX, now XXXX, costs is decrease results were of cash, $X.X stock-based revenue XXX,XXX our of as reported program increase $XX.X and common $XX.X objective XX, million ended General ended months the were legal like million XXXX. and $XX.X approximately a autoimmune for $X.X and incurred stock, of of We support Nicolaus are cash XXXX and The research sales from respectively. in equivalents ended through preclinical the the through first during funds research financial primarily respectively. as develop identifying and the receiving XX, generated further was Type of March Stifel, acted from of an additional expenses due for additional revenue three In same the the X Research for biologics million marketable equivalents believe allow and us and compensation XXXX, working with Company, our into who April, Immuno-STAT The as runway of under for with sale the million back quarter I'll approximately fees of cash, the marketable the turn the cash market our approximately of Dan our million. with ended including closing CUE-XXX securities, the our platform, in the the period to will XXXX, to million our support to over fourth in clinical cash of primarily and April, quarter ATM development equity XXXX, remarks. to extended due the of we our offering call We quarter received shares and & from agents. capital at XXXX. along Dan? compared securities approximately candidates development

Daniel Passeri

in and and to heavily Immuno-STAT proof-of-concept the support drug cells to single important study in disease, potential CUE-XXX CUE-XXX, the plans with the pretreated of and of series, as to activate to carcinoma, study also our based CUE-XXX HPV valuable the such combination the expand milestones on the important and head CUE-XXX with the which in support the monotherapy other second-half and an to recommended is for data neck from year. patient's NK candidate adjuvant cells tumor to a a step selection directly agent as this treat for XXXX, patient supports Thanks, CUE-XXX, relevant CUE-XXX this on initial to positive of T the from candidates and not include well, but initiate These cancers. We a results only anticipate our neo second-half the our dose for Kerri. milestones year, is possibility CUE-XXX clinical as of follow population, potential treatment beyond a as the of In evaluate conclusion, monotherapy. oncology, Phase second the for X method of a and our the microenvironment, product effects a challenging throughout CUE-XXX X activity pembrolizumab of a in of the provides as as confirmation IL-X platform expected number drug of body, path launch forward Phase further planned registration and of a by of development of line squamous further cell mid-XXXX, for of

as market CUE-XXX We and patients moving known with by KEYTRUDA path in the also continue to deliberate status demonstrating the where for trial clear and as market associated update next of We providing anticipate believe and and look focused trial mechanistic positioning aim size, strategy in studies. at programs. We agent of pembrolizumab and the upstream potential with a a preclinical therapeutic, advantage we trial call. corporate registration reach to provides single the combination to execute competitive our potential the provides forward enhance synergies, a that Immuno-STAT the demonstrated earnings our as forward platform manner, patient first prospects our to significant line monotherapy

we'd trials. for clinical activity assess of want a patients of opportunity Finally, the to like provide our potential board to over need. dedication us I and I'd candidates. through to questions. important commitment thank and much resources like essential importantly, assess back support to we corporate and the part study willingness professionalism, to call patients executing therapeutic directors their to our thank your promising to interest. in developing drug our operator work, involved very attention those therapeutic the and I'd continue Operator? But want their to for our for thank our With our and potential allows shareholders to of want us drug whose the employees families now with to thank to that, mission courage and in you strategy. who to Their the turn benefit guidance, us their continue for promising candidates allows be thank and our the development like clinical

Operator

you. Thank

question-and-answer will Instructions] We session. now begin first ahead. BTIG. Tom from Our question Please the [Operator comes from go Shrader

Tom Shrader

quite Thank you. be the It's you hopefully not to first, been the And let push. congratulate me but the a only response. on

I Anish. So mean getting in the might have what point for specific And have least congratulations. and as a you of in are question tumor, How general question, then curve you to levels? to levels a kind tumor-specific for many blood you I I at can where of if Tregs T levels this have the start example? cells probably blood do tissue-specific can. define And to a patients the

Anish Suri

Tom. sure. Thanks, Yeah,

detect data bleed happen about we patients. caveat T is the zero, we've able day our that so they of once injection and get at the third been middle clearly by things cells at that XX, fair day to a from the in there's EXs have about, after in in activated, So, bit extravasation because of I a so blood. Tom, of And, the evaluated expansion points major that times, drug in of far, sampling

outcomes. enough ex correlating a the I need in be significant as tissue, that, So, been from are no we insights and study, protocols. because just resection expansion, we view a analysis. PD read will mechanism the a with activity, sort And nine-fold for positive in the additional the this said any I and post-surgical tumor Having by also end first an et think with action a ultimately, of presented, to of the here, is target disease just about make saw that neo hard conclusions the just fact response. that numbers reasons whether you of able the day post additional increase as blood more blood Matteo have the say is blood that the these have in into the tissue simply the reveal meaningful objective why of vivo deeper to direct do that's that wonderful guaranteed you for a but the We and detection of to with think or about it's sort reported prior a presentation. field as at seven-fold adjuvant of administration. out. pushed doing Tom, to one This this and increase. a pre narrative at We'd follow data these pass Remember, have CUE-XXX looking patient when where have cetera, we was we've And actually access general will in stable

biopsies is The positive hopefully the I will from think rest current correlations. start to data on and fascinating, able the think through strengthen those a trial study, gathering perspective. neo we the I go it's adjuvant make of metrics and the be mandatory. in So, PD as not blood very year, the But are the we

you're well are aware, optional. these As

drug there that But kick patients sort us data and to thankful start to present there. mechanisms have effector to although been and the provided that grateful very can events we're administered. fascinating just the fewer So have is those, in is of nonetheless, Matteo the discussed after see immune

Tom Shrader

is disease you be Tregs in that of antigen? the anti-inflammatory data several you know Tregs the need and program, antigen. the data enough on get think Tregs exactly one or just quickly RNA yet? any a where can then Do your effect, you RNA you some like you would will of the sort there presumably have exactly model a And Or, it in RA, joint

Anish Suri

question, it's Tom. a No, fantastic

diseases Tregs many of So RA, think not modulating vast, would is having antigen they I turn in reactivity. or expands that and the it's it CUE-XXX asset like where control especially cases, because and extremely And like IBD, autoimmune of then, is is globally, the and like diversity in lupus, cases around beneficial, the chronic hope well-characterized. this

antigens case. In Merck DID, role like of in Tregs. exactly strategy and example, the fact, that's this of absolutely after the identity, antigen an these assessments actually That in like of And or cells. vast deploying our some had of that's the those Immuno-STATs, the reason we've antigens, focused to of potential agnostic been is you're for why are where a what goes diseases handful a really what in seen dual and that those pathway-specific that's for we're activity the well-characterized. regulation vitro in we've of dominant that's proinsulin collaboration, with But Immuno-STAT, right, But deploys are has contrast of antigen-specific diseases in seen. that with

Tom Shrader

Great. and again. Thank congratulations you,

Anish Suri

Tom. Thanks,

Operator

from next ahead. Our Please Mark question Oppenheimer. go from comes Breidenbach

Mark Breidenbach

the the little a let responding was patient, acquired my long more wondering bit been about congrats CUE-XXX? us resistance? progress, good whether a or could how not they were primary patient partial refractory And tell also, especially And receiving to was pembro pembro. and It's had this off the I before Or, of you case Hey, the me on if response. if add great news. on afternoon.

Daniel Passeri

take Ken, question? to want do that you

Ken Pienta

Yeah.

and the is, any checkpoint But, it's And all this patients, patients of have a the how inhibitor. be I hangs pembro into virtually sort pembro there been PR in on these that system. pembro system. wouldn't for XX-weeks some the So, patient of say treatment, with what controversial sure long can kind in confirmed failed think we

still study. patient's the on So

but more hesitant about be I'm patient, share to so, too report calls. that much we'll to the later happy And in

Mark Breidenbach

from of infiltrating collect Okay, can nice us. sequences follow-up you fair enough. just you from we if were biopsies biopsies able TCR post-treatment And see to quick one showed and analysis I'm the Thanks. really expect on responding inside patient. to lymphocytes. fair wondering an the I'm pre the glad tumor

Daniel Passeri

take will that. Anish Yeah,

Anish Suri

Yeah, Mark.

So that very an high for interest has been area us. of

the platforms oligoclonal As we know, functionality them, cell using expansions. in preclinical of studies TCR where and with study do to very the mug, also one and our is we response fair show data cell is able single here And have to bit and be the again, to with you the reported exactly only epitope, characterize but That in get specificity. Those fact, can done is of clonality for [ph] with neo identify ex-vivo in in TCRs, tears clinical Immuno-STAT adjuvant then intention expansion. well back single to that's show we a major expression, to clonality previous point to that the previously the for coming are both sort express we've the samples. analysis intend EX models there not a of goals pair intention that's to

Mark Breidenbach

Okay, perfect.

again the data. and to Looking on forward congrats it,

Anish Suri

Thanks, Mark.

Operator

ahead. Securities. Please Our next question comes from Reni go Benjamin from JMP

Reni Benjamin

questions, on seen terrific patient if just is was A bit on know relatively little as count I rapidly? study that news. we guess, to of you study, clinical about instances Hey, higher quite or that progressing? off is guys, this Was any you've You talk I well comments, patient couple were related progressing with stable just to fine? the Or, the you starting Can he's entry maybe prior peripherally? to he the if but slowly a cell still he can. highest congratulations can there levels? we date into the the saw make And, he is don't the T where doing CDA overall, that, mentioned other

Ken Pienta

patients study progression Patients' cancers relative term. I'll on and rate in and and of the comment on levels, clinically remain CDA progress I Anish let And I'll is guess, a but feeling Well, does good. the not the well. is, that's is, grow patient what say

went on patient the so And study.

like still the to the would I hesitate active, think, detail lot into about go patient a because really patient. I to is more

Anish Suri

by understand area we're into the insights able And expansion But, obviously we opposed deeper more that limited to we what on detect samples. in positive an driven in rare trying mature, emerge fold will add frequencies a just these understand increases. And even as is is to have But, contraction just have preclinical and able where to increase, basis Ken Reni engagement, prior you in more snapshot them. the to that of in hopefully fact, we've we sampling, see what with to cell in patients sort one done on time Matteo the caveat range, and get this noticed this. at cell the have get we've find primary major extremely more you sample continues point, it this can as do in to where fold a so well gather the that seen the what models, denominator And, that, you regular blood to nonetheless, in but amendments of and that it's situation. insights of this to increase been can that is to data of is kinetics T a expansion samples knowing kinetics accomplish by again, to is T want Remember, initially. Reni, this I the do so driven again, be can

Reni Benjamin

Fair enough.

are that dose, about think decision? that what kind can that to you X through becomes see responses, just recommended us the don't, drive X we declare whether you need As the Phase do I what have if factors to You additional see Phase that think and recommended have metrics easier, patients enrolled, or you're here the of are to going maybe you metrics considering? talk What other dose? the else nine what decision then you

Daniel Passeri

Ken, do take you that? to Yeah, want

Ken Pienta

we the Yeah, thanks. data, data, as within PD as the maturing, literally so. to the have which data clinical data, the of cohorts. Well, the believe we the it dose certainly will becomes next need the is I well that And choose speak for that of responses, the later totality or do we PK all safety as month

Reni Benjamin

Got it.

one Okay. probably final one for just me, Anish. And then, I for guess

TGF-beta to programs the progressing you front? could autoimmune Just the Merck are two how the us IL-X programs in sense the and as a give

Daniel Passeri

Reni. Sure, Yeah.

breadth there, approach, So And on specific the Immuno-STAT that Merck exciting we're potential have the is antigen-specific year. a for of lead clinical the by We've aiming us, end teams of this asset. because focused completed side really to for On fascinating fantastic the tremendous the studies X those of made candidate. towards CUE-XXX, application. progress with proinsulin evolving is the And Type molecule with the diabetes. this this a

a to IND-enabling on in we're so as studies, lupus, year, chronic out in to to preclinical are development actually so then been strategy ourselves about continue sort the [ph] talk indications, June that and autoimmune solidified which clinical us. of like position IBD, this The intentions foundational to and we've be invited models of validate well. thinking et would by Forsus end for we'll a initiating start generated data. to to big the RA have position cetera, be talking and cetera, presenting what stands look start have et a and about So, We to the

Reni Benjamin

Terrific. Thanks the questions. taking much very for

Daniel Passeri

Reni. Thanks,

Operator

Willey Our comes next Please from ahead. go Stifel. Stephen from question

Stephen Willey

Congratulations Dan. progress. Yeah. Hey, afternoon. on the Good

standard-of-care? two, if versus given forward trial CUE-XXX Or, to single your Do remarks, response, another of And should because response registrational I be seeing as low or potential re-emphasized this patients likely extended would confidence salvage? prepared about path event I your arm pursuing and forward. the do a I you that guys guess, current and of right you setting most guess having you best now? care with digit in that's you're think kind a this, like we study? Dan, you try that you in know push just I I are rate something How in of monotherapy supportive So, that in single see think anticipate thinking associated times think

Daniel Passeri

Yeah, I'm answer it as Ken going to to over broadly, that, I'll hand just well. but

looking So, these and how I think the it, it actually just you patients. that's at summarized we're answer to

As is of therapy. refractory, you there know, no going many palliative standard-of-care, basically on are them

to rate think it's one, at another response and step I So, bolster really of the looking couple would PRs confidence.

by emergence again, we're we're the disease, suggesting seeing advantage. to immune a we're as seeing what to We're confident date, escalation survival a in we're of seeing molecules And already as seeing So a a that, appears partial in stable data actively five monotherapy. confirmed relevant what it dose components. was modifying the be a confirmed response

going wants forward. basically confidence with data will this over turn confidence forward I'll but it a if going all path, So to that give us of it us giving will to And type that be of at is that, elaborate. registration he continuing Ken

Ken Pienta

emerging. is what registration we're as the a and as I you certainly study, at arm I what I think to bottom data path is, a that. looks have a Well, that's The single we it. think mean, like we're And hoping what it if that's we there line leave said going that pursue. that's

Stephen Willey

at design have a potentially So, Phase the in terms FDA rolled such patients could conversation I registrational recommended Phase of a that that the dataset? you X monotherapy then those and do into guess, X expansion expansion with be dose, cohorts

Ken Pienta

yes. answer, Short

Stephen Willey

then, here. bigger a question Understood. maybe just And

established and you And within accelerate de-risking, you How format? of do constructs Do in I do and just constructs you're that with got of proof-of-concept interesting But a how other do got because to with those the accelerate pipeline? Can that? series, the guys about XXX, prioritizing now the making these You've novel the you both on lot RDI-STATs. of CUE-XXX think about you've Neo-STAT accelerate think things you working on of opportunities each context guess the on KRAS? you try progress the the of on the WTX?

Daniel Passeri

complex a It's question, Steve.

resource or with is to implication a focus the it resource a do allocation. beachhead with in right Priority you access, of series. and by XXX, XXX establishing which As applies, know, foothold de-risking to has validation terms now on

with Asia, the well So, strategy we at and have LG here incorporates a the XXX, we XXX, patients Chem, looking so consider. that's of as partnered something in potential XXX, that U.S. as

actually if really of think important. it So, all one know I I don't it's priority, is

manner. sure is into continue to have XXXX. IND to forward expecting filed expanding XXX we profile the of we're Right that in make be a to foothold, QX as doing then with the we out now, timely a establishing pushing in program. are but And So high obviously XXX KRAS

as resources So, on that well. we're putting our

allocation. Going But now, forward, foundational efficiently of beyond really other be based as that, it's programs. XXX, and establishing access on the and out it's as principle can we focused to right expanding on really the going with resource

Stephen Willey

Understood. questions. Thanks for the taking

Daniel Passeri

Thank you.

Operator

next Our question from Baird. ahead. comes go from Brian Skorney Please

Brian Skorney

me Good offer lot sports, afternoon, seems activity. platform, XXX too my a agent really everyone. probably And it of It the like single the congrats series. Immuno-STAT in on let was particular,

you exposures in any relevant how cell accelerate think response to give through at would for of maybe escalation dose that do of sort driving XXX to closer guess, KRAS about I Phase T point, here the using what design opportunity would dose starting activity? a that through Xs in be and be Wilms? you to thinking this of monotherapy in think we Does So kind

Daniel Passeri

you do want Ken, that? to take

Ken Pienta

XXX the from but is will believe also needed. XXX, us Yeah, for also that than doses is to were as part we Question we we've CUE-XXX really would questions to learnings allow have that, But of we XxX based we've propose we And be lets start as forward? us able that cohorts going pre-IND trial great it, to for question. meeting. FDA the on of learned that higher that mention backfill design CUE-XXX. I like design, example, we our FDA, We accept what the certainly from this of used what will the part as do with which set

get to safety quicker XXX. much observed doses relevant with strategy based data that we'll to able and So, clinically on we'll But PK, that I we've the be use PD again. think

Brian Skorney

in those that And kind PD bit then Are side the little increase a the NK XXX -- anything maybe cells just I'm T on cells? the dose PD digging relationship, a clear EX-specific and/or of on data. you there tests shows is maybe of showing Cohort level dose to level just in is it maybe you trying where X? see where really activation, And a you X, peek this there doses don't get out aren't activity? higher see sort any Cohort like additional

Daniel Passeri

Anish, to do you want that? take

Anish Suri

data, Brian, Yeah. including about the PD X, very some to they're so, X think uptake you see at comparable. you the NK we emerging X but the and X if at Cohorts look X, start X, and at metrics, Cohort and that of

And we're relevant provides would, as be these a sort very stressed, move I that think mature relevant the So, the and increase to seeing, only sustained on comes metrics exhibit we metrics. PD with to with us you've EX-specific what baseline, -- more also appear the with Matteo activity, help side around strong but notable Tregs, to we I in can cell would NKs, the be expansion. the seem the uptake think and in sampling to what increase these, to is We case very as forward. about back a to dose of continue think you're looking strong, have emerging for cohorts what T as that on heard already very some able these and make this cohorts transient indicate just to appropriate obviously that some of

Brian Skorney

you. Thank helpful. That's

Anish Suri

pleasure. My you. Yeah. Thank

Operator

go question Our Berenberg. next comes Please Instructions] Shu [Operator ahead. from from Zhiqiang

Zhiqiang Shu

add to Thanks Hi, as for afternoon. my my to team question. good congratulations the well. I taking want

Daniel Passeri

Thank you.

Zhiqiang Shu

The safety favorable. I quite is know the it to first about looks ask like safety, the I want

supposed you curious of Just of to decrease, be seen idea have Wouldn't be cells sight designed the to activate an do T grade manner? X in cells we've this NK insight some length and for of decrease? IL-X why

Anish Suri

after on Ken, So, comment do follow-up and to want Ken. can I that, you

Ken Pienta

Alright, Anish. go ahead

Anish Suri

T cells of active noted raise as activity IL-X post likely what's explained that doses transient populations, I for likely again, has lymphocytic peripheral you and with including you're consistent see think that most NKs the extravasation, sort seen these been that measurements. pharmacological is in dips, these and So, aware, aspect, well activation, the been the prior of in

Ken Pienta

those the lymphocytes the non-specific moving Essentially, Yeah, in IL-X it's early into a time manner points. blood a it known represents effect. what of -- IL-X out moving is the at tissue

Zhiqiang Shu

them? I upregulated CUE-XXX. have Based upon ask about trial, then any seen And between observed CUE-XXX Understood. have synergies combination Okay. PD-X preclinical the your to As also want PDL-X to modeling, being you you treatment? and on

Anish Suri

as least evidence I of for in side good is a at only a So, lot synergistic. supports, of preclinical very which not can important but the take component the Zhi, that that provides

So of first right everyone as all, blockade absence of PD-X very like repertoire the checkpoint meaningful. appreciates is likely not and

was So CUE-XXX a than that. the tumor surrogate PD-X EX-driven CUE-XXX in better elicits whereas setting is published last that repertoire the murine that very alone Cancer the Research, TCX we our aggressive activity, in year And studies actually fact the in in meaningful that from saw monotherapy, we model, Clinical preclinical its activates no and vehicle.

of tumor higher from were the in his like infiltrated tumors we then as in present in are was combination you that the showed when one And again, Upon CDA examination Ken blockade this and within have where with done response However, from section, the locate there from from in except tumor-specific tissue cells. animals, model, trial, that are and could numbers was observed histo efficacy in mono cells expressing the by model both in in the PD anti-PD-X patients we numbers substantial a therapy, the tumor those nicely that very a those tissue. and closer monotherapy further combo, T animals. the path, T increase combined of

to on continue all well what trial observations favorable these sort preclinical build So for noticed really further combined parameters that proven a of should together, as putting build patients. preclinical, bode and think we I with combination it we've data

Zhiqiang Shu

final also is a one And [Indiscernible] great. also Anish. you probably Okay, question for

is I understand IL-X. it HLA Neo-STAT, construct For with empty

bind to antigen regardless TCR it is to guess, the I any So, [ph] to designed has? of tumor what

Anish Suri

we the concept chemistry. any have the do can So conjugation, then which tumor which chemical the of conjugate to using whole established using we scaffold peptide, Zhi, is Neo-STAT, to

covalent it's So, a linkage.

is WTX when a fused the significant antigens. Immuno-STAT, conjugated the HPV EX with an not you it peptide. compare made, So, actually to but that's of one product desirable epitopes of or epitope drug in HLA, is quite cases epitope, it's like the or rather a gets And empty multiple an where the when each

a one time tumor that and many separate can can each one generate molecule upon those drug words, Neo-STAT, different epitopes antibody cell other you conjugate. then With for based and separate of molecules with interest cell indications, that in serve a So line of that there. is areas have to scaffold the the wants line production one

different except tumor can started vision that still versatility since empty, on modularity cell to an clinic, is T cell and back. it's drug a in it's years That epitopes. And cost implications scaffold there, shelf deploy that significant line, a the allows the us antigen-specific, patients. it's the real-time fact for we after So three the about to and was much when very that to single go time off the one many obviously this essentially has

Zhiqiang Shu

Okay.

it's a vaccine cancer essentially, turbocharged? So

Anish Suri

Well, of is costings, interactions, immunotherapy. right the a APC, vaccine space that's vaccine single of big presentation, just this that and terms leap dependent upon a in it's actually in all et cetera. processing Every of the and specificity. the doing job antigen membrane kind We've bypass

Zhiqiang Shu

you. Got it. Thank helpful. That's very

Anish Suri

Okay. Thank you.

Operator

closing This over question-and-answer Dan for any conference like would turn the concludes I Passeri Instructions] the back to [Operator session. remarks. to

Daniel Passeri

to interest. progress forward observations these findings. for updates, important we to your want we look We And make attention periodic as continue thank and on providing to and everyone

soon sometime catching forward and you in to thank near look So, up the future. we

Operator

This concludes today's conference call.

participating lines. your pleasant you for day. and a disconnect have may Thank You

Cue Biopharma (CUE) 18 May 212021 Q1 Earnings call transcript