everyone. Thanks, Jed and hello,
always, our I'm today's participate in and meeting FDA. to As begin happy the the you call Arthritis with provide the from I'll on and upcoming program side. clinical updates progress with with Rheumatoid
trial completed As enrollment first quarter our quarter imaging on events IIb were update the Phase in I call, announced and study NAVX-XX. the in first
the critical were data As it you moving RA. forward and this to in from know, trial
in evaluated arms third of stability X, readout active and arm reproducibility tilmanocept we we at a three healthy an tilmanocept and to to of X arm, subjects mirrored the the data As in ability and the III efficacy. first with a help repeatability, early reminder, to of this to RA. the In was study a our serve upcoming imaging Phase with have both trial. obtain sample patients as look And sizing predictor the III, and Phase imaging for treatment in
as As full the positive we past, and and three have were data discussed X all presented in the arms promised. continued from interim Arm the very results
of alpha an standard in alpha is with as even in with predictive to results ability the short, of of effect quantitative in trial the We could provide see on XXM this highly X soon we a And RA, initial tilmanocept its who the a with now a alpha imaging meeting. a a with planned an journal. treatment of patients continued presentation imaging work we've point group prediction Arm rheumatologists active non-response that cost, to alone single these likely a rest side high early early non-responders complete hypotheses. can to capacity and for unlikely up clinical on represent the an the time patients, of reproducible scan, analysis able demonstrating fibroid and exhibiting we subtype data entire XX% an assessment. subset RA trial tool the gold otherwise completed anti-TNF from and for possible will this anti-TNF calls, class have possible patients. in was can from In out in baseline treatment to those in as discussed and full efficacy technetium would rule involved these particular an their in inflammation, in can to powerful avoiding that level continue a define RA International subjects, defined without of be use the worsening that X patients alpha for overall therapy, to tilmanocept dataset of from the therapy the possible is scan The that predict to rate robust provide from using accuracy of be anti-TNF low anti-TNF therapy This to own results the a and particular therapy. data patients high of imaging the at healthy prediction of predictive of to get-go, be for submitted scan value of previous effects on from therapies medical support the controls baseline strong In the almost our In case. write their has course, joints there joints uptake publication to from demonstrate Arm combination the be that upcoming and set disease tilmanocept
what done At address Phase program and II the B and End-Of-Phase need that the with we imaging has done patient large the also continue This we the II to briefing standard from written medical datasets, detailed They should Meeting constructive. feedback in we RA FDA proceeding our treatment. is a discussion submission beginning meeting, are positive of Phase interim prior on of entire are what planned that the development. the analyze package. B it, them. to we all way is and with tilmanocept Type analysis provided full with that an completed, moving March, could they request with held. trials End-Of-Phase called February, written once Meeting help complete are doing with of predictive of when time our III are the what requested of program form Type occurs and unmet II, with tool the dataset, how where in FDA FDA II Phase that is are back Phase full in in the the for the you proposing we Phase that have emphasize package IIb an that Once They in included a as meeting proposed was feedback NAVX-XX III. we official So doing, with remain along only. response remained This end the alignment. our RA and it like us was on response briefing FDA This a to that we doing plan At understood and the is of request. This only the but submitted drug Phase I of you results agree III. called then why typical Phase we IIb
very Our best strategy our with to been all success. program way work has closely along help to FDA chance in of give us the development the
in images So FDA and the submit quarter feedback think of July as all industry. the III the we the results images efficiently supremely Meeting, concert the much not people all last and personally work move completed be work the hard. meeting analyze X,XXX requested the assessments the work getting this of receiving be we late served in as for that proceeding. have to time pages detail, what amount data now some in that to our the you NAVX-XX request. alignment been and us interim will of here worked have update about comments analysis we statistics success for of evaluating report conference in and for of said, analyze II seven-day release. write Jed the to and seen and the so will and setting request and briefing when the amounts the to to we weeks. contractors, about with June, I well these have late we all the protocol complete trial I feedback we we this call our from FDA. the tell package many submitted analysis We trial the quantitatively can draft clinical and this the the the data their press of February assured the such be prepare the to individuals is interpret completed be the diligently, the considering and and in the and constructive nights with the in and and that this work and results with up a our all credit seen we with three for What you've to Phase updated heard With their from are our hand, FDA, discussion March. which time hopefully clinical done from have to has data are is They the done the response our up responded briefing Phase first has our FDA, the you September is beyond. than package best giant what means more sure chance that nor early In plan so as submitted X, of held and of qualitatively meeting then months happens told short from end study, Since team for and to to March ourselves here the to and span diligently in feedback, from in from comments All on End-Of-Phase from trial known submitted III. to group, along the and as study dedicated They statistical of full continue in
Following have things of for Phase opening III. stand the this a good meeting, we sense up should where
is ensure is with again for in everything Phase communication been along Our approval keep always possible goal move as a III we is the to the close place when complete. FDA that to
be open as to to the to to Jed quickly, want earlier, good in automating benefits continue should that up several key commercial also that finalized a I As we well we I quantification very sites will protocol have for given once have product. able approval. we as before, mentioned mention referenced the significant which progress image make
study RA X knowledge the for study control we control and that non-RA what us like impact on joints as accuracy, add predict in joint size is have joints to an Phase normative this a to inflamed start called database healthy nearly joints parameters, the set use enable current a We part with establishing establish of healthy will the healthy improved of discriminate database as the this normative III Phase these like looks database. should data This an with completed response. involved commercial of and will what ability This discriminate integral what inflamed to Arm completed our parameters to joint ability normal RA, of from to treatment tilmanocept from the our of We the positive those from a inflammation use have to should RA quantitatively. looks is tilmanocept well have product. IIb essential play the NAVX-XX normative to the in part both analysis data to don't our
note XXX in the program primarily I total acknowledged them the team. RA should four that credit matching also enrolled the we've population, age and enrollment that operations the subjects is was different while clinical weeks. these a As we recent must May, mention on the The sex them. rapid to complete numbers into projected this opened RA the the of so FDA rollout up to controls, we developments trial track remarkably interaction have of and for defined our first I in real We trial today, in in just are over sites and fill. groups and study a enrollment with should fast. also our are to healthy importance in of coming we out XXX are recruitment
in of patients joints. biopsy, we obtain joints density with comparing imaging correlation comparative are to the and imaging patients this results In from Our number RA. comparison patients each active order Phase subtypes between of study active histology imaging RA the imaging joint RA study, recruit in NAVX-XX our to is with to aim macrophages of the three signal in and establish tilmanocept IIb recruitment. We tilmanocept of to of pathology the and to
third have be end will and and at University week, the out Bard Angeles. in already. Los site our a of of open We London as this up Northwestern Rheumatology Health opened And Center Research
to planning required biomarker center with also of for initial will CDXXX RA related a not as RA the provide that standard trial well achieve readout for use our engage and it UK. fundamental open a also up this for going to indications therapeutics. RA. are RA, new to the of we are in as another critical as in is trials believe in information rheumatologists the pharma biology FDA gold patient’s approval of It is with imaging We its that for, in Remember we in to order but qualification
For invasive in be having determine might used demonstrate class of could that an example, to immediate patient's patients. to directly a this subtype have impact particular from work implications results or do would that what tilmanocept on management this And could without This biopsy. have study patient. therefore therapies imaging not RA might the RA of can for of
been is on thus plaque On sites the we they've co-published are the and with Mass NIH-funded and ongoing. tilmanocept we in what front, imaging been They of cardiovascular Hospital in imaging with with Birmingham, The Preclinical continuing seen have disease data initiated General atherosclerotic Boston. localization is studies plaque we of analysis ongoing. recently in of project line completed in our our also reported have tilmanocept them data of pilot at University for investigator to promising Gallium previously. Alabama, study terms an of far work atherosclerotic study the enrollment
the strides On forward. to make we front, continue therapeutic
Science's uptake of May Academy of York manuscripts. study, New targeted as methods at several preclinical on dose well drug our immunosuppressive delivery increasing drug reduction to Symposium combined in an now important delivery studies also using be on construct We've a alone. safety. For the and macrophage next-generation for for We grow proof-of-concept of move action of inhibitor a have in the a off-target work an reduced done versus two a to change approved the an well compared checkpoint combination evaluations related off-target seen models and latter studies or we localization studies efficacy drug have compounds with pro-inflammatory schedule whether mechanism performed first relating penetration results therapies. and including to interest as different looking of we therapy. related containing more these rate therapeutic the oncology, Further doxorubicin are animal and and of for preclinical this reaching are areas Put therapy our in tumours with indications by with results the demonstrate completing carried approved at molecule Immunotherapy to and Frontiers points growth These and much effect our simply, Cancer different characteristics the thus improving studies, need order biodistribution past in as state, to molecule, are the positive synergistic in are presented be of out approved a to of far. quarter excited These significantly this well. at from as labeled starting while a that as implications phenotype with in the tumour tumour it’d models to reducing that as with forward, different in could our radiopharmaceutical molecules far
and results studies presented. be where are preclinical these announce and will we will you completed, when As update
disease diseases months. the could We are weeks broad made reaching space, indication in in applications significant optimizing be therapeutic and in using metabolism. This payload. studies the have molecule coming autoimmunity, different that vitro targeted at performing as looking molecule payloads will dexamethasone have inflammation inflammatory these of and in in contains in and we progress And our also its we
forward. this As is have we moving and our therapeutic vitro, is in studies, animal already characterized construct begun pipeline so robust planning and
therapies the and fever USPTO caused diseases of patent diseases, the Viral including Methods “Compounds Diagnosis by of possible Treatment for issued has flavivirus. variety other for and the application viral the On intellectual and relates property for dengue, our yellow front, Infections.” to a This titled
claims “Synthesis involving Thereof” X, application and Dextrans allowance converted an Derivatives for of cells. titled of to and Defined diseases an Uniformly provisional foreign of Our patent application notice Molecular Weight jurisdictions diagnosis broadly expressing of application Mannosylated was involving and in we've on July CDXXX treatment AX received
active molecules touch focused just other with to current mean and So needed are discussion and we provide in database IP for you believe agents, continue strategy this largely the disease RA diagnostic the III of as on the we normative support well next-generation in for specifically update. will both and progress for Those I we last to as highlights hope the indications. study well that quarter and open can study, that and our the see rights We for diagnostic of and protection to remain preparation as the Phase an on to the upcoming on pipeline, therapeutic FDA while protections some as and wanted have therapeutic currently our while push our biopsy we our enrollment indications.
always, tireless their team As things to all for our of sites research to hard and you. thank for want moving collaborators network their here trial work. academic keep of clinical I and Thank forward efforts the
back to call I like to Jed. would Now turn over the