you, and thank bit us. for apologies again, a Steve, you little joining Thank this technical of problems. And to everyone -- for
transformative are But is through going year. I very transformational Precigen. XXXX to very, for we a be think poised a year
the track the II of our half starting from on the in in BLA lead way are QX to and to for PRGN-XXXX, our to potential second the XXXX. XXXX. provided and We filings by present done This the guidance a the discovery years, Phase over asset, submitting in work pathways the several in data to team is pivotal and due by FDA on intend XXXX, all part our in last tireless positive
later forward for I press the today's outlined release. assets, AdenoVerse are we and And our prudently on are today's our, rapidly focus UltraCAR-T and we platform, looking For as platform. working to readouts UltraCAR-T year our data advance will on in call, this obviously, to we
asset platform, are excited we registration. why about today, for AdenoVerse and jump me let our platform our So lead into just this
very might not do the differentiated Why who simple. familiar viral you very of It's platform this say of those rest a that? I this the For be with platform, from is platform.
adenovectors not the built based like gorilla platform other this adenovectors. the on all, is library of adenovectors. of are These First
the they that genes or because put little. a human very ability have number have there more But we First of can importantly, no is in capacity they all, pre-immunity of in them. a high
this doing vectors. with keep can You these
antibody, best, platforms one blank. all this twice, a when you're issues other of a your major responses. studying And at then the or, other vectors, after dose you neutralizing the you're this. That's which, vectors, With of eventually, viral getting while, once shooting in and vectors the inhibited just other
Here, the giving. of even neutralizing of the bay nature the now, can specific antibody, because this, a we you these other enhance it. don't on hand, of on these have And at vectors to is design keep when pre-immunity and because kept and doesn't biological there vectors,
have of we that times. the be bay. clinical Why various responses, kept have do the from the some indications, immune only neutralizing antibodies can data -- you We up have you dosed to patients I enhancing and have kept but patient, you the say in not XX that? actually at dosing And
which can And commercial specialized manufacturing is process, you finally, one that aspect the important, manufacturing very high platform, becomes And process. the important, very imagine titers. is other which of allows especially in
So into which let's is our dive our asset, lead PRGN-XXXX.
they trachea this HPV cord infection, patient, this patients. of tumors benign or on infection or disease of, of disease breathe then causes cause they the HPV that rare can't or has PRGN-XXXX respiratory which or and the virus. that been is X basically, Therefore, assets the and cells XX identify RRP with target in the the Why designed XX important? In papillomatosis, talk can't these is in this vocal X the these of are both. root Our and infected to a recurrent
danger, there continuous it not problem gets you patient, there the surgery the worse, except benign back. it's decades, disease through removing patients, have like What mowing no really tumor, this then And does a is Keep devastating do? have that solved. coming they first a keep result, and all, situation, as your grass, surgery. gone with These for this and is treatment, a of
HPV do, to In to Means to address immune the XX. that we designed to infection, patients, grow, are have the these them. this really responses to identify have that, benign tumors exactly you means what PRGN-XXXX underlying based what to this cause which the of and and the to then that you cells the the what? number and of at disease, looked address awaken on to And order X get root, patients. And these to have is done destroy we infected the is
you to XX,XXX In looking United patients. there are of estimated States, U.S., excess at are patients. XX,XXX between Ex XXX,XXX
in truly PRG months So started vaccine. patient first their our the trial of this is we patient we disease -- all, prior to XXXX, mentioned, When treatment. current the XX designed the have as devastating history we, we've trial a in receiving a no of with with that
from a a these And we safety, for flu resolves safety what pivotal which site patients, trial run, been receive that it of X, a or to we day first these within within at some or then X, very mainly rashes very days. I and all, that of vaccination shots single-arm this have of these they favorable similar then patients X, is recurrence the to get. you originally, perspective, see the XX X injection the observed a Grade after had Grade patients some fever, we a benign tumor. And then In Phase course was, following that, of
that can what the had about the to flu we any besides It the of require that and that was decided a is in safety right? done anything. endpoint for the We we population. to shot. design leg, require any don't very now, device. similar our or patient vaccine thing severe arm Secondly, go to saw, put, office any kind of this subcutaneously don't one given most of the be these again, We physicians, we So it's specific in
our upwards surgeries define at year. have prior that What that defined X surgeries that require surgeries patients average our and Ultra patients that, the number do of we was year. We X investigators in KOLs, per mean that? as by least in have the Actually, of
couple this a surgery. months, imagine, has patient you every of So can
they them, XX in the of prior Some surgeries year. have
refer not rate. these at any surgery, reduce they observed that require patient of and of XX was, as overall we population look did their looking XX% What are responder. XX% at the surgeries, we to response we after complete number months, them If follow-up we patients of
Okay.
when what increase Now HPV this XX, look is responses and patients, responses at the response, vaccine immunological to they we their of that is mechanism have complete these significant all a immune this of X had and exactly the patients a about. the they in
At we Actually, of more of they following patients This for are now to full the thing been these after say, response, patients and upward we to have months. in same XX X, have right? stress, XX months. are X mean token, average, be population the one again, these surgeries that of a And is vaccination. years I'm with to average number going than patient
And a well accelerated which Phase started, at, agreed given So had efficacy, any data, designation pivotal history for have, can on submit based a us time BLA. as as arm safety, as plus when and a act we path, can the we in FDA that on single that, also, look based pivotal. single-arm I II, the company, Phase our the data year, last we the we of breakthrough has the the first
and FDA mentioned, presenting II of we Phase in the of will are of second translation we So already as and our half we We Phase prior excited have to that poised finished published our BLA complete the data an And the by our BLA. be have the we end submit of really we enrollment I Phase that. enrolling in dataset we of full received year, last And action this mechanism that the to have QX. II, the we from are our are agreement year.
imagine, also of a this platform. this and exciting is can quite proof concept you as for So
onset and Simultaneously, recruiting neck we another disease. neck the advancing and enrolling the positioned Phase year, early of of have are cancer. XX HPV and to and has and with and and the initiated been And patients cancers, molecule, II PRGN-XXXX, head this neck cancer, studies that currently head cervical in XX we last been in has been arm already head
quite inhibitor, is been Why? neck, the exciting. rate and patients, of Because the at when look has the response even XX%. checkpoint the this And you head to
wide are objective responses, XX% a we HPV-related we at Last treated patients, complete year show when we ASCO, gap responses, Stage the for IV these patients, is had there basically, So improvement. partial these cancer that here responses. had, patients
responses, stress in again, were wherein population instance, And then a the for fell, a in at complete XX%, cervical XX%. neck, patients. they patient I in This and durable. had inhibitor these head year, We over the and that, checkpoint of they some cancers is response
have is this enrolled in quite head and neck, in trial positioning recruiting, with to and is we PRGN-XXXX early a arm. now an this the And exciting. onset So in patients pembro, combination
II we cervical pembro received we moved cancer. this And towards exciting. in from is to this asset metastatic the speak, are we an approval year, IND quite relapsed trial, we Phase combination currently, to in study FDA recruiting patient. cervical a and cancer Simultaneously, this as with the Last open
of its So and with PRGN-XXXX response has based for durability of that this from as our in you efficacy can that of with has administration, this efficacy. treatment it in the They molecule for a the this because rare the platforms, the lead differentiation in disease. has discussions on leader lot other and safety, disease KOL response of to us has and rare imagine, shown, platform, excitement where, this really positioned the become excitement all about also because generated have And investigators. clinical high ease clinical of of and with efficacy a
highlight, now CFO, a on our to Harry to us, as would that transfer financials. with Thomasian update our Harry? So give to I like an actually