Q3 2019 Earnings Call
Clinical updates conference call.
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I would now like to turn the conference over to Steve Harrison Vice President of Investor Relations. Please go ahead.
Welcome to the precedent business and pipeline update call.
Steve Harrison Vice President of Investor Relations for in trucks on and I'm pleased to be joined today by Dr. Heflin subsidiary President of Cross agenda.
During today's call, we will make various forward looking statements.
After his are cautioned that are forward looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated our forward looking statements.
Please read the Safe Harbor statement contained in this presentation as well as Intrexons. Most recent SEC filings for a more complete discussion of these risks and uncertainties.
As indicated last quarter, we'll spend today's call providing business some pipeline update unprecedented.
RJ Kirk Intrexons, Chairman and CEO will join Holland at the conclusion for acuity Sasha.
I would like to now turn the call over to Dr., Helen subs are very.
Thank you Steve I'm extremely pleased to be here today to highlight significant carquest presage and has made sense artificial company debuted during the JP Morgan Healthcare conference in January .
We have communicated previously we believe me hold a unique position in the biotech line, okay, having to all of the required technology platform for advancing precision medicine.
These technology platform are designed to enable us to construct a powerful multi gene program.
Optimize gene expression delivered these multi jet programs using <unk> non viral vectors big hi, payload capacity a controlled gene expression a regulator appeared in performance utilizing clinically as well switches.
Brad I'm divorced until a few of these platforms coupled with our expertise in immunology has positioned us to have an unparalleled holistic approach with the potential to deliver the core promised precision medicine.
Next slide please.
These platforms have allowed us to lay the foundation to build a comprehensive pipeline in immuno oncology.
Section diseases and auto immune disorders.
In 2019, we have successfully progress to first in class Ultra car T program into the clinic.
Matt P. ARQ <unk> 2009 toward potential life, Pete I plan to discovery program into preclinical testing.
Demise or or truck car T manufacturing process and built an in house GMP manufacturing facility to support our off the shelf I didn't know burst immunotherapy program.
Presses Gen now said I've done an inflection point.
I thought achievements during this year position presage and to deliver an important they don't read out in day coming quarter.
Given the breadth of our pipeline business development I'm product prioritization remain a key component of Precisions business model.
We remain disciplined in order to R&D spending and why we plan to develop select programs are not alone. We will also seek strategic partnership to advance our their pipeline programs in an efficient and cost effective manner.
On today's call I will highlight significant tend to try we haven't made since the beginning of the year.
Particularly in regard to our auto car T therapeutic platform and associated with ongoing trial.
Next slide please.
Our car T program, it's fundamentally differentiates it from the competition and addresses major challenges associated with the current generation car T therapy.
One key differentiator with ultra car T platform is the use of our non viral sleeping beauty gene delivery system.
<unk> optimize the sleeping beauty system, using our Ultravector DNA construction platform to produce multi jet make ultra car T cell.
These optimization produces homogeneous population of ultra car T cell, but most people genes are expressed on all modified T cells.
Our car T cells coal express and actually agenda specific color kill sewage membrane bound oil 15 simultaneously.
Presages proprietary membrane bound to Io 15 enhanced the persistent in vivo expansion and maintains this them like memory phenotype of all Trump card piece, though.
Lead to longer lasting anti tumor response compared to conventional car T cells, which is essential for successful targeting solid tumors.
Another key differentiator read the old trucks, but keep therapeutic platform is our de centralized rapid manufacturing process, which allows us to manufacture overnight, but the medical center cgmp facility and reviews the patients the next day.
We have evolved our manufacturing platform to advance rapidly towards the clinic to what commercialization.
Beyond the first company to implement non viral.
The centralized rapid manufacturing of car T cells into clinic.
You've demonstrated our ability to infuse patients the day after gene transfer at two different sites in our ongoing clinical trial.
And I'm pleased.
Two announced today that we have experienced 100% success in manufacturing of ultra car T cells for both the P.O.G. and 3005 on P.R.J.F. trade Thomson six clinical trials today.
We consider did a very significant milestone and demonstrating the potential of our cultural car T platform.
We believe that Precisions is poised to disrupt the current car T treatments landscape.
Next slide please.
Now moving to the program I'll detail P.O.G.N. 3005, oclock quite cheap.
This is an investigational therapy, using a collagen car T cells targeting the mute since 16 or marks extend protein.
Next extend is an attractive car T target for ovarian cancer. Since it is over expressed on more than 80% of ovarian tumors with limited expression in normal tissue and that is important.
It's all truck car T is multi Jenny.
Design to co expressed membrane bound 15.
Kill switch an antigen specific color that target Mark 16.
We have design, our muck 16 car to prefer actually target PRT and 3005 to tumor cells.
Furthermore.
Our team has an optimized then <unk> Oh I'm talking like 16 binding domain for optimal signaling by our car.
These genes are delivered via our non viral system, which enables.
Well more genius expression of these three gene and all modified T cell.
These car T cell phone with Genady is an important factor for future commercialization.
We choose ovarian cancer as one of our first tumor targets as these patients still have significant unmet need.
There are few treatment options on survival rates remain low.
It is also a large patient population with approximately 300000 patients diagnosed worldwide annually, including 22 tiles in India U.S. alone next flight. Please.
We are currently testing PR Gen 3005 in a phase one study in collaboration with the University of Washington, and Fred Hutchinson Cancer Center.
Leaders in immunotherapy caught treatment.
This is an investigator initiated dose escalation study to evaluate the safety and maximum tolerated dose of P.R.T. entry thousand five delivered by either intraoperative O'neil or intravenous infusion.
The study population include I'd van.
Page three or four recurrent ovarian fallopian tube I'm, probably maybe apart toenail cancer patients.
Platinum resistant unhappy progress.
After receiving a standard of care Kirk.
For both routes of administration, Yeah, again, 3005 will follow a treaty by treaty dose escalation factor.
We expect to enroll up to 41 patient total interest the study.
In August we communicate that that we had dose the first patient in this phase one trial and I'm very pleased to announce that we recently completed dosing the first cohort in the interrupt Perry Tony out or IP arm of the trial.
We are incredibly pleased with the progress of these trials.
Its execution to date demonstrates <unk> ability to enroll patients and rapidly manufacture holdco car T.
Why the phase one trial is obviously focus on safety.
We're also evaluating the maximum tolerated dose.
The ability of P.O.G.N. 3005 to expand in vivo it he factor for future success.
We are excited to continue the dose escalation I look forward to updating you on our progress.
We expect to provide an initial data readout from I.P. arm up this trial and the second half of 2020.
Next slide please.
I will now move to PRT, and 3006 or truck car T.
Yeah, Dan 3006 is an autologous car T therapy targeting patients beat the relapse or refractory acute myeloid leukemia, or AML and higher risk myelodysplastic syndrome or Mds.
There are approximately 20000 AML patients diagnosed in the U.S. annually.
Oh truck car T is multi journey and designed to co expressed membrane bombed out 15 kill switch an antigen specific caught that target see these 33.
He did 33 is an attractive targets for immuno therapy, because it is over expressed on M.L. block.
Okay Mcus themselves.
But is not expressed on a normal in mato plastic themselves.
85% to 90% told the am outpatient express CD 33 under tumor cells.
Hi, Melisa heterogeneous disease, with very high relapse rate and rapid progression.
Hi, I'm is all the assets for these patients.
Long manufacturing delays a viral based car T therapy can be an obstacle for successful treatment intervention.
Our old truck car T approach represents a significant advantage.
For the time critical treatment of these patients.
Next slide please.
PR Gen 3006 is being evaluated in a phase one one be a study of the treatment of patients with relapsed or refractory and now on higher risk Mds.
This is a non randomized investigator initiated safety and Tolerability study, all the P.O.G. and 3006 or truck car T. Following intravenous administration of escalating dose.
The trial is being wanting collaboration with the Moffitt cancer Center, a pioneer in court T. clinical development.
In the three by three dose escalation phase.
Patients will be treated in one or two arms, one well receive car T cell infusion without prior lymphodepletion.
Our two well received ltwenty pleasing chemotherapy.
The dose escalation phase of each on will be followed by a dose expansion phase at the maximum tolerated dose.
Since our old truck car T cells have potential for enhanced in vivo expansion and persistence without additional cytokine requirement.
We are very excited to evaluate PR Gen 3006 in patients without prior lymphodepletion.
In July .
We announced that we have completed dosing of the first patients into Piacente 3006 trial.
I'm happy to announce that we recently completed treatment of patients at the first dose level in on one without prior lymphodepletion.
As with P.O.G. and 3005, we are incredibly pleased with the progress of P., Yaki and 3006 and see if I add another validation of our ability to execute.
For comparison I would like to discuss PR Gen 3006, where says I Nx and 3004.
Boat targeting C.D. 30 tree, but we are very different manufacturing process.
Hi, a next.
And 3004 is a discontinued legacy investigational product that was in a phase one safety study of autologous T cells.
Lastly, use with lentivirus to express Cdthirty three specific car.
In patients with relapsed or refractory AML.
This study was conducted in collaboration with the MD Anderson Cancer Center.
Unfortunately after nearly two years only three patients where if you with the product.
This was due to failures of viral base ex vivo manufacturing that did not generate therapy fast enough for some patients whose disease progress before the therapeutic car T cells were available.
This is why we spend so much energy developing it if they don't <unk> art non viral manufacturing process to deliver ultra car T therapy to patients overnight.
We continue to believe that he'd be tardy tree is an attractive targets for treatment of and though on PRT and 3006 represents a viable treatment option for this patient population.
We are extremely excited about the P.R.J. entry thousand six clinical trial and evaluation of our platform with or without Lymphodepletion in AML patients.
We expect to provide an initial data read out from the ongoing trial in the second half of 2020 .
Additionally, we will present preclinical data at the upcoming American Society of Hematology annual meeting and Exposition in December .
Next slide please.
I'll now move to P. ARQ <unk> 2009.
Yes, you in 2009 is I'm off the shelf immunotherapy product candidate utilizing I didn't know worse the platform designed to activate immune system to recognize on target HPV positive solid tumors.
It should be positive cancers, we present significant health Burton and indications such as head and neck. So recall I didn't know and anal cancer.
Multiple approaches to targeting HPV positive cancers have recently been great interest in immuno oncology.
Oh Beach TCR T cell therapies are applicable to only a small subset of HPV positive cancer patients due to the L.A. polymorphism I know further restricted by manufacturing and high cost.
Uh-huh clinical cancer vaccines approaches have liked efficacy due to the combination of unlimited immune response, a novel antigen coverage.
You know Jan 2009.
Coverages are ultravector platform to optimize H.B.B. antigen design and coverage I know gorilla I didn't know vector, which had low to no pseudo problems in humans.
It allows for durable immune response and the ability for repeat administration.
[laughter] clinical testing of P. odds in 2009 has demonstrated robust antigen specific immune response and potent anti tumor activity in humanized mouse model.
Based on results from Invivo Mouse model PR. Gen. 2009 also represents a target opportunity for combination we treat men both within and outside of our pipeline.
This program is currently under development true and Credo with Dr. Jeffrey Schnell.
And world renowned investigator in immuno oncology at NCR.
This credo has been valuable to precedent as it allowed us to complete the preclinical work and the forthcoming phase one clinical trial in a cost effective way and at the very rapid pace.
It also provides for the potential for expansion into other targets and combination.
We are working very closely with then see I team on and I N D submission for PR. Gen 2009, we expect NCR to begin dosing patients in 2020 and are looking forward to providing additional details on this program in the near future.
Furthermore, the opening of our manufacturing facility, Germantown, Maryland, which we announced in April is designed to support our I didn't know worst platform based therapeutics, including P. R. D N 2009.
The opening up this facility is its strategic long term decision that will put pressure vision firmly in control of our early phase clinical and manufacturing needs for gene therapies and future product development next slide please.
Lastly.
Hi moved to our multifunctional therapeutic platform targeting solid tumors.
Why is checkpoint inhibitors have had the significant impact on oncology treatment.
A large percentage of patients fail to respond and among those that do approximately one to relax.
Our multifunctional therapeutics platform is designed to address multiple immunosuppressive pathway in the tumor micro environment.
We have taken a strategic approach to developing this platform with two preclinical assets PRT and 5001.
PR Gen 5002 with significant market opportunity.
Our first multifunctional therapeutic candidate PL. Gen 5001 has demonstrated their ability to enhance T cell activation and anti tumor effect in mouse model of tumors that do not respond well to anti PD, one checkpoint inhibitor antibody.
As shown in the latter section of the slide the highlight that in a humanized mouse model of head and neck cancer.
Our Gen 5001 showed an ability to overcome tumor microenvironment immunosuppression and significantly improved T cell function.
Compared to a standalone anti PD, one treatment leading to superior anti tumor response.
Our team has generated a strong pre clinical data package demonstrating the effectiveness of P.O.G.N. 5001 in multiple cancer model, where anti PD one treatment is not very effective.
Our second multifunctional therapeutic candidate PL Gen 5002 is advancing rapidly through preclinical development.
Our getting a different pathway to address tumor micro environment, driven immunosuppression to enhance efficacy over checkpoint inhibitors.
In a preclinical this study PR Gen 5002 exhibited enhanced infiltration of cytotoxic T cells into tumor and superior anti tumor effect in humanized mouse model cervical cancer compared to anti PD one therapy.
Our multifunctional I'll therapeutic platform, including P. again, 5001, PR Gen 5002 has tremendous potential in multiple cancer indication and we continue to evaluate.
The optimal pod for war for their development, including partnership opportunity.
Next slide please.
To conclude I.
I like to again highlight.
Presses Jan is highly differentiated from other immuno oncology comp.
We have made significant progress in advancing our pipeline.
We expect says well data readout in the coming quarters.
The current this slide shows the objectives, we outlined during the J.P. Morgan Conference in January .
I have already achieved these objectives as we have.
Initiated a phase one one be trial in AML and Mds for P., Archie and 3006 Ultra car T and completed dosing of the first cohort.
Oh initiated a phase one trial for ovarian cancer for P.O.G., and 3005 old truck car T and completed dosing of the first cohort.
If that's the P.R.J. in 2009 for solid tumors.
Yep advanced one infectious disease candidate and finally, the have also advancing multiple preclinical candidate.
I look forward to providing our key objective for 2020 I did JP Morgan conference in January .
Well now open the call up for questions.
We will now begin the question and answer session.
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Thank you.
At this time, we will pause momentarily to assemble our roster.
Our first question comes from Jason Butler of JMP Securities. Please go ahead.
Hi, Thanks for taking the questions and how long congrats.
This year.
I want to start off by.
Following up on the comments that you had about success in manufacturing, 100% success rate for the ultra car chief clinical programs.
Can you, maybe just give us a little bit more color on what defines manufacturing success and if the clinical experience you already have gives you weren't manufacturing experience you already have.
Your confidence that you will succeed at the higher doses also.
Thank you Jason.
Nice talking to your excellent question in regard to our manufacturing success. As you know we are and I believe we are they only company correctly that have a and non why raul overnight basis.
Based cock T Ultra car T platform in the clinic and redo D. Under two days overnight basically on the patients. The next they are receiving this.
As you can imagine we had to put a lot of research says an effort and making this happen and from the FTC perspective. This was consider first in man kind.
And what we have achieved currently is in every cohort boating solid tumors and hematologic called that did GMP facilities a hospital based on that.
Oh piece that we have provided them on training that they have received they have been hundred percent successful to actually manufactured the dose that they need.
Under the two days or overnight I should say on infuse their patients without fail and do you have done that in hematological tumors, a very tough scenario and am now as you can see some of these patients can have access of 90% blast.
In the blot, which really make their T cell number very very low and also in ovarian cancer patients in the solid tumors.
We are confident that to be can now provide this higher doses as we move on that we are very excited about the cohorts that we have already.
Finished and as we are moving to the higher dose.
Great. Thanks, and then just a quick follow up on a PR Gen 3006, I I think.
The advantage of clinical advantages of not having to go through Lymphodepletion are clear, but could you maybe just walk us through that timeline advantages that you would also have ahead of a ahead of treatment.
By not having to go through lymphoma patients.
I think you see a very important because first of all as you know that lymphodepletion. It's toxic it's basically treatments with their chemotherapy and put the patients even further in danger patients that are currently not in a very good stages.
But most importantly, the process of and Lymphodepletion, especially in a hematologic called it takes somewhere between five days to more than a week, depending on what regiments. They receive and then in the previous setting they have to go to they're lumpy viral car manufacturer.
Which by itself takes another three to four weeks, if it's successful and I know there was a 25% to 30% rates or failure there at least.
So having said that we did we actually.
I think you perceive it like we have turned the old truck car T.
As close to as off the shelf you can make it.
Because you really.
Don't have that much preparation the day before the patients get a free and then overnight we have our non viral system transaction and the next day, the patient gets infused with their own autologous.
Basically car T. He sees and major achievement because really now you don't have to go through the Allergan 820 cents again expansion on in a best case scenario people can dose hundred patients with one preparation.
Yes, we take the patient car T directly.
Hi expanded overnight, but I suspect it was on expanded at all and then the next day infuse.
And debt expansion takes place into patients and this is one of the things. We are following I'm here looking forward to reporting on it in the upcoming quiet.
Right.
Helpful. Thanks for taking the questions sure. Thank you.
Our next question comes from Tyler Van Buren Piper Jaffray. Please go ahead.
Hi, guys. Good morning. My first question was on a 3005 or the ovarian program.
Can you.
I guess tell us about what doses, you're using or what range of doses, you'll be exploring in the escalation and the invivo expansion is obviously a unique component. So can you also discuss what magnitude of in vivo expansion, you expect or maybe you've already seen what this firm.
Cohort and how that compares to.
No other therapies that don't have the membrane bound oil 50.
Great Hi, Tyler good to have you want to called absolutely great question. So number one in regard to debt doses that we have not disclosed the doses, but I can speak this way Oh, we are log it's different in regard to walk doses as.
We are infusing the patient currently.
We are nowhere close to withdraw it was that Lentiviral cars on the ultra car T platform is designed <unk>, that's a way that by having a member inbound 15, the car T. We can actually expand them directly in pay.
<unk>.
D., so because they have the membrane bombed out 15, they come for success.
Even in the absence of antigen or when they are not seeing the antigen and this is what it makes our ultracargo really different than any other car T that currently exist in that landscape. So from that perspective, all doses. We are looking forward to show.
With that and that upcoming quarters as our investigators will report on it.
And in regard to the expansion Oh, we have not disclosed. This obviously, we are moving to <unk> are there cohorts as well be I'm very excited about this program and a we will be reporting on that in a very near future.
Okay. That's helpful and just as a follow up on NIM 16, as a target you spoke about the expression, but can you remind us of what you've seen preclinically that gives you all confidence and using it as as a target for the therapy, absolutely so and that Mark 16 is actually as I mentioned it.
Expressed at in a large amount of ovarian cancer and tumors.
What we have done we have done very is humanized ovarian cancer tumor model.
And Oh, we have put or overnight manufacturing process with our own truck cars. They contain dimmock 16.
I'm remembering bound piled 15, I'm to kill switch, which by the way all three simultaneously ought expressed in our old car, which is another differentiate their factor because now you have a drug product home would generate 80, which is extremely important for commercialization.
And what we have seen is our old truck caught eat much superior.
Even having got regular car would just mark 16.
And do we have done in various tumor models in humanized mouse model and also because of having gotten membrane bound.
Seen index, we show would that be sell directly expand.
Nvvault they persist.
And they completely eradicate the tumor.
But it's also very exciting for us and based on the preclinical data that we presented to F.D.A., we would actually see that D to help if they function on even after eradication up tumor for a long period of time I did again.
And it speaks to the persistence Nvvault and we are looking forward to our clinical trials and investigate didn't get similar kind of observation.
That's great. Thanks for taking my question Tony Thank you title.
Our next question comes from Tyco Peterson of JP Morgan. Please go ahead.
Yeah, Hi, this is Dave that's on for Tycho. Thanks for taking my questions. Alan you spoke about some preclinical data coming out at Ash and then some initial read outs for 3005 and 3006 in the back half of next year.
Just thinking about sort of the next 12 months can you help us understand what is the two or three like most important read outs that investors should be focused on your and perhaps if you can lay out like what conferences are those are likely to happen I back would be super helpful.
So currently I mentioned, our PR gentry thousandsx will be the preclinical data will be.
Presented at Ash very similarly, we have done extensive preclinical analysis of our old truck car with the CD 33, and a member in bound I'll 15, and indeed I actually presentation.
For the first time their audience would get to see how effective our old truck Cauteries holiday persist over long periods of time and how they can eradicate the tumor and that is compared to 40 cents, having the car alone or in data versus having a member inbound 50.
I will be presenting also as a keynote <unk> at that wall vaccine called France, and the beginning of December which I alluded to some of these work and we have plans for that 2020 , which currently I cannot disclose but there will be presented chance and we look forward.
That add to that vote at the scientific arena as well as obviously updating our investors and shareholders.
Got it and that in terms of your broader portfolio can you just walk us through your thought process than choosing where to partner and better to sort of deployed go. It alone approach in terms of your Ah you know a commercialization efforts absolutely I think that's an excellent question Tyco.
I think.
When you look at our portfolio. This portfolio has been designed actually a very specific concepts in mind, it's not a random portfolio. The areas that we have picked has been picked because we wanted to maximize our <unk>.
Portfolio, you basically utilization of the technology that we have and the targets that we have at times and therefore, having autoimmunity 40 cents to the flip side of immune oncology. If you know how to activate their immune system tremendously you also know how to suppress it somewhat.
Or vice versa. So we have used all of the knowledge the technology and the knowledge that'd be having immunology and focused on three areas. One other aspects that I have to say, especially in the field of immuno oncology, which is at Conversely, the deficit in the field.
People are approaching targets on their random fashion.
And the combination, Iran, and therefore billions of dollars and billions of dollars worked all failures. Unfortunately in the clinic for the patient what we have done for any sense in regard to odd.
Multifunction all on multi Jenny platform is based on indication we have identified based on technologies that we have the immuno suppressive mechanism that daughter specific to that indication.
He hobbs target it.
Yes.
Multi genic platform around that so it's not the random it's very specific and that's life. When he says and at five stuff to you see that it's very specifically place then.
And so I recall.
Our anti PD ones are not working it really hot shown and a significant eradication of tumors in preclinical setting having said that what also we are very disciplined in our R&D I.
I don't want to give an impression that we basically go after every molecule reprioritize our portfolio.
You see to benefit from the technologies that we have.
On fully aware.
No one company it can develop everything on their own and that's not the off plan B prioritized on where we are asked to develop or we have the collaboration and partners that they can do that and also we look at.
Partnership an interest that'd be a receiving to see what would be the best dropped for partnering a certain assets and the value of that for patients because we want to get to clinical trials rapidly and it's very very important to have the right partners that they can do that.
The only financially, but from a perspective of speed to get that for the patients and obviously for our shareholders and investors. So we take all of that into consideration and let me just say a dissuade me don't take this like.
It's very well talk around on V approach it in and logical fashion, but what would be best for this portfolio for the company for the patient and for the shareholders.
Got it and Alan if I can ask one final one youre more often than Fracs. On question. Then imprecision question again, Steve maybe you can take this I mean can you help us sort of thing through the bridge from you know the 90 million or so in cash and equivalents and the balance sheet today and your goal of hundred and 75 million by year end.
And perhaps if you can update us on your plans for the sale of exemplar Unpronounceable <unk> is this still expected to occur by year end.
Hi, This is our Jay I think we provided that bridge in our press release issued this morning.
So as you know.
I've made an offer personal and and we're also in discussions with numerous parties about numerous assets.
Based on all of that we feel that we can give the guidance reiterate the guidance we've given in the past, which as we expect to be able to conclude the year with committed funds of 175 in cash Wonder 75 million.
We didn't believe that we wouldn't have said it [laughter] certainly wouldn't have said multiple times.
So beyond that.
Obviously, we can't discuss individual transactions.
Individual.
Okay.
Let me offer I've made will be considered by independent members of the company's board of directors.
With the board of their legal and financial advisors.
So we're not going to provide further specifics at this time.
Got it thanks, so much.
Our next question comes from sale of Cola Ramakanth of H.C. Wainwright. Please go ahead.
Thank you. Thank you I'm, taking my question. So then congratulations on the Congress working.
No not choosing.
Sure Jim.
You know I'm talking with them on pricing structure that you have so far.
Nickel program I'm, just trying to understand worked.
Anything.
Are you going to doing this real time from from a clinical study, especially going on the manufacturing processes Actuate Juicy still were what do you think you can get done drugs, but for the patient within 48 hours.
But it's good to have you under call and actually we have done that already so when I spoke to the first cohorts Oh, well PR Gen 3005, I'm PR, Jan 3006, clinical trials or our manufacturing a happened.
Boats, Fred Hutchinson side, as well as and Moffitt cancer center, and that everything, including QC and a infusion. It's all went overnight and the next day infusion and I think it is why we're so excited because not only.
We have met all the criteria is that if they had to ask us.
And for liability, but also as you mentioned you brought that great point about the QC and having that drug product ready, but also because all ultravector does that we have the multi genic ultra vectors that we have we are capable.
All right now.
Producing a very homogeneous drug product, which means.
The ultra car T R.
Either they all express all the genes that caused the membrane bound I'll 15 under kill switch or they expressed nothing.
Indicates that they don't express anything the T cells of the patient is return to a patient there's nothing wrong with that and if the accepts that and the other case, we have to see the everything the old trunk cars and the doses on V. By the way we have been able to do all that I say that needs to be done.
Under the timeline.
And infuse the patient and that's why we're so excited about that hundred percent.
Success rate boats in solid tumors and hematologic called one ended clinics up to date and they're looking for what the rest of the arms and a dose escalation as we are currently moving through rapidly.
Thank you for that.
Even as it apart from Wow.
The first one for bigger is better rates for you to occur it HM.
Into Oh or do you think you how since it gets its kind of the although program you might have to be going through the full line.
I'm appears to undefeated <unk>.
Uh huh.
Excellent question are basically obviously, we are currently.
Going through their safety and a dose escalation as well as what we would.
Present is the expansion.
Potential of our old truck caught directly impatient, but one of the most important thing that we are quite aware off because of a differentiated platform that to be half, which we can do a very rapid manufacturing with very low cost compared to that basically lentivirus and all the other.
Caught and including TCR, what you are looking for work to Ais B basically finish our phase one you have dialogue with the F.D.A. in regard to what would be the best way to advance basically our platform and in occasion, especially.
Early in the two disease areas that we just thought that.
It's both of them are unmet need for these patients and a in a way they consider at orphan diseases. So we have very high hopes that we can have great discussion with the F.D.A. and discuss various path for approvals as rapidly as possible for the patient.
Thank you for lock or somehow I'm all set us apart.
Uh huh, so what works the pull them, but Uh huh.
She on the most oh, so the coffee ones.
So.
I have to say that the way I approach program.
Is based on the science and how fast we can get them to the clinic for the patients I'm, but we are seeing preclinically I think the portfolio. What we are holding and continuously evaluating is based on the data that we see for go no go down and in the immuno oncology.
Currently besides our and ultra car T. R. I didn't averse platform an off the shelf and we are moving in 2009 and as I mentioned, we're looking forward to dosing patients in 2020 with the off the shelf I didn't alert platform that we have for H.P.
<unk>.
You know currently <unk> lot of effort is going on in manufacturing you see ours for instance for HPV or some they have put vaccines in that what we have on is actually used our technology.
And leap frog in a sense of developing a platform that is off the shelf you can get that.
Repeatedly and it cost much lower and you basically create H.P.B. specific T cells with the high affinity because we are.
Platform of ultra vectors that I'm teach ins that we have picked is very different.
And the delivery that mechanism that we have is unlike what other companies have and that differentiates. It. So I'm looking forward to be it's a platform definitely but at the same token I have to say we are quite excited about our multifunctional platform. Because now this is not one molecule.
Anymore, we have made a platform that based on different indications, we can take the immune suppression away from the tumor micro environment, especially and all indications that the checkpoint inhibitors are not functioning so those on immuno oncology ought exciting to me.
And what I would say in regard to our ultra immunity and especially infectious disease I would like to say you should a wait and we will update you in upcoming future because.
I think it will be a very exciting programs that are currently in a preclinically. They are moving for worked very very rapidly as well.
Thank you thank you with him.
Thank you.
Oh.
This concludes our question and answer session I would like to turn the conference back I've heard a doctor Helen SAB severity for any closing remarks.
Thank you for taking the time to join us for our business and pipeline update I.
As you can see we are very excited with the progress Weve made and look forward to providing you with the updates in the coming months have a wonderful day and thank you for attending.
Oh Conference has now concluded. Thank you for attending today's presentation you may now disconnect.