Q2 2019 Earnings Call
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For designation as an orphan medicinal product for the treatment of glioma.
You'll recall that the FDA previously granted orphan drug status for the controlled IL 12 program in recurrent GBM.
And early in Q2, ZIOPHARM announced that FDA granted fast track designation for our controlled IL 12 program for the treatment of recurrent GBM and adults.
We have worked very hard and trying to improve ZIOPHARM business execution and you can tell from the long list of updates our team has been quite busy in the past quarter.
Finally, it gives me great pleasure to turn over the financial updates to our highly credentialed CFO mr. soft shoe CLO.
I am really pleased to introduce staff, who started with US officially on July 22nd.
Let me first give you some insights on why we're so thrilled to welcome him to our leadership team.
With 20 years of strategic corporate and financial leadership experience soft joins us following seven years with vertex Pharmaceuticals, where he was vice president and global head of corporate finance, having witnessed first hand, the growth of the company first valued in the mid single digit billions. When you started now all the way to more than $40 billion, where it resides today.
And his most recent role there he directed financial planning and analysis budgeting and led the long range planning process encompassing vertexs entire portfolio and operations across more than 30 countries.
These are experiences that are critically important as we look to build a world class immunotherapy company with a global presence.
Here's ZIOPHARM SAP will direct all financial planning analysis, and reporting Treasury and tax functions and will take on a key leadership role in the company's capital capital strategy development business development initiatives and Investor Relations activities.
I have gotten to know Sop quite well in the past few months and I can tell you. The difference. He has already made is palpable for all of US welcome SAP.
Thank you David Hello to everyone on the line I know that there are many on the call, whom I have looked at that in the past and many others I look forward to speaking with and meeting in the quarters ahead.
Im truly delighted to join the team at such an important time in ZIOPHARM history, and I'm very excited by the growth prospects on our company.
In my own due diligence I became convinced that ZIOPHARM is now well positioned to achieve this objective of bringing transformative immuno therapies to the market.
The science is compelling and that strength and talent and financial resources. The management team is laser focused on executing our strategic plan.
To advance tenant vslam patients and create value for the company and our investors.
Now turning to the financial results led ZIOPHARM second quarter of 2019.
Net loss for the quarter was $14.6 million or nine cents per share.
Compared to a net loss of $17.5 million or 12 cents per share for the second quarter of 2018.
The decrease in net loss resulted primarily from the elimination of approximately $5.5 million of dividends to preferred shareholders caused by the cancellation of preferred stock in October 2018.
Research and development expenses were 10 million for Q2 of 2019.
Compared to 7.5 million for Q2 of last year.
The increase was primarily due to milestone payments under our patent license agreement with the NCR.
And increased Nonclinical R&D to support our cell therapy programs.
Gee any expenses.
But $4.8 million for the second quarter of 2019 slightly below the $4.9 million for the second quarter of 2018.
The company ended the quarter with unrestricted cash resources of approximately $43.6 million.
This is the primary funding source for our controlled IAH cloud platform.
Our work with the anti.
As well as the GNS support for our business.
As a reminder, we also hedge of prepayments balance of approximately 24.2 million.
At the end of Q2 clinical and preclinical work should be conducted by the company at MD Anderson Cancer Center under the current Cdnineteen research and development agreement.
And as David mentioned, just last week, we announced that the company raised approximately 45 million.
Through the exercise of existing ones.
We believe that these aggregate liquid resources of more than 100 million will be sufficient to fund planned operations and execute our strategy into 2020 one.
And to allow for visibility into key clinical data readouts for each of our core programs.
This encapsulates our forward looking financial management strategy.
To prioritize and enable our R&D efforts, while staying disciplined on our DNA opex and showing optimal capital allocation.
In summary, I am excited to be here and I look forward to getting to know many of you in the months and years to come as they build a truly great company.
Over to you Laura Thank you Saf, it's wonderful to have you on board.
Reflecting on the list of recent milestones and news items, we have made considerable progress on both the sleeping beauty and controlled IL 12 platforms operationally, we have important new additions to the team and now enjoy significantly strengthened balance sheet.
It was certainly a busy first half of the year for ZIOPHARM and the pace does not appear to be slowing at all as we look ahead.
As the year progresses, we are sharing our vision in greater detail for the future ZIOPHARM with the investment community.
In broad terms ZIOPHARM aims to the leading developer of Immunotherapies to target cancers by harnessing the power of our two platforms.
Sleeping beauty and controlled IL 12, along with the associated three programs.
Let me start with the TCR T program.
One of the most exciting areas in immunotherapy is built on the use of the T cell receptors are tcrs to target neoantigens for the treatment of solid tumors, the leading cause of cancer deaths in the United States and a major opportunity for us globally.
We refer to the infusion of T cells expressing introduced TCR as quote TCR team.
ZIOPHARM is developing a solution for TCR t. using the sleeping beauty system, which we believe is the most clinically advanced non viral gene therapy platform and enables the production of clinical grade T cells expressing neoantigens specific Tc hours.
The simplicity and elegance of this non viral gene transfer technology sets us apart from the complexity and cost of genetically modifying TCR T cells with virus.
We are emerging as a leader in the non viral manufactured genetically modified T cells and as drew will highlight we have years of know how in generating tcrs to neoantigens.
We believe this expertise along with our recently licensed IP creates barriers that barriers to entry for our competitors.
The foundation of our solid tumor TCR T program as a cooperative research and development agreement agreement or Korea, with the National Cancer Institute under the direction of one of the most recognized leaders in the field Dr. Steven Rosenberg.
We made two announcements related to our relationship with the anti in the past quarter. These underpin what I refer to as our two shots on goal for the TCR T program, which will enable us to expand beyond the anti.
First.
The FDA cleared an indie submitted by the end Psi for a clinical trial in solid tumors to evaluate TCR T utilizing ZIOPHARM CPT platform.
This trial can be character as characterize as.
From the patient and for the patient.
As autologous T cells are genetically modified using TCR obtain from the patient to target a suite of their own tumor specific neoantigens. This is a superb example of personalized immunotherapy.
This trial is under the control of the NCR and Dr. Rosenberg team is already working to detect neoantigens to be targeted isolating the tcrs and identifying the patients.
In other words, while the anti completes final internal site activities. There at the same time facilitating their ability to enroll patients onto the clinical trial, which makes the trial more efficient over the longer term.
The second major event was the ZIOPHARM exclusively licensed intellectual property from the anti.
For the development and commercialization of TCR Ti for cancer, including TCR as against Neoantigens in the important hot spots K Ras P 53, and EGI fr for transpose on technology.
This license immediately created a second clinical path for our company to use a broad collection or library. If you would of pre prepared PCR as targeting these hot spots.
These hotspots are important as they are pan cancer in other words they occur in multiple types of tumors. This increases the commercial appeal of the TCR library as it expands the eligibility of patients to have a range of solid tumors.
And to have rapidly deliver the sleeping beauty modified T cell product, we refer to this trial as from a downer for multiple patients.
This terminology highlights that the specificity of patient derived T cells is redirected to hotspots targeted targets by expressing TCR withdrawn from the library that we generated from third parties in this case, starting with the Npis Library.
We are working on the infrastructure and partners to leverage the Npis experience. So the ZIOPHARM can continue advance advancing the TCR technologies.
You will hear more about this in the coming months, but one important piece is the hiring of experienced scientists and other personnel to ZIOPHARM as we execute on this program.
From the slides presented during our webcast. We cited publications about work that has been undertaken to evaluate and validate the sleeping beauty platform a prominent author of those publications as Dr. Drew Doniger, who has worked closely with Dr. Rosenberg at the end spy since 2013. He served as a lead investigator for the group's efforts in three initiatives.
Identifying hotspot neoantigens and the associated TCR the T cell therapy.
Targeting neoantigens in cancers, and preparing for the start of the upcoming clinical trial using the sleeping beauty platform to generate TCR TV targeting neoantigens.
In July we announced that drew is joining ZIOPHARM to lead our t. CRT efforts targeting neoantigens for personalized immunotherapy of solid tumors.
He will be based in our Houston offices collaborating closely with Dr. lead the group, our EVP and GM of cell therapy, and while drew could not be with us in Boston today, we are delighted they could join us by phone. So welcome drew.
Thank you our it's for the generous introduction and kind words, good morning, everyone I'm thrilled to be joining so far is such an important.
Time in the company's history as Lawrence noted evaluating and validating the sleeping beauty platform is for the research priority during my six years of work.
Directly with Dr. Rosenberg of Tunisia.
It is clear to me that utilizing sleeping beauty genetically modified T cells as a compelling path to treat treating solid tumors and I am excited to be able to join warrants early in the ZIOPHARM team as we advance to CRT into the clinic with two important shots on goal.
First the ZIOPHARM is planning a trial that broadly enroll recipients with multiple types of tumors. The TCR is targeting multiple neoantigens are made from for the patient similar to our experience.
Targeting patient specific neo antigens with TCR modified T cells at the MCR.
Second as a TCR T trial referred to as from a donor for multiple patients treating with a library of Tcrs that target shared neoantigen hot spots. Thus I will lead our efforts to expand the library of Tcrs reactive to neoantigens with commonly mutated cancer genes, including clearance P 53 in each area for.
I participated in growing the hotspot library to Sarah Library at the MCR and ZIOPHARM broad license with them. So that gives the company a very powerful differentiating starting point.
The initiation of the NCR trial is imminent. This trial is the culmination of several years of work for awards Dr. Rosenberg and me as well as a large group of supportive people at NCR and so for the Npis completing the necessary final internal steps to activate the trial.
As the final anti boxes are being checked we stand ready to execute on our own efforts to replicate the MCR process for commercial use later phase clinical trials.
I spent many years at the end see I working on this project and it's very exciting to see the clinical trials, so close to opening and treating patients with solid tumors, who are in serious needs of effective therapies DNC I would not have submitted the island and we would not be going forward unless they had a very robust and scalable approach based on the work I hope to those.
As I was thinking about the opportunity to speak with you today I anticipated three questions you might have so let me walk through my answers.
First.
How the sleeping beauty, how does this sleeping media approach compared to other genetic transfer technologies that we have seen or worked with for TCR too.
My answer to this question is directed brief this is the path forward.
The infusion of T cells is the answer for eliminating solid tumors, they will likely benefit.
By genetic modification and targeting of the tumor through and introduce immuno receptor tcrs have an amazing ability to surveil all parts of the tumor such that the entirety of the cancer is open to targeting right T cells sleeping beauty has a unique advantage over competing technologies because it only requires plasmid DNA for genetic transfer of the TCR.
That simplifies the process lowers the cost and speeds up the throughput by which we can do business.
Sleeping beauty and mutated Neoantigen Tcrs are the perfect marriage, and my excitement level cannot be higher.
Xyo firms technology and approach to to CRT is years in the making and I believe we have considerable lead in terms of what we have learned to date and with what so from its recently licensed the second question is based on summarizing my work with Dr. Rosenberg at the NCS. Some important accomplishments are worth, noting I was able to adapt the sleeping beauty system to efficiently.
Express Neo antigen specific Tcrs at then went on to lead the development of a manufacturing process to prove deuce clinical great T cells that were genetically modified with the TCR transpose on.
And to target.
Neoantigens. This process was further adapt it to generate populations of T cells with several specificities expressing multiple tcrs.
Which addresses the complexity of the tumor antigen space.
And.
Which is the basis of the recently cleared I NT. This work also provided the impetus for me to further adapt the sleeping beauty system to take advantage of a library of Tcrs that I was on covering.
Which is now the basis of the planned hotspot trial by joining ZIOPHARM I will now be able to advance this work towards the commercialization of TCR Ti as Lawrence as envisioned or.
The third question.
Is.
What is special about sleeping beauty Tcrc T trial at the NCS.
The NCR has an unmatched ability to quickly identify T cells with specificity.
To patient derived neoantigens and to isolate their mutation reactive tcrs in time for therapy.
There are blueprint moving forward and I will implement the best of their practices. It so for him to move us towards commercialization of personalized TCR cell therapy.
The sleeping beauty clinical trial at the MCR is unique as it is the first non viral TCR protocol and their steam district.
This protocol also lays the groundwork for future ZIOPHARM clinical trials and established critical infrastructure, especially with regulators and logistical considerations. Moreover, we will continue to collaborate with Dr. Rosenberg and NCR and future sleeping beauty trials to advances in our mission to radically cancer.
Again, my confidence is high and I believe the core technology that so from indeed represents a potential game changer in the treatment of solid tumors. Our foundation is in place and I look forward to my part and building a great company.
It is a real pleasure to be here and I. Thank you all for the chance to speak today I'm delighted to be here in Houston to look forward to all that lies ahead Laurence back to you.
Thank you drew we appreciate you sharing your experience and perspective. It is fantastic to have you here ZIOPHARM. We will let you dropped from the call. So that you can get back to the team in Houston.
In summary, the advancements in additions we have made to our TCR T program underscores the prominent roles ZIOPHARM expects to play in this evolving space. We are working with the right team Dr. Rosenberg of the anti Andrew and colleagues here at ZIOPHARM and we are we're targeting the right target.
Neoantigens inside and outside hot spots with the right tool the sleeping beauty system to genetically modify patient derived T cells combined this creates two compelling clinical path or two shots on goal for ZIOPHARM to pursue in the future.
I will now touch upon our other two programs.
Let me turn to the car T program.
Our second program also built on the sleeping beauty platform is the rapid personalized manufacturer or as we refer to it RPM of Cdnineteen specific car T, which we are advancing in collaboration with MD Anderson cancer Center in the United States and through our joint venture Eden bias Alpha Greater China.
The technology associated with rapid personalized manufacture is designed to generate car team within two days of gene transfer.
We reiterate our plan to commence a third generation phase one trial for rapid personalized manufacture a sleeping beauty cdnineteen specific car T with membrane bound I'll 15 later this year with colleagues at MD Anderson.
With independence from our former partner, we set two challenges for ourselves. The first was to improve the manufacturing process and the second was to evaluate the car T space for unrecognized needs from a clinical and perhaps competitive viewpoint.
Let me now share with you the three learnings from these past 10 months.
The first is that we remain focused on the only approved car T target, which is of course cdnineteen.
Recall that ZIOPHARM among other milestones renegotiated is Pos relationships last October gaining exclusive rights to Cdnineteen and one other unnamed car target.
Our twoq hard targets have been validated to work in the clinic.
But the hurdles of cost and manufacturing complexity, Rob investors and patience of achieving their potential.
We cannot justify the work required to validate and develop new untested car T targets, given the expense and time needed while competing in the crowded TCR excuse me in the crowded car T space.
However, what is needed and what diaphragm seeks to provide is an approach to reduce the cost and complexity for the two existing car targets that have commercial appeal.
Furthermore, our topline strategic plan is based on our findings the TCR will be greatly superior to cars for the T cell targeting of solid tumors.
As this is largely untapped territory. It represents another significant opportunity for us.
Secondly, during the past 10 months of work, we have understood how to produce T cells to achieve the threshold of 70% viability as required by the FDA. This gives us great confidence in moving forward with clinical trial.
Thirdly.
We have identified an opportunity for CD 19 specific car T that we believe is special desire farms efforts. We base. This on the time honoured knowledge that the only established care for patients with acute lymphoblastic leukemia, or AOL is allogeneic bone marrow transplantation.
This is why many patients who currently receive cdnineteen specific car T phone commercially approved therapies go on to receive a transplant as treating physicians justifiably concerned about relapse.
This just in case mentality further drives up the cost for these patients as they now undergo not one but two expensive procedures.
Car T and bone marrow transplantation.
This represents an opening for ZIOPHARM, which we may wish to seize by infusing our very rapidly manufactured car T in patients who relapsed after allogeneic bone marrow transplantation.
While transplantation is established as a cure for some patients with ALS a sizable number still relapse. This is a desperate clinical situation as there are no approved therapies and ZIOPHARM will now stepping in to fill this void.
Thus, we have prioritized these patients who appear to go unnoticed as a path forward.
We expect to file an investigational new drug application with FDA later this year to treat recipients with cdnineteen expressing leukemias and lymphomas, who relapsed after transplantation.
The.
ZIOPHARM will deliver our product consisting of healthy donor derived our allogeneic T cells that will prove this year.
The concept of rapid personalized manufacturing a party.
The trial design will also help assess whether lymphodepletion is needed and whether we can favorably impact the rates of relapse, particularly for patients who progressed with cdnineteen negative leukemia, which is currently undermining the effectiveness of commercially available carty.
While we have prioritized. This effort, we will continue to advance our autologous Cdnineteen program to allow us to address the entire continuum of patients with Cdnineteen expressing malignancies.
With regard to eat and biodiesel, we returned from Asia following productive meetings regarding our joint venture with our partners at try on therapeutics to develop Cdnineteen specific car T based on our rapid personalized manufacture.
In Shanghai, we toured that GMP facilities I met with the leadership team to advance our plans the clinical development.
That this trip reinforced why our part as a trial are ideal for this joint venture as they have in greater China excellent relationships with frontline positions and and officials at leading hospital and regulatory bodies.
A commitment to conduct high quality trials and state of the art facilities.
Finally, a few words on our controlled IL 12 program.
ZIOPHARM can precisely regulate the production of human interleukin 12, which activates the immune system to recruit cancer fighting T cells into solid tumors.
This powerful switch technology is the basis for developing IL 12, as a drug for the treatment of recurrent glioblastoma by advancing controlled idled 12, as monotherapy and in combination with immune checkpoint inhibitors.
In our clinical studies, we have demonstrated an apparent improvement in overall survival, which is a likely based on I'll twelves ability to recruit and sustain a T cell response within the tumor.
These T cells up regulate PD, one which provides a compelling rationale to combine our controlled IL 12 with immune checkpoint inhibitors.
Let me quickly emphasize a couple of clinical points regarding our recent news.
Firstly in our phase one combination study with Opdivo, we completed enrollment in the third dosing cohort during the second quarter.
Based on a favorable safety profile I'll trial investigators requested and received approval to expand the study we now expect to enroll up to 12 additional patients at the highest dosing level.
Next we have begun enrollment in our phase two combination with regenerons the tile in June .
With about 10 sites enrolling to this approximately 30 patients study and the same strong patient and clinician interest level, we have seen in the Opdivo study, we anticipate that this trial will briskly enroll.
Next.
As per a CR last June we expect to provide another interim data update for both monotherapy and combination therapy trials at the society of Neuro oncology annual meeting in New Orleans. This November .
And lastly, as announced just this morning, we are delighted that the program received a positive opinion for the orphan drug designation in Europe .
In closing the past quarter has been one off if not the most productive periods. During my tenure as ZIOPHARM, our efforts to reshape restructure and refocus the company beginning in the fourth quarter of last year were transformational and we have worked to build on that momentum evidence.
Over these past 10 months ZIOPHARM has emerged as a tangibly different company. We are executing on our timelines we have secured our balance sheet and we continue to attract and welcome new talent throughout the organization. We have the vision the data resources and partnerships to continue to deliver on the expectations of our shareholders the needs of our patients and the high standards, we set for ourselves.
And with that we turn the call over to the operator for questions.
Thank you ladies and gentlemen, if you have a question at this time. Please press Star then the number one your touchtone telephone.
If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
To prevent any background noise, we ask that you. Please place your line on mute. Once your question has been stated.
And as a reminder, we ask that you ask one question and one follow up at this time.
Our first question is from David Novak with Raymond James Your line is open.
Good morning, Thanks for taking my questions and congratulations on the outstanding progress in the quarter. So two questions from me I'm, starting with the third generation car T program could you update us as to where the Houston Engineers. Currently are in terms of viable non viable cell ratio and and maybe a bit of color into what type of protocol tweaks have been or are being implemented to drive higher viability.
Yes, thanks very much so.
The the question around the the really whats process development and the goalpost of achieving 70% viability.
As you and the listeners on this call know that was one of the major feedback from the FDA regarding the whole for this clinical trial.
My comments today, we are really designed to give reassurance that that 70% benchmark.
Can be achieved so this is really what we have been working on a lot of these past months essentially since we reshaped our relationship with our former partner.
And it really involves an engineering solution.
That the team in Houston have executed on I don't want to go into too many details for obvious issues of competitive intelligence, but suffice to say.
It is both elegant and within the confines of the rapid personalized manufacturing process. So it can be readily accomplished within the two days.
That we designed for this procedure.
Excellent and just for a follow up maybe moving onto the controlled IL 12 program and I think the highest opdivo dose. We've seen to date is three makes per case Q2, w. if I remember correctly in the phase two starting dose with less Tiotwo is 350, Meg Q3, W. could you just walk me through the rationale and establishing the starting dose of live tyo versus the Max dose tested in the phase one combo with Opdivo, Yeah, I know I. Thank you for the question and Thats I see very good the to clarify this so the phase one study with up with Opdivo.
Accomplished several goals. The first was for the first time IL 12, with combined with an immune checkpoint inhibitor and targeting PD one for patients with brain tumor that learning was accomplished by a series of cohorts in which the IL 12 dosing and the PD, one or Optivo dosing were stepped up we announced that essentially we have achieved maximal dosing for both the aisle 12, and the Opdivo and now we're expanding that study. So so that that playbook. If you would for the phase one trial.
Gave us the inside the maximal dosing a PD one inhibitor would say.
We then translated that data into the phase two trial with regeneron asset that asset that tile. We now can enroll to a phase two trial without having to do the stair step function because we can give essentially the maximum dose of the tie out with what we also know to be the maximum dose that appears to be efficacious of IL 12. So in song the phase two trial really build up the phase one trial, because the TTI outcomes in app that maximum dosing.
Got you perfect well. Thank you very much for the color and congrats again on the progress and I'll drop back in the queue.
Thanks.
Thank you and our next question is from Thomas Flatten with Lake Street Capital. Your line is open.
Thank you good morning, just a follow up on the question about the car T program can you give us some color on the ongoing discussions with FDA and timing and resolution of the hold.
Yes, no. Thank you so we have.
Prioritized.
As the allogeneic trial over the autologous drop so let me just walk through that terminology, we see white space for patients who relapsed after allogeneic bone marrow transplantation, who have cdnineteen specific malignancies that bought it that is to be Frank a death sentence for those patients.
But it's a real opportunity now for ZIOPHARM, because with our rapid manufacturing process. We can infuse donor derived T cell in that context, and as I mentioned in my prepared remarks ancillary questions can be answered around lymphodepletion and relapse rates.
The playbook, if you would for that is based on dialogue with the regulators that guidance that we will submit a new R&D.
And that's an important part of the puzzle, but it should not disturb the investor base, because it doesn't disrupt our timeline as we've said all along.
We will be in the clinic with this program will initiate a trial in this program this year.
The hold issues associated with the autologous car T really allow us to know what the FDA needs to here in this new line D. So all the process development that we've done in the in Hollywood trial. If you would is being applied to this new R&D, hence I can get essentially confidence about the timeline.
Let me just add one other I think framing statements.
One quarter a growth ago ZIOPHARM had one shot on goal for its TCR program that was really from the patient and for the patient.
In one shot on goal in the car T program and that was the autologous car T therapy.
By one quarter later this quarter, we have now essentially given two shots on goal for both of those programs in the TCR T program, we have.
From the patient for the patient.
And from a donor promotable patients that the hotspot trial and in the car T program, we've expanded essentially beyond the autologous cell therapy setting to now include this allogeneic cell therapy.
Program, which we think will be I think special to our technology.
That's great and to confirm the allogeneic study will that be done in collaboration with MD Anderson as well or is that is that separate from the agreement you have with them no. That's within the confines of the agreement at MD Anderson.
Got it thank you I'll get back in the queue.
And our next question comes from the line of Yale Jen with Laidlaw. Your line is open.
Good morning, and thanks for taking the questions and congrats both audit advancements Oh I have two questions basic.
Related to that be.
First one is for the PC.
He per win in the end.
Could you give a little bit more color regarding what might be.
Activity over the next 12 months in terms of the.
Study.
Based on study and also all would you guys prioritize between.
The hot spot and individual needs the noble Neoantigens <unk> was that batesville patient indication or any other criteria.
Those those are great questions jail. Thank you so in terms of the anti activity over the next 12 months.
The.
It is the Investor base.
Well really been benchmarking us on the clinical trial data.
That obviously, where we're heading and that we expect to be able to share in the next 12 months.
It's a it's a process it starts essentially withdrew.
And all his find work. It then bubbles up through the eye in the regulatory gate that Weve now passed it then executing on that island, the anti going through essential that our internal processes and then its beginning the trial. This fall the patient from the patient identifying the neoantigens identifying the TCR. The manufacturing process. This is what the NCR is to.
So let me transition now to the to your other question, which is also very perceptive and that is how old's off our managers essentially or prioritize between the two trials.
The from the patient for the patient that idea that we're harvesting the patients own TCR ours and delivering them back against the suite of targets and then the quote hotspot trial from a donor from multiple patients in which patients are being screen and then libraries are being extracted from the shelves to make their products.
That that that essentially two opportunities can run in parallel.
And given the number of patients quite frankly with solid tumors is easily enough demand for both of those trials.
However, there is also opportunity for patients to naturally progress through essentially the two trial design.
Imagine for instance, a patient who comes in tomorrow into ZIOPHARM, he or she can be screened essentially and that tcs can be identified but at the same time. We can also look to see if they have a hotspot mutation and we have a TCR on the shelf. So we can make a decision really in the patient's best interests do they have a hotspot TCR ipso boom. They go right on the trial or are they part of the broader population for which they don't have a TCR in that library and then we have essentially that a requisite MPAR and quite frankly preeminent technology to develop their own T cell receptors for that particular patient.
Okay, great. Thanks.
I have one follow up question, which actually came from investors.
Related to the copy.
Studies in that.
And that.
He would like to I know you mentioned about a 70%.
Minimum.
Oh by the FDA. The question is how do you ensure the consistency and the reproducibility of Oh by the way you try to achieve that and also by achieving that could that potentially have any other diverse sort of a lot of patients, which will be impacting or other aspects of the copy.
Yes, that's a that's a really good question as well. So just in case there is some difficulty on the line I will leave our feedback to the audience. So the question really went around.
The consistency of the process to achieve that 70% benchmark with respect to the British production of the car T.
So one.
One solution is we've repeated this a lot of time and Thats really you know what's expected I think of a first class drug developer. So we have a set of data that allows us essentially to have a confidence interval around that 70% benchmark.
But there is also I think underlying gale sophistication to your question and that is around the heterogeneity of patients I mean sitting around this room people look different and thats not just their outside apparent but inside their different in other words people have different types of T cells in terms of quality and quantity, but ZIOPHARM a sole for that because the first is by having a very rapid manufacturing process you essentially limiting the variability that introduced during the growth of the T cells. Other companies for instance, viral producing viral using companies have a pretty lengthy production process and variability creeps in during those days to weeks of manufacturer.
And the second.
Way essentially to smoothed out to the heterogeneity between people is the use of IL 15.
This is such a powerful signal for T cells to go and grow that if patients.
Had for instance, poor quality T cells that I'll 15 heels that allows those T cells, essentially then to execute their function inside the body.
Okay, Great that's very helpful and again congrats.
Thanks.
With multiple fronts.
Thank you.
And our final question is from Sean Lee with HC Wainwright. Your line is open.
Good morning, guys and thank you for taking my questions.
My first question is on the controlled IL 12 program.
Could you give us some estimates on the expected timelines for the currently enrolling colorants.
When do you expect them to be fully enrolled and when can we see some up.
Updates on the results.
Yeah, Thanks, very much on so the.
Expansion study, which is that monotherapy study really designed to drill in on what we think is the optimal dose of Elevenx 20 milligram with the right environment in other with low dose steroids those that that expansion cohort is already accrued and we did a very rapidly and we now have those additional 36 or so patients that we are added to the prior phase one data set and that's now maturing and we will start to see that data towards the end of the year as I indicated as society of neuro oncology would be one bite of that data and then into next year.
The two combination trial.
The first being that phase one trial with.
Opdivo and the second being the phase two trial with let's hire those trials are both running in parallel, but a slightly different because the phase one trial with Opdivo essentially had completed its dosing we've achieved the maximum dose level, but we had demand for that trial and put on an additional about 12 patients. So we'll have essentially a.
And oversubscribed dataset that will again read out the initial bite being around society of neuro oncology in November of this year and then into next year.
And then lastly, the combination trial with Sumitomo lead time, so that's a phase two trial, we just announced today around the enrollment David made that announcement in his prepared remarks. So we are accruing and quite frankly, given the invest excuse me given the patience and the providers enthusiasm. It really should go very briskly I would think it will be done.
Roughly by the end of this year, so you'll start to see that clinical data then perky laid out in 2020 I think also this is a good example, a good question to demonstrate the importance of the financing we disclosed in the idea that our data sets in all three programs will provide us.
A maturity level that we think will be value, creating so if you assume that we would have the potential to have all of our patients enrolled during the calendar year. This year and then you secondarily assume that any follow up greater than nine months is meaningful in the RGB EMM space. The dataset in 2020 would be extremely powerful for us for the Isle 12 program.
Okay, great. Thank you for the clarity on that.
Mike.
Second question is on the Eden bile so venture into your prepared remarks, you mentioned that the GMP facility in China is almost complete just I'm just wondering what are the next steps planned for that program.
Yes, so thanks very much so it's just remarkable.
What can be accomplished.
In greater China.
We'd been visited.
The beginning of the year and then just a short few short months later.
It's gone from.
A work in progress to work that has real now maturity.
People have been hired infrastructures established GMP is coming online. This now enables us with our partner even biodiesel to essentially begin the regulatory process to get the car T trial going.
And so that's where we are with them it that technology transfer a moment they are inhaling, what weve learnt and they're getting ready to execute on that trial for greater China.
I see okay. That's all I have thank you Rick skins for taking my questions.
Thanks, Ron Thanks, very much so just a summary, and the closing for me. This has been an amazing last few month for us I just thank my team for all the incredible hard work and for the support of our investors and our patients on our trial. So thank you very much everyone.
Ladies and gentlemen, this does conclude the program you may now disconnect everyone have a great day.