Q4 2020 Turning Point Therapeutics Inc Earnings Call
Yeah.
Yeah.
Ladies and gentlemen, thank you for standing by and welcome to the turning point Therapeutics fourth quarter, 'twenty and 'twenty conference call.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session to ask a question. During day session you will need to press star one on your telephone.
If you require any further such gains each press star zero and.
I would now like to hand, the conference over tiers feature today, Mr. Jim Missoula head of Investor Relations. Thank you Sir Please go ahead.
Okay. Thank you and good afternoon, everyone. Following market close today, we filed our form 10-K and issued a news release with a summary of our results for the fourth quarter and full year 2020, we also updated our investor presentation and you may find these documents posted on the investor pages of <unk> Therapeutics Dot com and.
Leading the call today will be turning point's, President and Chief Executive Officer Doctor Athena country artists, who will provide an overview and update of our business results opinions remarks will be followed by a review of our financials by our CFO E. Larson, we will take questions. Following our prepared remarks, the three of us are and separate locations today. So please bear with.
With us as we manage the call remotely.
Before turning to begins I want to remind you that during this conference call, we will be making forward looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward looking statements and for a description of risk factors associated with investing and turning point therapeutics. Please refer to our recent filings with the Securities and Exchange Commission.
Now, let me turn the update over to Athena.
Thank you Jim and good afternoon to everyone joining us from today's call.
Today I want to briefly recap our progress from 2020.
Share a number of updates across our programs and focus on our goals for 2021.
For all we continued to make progress and developing our for internally discovered next generation tyrosine kinase inhibitors that target and genetic drivers of cancer.
In addition, we are investing and a discovery engine with the goal of establishing a pipeline for long term growth for.
And the progress and investments we have made are all directed towards advancing our vision to be the leader and precision oncology.
Starting with our lead program reap attracting and in 'twenty and 'twenty and in January 2021, we reported encouraging preliminary data from our Registrational phase two Trident one study.
We are attracting and as a next generation Ross, one and track GTI with greater than 90 fold higher preclinical potency than croissant nib and.
Greater than 50 fold higher preclinical potency and interesting Ed against Wild type Ross one week.
We've been tracking and has been granted several key regulatory designation, including breakthrough therapy designation and the United States for the treatment of patients with Rockwell and positive he can naive metastatic non small cell lung cancer.
To recap our clinical data update, which we believe support a potential best in class profile as of a December 31, 2020 data cutoff date in 15, Ross one positive PK and naive advanced non small cell lung cancer patients who had at least two post baseline scans and phase II portion of the Tri net one.
Study.
And the confirmed objective response rate by physician assessment was 93% or 14 or 15 patients with a 95% confidence interval of 68 to 100.
At the time of the day to cut off the one non responder remained on treatment with a 13% tumor reduction.
And 22 patients pools from the phase, one and phase II portions and try it one the confirmed overall response rate with 91% with a 95% confidence payable of 71 to 99.
For historical reference both of our core and Roswell track are approved and this patient population with confirmed overall response rate of 66% and 67% by blinded independent Central review respectively.
Equally important is the duration of treatment and in the pooled phase one patient and the duration of treatment ranged from 10.9 to 37 three months, and then and a 39 months, which we find encouraging given and it compares favorably to the published data for Zelle, Corey with a median duration of treatment.
And <unk> of 22.4 months.
Turning to the preliminary safety profile.
As of and October 30th 2020 data cutoff date, and a total of 185 patients from the phase one and phase II portions of this study, we protract and it was generally well tolerated.
In addition to the recent update from our Roscoe and positive Teekay and naive.
And cancer patients within Trident, one last August and 2020, we reported early encouraging data from multiple other cohorts of the phase II Trident, one study and TGI pretreated patient Ross one positive non small cell lung cancer or and truck positive solid tumors, we look forward to sharing more data.
And from the ongoing Trident, one study and the second half of this year and.
Want to now share and enrollment update.
First we continue to be pleased with enrollment and patients with Roswell and positive teach and naive non small cell lung cancer, which is cohort one of the current study.
And the second quarter, we now anticipate reaching 50 patients pool from the phase one and phase II portions and plan to discuss next steps with the FDA during a type B meeting, which was requested based and our recent breakthrough therapy designation being granted.
We hope to be and are positioned to discuss our path to potential registration. Following this meeting.
As it relates to the other cohorts of the study we continue to steadily enroll patients and the CCI pretreated rock for and positive and and truck positive cohort and it is our goal to provide and enrollment and clinical data update and other cohorts of the Trident, One study and the second half of the year.
In addition to our development of <unk> and the Trident One study our team continues to make progress towards the planned initiation of the first cohort of our multi arm tried and two combination study in mid 2021.
This planned phase <unk> study and K Ras mutant solid tumors is based on <unk> inhibition of JAK, two dark and stack, which is believed to suppress stacked three and <unk> signaling known mechanisms of oncogenic resistance.
We will provide further details of the study design closer to initiation and plan to present additional preclinical data highlighting we protect and its combination potential and <unk> and disease at an upcoming medical conference and the second quarter.
Next and our pipeline is <unk>, our net SAARC and CSF Oner inhibitor currently being studied and our ongoing phase one shield one study in patients with advanced solid tumors harboring genetic alterations in met.
Net driven cancers represent a heterogeneous population across multiple tumor types as was reflected in our early clinical data update last October.
While there are now two therapies approved for met exon 14, skipping non small cell lung cancer. We continue to believe we have the potential to expand the development of <unk> and focus on net amplified non small cell lung cancer, both as a single agent and and combinations as well as Gi tumors.
Additionally, we believe there is room for improvement and the exon 14 space given the limited duration of response and.
And safety profile of the two approved agents.
As a reminder, our preliminary data update last year showed objective responses across multiple tumor types with a generally well tolerated safety profile and a heavily pretreated patient population.
The phase one study continues to enroll patients, including those with met amplification and net exon 14 skipping alteration.
Similar to how we approach the phase two dose for re protracted and we are evaluating multiple doses and schedules for <unk> to further characterize the pharmacokinetics safety and efficacy profile before determining a recommended phase II dose.
We are currently enrolling patients from the phase one dose finding portion of shield one with the goal of selecting the recommended phase two dose in the second quarter.
After which we anticipate preceding directly into the phase one dose expansion and multiple patient cohorts.
The dose expansion will include select patient populations, including patients who are both teekay and naive or TGI pretreated.
We have multiple updates anticipated in the second half of this year in our <unk> two program, including and additional clinical data update from the phase one dose finding portion of shield one.
A planned discussion with the FDA to potentially modify the shield one study into a registrational phase <unk> design.
Initiation of the phase two portion of the study pending FDA feedback and finally, initiating our combination study with an egfr targeted therapy.
Lastly, I want to highlight that in January we signed our second licensing agreement with XI lab.
Similar to our licensing agreement for <unk> and at the latest agreement included rights for XI lab to develop and commercialize <unk> and greater China.
There is a significant unmet need and net amplified cancer in China, particularly and gastric cancer, where 40% of the world's cases are diagnosed and are often advanced at the time of diagnosis.
Next and our pipeline is our ret inhibitor <unk> zero zero for six.
They are there for six has demonstrated preclinical potency against wild type ret and ret solvent front mutations.
And the dose finding portion of our ongoing study we continue to evaluate multiple doses and schedules to further characterize the pharmacokinetics safety and efficacy profile.
We plan to provide a preliminary data update in the second quarter, which will focus primarily on safety and any early signals of efficacy from initial patients.
And we anticipate approximately 15% to 20 patients across multiple doses in this data update.
Lastly, and our pipeline to keep the ex 0131, and our fourth drug candidate patients without positive disease comprised approximately 3% to 5% of non small cell lung cancer and sales and approved therapies were estimated to be approximately $2 billion globally in 2020.
While there are several other inhibitors currently approved we believe <unk> could have great potential initially and CCI pretreated patients.
Low brenna is the current standard of care in this setting yet 0131 is considerably more potent pre clinically against many clinically observed resistant mutations, including with sub and animal or potency against the most common gene <unk>, our solvent front mutation and <unk> 96 and gatekeeper.
Patients and multiple compound mutation TD.
<unk> 0131 has been designed with a compact macrocyclic structure and in preclinical in vivo studies has shown significant brain tissue penetration after repeat oral dosing supporting its potential to cross the blood brain barrier and humans.
We are excited to have already received approval by the Australian Ethics Committee and plan to submit our IND for the FDA later this month and anticipate initiating our phase <unk> clinical study in the second quarter. We also look forward to presenting additional preclinical data highlighting the profile of <unk> three one at a medical.
<unk> in the second quarter now.
Now, let me turn the call over to <unk> for an update on our financial results.
Thank you Athena you will see and our press release and financial tables that operating expenses for the fourth quarter totaled $47 9 million compared to $23 1 million and the fourth quarter of 2019 and.
25 million increase was driven by a $17 million increase and R&D expenses, and an $8 million increase and G&A expenses increased expenses were attributable to the investments we made to develop our pipeline and earlier stage discovery and and personnel.
For 2020 operating expenses totaled $186 8 million compared to $77 7.002 million 19 for.
For 109 million increase was driven by a $55 million increase and R&D expenses and $54 million increase and G&A expenses.
Excluding a onetime noncash stock based compensation charge from the first quarter of 2020, non-GAAP operating expenses increased by $78 million driven by investments made to develop our pipeline and earlier stage discovery and and personnel.
Net cash used during the year totaled $82 8 million recall, we recorded $25 million and revenue during the third quarter from the XI lab licensing agreement for <unk> and greater China.
This revenue, partially offset cash used during the year cash.
<unk> cash equivalents in marketable securities at December 31 totaled 1.1 billion compared to $409 2 million as of December 31, 2019.
The increase was driven primarily by net proceeds from our two follow on public stock offerings and May and October of 351.6, and $433 9 million, respectively, partially offset by cash used in operating activities.
Looking ahead to 2021, we continue to expect expenses will increase during the year as we execute across now for pipeline programs initiate three new clinical trials and make investments in our earlier stage discovery efforts. We continue to project our cash position funds current operations into 2020 for now.
I will turn the call back to Athena.
Thank you D.
To close I will summarize our goals for 2021, beginning this month with our anticipated submission of the IND for TPS 0131, and our novel Alch inhibitor.
We have a busy second quarter expected with anticipated milestones, including reaching enrollment of 50 patients in cohort one of the tried and one study and discussing next steps towards registration and this population with the FDA.
In addition, reporting early interim data for <unk> zero zero for six initiating.
Initiating the <unk> zero 131 phase <unk> clinical study.
And multiple pipeline presentations at medical conference.
Moving onto mid year, we expect to initiate the first cohort of our tried and two combination study.
And in the second half, we anticipate providing and enrollment and clinical data update and other cohorts of the Trident one study.
Abiding a clinical data update from the phase one portion of the shield one study and initiating the phase two portion of the study.
And initiating the shield two combination study.
And finally outlining our research strategy, including our focus and anticipated timeline to development candidates.
With that update we are now ready to take your questions before we do I want to close by thanking our great and growing turning point team for all day accomplished in 2020, we are looking forward to another great year in 2021, operator, you may now open the line for questions.
Thank you ma'am.
A reminder to ask a question you will need to press star one on your telephone keypad.
And you would draw your questions Pease fresh and hashed and.
Please standby, while we compile the Q&A roster.
And man we have your first question from Michael Smith of Guggenheim.
Sir Please ask your question your line is now open.
Hey, guys. Thanks for taking my questions Athena I had one on repo tracks and there maybe more specifically around the Ross one market and maybe I was just wondering if you could maybe share.
From your experience and rolling of Trident, One study and what you're seeing at the moment in terms of what percentage of patients is actually receiving a and approved Ross one GTI vs.
And being treatment naive for it seems like your T. J on each cohort is enrolling pretty quickly here just wondering if you could comment on that and then a follow up as well.
Yeah, Hi, Michael I'm happy to do so so our belief is that the rosslyn market remains at approximately 2% of non small cell lung cancer and I will say, we've gone through with the leadership of our Chief commercial officer, a very large market research campaign internally to help prepare us for hopefully potential registration and <unk>.
Launch for a protracted and it does appear that at least in the United States that forgot and it is still the standard of care and Theres been very little change and the annual sales for <unk> year over year.
That said the uptake for also track appears to have modestly improved.
And I still would say that it's a modest launch at least a year now into its commercial opportunity that said as it relates to enrolment for our trial I definitely we are the most pleased and that our cohort one has exceeded our initial projections. Despite the competition, obviously thats and the commercial landscape. So thats why we have been.
Much focus there of course, we have gotten breakthrough therapy designation, there and now moving as quickly as we can for the type B meeting with the FDA.
Great. Thanks, and then on EPS.
For six year Ret inhibitor.
Yeah.
<unk> against solvent front mutations and I was just one other.
Other characteristics that could potentially address potential shortcomings of currently approved for ret inhibitor honest and.
And how investors should be thinking about the upcoming phase one update in terms of interpreting the data cut there.
So as it relates to owe for six what we've consistently shown is that it is equally potent to the other two molecules based on our preclinical studies and the wild type setting and again as for the point you mentioned on solvent front mutations that Oh for six is more potent specifically against certain solvent front mutations and that.
We don't we have very little limited information as it relates to the prevalence of those mutations, but clearly we have been enrolling patients who not only our free cash retreated, but also have solvent front mutations as well as patients who Archie can I E. The trial has essentially been enrolling for approximately a year on a standard three by three design and where we are.
Today is continuing to evaluate additional doses and schedules. We tried to guide today, we anticipate similar to what we did with the net program of the mid teens and we estimated 15 to 20 patients and the initial update but we've been consistent in saying that the first update really will focus predominantly on safety as.
Well as any early signals of efficacy across multiple doses.
Great. Thank you so much.
And ma'am you have your next question from Paul Choi of Goldman Sachs.
Sir Please ask your question your line is now open.
Hi, This is corinne Jenkins on for Paul.
Combination studies that rep per checking them and chaos and policy risk can you just talk about where you see the clinical hurdle for combination programs and.
And especially given there's a lot of development and that area. These days.
Yeah, Hi, Corinne and please say hello to call for us.
So the first thing I would say we've been very pleased with the progress we've been making not only within the combination preclinical data sets that we've been developing around re protracted net but towards initiation of the trial, we gave a little bit more information today to highlight that this is going to be a multi arm trial, we will initiate the first cohort.
In the middle of this year.
Goal, obviously is to submit the IMD relatively soon to enable that and we don't typically give too much guidance as it relates to trial design until our <unk> are submitted and and ultimately filed but we do have more data coming out and medical conference and the second quarter and I'm sure you can anticipate which conference that is to support this and I think much of.
The data we've shown so far is in combination with AMG 510, and the <unk> setting. We've also shown data with turn out and they are in the <unk> setting so without trying for that for run too much on what we think the clinical hurdle will be I think that'll be important for us to show you the design.
As it relates to which combination partner, we're using and then we can start talking in terms of what we and hope to anticipate showing as it relates to response rate duration and safety.
Okay. That's fair and then as you think about the upcoming type B meeting and you just talk a little bit about the key questions you'd like to get answered and and where you'd like to be exiting that conversation.
Yeah. So of course, the type B meeting is exclusively focused on cohort, one which is our Ross one and Teekay and naive population and that's because of this meeting was requested and the context of breakthrough therapy designation and while it is not a pre NDA meeting we do have an extensive briefing documents that will outline our preliminary clinic.
Pharmacology studies, our CMC plan, our companion diagnostic plans and the patient population and inevitably I think the key component here and try to get some guidance and potentially clarify regulatory path for cohort one as it relates to number of patients and we'll follow up as you know <unk>.
And the trial to mirror croissant, and is and <unk>, which had essentially 50 patients and their initial applications and our current guidance and that we will have 50 patients and the second quarter. So there are quite a few questions. We hope to get answered I will say I've been trying to be conservative here and saying that this is the first meeting and having b.
So it's a preliminary discussion and you obviously don't have as much until you have the pre NDA meeting, but I do think any additional information we can receive in terms of regulatory clarity will be very helpful. At this point.
Great. Thank you.
Okay and listen Brennan.
And.
Yes. Thank you Sir your next question from David No and Gartner for.
And all of what Bush Securities. Sir Your line is open. Please ask your question.
Hi, Thanks for taking the question.
A little bit of a follow up to the previous one which is when do you think about potential combinations.
AMG 510, and this is one you mentioned from that nib.
And kind of May.
And maybe if you wanted to elaborate a little bit on your strategy for expanding.
But the reach and the potential reach your I mean are you.
And kind of planning to have a kind.
And have them a multipronged approach or are you just looking at these first two and kind of.
Progressing to approval eventually and then looking at additional combinations and I'm just kind of curious as you think about sequencing and potential combination studies kind of what your priorities are and.
And what that might look like over the medium term of let's say a couple of years from now.
Yes, Hi, David So let me just start with <unk> because obviously this is a year, where we're going to initiate two combination studies. The first to reap attract and yet began is trying to take advantage of the fact that it also has strong potency against Jack too Stark and fact, which as I mentioned in the prepared remarks do you suppress battery and AKG signaling for the goal.
<unk> in our K Ras pathway to try to hit bypass resistance multiple ways. What we've shown publicly so far and again trying not to jump too much other medical conference, that's coming and we have more data coming in our combination strategy, but what we have shown previously is with AMG 510, and the <unk> setting and from that net we do.
More data with other <unk> inhibitors, we do have more data with other net.
<unk> inhibitors, and so right now all we are publically guiding to is that the initiation of this trial will occur in the middle of 2021 pending FDA filing and that it will be a multi arm approach and how many drugs will be a part of this trial is still to be determined as the trial will initially starts in <unk> and solid.
Tumors, and then potentially narrow down into and non small cell lung cancer and to our colorectal and pancreatic cancer setting, but thats all still again to be determined and I am sorry, but I can't give too much margins such as kind of against our standard practice.
And that's fine and this is competitive space and I know thanks.
Yeah.
And ma'am. Your next question from Matt Biegler of Oppenheimer. Sir Your line is open your line you May ask your question.
And thanks for taking my questions I had a question going back to the shield trial eligibility and it's one that get inbounds on.
So for met amplified patients did you exclude copy number low patients I think similar to what we've seen and some of <unk> recent data.
No and thanks for the question, Matt So just as a reminder, and thanks for fielding questions of course.
And the phase one shield one study essentially is and trial is open to all met alterations and so this by far has the majority of patients with non small cell lung cancer, but as you saw from our updates last fall, we have enrolled multiple gi tumors, whether its gastric cancer <unk> cellular colorectal and I can tell you we're continuing.
And to enroll other cancer types, including Gi and tumors and so it's open and irrespective of gene copy number for met amplification.
Open to exon 14 mutations of course and then it's also open right now two kinase domain fusions.
As we move toward the recommended phase II dose, which we're anticipating now will be within the second quarter and move directly into phase one dose expansion. This is where we will narrow down the patient population into select cohorts. We may at that time change the criteria to have a cutoff to your point on <unk>.
And copy number we have not made that determination yet, but we will for sure decrease the amount of prior chemotherapy for the lung cancer and that amplified patients that were enrolled in the initial update that we gave last fall. The median was three prior therapies, but again these patients had more like for.
And five rounds of prior chemo and our immunotherapy. So those are the patients patients that will now potentially be excluded from the expansion, but no is the answer to your question. We did not exclude patients based on gene copy number.
Great.
And that's really encouraging maybe just a quick follow up if I may just something more on broad strategy here as you think about expanding the pipeline.
Do you foresee focusing exclusively on macrocyclic scaffolds and the future or are you thinking about being more agnostic truly any type of structure or type of CGI.
Thank you for the follow up I think for the company. Obviously at this point is very well known for our for drug candidates at all came off of the initial macrocyclic scaffold I can tell you our chief Scientific officer, Craig has been not only mining that but also looking at other opportunities when he is evaluating targets for future.
Development candidates. So right now I would say that we do plan on continuing to evaluate our current macrocyclic scaffold, but I would also not be surprised if we were to go down a slightly different path, but with the same idea of trying to maintain low molecular weight as well as highly potent potentially best in class <unk>.
Our first in class drug candidates.
Thanks, Athena and congrats on the progress.
Thank you very much Matt.
And maybe you have your next question from Nick Nick and but Wells Fargo. Sir Your line is open and discounts for your question.
And good afternoon, and thank you very much for a very good day.
And maybe just a quick question and 131 and you indicated that channel.
And this molecule and its good green penetration and it looks like on the corporate deck that Youre and iron page.
Patient segments.
And kinetic brain metastases.
Do you think youll see more of those kinds of patients.
And as soon as penetration with this molecule and perhaps typical for phase one trial.
Yes.
Well, thanks for the question and congratulations.
For you I would say one thing first of all and we just start I am excited about the outcome here because I think in many ways. It mirrors free protract and have the most when I look at our pipeline it.
It is not only very potent and the wild type setting and what you see on that corporate debt is somewhere between 10, and 30 fold more potent than the second Gen <unk>, which you would say electing at this is the standard of care.
Italy, we're getting over 100 fold more potent for <unk>. So again, it's a similar story to what you saw with the protracted nib and again of course free protect and have had CNS penetration. So I don't know if the patient population will be skewed and not direction initially and what you see on the slide we gave a little bit of information on the.
Trial design is that we will limit down the number of prior <unk> and chemotherapy and this is all up for FDA discussion still of course, because the IND has not been submitted but I don't know, specifically, which patients we will see in terms of CNS disease or not I will say that we are hoping to go through dose escalation as quickly as profit.
And we didn't give too much guidance, yet, but the goal is to try to use a some type of a single patient dose escalation and go as fast as we can take accounts.
Okay. Thank you and then maybe it's for follow up and net net.
And when you think about the tried and true combination study.
I mean, how potent <unk> inhibitor is really per trip.
Part of the question relates to <unk>, and then you do see anemia, and so great to retreat and related adverse event is that related to JAK, two and then grow with JAK, two and interferon gamma mediated and efficacy.
And this PD lone resistance and is that is there a concern that it could be.
Paint and.
And to pay past with potential PD one combinations.
Yeah first of all it's a fair question and maybe back step on the anemia component first and then I can go to the potency. So one thing we've seen with the initial dataset and remember for our safety profile, which we showed in January of 185 patients and about half of that was coming from the phase one and remember all of the phase one.
And about a third came from heavily pretreated outpatients. So the majority of the patients were that had and EMEA came in and not only with some type of baseline low hemoglobin, but also were heavily pretreated outpatients and when.
You look at the in.
And vivo excuse me the in vitro potency data we have for Ross one of course, we're sub one animal or and project for you were about one animal or so it is not as strong as a JAK inhibitor. Obviously as it is a ross one inhibitor, but still incredibly potent so we'll have to see in terms of the translation into the clinic to your point.
Object to inhibitors being.
Unfortunately prone to two and EMEA.
Okay. Thank you very much.
Thanks, Nick.
And then you have your next question from TD Gela of Ruth Capital market Partners. Your line is open. Please ask your question.
Hi, guys. Thanks for taking my question are.
The other piece have been really good wanted to start with we protect and it just kind of wanted to know how much data do you think you will have at the time of day type do you mean and I know you talked about.
Having got on 50 patients, but perhaps be the minimum duration of follow up at the time for the meeting and then are we likely to expect and then day initially on cohort one and then the other cohorts.
Cohorts cabal of the label expansion.
Hi, Doug Thanks for the question. So we're putting the briefing documents together now so I can't give too much information as it relates to the duration of follow up and what not.
Do you feel comfortable saying as the FDA will be seeing slightly more data and then what you've seen from world lung.
But again it fits the follow up it to me is not more.
Important component it really is where we are with response rate confidence interval duration of response and the overall safety profile for the totality of the follow up of course will be important as we get closer to NDA submission, which I think to your second question at this point and we can't predict where we will be in terms of what indication will go in for.
Because to some extent that will be dictated by the conversation we're going to have with the type b for frontline, but we are pleased with the way that the other cohorts are enrolling as well so more to come of course, the type B meeting is in second quarter and pending minutes, we will give guidance as to the outcome of backhaul.
Okay.
And then.
Paul.
Helpful Homebound donation haynesville well.
<unk> coupon.
<unk> tried and one and then it does seem from my perspective at least that the partnership for us to choose a.
And they talk a little bit sooner. So I was just wondering are there going to be a lot more involved with our clinical development for that program.
My apologies I thought it might be the polycom on my side and the office here I couldn't hear the first part I heard the second part as it related to OTT, but was there a first part of your question.
Yeah. The first part was just about you know Ah ha help for his Viper and in terms of bought and put them out for Trident one from four Oh, Okay. Understood. Thank you. So <unk> lab reported this morning, and they announced that they will be participating and Trident, one and the first half. So we're I would say that they've been incredibly helpful is not only helping us understand more and the <unk>.
<unk> in their region, which obviously they are the experts and my opinion and in that region and getting us prepared to initiate the trial within greater China and Thats, what I can say as it relates to re protracted and youre.
Right and that the <unk> I think I heard your second part you're right and that the OTT.
And collaboration was signed earlier and that we had less patient data, but remembering that when we originally signed with XI lab. They did have a right of first negotiation for other assets within the pipeline. So it was always my thought and that is then that data was encouraging, especially given the prevalence of gastro <unk>.
Answer within China that that would be a collaboration that could benefit us growth. So I was not surprising and any way that that that one was signed with much less clinical data and I think if you were to speak to Samantha I think she would also say that I've been on calls with her recently that it was also a testament to how she has seen and the team deliver so I don't know if I.
Can predict too much in terms of faster pace of additional collaborations of course, we maintain worldwide rights for the other assets and the pipeline.
Thanks for Athena.
Thanks.
And then you have your next question from Silvan.
Oregon.
G. B M Securities. Please ask your question. Your line is now open.
Hi.
Thank you very much for taking my questions and.
Congrats on the quarter.
I see that you talked about initiating shield to the combination study of <unk> with the Egfr and the second half of this year.
Could you tell us if this could also become a multi arm study similar which will protect NAV.
Where I was trying to where you could actually add a couple more compounds for this and also what are your objectives for the Egfr combo in terms of the setting and tumor types you're looking for.
Well first thanks for the question I know I know you're not a G. P. M. Here at JMP. So I'm sure that gets unfortunately, quite often and sorry for you.
And you know and unfortunately, it's not our standard practice to give too much in terms of trial design prior to IND submission and and my approach is really until IND filing by the FDA. So I think you're right on track with our thoughts in terms of there are potentials for multiple egfr inhibitors to whether they are by specific for <unk>.
To include <unk> combination, we just haven't given that guidance, yet and that Unfortunately also segue to the second part of your question of whether we will be using this and patients who have already progressed or frontline and we haven't given that guidance, yet, but again as the study gets closer to initiation and 90 clearance we will give more in terms of the study design.
Great. Thanks, and then maybe more of a hypothetical question for you Okay Ross strategy.
And what do you think is the best way these days to develop a <unk> combo.
And there are multiple companies out there was chaos and and they have multiple combinations would you eventually want to have a from a strategy of partnership or do you think we're just.
For your development side by side.
But for multiple chaos.
And so what do you think is the best strategy.
Well I would just speak to the data that we have currently which of course is with one of the <unk> 12 T inhibitors. That's what we've shown publicly and the preclinical setting and one commercially available <unk> inhibitor and <unk>.
And all I can say at this point is that we are already saying now that our trial will be multi armed. So you know that there will be more than just one drug that we're combining we've attracted and with we're just not saying, yet which I do think that there's lessons to be learned with the ship cues and others that are currently ahead of us taking a slightly different approach and potentially on a different pathway.
Of course, we're not targeting ship to or targeting JAK, two stark and fact, but really much more to say about this trial design once the IND is filed.
Okay, Great and I think we have our last question now operator.
For sure we have our last question from me.
Of Canaccord empty sense. Your question. Your line is now open.
Hey, guys congrats on retirement.
I had maybe a follow up question on your FDA meeting.
Considering you.
I think FDA saw low.
And a dozen patients worth of Rosslyn naive patients for me.
Granted breakthrough designation and now that you have 50 I'm curious.
Utah and.
She is what exactly.
Are you looking for from.
Their feedback and is there or what's gating and do you think two filings and I know you want to be conservative ahead and is.
Chatting with them, but is there a durability question do you think Skus Inc.
Additional patients and are those type of continuing to evolve.
Thank you.
Let me make sure I heard the last part what was your last part of Ireland I'm, sorry, you were tailing off something about enrollment.
Yes are you continuing to enrol GTA and naive patients.
Okay and other patients.
Sure. So let me respond to the first part I mean for.
First of all looking at small sample sizes of course as as each of the data updates have com hopefully you've seen and specifically from last August where we only had seven patients to the most recent update a tightening of the confidence interval and specifically the lower bound and that's important and so I think that's an important component to bring to the FDA, but also at the same time.
As a background receiving breakthrough therapy designation in December of last year. The FDA asks us to have a type b meeting within six months and so this is really now the opportunity for us to discuss with the head of the division our overall path and that includes as I said much more than just the number of patients, it's where we are with our.
Pharmacology studies in healthy Volunteer studies, DDI studies, hepatic impairment and studies CMC and where we are with our formulations, where we are with our companion diagnostic and of course, where we are in terms of the patient data. So there is quite a bit to get initial feedback from because remember at this point, we've had and end of phase one meeting with the agency and we've had it.
Type C meeting last August which was focus more on the pretreated and follow up and pooling of phase one and phase two patients. So this level of conversation that we're going to hopefully have is much more than we've had before and so it's an important meeting for much more than just the number of patients or duration of response as it relates though to the key question for.
For NDA timeline, that's important just to really understand is there any difference from the prior guidance, which is the guidance that you've given us to date is debt approximately 50 patients with a minimum of 12 months of follow up half the last responder to support standard approval. So that's a key question for us to try to <unk>.
Understand if theres any difference there as well based on our emerging data, but it's a much bigger meeting and then just discussing number of patients duration of response et cetera.
Great. That's super helpful and then on the enrollment of them.
Continuing to enroll and I apologize, yes, I'm, sorry, I didn't answer that that I'm, sorry. So I mentioned in January we had approximately 40 patients we have guided that in the second quarter. We anticipate we will have 50 patients and Ive also recently said that even after we get to the 50 patient we will continue to enroll teekay naive patients.
Especially to help benefit our partner and XI lab, who obviously are coming into the trial at a time, where we're getting close to enrollment completion within cohort. One. So we will yes continue to enroll and that's also important if you look at all of the precedent with the approved two ret inhibitors and the two approved and met inhibitors is.
Well as Roswell track all five of those approvals there were more patients and more follow up if the agency required in the context of their approval letters and so that that will be something we will also mirror.
Thank you very much.
Thanks Arlinda.
And speakers so it'd be our last question for this call joining back over to Mr. T D.
Thank you very much operator, thank you everybody for dialing in today and of course for your interest and support of turning point Therapeutics I hope that all of you and your families remain safe and continue to stay well I was incredibly happy to see many of employees today in the office and I will just say personally I can't wait to hopefully see all of you face to face.
In the near term operator, you may now close the call. Thank you very much.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you all for joining you may now disconnect.
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