Q1 2022 Allogene Therapeutics Inc Earnings Call
Okay.
Operator: Thank you for standing by and welcome to Allogene Therapeutics first quarter 2022 conference call. At this time, all participants on a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone.
Thank you for standing by and welcome to the allergy and Therapeutics first quarter 2022 conference call. At this time, all participants on a listen only mode. After the speaker presentation, there will be a question and answer session.
To ask a question during the session you will need to press star one on your telephone please be aware that today's call is being recorded.
Operator: Please be aware that today's call is being recorded. If you require any further assistance, please press star zero. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Please go ahead.
If you require any further assistance. Please press star zero I would now like to turn the call over to Christine Casiano Chief Communications Officer. Please go ahead.
Christine Cassiano: Thank you, Operator, and welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the first quarter of 2022. This press release and today's webcast are both available on our website. As a reminder for this call, we ask that all keep their questions to one per person. Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amato, Executive Vice President of Research and Development and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer.
Thank you operator, and welcome to all who have joined this call. After the market closed today, Alex <unk> issued a press release that provides a business update and financial results for the first quarter of 2020 Q. This press release and today's webcast are both available on our website as a reminder, for this call. We ask that all keep their questions to one per person.
Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado Executive Vice President of research and development and Chief Medical Officer, and Dr. Eric Schmidt Chief Financial Officer.
Christine Cassiano: During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filing, future research and development efforts, manufacturing capabilities, and 2022 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and the latest SEC Disclosure Document.
During today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials data presentations regulatory filings future research and development efforts manufacturing capabilities and 2022 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change.
Scriptures of potential risks can be found in our earnings press release and the latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements and Allergan disclaims any obligation to update these statements I'll now turn the call over to David.
Christine Cassiano: You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'll now turn the call over to David. Thank you, Christine, and good afternoon. This month marks the fourth anniversary of Allogene's inception. We found it out, with a belief that for self-therapy to truly change the lives. It would need to be industrialized.
Thank you Christine and good afternoon. This month marks the fourth anniversary of our audience.
Inception.
We founded out of June with the belief that with cell therapy could truly change the landscape it would need to be industrialized.
David Chang: Today as a report on the first quarter of 2020. I'm immensely proud of all we have accomplished. The last voice.
Today as we report on the first quarter of 2022.
Immensely proud of all we have accomplished in the last four years.
David Chang: These include delivering proof-of-concept data from our CD19 and BCMA programs that is differentiated in the field, including the most comprehensive set of allogeneic CAR-T data demonstrating durability, as well as Operationalizing Self-Organization. Advancing our Albuquerque programs into South Africa. Progressing Multiple Clinical Programs with Each Testing Innovative Concepts that Have the Potential to Fuel the Growth of Allogeneic Heart, And most importantly, bringing our lead allocarci product candidate to a cusp of a pivotal trial. We are proud to have.
This includes deliberating proof of concept data from our CD 19, NBC MA programs that is differentiated in the field, including the most comprehensive set of allogeneic car T data demonstrating durability.
As well as operating realizing itself for each one.
Advancing our car T program into solid tumors.
Progressing multiple clinical programs with each testing innovative concepts that have the potential to fuel the growth of allogeneic car T.
And most importantly, bringing our lead allo car T product candidate to a pivotal trial.
We are proud to have treated more patients with our allo car T candidate than any other player in the field, but the true promise of allogeneic therapy comes not from trading tenants, while EBIT hundreds of patients in clinical trials, but from being able to serve tens of thousands of patients.
David Chang: More patients with allergy candidates than any other player in the field. But the true promise of allogeneic therapy comes not from treating tens or even hundreds of patients in clinical trials, but from being able to serve tens of thousands of patients, in a commercial setting. With each advance we make in manufacturing, clinical development, research, and execution, we are one step closer to achieving our vision of creating a new reality for patients.
Converts upsetting.
Each advance we make in manufacturing clinical development research and execution, we are one step closer to achieving our vision of creating a new reality for patients.
David Chang: A reality in which all eligible patients can access this important modality. As someone who has had the privilege of playing a role in the development of autologous CAR T-therapy, I am proud of the progress the field is continuously making. Just last month, the first autologous cardiac therapy was approved by the FDA as a second-line treatment for adults with large B-cell lymphoma that is resistant to initial therapy or relapsed within one year of the start of the frontline treatment.
Reality in which all eligible patients gain access to this important modality.
Yes, Simon who has had the privilege of playing a role in the development of autologous car T therapy.
The progress that field is continuously making jess.
Just last month.
This car T therapy was approved by the FDA as a second line treatment.
With large b cell lymphoma that is resistant to initial therapy.
We left within one year of the start of the frontline treatment.
David Chang: This treatment is also the first CAR T therapy to receive a National Comprehensive Cancer Network Category 1 recommendation based on high level of clinical evidence that the therapy is appropriate. In February, the FDA approved the second BCMA-directed autologous cardiac therapy for patients with relapsed or refractory multiple myeloma. These are meaningful advances that will change the practice of medicine. And we are pleased to see the increase in the number of patients who can potentially benefit from cardiac therapy. But broader treatment recommendations create inherent challenges for therapists that must be manufactured and delivered on an individual patient basis.
This treatment is also the first car T therapy to receive a national comprehensive cancer network category, one recommendation based on high level up clinical evidence that the therapy is appropriate.
In February the FDA approved the second be CMA directly to a <unk> car T therapy for patients with relapsed or refractory multiple myeloma.
These are meaningful advances that will change the practice of medicine.
And we are pleased to see the increase in the number of patients who can potentially benefit from car T therapy.
That brought our treatment recommendation create inherent challenges, but therapies that must be manufactured and delivered on an individual patient basis.
David Chang: The logistical challenges and costs of manufacturing, patient by patient, as well as waiting times and potential for manufacturer failure must all be addressed in order for the field to move forward. Markets like Second Line, Large B-Cell Lymphoma, and VLS, Refractory Multiple Myeloma are large, consisting of many thousands of potentially suitable patients. Autologous therapies have simply not been able to keep up with demand.
The logistical challenges and cost of manufacturing patient by patient as well as waiting times and potential flood manufacturer failure must all be addressed in order for the deal to move forward.
Markets like second line large b cell lymphoma, and relapsed refractory multiple myeloma large consisting of many thousands of potentially suitable locations.
While August therapies have simply not been able to keep up with demand sadly no matter, how efficacious and autologous car T therapy, maybe its benefits do not extend to those patients who are electing leading the.
David Chang: Sadly, no matter how efficacious an autologous cardiac therapy may be, its benefits do not extend to those patients who are left in waiting. The recent approvals and expected approval of additional indications will place more pressure on the supply bottleneck. Pharmacologist companies are building up manufacturing capacity, in response to growing demand, but creating ready, available, and scalable supply with personalized therapies simply isn't possible when production runs need to be individually tailored, for an autologous therapy to serve 25,000. It must successfully execute 25,000 manufacturing runs.
The recent approvals and expected approval of additional indications, we will place more pressure on the supply bottleneck.
Autologous companies are building manufacturing capacity in response to growing demand, but creating ready available and scalable supply with personalized therapies simply isn't possible and production months needs to be individually tailored.
Brian Autologous therapy to serve 25000 patients it must successfully execute 25000 manufacturing runs.
David Chang: The most efficient way to meet such demand is an allogeneic CAR-T product, which also provides the promise of growing the market. Based on our experience with ALO501A, we project that at scale we can manufacture approximately 20,000 patient doses annually and reduce the number of required manufacturing 100-fold as compared to autologous CAR-T therapies. While, importantly, delivering this product on demand to any eligible patient who needs, We think this type of step function improvement in both efficiency and production.., speed of treatment will be a requisite for treating the large number of patients who tend to benefit from cardiac therapy.
Cost efficient way to meet such demand is an allogeneic car T product, which also provides the promise of growing the market.
Based on our experience with Allo 500, <unk>, we project that at scale, we can manufacture approximately 20000 patient doses annually and reduce the number of required manufacturing 100 fold as compared to a <unk> car T therapies, while importantly, delivering this product line.
Demand to any eligible patients in need.
We think this type of step function improvement in both efficiency and production and speed of treatment will be requisite for trading the large number of patients who stand to benefit from car T therapy.
Okay.
David Chang: We recently conducted a virtual unveiling of our new manufacturing facility, CELFORGE1 or CF1, in Newark, California. From the beginning, we knew that controlling the production of our aloe CAR T products would be key to our ability to deliver off-the-shelf CAR T products faster, more reliably, and at greater scale.
We recently conducted a virtual unveiling of our new manufacturing facility self <unk> y La <unk> in Newark, California.
From the beginning we knew that controlling the production of our allo car T products would be key to our ability to deliver off the shelf car T product.
Aster more reliably and at greater scale hence.
David Chang: Hence, our decision to build out our own cell manufacturing facility at an early time. CFR was built to support clinical and commercial manufacturing, analytical testing, and the distribution of our cell therapy products with a flexibility that would allow optimization of all steps in the manufacturing process and incorporation of new learnings for next generation of allopathy products. Thank you for those who participated in this facility's virtual unveiling. In this case, I truly believe a picture is worth a thousand words, and our virtual event provided powerful visualization of the unique aspects of our facility design.
Hence our decision to build out our on cell manufacturing facility at an early time point.
<unk> was built to support clinical and commercial manufacturing analytical testing and the distribution of our cell therapy products with a flexibility that would allow optimization of all steps in the manufacturing process and incorporation of new learnings with next generation of our call.
These products.
Thank you for those who participated in this facilities virtual unveiling.
In this case I truly believe a picture is worth a thousand words and our virtual event provided powerful visualization of the unique aspects of our facility design.
David Chang: And based on the feedback, we are thrilled so many of you found this event to be insightful and highly educational. On the clinical front, as most are aware, we promptly resumed clinical study activities after the FDA lifted our clinical hold early this year. We are actively enrolling patients in our trials for ALOS-715 and ALOS-605 in relapsed refractory multiple myeloma, and Allo316 in advanced or metastatic renal cell carcinoma. We have also chosen to continue enrollment in our Phase 1 study of LO501A in advance of initiating our pivotal trial that is projected to start mid-year.
And based on the feedback we are thrilled. So many of you found this event to be insightful and highly educational.
On the clinical front as most are aware, we probably we assumed clinical study activities. After the FDA lifted our clinical hold early this year.
Actively enrolling patients in our trials for Allo 715, an allo 605 in relapsed refractory multiple myeloma.
And our 316 in advanced or metastatic renal cell carcinoma.
We have also chosen to continue enrolment in our phase one study of Allo 501 eight.
Lance.
Initiating our pivotal trial data is projected to start midyear.
David Chang: We are completing CMC activities that should enable us to initiate the pivotal program using materials produced at CF1. We view this as strategically important and a major competitive advantage that could reduce timeline to BLA filing and potential FDA approval. Lastly, I would like to take a few minutes to welcome Susie Lundeen, our new Chief People Officer, to our senior leadership. In this newly created position at Allogene, Suzy will oversee our human resources effort as we scale our teams in support of advancing our pipeline. Her breadth of experience in designing and implementing systems and strategies to support companies as they transition from development to commercial stage will be key to our success.
We are completing CMC activities that should enable us to initiate the pivotal program using materials produced scf one.
We view this as strategically important and a major competitive advantage that could reduce timeline to BLA filing and potential FDA approval.
Lastly, I would like to take a few minutes to welcome Susan <unk>, our new Chief people officer to our senior leadership team.
In this newly created position that allergen Susie will oversee our human resources effort as we scale our teams in support of advancing our pipeline.
<unk> breadth of experience in designing and implementing systems and strategies to support companies as they transition from development to commercial stage will be key to our success.
Thank you for joining us today, we are grateful for your support as a vision for the future of Allogeneic car T continues to materialize with each patients we treat.
Rafael Amato: Thank you for joining us today. We are grateful for your support as our vision for the future of allogeneic RT continues to materialize with each patient we treat. I'll now turn the call over to Rafael for further updates on our research and development activities. Thank you, David.
I'll now turn the call over to Rafael for further updates on our research and development activities.
Thank you David our clinical teams have been incredibly engaged with clinical trial sites and investigators as we enrolled patients across four octave studies.
Rafael Amato: Our clinical teams have been incredibly engaged with clinical trial sites and investigators as we enroll patients across four active studies. Universal for ALO715 and IGNITE for ALO605 in relapse or refractory multiple myeloma, Traverse for ALO316 in renal cell carcinoma, and the extended Phase 1 portion of the ALPHA-2 trial for ALO501A in relapse or refractory large-speed sampling foam. We are keenly focused on initiating our pivotal trial on ALOF-501A in third-line large-species lymphoma around the middle of this year.
The versa for Allo 715 on ignite for Allo 605 in relapsed or refractory multiple myeloma.
<unk> four <unk> hundred 60 in renal cell carcinoma, and the extended phase one portion of the all types of trial for <unk> in relapsed or refractory large b cell lymphoma.
We are keenly focused on initiating our pivotal trial on auto pilot <unk> in third line box B cell lymphoma around the middle of this year.
Rafael Amato: Given ongoing FDA discussions directed at finalizing clinical trial design, chemistry, manufacturing, and controls requirements, and the competitive nature of the field, we will share details about this single-arm study at the time of initiation. In the meantime, and as noted by David, we continue to enroll in the Phase 1 portion of the study to offer allo501A to patients. Separate from Alpha-2 pivotal trial, we are preparing to launch the EXPAND trial to support registration of ALS647, a proprietary anti-CD52 monoclonal antibody. Span is designed to establish the contribution of ALO647 to the lymphodepletion regimen.
Given ongoing FDA discussions directed of finalizing clinical trial design chemistry manufacturing and controls requirement on the competitive nature of the field. We will share details about this single arm study at the time of initiation.
In the meantime on as noted by David We will continue to enroll in the phase one portion of the study to offer allo 501 to patients in need.
Separately from Alpha to pivotal trial, we're preparing to launch the expand trial to support registration of Allo 647, our proprietary anti <unk> monoclonal antibody.
Expand is designed to establish the contribution of allo $6 seven to the link for depletion regimen.
Rafael Amato: We deploy ALO647 as part of our lymphodepletion regimen in order to enable enhanced function and persistence of alocar T cells, and we have shown a strong correlation between serum concentrations of ALO647 and the likelihood of clinical response. Based on this data, we believe this trial will not only result in a positive outcome, but also competitively differentiate our platform by demonstrating that ALLO647 contributes to superior outcomes. In particular, we believe the rate and durability of responses demonstrated to date with Allo501A is in part related to the degree of lymphodepletion enabled by the use of Allo647, which differentiates our platform from that of others in the allogeneic field.
We deploy allo $6 seven as part of Harley unnamed for depletion regimen in order to enable enhance expansion and persistence of car T cells.
Have shown a strong correlation between serum concentrations of IOC for seven and the likelihood of clinical response.
Based on this data we believe this trial will not only result in a positive outcome, but also competitively differentiate our platform by demonstrating that almost $6 seven contiguous to superior outcomes.
In particular, we believe the rate on durability of response system illustrated to date with Allo 501 is in part related to the degree of Lincoln depletion enabled by the use of Allo, 647, which differentiates our platform from that of others in the allogeneic field.
Rafael Amato: To that end, we do intend to have an update on longer-term follow-up from the ALSA studies by the end of the year. Our BCMA program is the first and only a la carte BCMA program to generate clear proof-of-concept data.
To that end, we do intend to have an update on longer term follow up from the Alpha study by the end of the year.
Our <unk> program is the first and only allo car T D. TMA program to generate clear proof of concept data date.
Rafael Amato: Data from the universal trial on ALO715 continue to be well-received by investigators, and we are optimistic that we will have a competitive product for the treatment of relapsed refractory multiple myeloma. As David mentioned, there is tremendous unmet need in myeloma, and despite the recent approvals of autologous CAR T therapies, there remains strong interest in a product that can be delivered in days and without need of bridging chemotherapy. Our approach to myeloma gives us four shots in all, with our first, ALO715, as a monotherapy, already demonstrating a profile that appears attractive relative to that of a VECNA and approved autologous CAR T therapy. We are also evaluating ALO715, utilizing consolidated dosing and in combination with ScreenWorks Therapeutics Investigational Gamma Secretase Inhibitor Neogasmastat. Lastly, Allo 605, our first turbo car candidate.
Data from the Universal trial on Allo 715 continued to be well received by investigators and we are optimistic that we will kind of a competitive product for the treatment of relapsed refractory multiple myeloma.
As David mentioned, there is tremendous unmet need in myeloma and despite the recent approvals of autologous car T therapy.
<unk> strong interest in a product that can be delivering day without need of bridging chemotherapy.
Our approach to myeloma, just as poor shut some wall with our first southern loans private some monotherapy already demonstrating a profile that would be attractive relative to that of our beckman.
On a proof of autologous car T therapy.
We're also evaluating allo 715, utilizing consolidator dosing and in combination with spring work Therapeutics investigational Gamma Secretase inhibitor Neal about this that <unk>.
Lastly, allo 605, our first suitable card candidates in phase one evaluation.
Rafael Amato: Phase 1 evaluation. Thank you. As you may recall, turbo CARs are designed to provide selective, programmable cytokine signaling to CAR T-cells to counter T-cell exhaustion, improve T-cell function and potency, and potentially reduce cell dose requirements.
As you May recall total cars are designed to provide selective programmable cytokine signaling to car T cells to counter T cell exhaustion improves T cell function and potency and potentially reduce cell dose requirement.
Rafael Amato: Just last week, ALO 605 was granted orphan drug designation by the SBA. Notably, in March, we announced the publication of clinical results in cancer research communications which demonstrated strong evidence of the superior long-term myeloma killing activity of allogeneic anti-BCMA, Thank you. We remain eager to better understand the potential of our autocard keys in solitary. Our first candidate, ALO316, targeting CD70 for the treatment of advanced or metastatic clear cell renal cell carcinoma is proceeding through phase one dose escalation.
Just last week <unk> was granted orphan drug designation by the SBA.
Notably in March we announced the publication of preclinical results in cancer Research Communications with demonstrated strong evidence of the superior long term myeloma, killing activity of allogeneic <unk>.
Car T cells manufactured from healthy donors compare with anti <unk> car T cells from patients with multiple myeloma, we intend to provide a holistic update on our <unk> program by the end of the year.
We remain eager to better understand the potential of our allo car T. In solid tumors. Our first candidate Allo 316 targeting CD 70 for the treatment of advanced or metastatic clear cell renal cell carcinoma is proceeding to phase one dose escalation.
Rafael Amato: Last month, we presented preclinical data at the 2022 American Association for Cancer Research Annual Meeting, which supports the clinical evaluation of ALO316 for the treatment of patients with renal cell carcinoma and other CD70-expressing tumors. The findings, simultaneously published in Cancer Research, followed our announcement in March that the FDA granted ALO316 fast-track designation based on its potential to address the unmet need for patients with renal cell carcinoma who have failed standard therapy. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and a five-year survival rate for patients with advanced kidney cancer is less than 15%, creating a necessity for scientific innovation.
Last month, we presented preclinical data at the 2022 American Association for Cancer Research annual meeting, which support the clinical evaluation of our 316 for the treatment of patients with renal cell carcinoma. Another CD 70, expressing tumors the finding simultaneously published in cancer research carload.
Our announcement in March that the FDA granted <unk> fast track designation based on its potential to address the unmet need for patients with renal cell carcinoma, who have failed standard therapy.
Metastatic solid tumors has historically been a challenge regardless of treatment modality and the five year survival rate for patients with advanced kidney cancer, it's less than 15%, creating a necessity for scientific innovation.
Rafael Amato: While we still have a long road ahead of us, we continue to make progress and look forward to generating data from our ongoing Phase 1 Traverse trial as we plan for the testing of Apollo 316 and other CD70 Express in two more times. In addition to advancing our clinical work, our research teams are making good progress progressing multiple preclinical candidates and innovative technologies. We expect these to ensure allogene's leadership position in the field of allogeneic heart disease for years to come.
While we still have a long road ahead of US we continue to make progress and look forward to generating data from our ongoing phase <unk> trial as we plan for the testing of policy wanted to dig in other <unk> expressing tumor types.
In addition to advancing our clinical work our research teams are making good progress progressing multiple preclinical candidates and innovative technologies. We expect these to ensure allergists leadership position in the field of allogeneic car T for years to come.
Eric Schmidt: I'd like to now turn the call over to Eric for an update on our... Thank you, Rafael, and good afternoon, everyone. The current bear market for biotech has been long and steep. This is truly a time where experience is critical. At Allogene, we are very fortunate that our leadership team has weathered such markets before and that we have the financial strength to weather the current downturn. We have a strong balance sheet and a sizable cash runway that should allow us to focus on execution as we advance multiple potentially first and best-in-class AllocRT candidates through pivotal trials. We ended the quarter with $733 million in cash, cash equivalents, and investments.
I'd like to now turn the call over to Erik for an update on our financials.
Eric Schmidt: The first quarter of 2022, our research and development expenses were $60.2 million, which includes $11.1 million of non-cash, stock-based compensation expenses. General and administrative expenses were $19.9 million for the first quarter of 2022, which includes $11.2 million of non-cash stock-based compensation expense. Our net loss for the first quarter of 2022 was $79.9 million, or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million.
Thank you Rafael and good afternoon, everyone.
The current bear market for biotech has been long and steep this is truly a time where experience is critical.
<unk>, we were very fortunate that our leadership team has weathered such markets before and then we have the financial strength to weather the current downturn.
With a strong balance sheet and a sizeable cash runway that should allow us to focus on execution as we advance multiple potentially first and best in class Allo car T candidates through pivotal trials.
We ended the quarter with $733 million in cash cash equivalents and investments in.
In the first quarter of 2020 to our research and development expenses were $62 million, which includes $11 1 million of noncash stock based compensation expense.
General and administrative expenses were $19 $9 million for the first quarter of 2022, which includes $11 2 million of noncash stock based compensation expense, our net loss for the first quarter of 2022 was $79 $9 million or <unk> 56 per share, including noncash stock based.
Compensation expense of $22 $3 million.
Eric Schmidt: We continue to expect our full year 2022 operating expenses to be between $360 and $390 million. This includes an estimated non-cash, stock-based compensation expense of $90 million to $100 million and excludes any impact from potential business development activity. With that, we will now open the call for your questions. Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key.
We continue to expect our full year 2022 operating expenses to be between $360 million and $390 million. This includes an estimated noncash stock based compensation expense of $90 million to $100 million and excludes any impact from potential business development activities.
We will now open the call for your questions.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press. The pound key please standby we compile the Q&A roster and we do ask that you limit yourself to one question again, we ask that you limit yourself to one question and a fair.
Operator: Please stand by. We compiled the Q&A roster. And we do ask that you limit yourself to one question. Again, we ask that you limit yourself to one question.
Operator: And our first question comes from Tyler Van Buren from Calen. Your line is now open. Hey guys, congrats on the progress. Thanks very much for taking the question. So there's a continuous focus, of course, on comparing your aloe CAR T data to the autologous data for the approved products, but can you just remind us what exactly you need to show in a pivotal aloe 501A trial for approval? And just as a quick follow-up, when aloe 501 reaches the market, is the goal to focus on patients who don't have access to autologous products or the low-hanging fruit, or are you just as focused on competing head-to-head with the autologous product? Hi, Tyler. I'll take your question. This is Rafael.
Question from Tyler Van Buren from Cowen.
Your line is now open.
Hey, guys.
Congrats on the progress thanks, very much for taking the question.
So there is a continuous focus of course on comparing your outlook or two data to the autologous data for the approved products, but can you just remind us what exactly you need to show in our pivotal Allo 501 trial for approval and just as a quick follow up.
Allo 501 reaches the market is the goal to focus on patients who don't have access to autologous products, where the low hanging fruit or you're just as focused on competing head to head with you told this products.
Rafael Amato: In general, we are incredibly pleased by the data that we've generated thus far, and it was last presented at ASH in 2021. You could see the response rates, you could see the durability, showing 14 complete responders, 10 of whom were still in complete response, and of all the patients that have had an opportunity to be followed for 6 months, they were all still in complete response, and some of them are outpatient.
Hi, Tyler I'll take the question this is rafael.
In general we are incredibly pleased by the data that we've generated thus far and it was presented at ash in 2021.
You could see the response rates you can see the durability showing 14 complete responder instead of whom we are still in complete response on a relative basis that have had an opportunity to be followed for six months.
We're all building complete response some of them are out.
Rafael Amato: So we think that there is comparable durability and complete response and then the safety profile of the product actually with regards to ICANNs and CRS, particularly in grade 3 and beyond, is actually very denying with comparable infection rates.
So we think that there is comparable durability of complete response, and then the fixed fee.
The profile of the product actually with regard to Iqos Crs.
Any grade three and beyond is actually very benign with comparable infection rate. So I think.
Rafael Amato: So I think regarding, you know, your premise, we think that these products are going to be comparable to autologous and so we're not looking for the nature of patients that cannot be treated with autologous. We're looking to really establish this as a therapy that can be off the shelf and treat everybody that needs it within a very short period of time and really transform the way that, you know, self-therapy is used today.
We think that these products are relatively comparable to Oliver. So we're not looking forward the nature of patients that cannot be treated with our partners. We're looking to really establish a therapy that can be off the shelf and everybody that need FID.
Within a very short period of time and really transformed the way that both therapies today.
And thank you.
Rafael Amato: And thank you. And our next question comes from Michael Yee from Jeffrey. Your line is now open. Hi, this is Ition for Mike. So what are the dating steps to starting the pivotal phase two DLBCL study? And what are like still the manufacturing things that need to be signed off?
Our next question comes from Michael Yee from Jefferies. Your line is now open.
Okay.
Hi, This is <unk> on for Mike.
So what are the gating steps to starting the pivotal phase III <unk> study in what are still the manufacturing things that need to be signed off.
What are the limiting steps and can you give us some additional visibility into these things.
And is there any difference now and then between the tight days or other data when people didn't have issues starting a pivotal study.
David Chang: What are the limiting steps? And can you give us some additional visibility into these things? And is there any difference now then between the tight days or other days when people didn't have issues starting at, Yes, so, you know, multiple questions there, and, you know, this is Dave Chang. You know, we won't be giving any play-by-play details, you know, other than to say that ALO501A pivotal study is on schedule to start mid-2022.
Yes, so multiple questions there.
This is Dave Chang.
We won't be giving any play by play detail other than to say that allo 501, a pivotal study is scheduled to start in mid 2022.
David Chang: And as we have commented in the prepared remarks, we are completing CMC activities that should enable us to initiate the pivotal studies using commercial-ready materials produced at Fall 421, which we believe is of strategic importance and competitive advantage. Our goal, obviously, is to position Allo501A to be the first allogenic IT product to gain approval. And thank you. And our next question comes from Corey Kazimoff from J.P. Morgan. Your line is now open. Hey, good afternoon, guys.
As we have commented in the prepared remarks.
Completing CMC activities that should enable us to initiate the pivotal studies using commercial readiness areas produced at South <unk>, one, which we believe is a strategically important competitive advantage.
Our goal obviously is to position allo 500, <unk> to be the first allogeneic car T products to gain approval.
Okay.
And thank you and our next question comes from Cory <unk> from JP Morgan.
Your line is now.
Rafael Amato: Thank you for taking my question. I wanted to ask about trial design for Alpha-2. Is consolidation therapy going to be standard for all patients, or will you look to have a robust sample with and without, and kind of how do you determine that, what the appropriate time to institute consolidation therapy? Thank you. Yeah. Hi, Corey.
Hey, good afternoon, guys. Thank you for taking my question.
Wanted to ask about trial design for <unk> Alfa too is consolidation therapy going to be standard for all patients or will you look to have a robust sample with and without and kind of how do you determine that.
The appropriate time.
<unk> tends to consolidation therapy. Thank you.
Rafael Amato: This is Rafael. I'll take the question. We've treated, I think, more patients than anyone else in large pieces of lymphoma with various regimens and schedules. And we have a wealth of data, not just clinical but also translational. And this has allowed us to go into deep analysis to really look into what is the most favorable regimen. Because of the competitive nature of this field, we're not reviewing these and other details of the Phase I study until the study starts. But we are very confident that we do not need any more information to actually come up with a dosing schedule that we're going to use.
Yes.
This is Raphael I will take the question with treated.
More patients.
Were announcing large b cell lymphoma with various regimens with schedule, apparently we have a wealth of data and the clinical but also translational.
And this has allowed us to go into.
Deep analysis to really look into what is the most favorable regimen.
Because of the competitive nature of this deal we're not reviewing diesel and other details of the phase four study until until the study starts.
But we are very confident that we.
Do not need any more information to actually come up with a dosing schedule that we're going to use.
And.
Therefore, this study with regards to the design and the dosing is already set and ready to start in the middle of the year.
Rafael Amato: And, you know, therefore, the study with regards to the design and the dosing is already set and ready to start in the middle of the year. Thank you. And our next question comes from Salveen Richter in Goldman Sachs. Your line is now open. Thanks for taking my question. How comfortable or confident are you that you'll know how to proceed with the BCMA program with all your data, but by your end? Yes, hi, Salveen.
Thank you and our next question comes from Selvey Ritchie from Goldman Sachs. Your line is now open.
Thanks for taking my question.
Comfortable are.
Are you that you'll know how to proceed with the beef TMA program.
With all your data by year end.
Rafael Amato: So, we actually are very pleased by the pace of our DCMA program. You know about our data at ASH, which resemble very much, you know, the data with the VEGMA, we're using 320 million cells, where we had over, you know, 20 patients' worth of data with responses upwards of 70% and VGPR plus in the 46% range. And this was relatively early data.
Yes, Hi, <unk>. So we actually are very pleased by the pace of RBC MMA program, you know about our data at ash, which resemble very much the data with our background, we used 340 million cells, where we hand.
Over 20 patients worth of data with responsive.
Obtaining 70% on <unk>, plus and there are 46% range and this is relatively early data will continue to follow these patients.
Rafael Amato: We continue to follow these patients. The median follow-up is obviously increasing, and we look forward to giving an update towards the end of the year. But as you know, we continue to look for ways to improve this data in addition to, you know, seeing what's happening with the patients that we've treated thus far. We mentioned 605, which is our turbo car, which is enrolling now after the poll was lifted.
Median follow up is obviously increasing.
And we look forward to giving an update towards the end of the year, but as you know we continue to look for ways to improve this data in addition to.
Seeing what's happening with the patients we've treated this far.
Rafael Amato: And we are also using neurogastrostat as well as consolidation to look at outcomes. So, everything that we are hearing from investigators is that we've got a profile that is actually worthy of pursuing in pivotal studies. So, given, you know, the competitive nature of this field, we want to actually be able to position this with the optimal benefit-risk profile.
We mentioned.
<unk>, which is our turbo car, which.
It's enrolling now after therefore lifted.
We are also using the Augusta Thats, where a lot of consolidation if you look at.
Outcome so.
Everything that we are hearing from investigators is that we've got a profile.
That is actually.
Worthy of pursuing in pivotal studies.
Rafael Amato: So, that's why we're looking at these other modalities of treatment. And with regards to whether we're confident to make a decision by the end of the year, the answer is yes. Accrual is proceeding briskly, and we are confident that we will have the data to make the decision.
Even.
The competitive nature of the field, we want to actually be able to position. This with the optimal benefit risk profile. So that's why we're looking at this all the.
Modality of treatment and with regards to whether we're confident to make a decision by the end of the year. The answer is yes accrual is preceding briskly and we are confident that we will have the data to make the decision.
Operator: Thank you. And our next question comes from John Newman from Canaccord. Your line is now open. Hi, team.
Thank you and our next question comes from John Newman from Canaccord.
Your line is now open.
Operator: Thank you very much for taking my questions. My one question is, given you're intending to use commercial ready product from Cellforge in your pivotal study, Do you have any plans at all to work on the phenotype of the product? Maybe to push that more towards younger memory-type cells, or are you happy with? Hi, John.
Hi team. Thank you very much for taking my questions.
One question is given you're intending to use commercial ready product from so forge in your pivotal study.
Do you have any plans at all to work on the phenotype of the product.
Maybe to push that more towards younger memory type sales or are you happy with the current formulation from that aspect.
David Chang: Thanks for that question. You know, this is David, and I'll take the question. You know, I have to say that, you know, having been involved in cell therapy, you know, manufacturing for some time, you know, I'm, you know, extremely proud of what the team at Allogene has done. I mean, this is, of course, you know, many different, many different aspects of manufacturing, not just manufacturing the cells, but analytic assay development and deployment, you know, continuously improving the manufacturing process and also taking care of all the supply chain issues, including distribution of allocar T products to multiple clinical sites.
Hi, John Thanks for the question. This is David and I'll take the question.
I have to say that having been involved in cell therapy manufacturing for some time.
Extremely proud of what the team at Allison has done I mean this is across many difference in many different aspects of manufacturing not just manufacturing the cells, but.
Analytic assay development and deployment.
Continuously improving the manufacturing process and also taking care of all of the supply chain issues, including distribution of Allo car T products to multiple clinical sites.
David Chang: You know, your question around the cell phenotype, we get asked quite a lot, but, you know, we have looked at this in multiple different ways, and what we are finding is, starting with the healthy donor cells, we end up with cell products that generally has much so-called juvenile phenotype, either central memory or sometimes naive cells constituting the majority of the cells.
Question around the self payment side, we get asked quite a lot, but we have looked at this in multiple different ways and what we are finding is starting with a healthy donor cells. We end that would sell products that generally has much.
Children phenotype, either central memory, or sometimes naive cells constituting the majority of the cells.
David Chang: You know, we will certainly continue to look for additional ways to improve, you know, the quality of the cell products as well as the use of manufactured products, but as for the cell phenotype, you know, we are at a pretty comfortable place, and, you know, nothing will stop us from moving forward into the pivotal program using the manufactured cells coming from CF1. Thank you. And our next question comes from Mark Griedenbach from Oppenheimer. Your line is now open. Hi, this is Jacqueline from Marks.
We will certainly continue to look for additional ways to improve that.
Quality of the cell products as well as the yields of manufactured products, but as for the cell phenotype.
At a pretty comfortable place and.
And nothing will stop us from moving forward into the pivotal program using the manufacturer sells coming from <unk>.
Yes.
Thank you and our next question comes from Mark Breidenbach from Oppenheimer. Your line is now open.
Hi, This is Jacqueline from March thanks for taking our question.
Operator: Thanks for taking our question. So a couple questions on the expense study. Does the pivotal Phase II portion of Alpha-2 have to start enrolling before the expense can begin? Like, instead of enrolling more patients in the Phase I portion of Alpha-2, could they instead be redirected into the expense study? Yeah, I'll take that question. This is Rafael.
So a couple of questions on the expense study does the pivotal.
Pivotal phase II portion of all thought you have to start enrolling before the expense can begin.
Instead of the enrolling more patients in the phase one portion of all thought you could they in fact be redirected into the expense study.
Rafael Amato: It is a good question. The EXPAND study is going to start after the Alpha 2 study. The Alpha 2 study obviously is the registration trial for 5018, the most important trial of the two. Obviously, we need the co-development of ALO647. And just to remind us on the line that may not be as familiar, this is a study that is truly isolating the effect of ALO647 and, therefore, randomizes fluoridibene cyclophosphamide to fluoridibene cyclophosphamide and ALO647. It is a relatively small study.
Yes, I'll take that question this is rafael.
It's a good question.
One study is going to start after the Alpha study.
Therefore, the study obviously the registration trial for 501, and what's important to all of the two obviously relive the codevelopment of allo six or seven.
And just to remind us on the line.
There will be a familiar this is a study that is truly isolating the effect of six or seven.
Therefore, we are on the line for us without any cyclophosphamide to Fludarabine and cyclophosphamide on six or seven.
Rafael Amato: We have a wealth of translational data that indicates that there is a dose-dependent degree of lymphodepletion that correlates with expansion, that correlates with clinical outcomes. There is data out there from other sponsors where they have been using anti-CD52 antibody in at least nine patients. It's a wealth of data from programs in anti-CD19 and anti-CD22 showing no expansion whatsoever and no responses. So, I think the fact that lymphodepletion and optimization with an agent like an anti-CD62 antibody is required, I don't think there's much doubt of that. So, it is going to be randomized because we need that information.
It is a relatively small study we have a wealth of translational data that indicate that there is dose dependent.
Degree of flu for depletion that correlates with expansion that correlates with clinical outcomes.
Data out there from other sponsors where they havent USL by CD 52 antibody at least nine patients worth of data for from programs in 2019, and anti CD 22, showing no expansion whatsoever. No responses. So I think the fact that new completion and optimal.
Patients with in Asia like an anti <unk> two antibody is require I don't think theres much doubt of balance. So it is going to be around the mines, because we need that information.
Rafael Amato: And it will start after the 5018 single-arm study starts. So, this is sort of the cadency that we're going to follow this year, finish the Phase I study, the 5018 first, and then expand. Thank you. And our next question comes from Luca Issi from RBC Capital. Your line is now open.
And you will start after the private <unk> single arm study.
So this is sort of the cadence.
We continue.
We're going to follow this year finish the phase one study with 501 first and then expand.
Sure.
Thank you and our next question comes from Luca <unk> from RBC Capital. Your line is now open.
Operator: Oh, great. Thanks so much for taking my question and congrats on all the progress. Maybe one on EXPAND, can you just talk about how you're thinking about the primary endpoints for that tryout? Do you just need to show like higher T cell expansion or do you actually need to show better efficacy versus traditional lipid depletion?
Oh, great. Thanks, so much for taking my question and congrats on all the progress maybe one on expand can you just talk about how you're thinking about the primary endpoint for that trial, you just need to show like higher T cell expansion or do you actually need to show better efficacy versus traditional lithia depletion and then if I may.
Rafael Amato: And then, if I may, I know you mentioned in the past that 501A and 647 will ultimately be approved simultaneously. It's kind of similar to IL-6 and ESCARTA back in the day. But do they require two separate BLA or can you have one BLA for both combined?
I know you mentioned in the past the 500, <unk> and $64 seven will ultimately approve simultaneous lease kind of similar to IL six and your scarred up back in the day, but do they require two separate BLA or can you have one one BLA for both combined thanks so much.
Rafael Amato: Thanks so much. Yeah, thanks for the question. I think in terms of the endpoint, I'm going to sort of reserve the answer until the study opens. These are, you know, discussions that we've had with the agency and, you know, they're finalized and we know well what needs to happen.
Yes, thanks for the question.
Terms of the endpoint.
I'm going to sort of.
Reserve the answer until the study open.
These are.
The discussions that we've had with the agency.
The finalized and we know well what needs to happen.
Rafael Amato: With regards to, I mean, it is something for the treating agent, but the actual endpoint, you know, we will reveal once we talk about the design of the study in more detail. With regards to, you know, how we're going to register this, I think we've mentioned in the past that it's a core development, so each one of the agents will require its own VLA, and that's the pathway that we intend to follow. Thank you. And our next question comes from Ren Benjamin from JMP Security. Your line is now open. Hey, good afternoon, guys.
With regards to I mean, it is linked to the bidding agent.
But the actual endpoint.
We will reveal once we talk about the design of the study in more detail.
With regards to.
How we're going to register this I think we've mentioned in the past.
Is to have core development. So each one of the agents will require its own BLA and thats the pathway that we intend to follow.
Thank you and our next question comes from Ren Benjamin from JMP Securities.
Line is now open.
Operator: Thanks for taking the questions. I just wanted to talk a little bit about ALO316. You know, you guys had some interesting preclinical data at AACR showing that these cells didn't undergo fratricide, and I'm just trying to understand a little bit better this whole idea of masking and how, while masking might, you know, protect and help with the longevity of the cells, how it might, Could it impact efficacy as well, or do we just need to kind of see how things progress in the clinical trials? We'd just love to get your thoughts based on some of the mechanisms that were uncovered at AACR. Yeah. Hi, Drew.
Hey, good afternoon, guys. Thanks for taking the questions.
I just wanted to talk a little bit about allo 316, I guess.
Some interesting preclinical data at ACR.
Showing that the cells didnt undergo fratricide.
I'm, just trying to understand a little bit better this whole idea of masking and how well masking might protect and help with the longevity of the cells how it might.
Could it impact efficacy as well.
Or do we just need to kind of see how things progress in the clinical trials, but just love to get your thoughts based on some of the mechanisms that were uncovered at ACR.
Rafael Amato: Thanks so much for the question. It is, I think, a fascinating story. The team tested a number of CARs, and obviously, fructoside is a problem with anti-CD70 because if you activate the cells to grow them and make sufficient cells to treat patients, they start expressing CD70, and therefore, the cells, the CAR-positive cells, like them, and there's paratoxicity to those cells. So, you essentially are unable to produce these cells.
Yes, hi, Brian Thanks, so much for the question.
It is.
I think thats a fascinating story.
The team.
<unk> tested a number of cars and obviously fructose side is it's a problem. We soundly exceeded 70, because those few activate itself to grow them and make sufficient staff to treat patients.
Start depressing 2017, and look forward to sell.
The card market itself.
Lifespan.
Toxicity yourselves. So are you essentially are unable to produce these cells and so some have resorted to actually knock announced <unk> 70, which includes some other gene edited with testing some complexity.
Rafael Amato: And so, some have resorted to actually knocking out CD70, which includes another gene edit, which has its own complexities. Our team opted for a CAR that is able to actually mask the CD70 epitopes so that the neighboring cells are not able to encounter CD70 receptor and, therefore, like those cells. Now, your question is what happens in vivo. You know, this masking occurs during manufacturing. Then, once the cells are in circulation, we believe that the epitopes that are exposed in the CD70-positive cells could be targeted by the CAR-positive cells. And this is probably just a geometry in terms of, you know, how many cells or how many epitopes are covered versus free and exposed.
Our team opted for a car that is able to actually not that.
The CD 70 epitopes.
Neighboring cells are not able to encounter CD 70 receptor and therefore life.
Your question is what happens in vivo.
Six months.
Occurs during manufacturing there once the sales are in circulation.
Belief that.
The epitopes that are exposing a CD 70 positive so it could be targeted by the card market itself and this is probably desktop chemistry in terms of how many sales are how many episodes start cover versus.
Versus pre unexposed.
Obviously, it's very early to know what that's going to show because we're still in dose escalation.
But we are confident that this market will allow us to produce the product and at the same time have an impact.
Rafael Amato: Obviously, it's very early to know what that's going to show because we're still in those escalations, but we are confident that this masking will allow us to produce the product and, at the same time, have an effect. Thank you. And our next question comes from Kalpit Patel from V. Riley. Your line is now open. Yes, hi.
Thank you and our next question comes from <unk>.
<unk> from B Riley Your line is now open.
Operator: Thanks for taking my question. You mentioned the approval of Axe-Cell in the second-line treatment for B-cell lymphoma. I guess, how are you thinking about the potential impact that this approval would have on the pool of patients that would be eligible to receive an Allogene CAR-T in the third-line setting? Is there a percentage or is there a number in mind that you have internally discussed? Kalpit, this is Eric.
Yes, hi, thanks for taking my question.
You mentioned the approval of <unk> cel in the second line treatment for B cell lymphoma.
How are you thinking about the potential impact that this approval would have on the pool of patients that would be eligible to receive an allogeneic car T and the third line setting is there a percentage or is there a number in mind that you have internally discussed.
Calculate this is Eric thanks. Thanks for the question. It's a good one and one that we are actually frequently asked so I appreciate the opportunity to address it here.
Eric Schmidt: Thanks for the question. It's a good one and one that we, you know, are actually frequently asked, so appreciate the opportunity to address it here. You know, these are game-changing results that we're seeing with Yaskarta and Brionzi in the second-line setting, and certainly we expect them to have practice-changing implications. But, you know, even five years after the launch of these products and similarly game-changing results in third-line LBCL, only a very small minority of appropriate third-line patients are receiving CAR-T therapy.
These are game changing results that we're seeing with this quarter in <unk> in the second line setting and certainly we expect them to have practice changing implications, but you didnt five years. After the launch of these products and similarly game changing results in third line <unk> only a very small minority of appropriate third line.
To receiving car T therapy, I think our market research suggests between 20 and 30% of all third line patients are getting therapy. So it's obviously going to take some time before these agents move upfront into the second line setting and I think that.
Eric Schmidt: I think our market research suggests between 20 and 30 percent of all third-line patients are getting therapy. So it's obviously going to take some time before these agents move up front into the second-line setting, and I think, you know, that time really, in many ways, reflects the complexity of delivering an autologous product.
At that time really in many ways reflects the complexity of delivering on the autologous product, obviously with an off the shelf product. We think we're going to do much better in terms of our penetration grow the market and certainly treat patients more rapidly.
Operator: Obviously, with an off-the-shelf product, we think we're going to do much better in terms of our penetration, grow the market, and certainly treat patients more rapidly who need on-demand treatment. Thank you. And our next question comes from Enon Kanner from Truist. Your line is now open. Hi, this is Anand Chan for Asthika.
The need.
<unk> treatment.
Thank you and our next question comes from <unk> Khanna from Truest. Your line is now open.
Hi, This is an onshore for us picker, while our near term priorities on the pivotal <unk> study when do you guys actually plan to start Rolling out studies in second line <unk> Allen what specific patient subgroups do you think would make the most sense to target first.
Operator: While the near-term priorities on the Pivotal Alpha-2 study, when do you guys actually plan to start rolling out studies in second-line LBCL, and what specific patient subgroups do you think would make the most sense to target first? Thank you. So, we are aware of, obviously, the… Potential movement to second line, although we think that this is going to be slow and that there's still going to be sufficient number of patients, as Eric just alluded to, in the relapsed refractory setting. But given the fact that these products are so active in second line, we intend to move the product into second line therapy as well.
Yes.
So we are aware.
<unk>.
Obviously that.
But there is a movement to second line. Although we think that this is going to be slow and theres still going to be sufficient number of patients. It's Eric just alluded to in the relapsed refractory setting.
But given.
The fact that they sell.
So far as these products are still active in second line.
We intend to Mr product into second line therapy as well, obviously, we have a total order to get to clinical trial pivotal studies done.
Operator: Obviously, we have a tall order to get two clinical trials, evapotox studies, standing this year, the EXPAND trial as well as the Alpha 2. But very shortly after, we intend to start the second line study as well. So, stay tuned to the cadency of our studies. This is something that we will be doing, and it will be following shortly, the pivotal trials in relapsed refractory. Thank you. And our next question comes from Raju Prasad from William Blair.
This year.
The expand trial.
So two very shortly after we intend to start the second line study as well.
Stay tuned to the cadence of our studies. This is something that we will be.
Doing and.
It will be following shortly.
Trial in relapsed refractory.
Thank you and our next question comes from Raju Prasad from William Blair.
Operator: Your line is now open. Thanks, Jake, and the question, we, you know, we get a lot of questions on kind of the vector supply for some of the autologous therapies, and obviously, given the fact that you're talking about 20,000 doses annually at scale, the self-forge one, I was just kind of curious to know your, how you're viewing kind of the potential competition with autologous products that might be having, you know, vector supply issues, and how you kind of view that from a potential, you know, competitive perspective. Well, David Chang, you know, I'll answer that question.
Your line is now open.
Thanks for taking the question.
We we get a lot of questions on kind of the vector supply for some of the autologous therapies and obviously given the fact that you are talking about.
<unk> thousand doses annually at scale.
Gulfport is one I was just kind of curious familiar how you're viewing kind of.
<unk> competition with autologous products that might be having.
Vector supply issues, and how you kind of view that from a <unk>.
Potential competitive perspective thanks.
David Chang: I mean, you know, back to, you know, as well as manufacturing supply, this is something that we have been working very closely over the last two and a half years. So I think we are at a very comfortable place. And also, another thing that I emphasize is that, you know, we currently estimate, you know, that our manufacturing facility can produce, you know, 20,000 doses per year, you know, which is a, you know, tremendous capacity, you know, coming out of a single manufacturing facility.
Hey, Raj.
I'll answer that question.
Sure.
Back to <unk> as well as manufacturing supply. This is something that we have been working very closely over the last two and half years. So I think we had a very comfortable place.
And also another thing that I emphasize is that we currently estimate that our manufacturing facility can produce.
<unk> thousand doses per year, which is.
Tremendous capacity coming out of a single manufacturing facility, but as an allogeneic cell product I mean, we expect that each manufacturing run to produce 100 plus doses. So obviously that is.
David Chang: But as an allogeneic cell product, I mean, we expect that each manufacturing run, you know, to produce 100-plus doses. So obviously, that is, you know, totally different, you know, sort of demand compared to the autologous manufacturing.
Totally different set of demand compared to the autologous manufacturing and this is really some of the things that sure.
David Chang: And, you know, this is really, you know, some of the things that should really be highlighted as, you know, the advantages of allogeneic manufacturing. So, you know, there's a lot more that we can go into what we are doing into the LBB supply. But just be assured, we have covered that area very well. Thank you. And our next question comes from Dane Leon from Raymond James. Your line is now open.
<unk> really be highlighted as well.
Damages allogeneic manufacturing so.
Yes, there is a lot more that we can go into what we are doing into the LPG supply.
Just be assured we have covered that area out there as well.
Thank you and our next question comes from Dane Leone from Raymond James.
Your line is now open.
Operator: Hi, thank you for taking our questions. Congratulations on progress. Could you maybe provide a little bit more color?
Alright, Thank you for taking my questions congratulations on progress.
Could you maybe.
Provide a little bit more color in terms of what.
David Chang: What the clinical learnings do you expect to present for CD19 and BCMA in the back half of the year are? And then, any expectation in terms of when we might see first data out of the CD70 program? It sounds like it might be more of a 2023 event. Thank you. Okay, so I think – this is David.
Clinical earnings do you expect to present, <unk> 19, and <unk> in the back half of the year and then any expectation in terms of when we might see first data CD 70 program. It sounds like it might be more of a 2023 of that thank you.
David Chang: Let me take the question. You know, our plan is to, you know, provide additional updates on both the CD19 program and, you know, the BCNA program. Raphael talked about, you know, how we will, you know, make a decision on the BCNA program. And, you know, that's really part of the, you know, update that we will be presenting at the year-end. You know, that's, of course, not just 715 studies, but other strategies that we are – we have been, you know, employing, you know, over the last year and a half.
Okay.
This is David let me take the question.
Our plan is to provide additional updates on both CD 19 program and be CMA programs.
<unk> talked about how we will make.
Make a decision on the CMA program and that's really.
Part of the update that we will be presenting at the at the year and Thats across not just 715 studies, but other strategies that we.
We have been in.
Point over last year, and a half in terms of details and how many patients we will.
David Chang: In terms of details and how many patients, you know, we will, you know, just have to hold that, you know, until more appropriate time. You know, CD19 is additional program that we will be presenting the update. Last year at ASH, you know, we presented the long-term durability, and as Raphael has covered, we are very excited about the durability data that we are seeing. You know, 14 complete responders, and once the responses last six months, you know, after that, you know, we are not seeing many people. And, in fact, you know, the seven patients who have passed a six-month time point, none have progressed at the time of the data cut.
Have to hold that till more appropriate time.
2019 is additional program that we will be presenting the update.
Last year at Ash.
Presented long term durability and Thats Rafael has coverage we are very excited about the durability data that we have seen 14 complete responders and once the responses last six months. After that we are not seeing many people and in fact.
Patients who have passed a six month time point not had progressed at the time of the data cut. So these are very encouraging data that really differentiated allogeneic car T therapy products from other allogeneic programs and we are following those patients and the longer term follow up will be a big part of the.
David Chang: So these are, you know, very encouraging data that really differentiated allogeneic CAR-T therapy products, you know, from other allogeneic programs. And we are following those patients, and the long-term follow-up will be a big part of the additional data presentation at the year-end. 316, that one, you know, we are still, you know, in the dose escalation, you know, there's a lot of expectation on that study from the investigator perspective, but we will be generating additional data, and exactly when we will present, I mean, at this point, we're guiding more towards next year rather than this year, but we will see.
Additional data presentation.
At the year end.
316 that one.
Yes.
In the dose escalation.
There is a lot of expected on that study from the investigator perspective, but we will be generating additional data and exactly when we will present at this point, we're guiding more towards next year, rather than this year, but we will see.
Yes.
Operator: And thank you. And I am showing no further questions. I would now like to turn the call back over to management for closing remarks. Well, thank you for joining us today and for taking part in our journey to define, shape, and advance the future of not just allogeneic cell therapy, but the cell therapy market as a whole. We are pleased with our ongoing progress and look forward to what lies ahead for the rest of the year.
And thank you and I'm showing no further questions I would now like to turn the call back over to management for closing remark.
Well, thank you for joining us today and for taking part in our journey to define shaping advance the future of our not just allogeneic cell therapy about the south start the market as a whole we are pleased with our ongoing progress and look forward to Bud lights ahead for the rest of the year operate.
Operator: Operator, you may now disconnect. This concludes today's conference call. Thank you for participating. You may now disconnect. © BF-WATCH TV 2021, © The Ultimate Parody Site! Thanks for watching, and don't forget to subscribe to our channel.
You may now disconnect.
Yes.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
Yes.
Sure.
Yes.
Okay.
[music].
[music].
[music].