Q2 2020 Evelo Biosciences Inc Earnings Call
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Operator: Tolstoy Editing by J.R.R. Tolstoy; Music by J.R.R. Tolstoy BF-WATCH TV 2021. Good morning, and welcome to the Avalo Biosciences second quarter 2020 financial and operating results conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Jessica Cutrone of Avalo. Please proceed. Thank you, Operator. Good morning, everyone.
Good morning, and welcome to the envelope Sciences second quarter, 2020 financial and operating results Conference call.
It's time, all participants are no listen only about following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request at this time I'd like to turn it over to just pick a drone Apollo. Please proceed.
Thank you operator, good morning, everyone. Good morning, we issued a press release outline the topics we plan to discuss today. Its release is available at Www dot.
Jessica Cutrone: This morning, we issued a press release that outlines the topics we plan to discuss today. This release is available at www.avelobio.com under the Investors tab. Today on our call, Simba Gill, Chief Executive Officer, Mark Bodmer, President of R&D and Chief Scientific Officer, and Duncan McHale, Chief Medical Officer, will review our second quarter 2020 financial results and recent business highlights. Before we begin, I'd like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about our objectives and anticipated clinical milestones for 2020, the impact of any of our mono Such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. However, actual results could differ materially from those indicated by the forward-looking statements due to the impact of many factors.
Alibi dotcom under the Investor a cat can enter calls to Mcgill Chief Executive Officer, Mark Bodmer, President of R&D, and Chief Scientific Officer, Dunkin account Chief Medical Officer overview, our second quarter 2020 financial results and recent business highlights before we begin I'd like to remind everyone that statements made during this conference call.
Jessica Cutrone: Participants are directed to the risk factors set forth in Avelo's quarterly report on Form 10-Q for the quarter ended June 30, 2020, and the company's other filings with the Securities and Exchange Commission. It is now my pleasure to pass the call over to Simba. Thank you, Jessica.
Okay, and not really matter that historical facts, including statements about our objective in anticipated clinical milestones for 2020, the impact if any of our monoclonal microbial and the timing and resulted any clinical studies in the sufficiency of cash to fund operations should be considered forward looking statements within the meaning of the private Securities Litigation Reform Act.
1995, such forward looking statements are intended to be subject to the safe Harbor protection provided by the reform.
Actual results could differ materially from those indicated by the forward looking statements due to the impact of many factor.
The answer directly to the risks factors set forth in Abella quarterly report on form 10-Q for the quarter ended June Thirtyth 2020 in the company's other filings with the Securities and Exchange Commission any forward looking statements made today speak only two of Ella's operations as of today.
Disclaims any duty to provide updates with forward looking statements even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over December.
Thank you Jessica good morning, everyone and thanks for joining us to review our progress during the second quarter.
Simba Gill: Good morning, everyone, and thanks for joining us to review our progress during the second quarter. This is an exciting and important time for us. We recently completed our follow-on offering, which provides the capital to advance our programs in information and oncology through the next phases of clinical development while continuing to invest in our platform and our pipeline. We expect to generate six clinical readouts within the next six to 12 months, including data from a phase two dose-ranging study with EDP1815 in psoriasis, and data from the Phase II and Phase II-III trials of EDP1815 Additional data from the Phase 1-2 trial of EDP-1503 in triple-negative breast cancer and data from two phase one trials in atopic dermatitis with each of EDP1815 and EDP1867.
This is an exciting and important time for us.
We've recently completed a hole in offering which provides the capital to a bumper programs and information and oncology through the next phases of clinical development.
While continuing to invest in a platform handle pipeline.
We expect to generate six clinical readouts within the next six to 12 months, including data from a phase two dose ranging study would you be 18 15 in psoriasis.
[noise] data from the phase two and phase two three trials that you can see 18 15 encoded 19.
Additional data from the phase one two trial.
Taking a tree in triple negative breast cancer.
And they get from two phase one trials.
And I told the dermatitis with each old <unk>, reaching 15, and ATP 18th 67.
Our vision is to harness the small intestine axis, well syntax to develop a new Clos have mentioned that all affective safe convenient and affordable.
Simba Gill: Our vision is to harness the small intestinal axis, or syntax, to develop a new class of medicines that are effective, safe, convenient, and affordable. In both our inflammatory and oncology programs, we have demonstrated that the effects observed in preclinical models translate to humans, showing that we can harness syntax to modulate clinically relevant pathways. As you know, in inflammation, we are initially focused on the treatment of individuals with moderate disease. These people are not generally treated with existing anti-inflammatories such as antibodies or JAK inhibitors because of safety concerns, cost, or the inconvenience of injection or infusion. Over 3.5 million people in the US and EU alone have mild to moderate psoriasis or atopic dermatitis. The numbers globally, including China, are estimated to be at least five times this level.
In both on phlegm treat handled quality programs, we've demonstrated that the effects observed in preclinical models translate to humans.
Sure we can harness in talks to modulate clinically relevant pathways.
As you know and information we are initially focused on the treatment of individuals with multiple disease.
These people are not generally treated with existing out the inflammatories such as antibodies with JAK inhibitors, because a safety concerns cost.
Well the inconvenience of injection for infusion.
Over 3.5 million people in the U.S. Yoo by the whole loan hub mild to moderate psoriasis I told the dermatitis.
The numbers globally, including China are estimated to be at least five times this level almost 20 million potential patients globally.
Simba Gill: Almost 20 million potential patients globally. This also holds true for broader immune disorders, with more than 600 million people around the world living with conditions such as psoriatic arthritis, rheumatoid arthritis, asthma, allergies, and multiple sclerosis. As you know, resolving inflammation is important not just for the treatment of immune disorders but also for treating viral infections such as COVID-19. The Goldilocks effect of EDP1815 we observed preclinically in which hyperinflammation is resolved whilst preserving antiviral activity gives EDP1815 differentiated potential to help COVID-19 patients. Turning to oncology, our data suggest that EDP-1503 is well tolerated and amplifies innate and adaptive immunity to augment tumor killing. EDP-1503 has the potential to provide additional patient benefit in multiple tumors across all stages of cancer, from first line to last. We have a lot going on, and following the $52 million financing that we completed in June, we can execute on our clinical milestones while continuing to explore the potential of SYNTAC. With that, I will now turn the call over to Mark.
There's also holds true the broader immune disorders.
With more than 600 million people around the world living with conditions, such as story after cost right just rheumatoid arthritis asked about allergy and multiple sclerosis.
As you know, resulting information it's important not just for the treatment of immune disorders, but also in treating viral infections, such as coupled with my team.
[noise] the goldilocks effectively taking 50, we upsets preclinically and Wick hyper inflammation is resolved while preserving antiviral activity gives you the P. Eighteenfifty differentiated potential to help cobot 19 patients.
Turning to oncology a data suggest that GDP 15, as three is well tolerated and.
And amplifies innate and adaptive immunity the opened human too.
You do P 50 units suite has the potential to provide additional patient benefit in multiple chief minister across all stages and kind of so from first line to lost one.
We have a lot going on I'm. Following the 52 million dollar financing that we completed in June we can execute on our clinical milestones, while continuing to school the potential of syntax.
With that I will now turn the call over to Mark.
Thank you.
Mark Bodmer: Thank you. Simba referred to the Goldilocks effect of EDP-1815. In scientific terms, this means being able to resolve inflammation without damaging the immune surveillance needed to protect us from infection and cancer. This is what the body does naturally, but we haven't found any drugs that mimic this natural physiology.
Civil referred to a goldilocks effect to the CHF 15.
And scientific times, this means being able to resolve inflammation without damaging the unions surveillance needed to protect us from inflection at 10 so.
This is what the body's does not for me, but we haven't found any drugs.
This natural physiology.
Based on what we've seen preclinically and clinically it seems to have a control of inflammation throughout the body by the small intestinal axis, maybe biology, the willa catalyst to create such medicines.
Mark Bodmer: Based on what we've seen preclinically and clinically, it seems that the control of inflammation throughout the body by the small intestinal axis may be the biology that will enable us to create such medicine. Many important new biologic and small-molecule drugs have been created over the last 20 to 30 years. They all work by extinguishing the mediators of inflammation rather than by inducing processes of resolution, and they have two shared properties.
Many important new biologic and small molecule drugs have been created over the last 20 to 30 years.
Look like distinguishing the media because of inflammation rather than by introducing processes of resolution.
Mark Bodmer: First, they carry attendant risks to immune surveillance. Second, they target single pathways of the complex interconnective inflammatory process. The next frontier in anti-inflammatory therapy will be oral drugs that resolve this complex process of inflammation in a safe manner. Simpax Medicines may offer a solution, by coordinately downregulating multiple inflammatory pathways without suppressing type 1 interferon mechanisms of immune surveillance. Our evidence for not impacting type 1 interferons is preclin
And they have to shed properties first they tell me attendant risks to immune surveillance.
Second the target single pathways are the complex interconnected inflammatory process.
The next frontier and anti inflammatory therapy will be all drugs with resolve this complex process of inflammation in a safe manner.
The tax medicines may offer a solution.
Hi, coordinate the down regulating multiple inflammatory pathways without suppressing type on into filling mechanisms of immune surveillance.
Oh evidence, but not impacting pipeline interferons is preclinical.
Mark Bodmer: Following the recently announced results with dexamethasone in the recovery trial in COVID-19 patients, we've been comparing and combining EDP1815 and dexamethasone in preclinical models. This work has yielded results that have implications for all inflammatory diseases beyond the potential for COVID-19 treatment. EDP-1815 and dexamethasone are similarly effective as anti-inflammatories preclinically. However, dexamethasone heavily suppresses interferon-alpha and completely suppresses interferon-beta, the type I interferons required for immune surveillance.
Well only recently announced results with text messaging in the recovery trial in Cobot 19 patients we've been comparing a combining GBP 18, 15 index a message zone in preclinical models.
Mark Bodmer: By contrast, EDP1815 has no effect on these type 1 interferons. We also noted that combining EDP-HC15 and low-dose dextromethazone had additive and synergistic effects on various aspects of the inflammatory response. Turning to the Complexity of Inflammation, EDP1815 leads to the reduction, but not complete suppression, of multiple inflammatory cytokines. This is as important therapeutically as the sparing of type 1 interferons. Planetary cytokines have many protective roles when present at the right levels, at the right time, and in the right place.
It's what's yielded results that have implications for all inflammatory diseases beyond the potential because at 19 treatment.
You get the 18th 15 indexing Matheson similarly affected as that he inflammatories preclinically.
But that's something that's a message zone heavily suppresses interferon alpha.
He'd be suppresses into filling Peter the pipeline into pheromones required immune surveillance by contrast, GDP 18, 15 has no effect on these type one interferons.
We also noted that combine 80, P.H.B. 15, and motors that massive on attitude and synergistic effects on various aspects inflammatory response.
Turning to the complexity of inflammation.
GDP 18, 15 leads to the reduction, but not complete suppression of multiple inflammatory cytokines.
This is as important therapeutically asparagus type one interferons inflammatory cytokine somebody protected roles when prices are the right levels at the right time did the right place.
Mark Bodmer: Our evidence for this aspect of EVP1815 is clinical as well as preclinical. You may recall that we reported reductions in the production of IL-6 and IL-8 in vivo-stimulated blood of patients treated with EVP 1815. Excess excursions of these cytokines were prevented, but basal levels were maintained.
Our evidence that this aspect of GBP 18, 15 is critical as well as preclinical.
You may recall that we reported reductions in the production of Iosix and highlight.
Ex vivo stimulate a blood a patients treated with GDP 18 15.
Excess excursions of beside the claims were prevented the basal levels were maintained.
I realize this is a complicated story I mean, we've learned a great deal in the last few months sort of mechanism of action, although syntax medicines, but preclinically and clinically these lessons of the science and pharmacology a critically important enable us to explain more clearly the potential impact of syntax and these new medicines.
Duncan McHale: I realize this is a complicated story, and we've learned a great deal in the last few months about the mechanism of action of our Syntax medicines, both preclinically and clinically. These lessons from the science of pharmacology are critically important. They enable us to explain more clearly the potential impact of Syntax and these new medicines. If we can continue to build on the translation of our preclinical work into clinical studies, we will capture this new frontier of anti-inflammatory medicines that resolve inflammation without suppressing protective immunity. I'll now hand over to Duncan for a clinical update. Thank you, Mark. I'm pleased today to review the recent progress across our Inflammation and Oncology program. We have received regulatory and ethics approval at sites in the U.S., U.K., and E.U.
If we can continue to build on the translation of our preclinical work into clinical studies, we will capture this new frontier that inflammatory medicines, which was old inflammation without suppressing protective immunity.
I'll now hand over to Duncan clinical update.
Thank you Mark I'm pleased today to review the recent progress across our information and oncology programs.
Duncan McHale: for our Phase II dose-ranging trial for EDP1815 in moderate psoriasis. We remain on track to initiate the trial in the third quarter of 2020, with interim data expected by mid-2021. As we have stated previously, the study will evaluate three doses of EDP1815 versus placebo in approximately 225 individuals, and the primary endpoint will be the mean reduction in PASI score at week 16. We will also evaluate other clinical measures of disease, such as IgA, BSA, IgA x BSA, and LSA.
We have received regulatory and ethics authorization attacks in the U.S. UK and E U for phase two dose ranging trial ATP Eighteenfifty in Madrid psoriasis.
We remain on track to initiate the trial in the third quarter of Twentytwenty with interim data expected by mid 2021.
As we've stated previously the study will evaluate three doses of GDP 18, 15 versus placebo in approximately 225 individual and the primary endpoint will be the mean reduction Patti school or do we succeed.
We would also evaluate other clinical measures of disease, such as I, G.A.B., I say, hi, Jay times, B., I say and Alessa.
The study population includes individuals are feeling topical treatments through two individual approaching the need for biologic therapy.
Duncan McHale: The study population includes individuals who are failing topical treatments through to individuals approaching the need for biologic therapy. As Simbas said earlier, we believe EDP1815 could have the activity and tolerability that would potentially make it the first choice agent across this broad and poorly served group of patients. Now turning to COVID-19, the preclinical and clinical data suggest a clearly differentiated role of EDP1815 in the early treatment setting. A therapy that preserves the antiviral response and prevents the development of hyperinflammation and cytokine storm would potentially be an ideal therapy to be used early in the disease process.
I would simply said earlier, we believe 80 pacing 15 could have the activity and tolerability that would potentially make it first choice agents across this broad and 47 group of patients.
Now turning to cover 19, the preclinical and clinical data suggests a clearly differentiated drove a BDP eighteenfifty in the early treatment setting.
A therapy, which presents the anti viral response and prevents the development the pipe inflammation and cytokine storm.
Would potentially be an ideal therapy.
To be used early in the disease process.
Duncan McHale: The results that Mark described combined with the tolerability observed to date give just this potential profile for EDP1815. We are pleased to report that the U.S. FDA recently authorized our INC application for our Phase 2 COVID-19 trial, and we expect data from this trial in the fourth quarter. For the already approved Phase 2-3 trial in the UK, Tactic E, we are working with Adam Brooks Hospital in Cambridge to bring in new sites globally and continue to expect interim safety data and futility analysis by the year end. If the data from these trials are positive, we plan to explore EDP1815 as a potential therapy for other viral-driven inflammatory diseases, such as the pulmonary complications of influenza, in which hyperinflammation and cytokine storm also play a key role.
The results that Mark described combined with the Tolerability observed to date.
Just there's potential profile for easy pay 10 15.
We're pleased to report that the U.S. after <unk> recently authorized the IP application for our phase two covered 19 trial, we expect they'd come this trial in the fourth quarter.
But the already approved phase two three trial in the UK tactic, Amy we're working with Adam Brooks Hospital in Cambridge to bring on new sites globally. We continue to expect interim safety data and futility analysis by the year and.
If the data from these trials are positive we plan to explore easy pay to 15 as a potential therapy for other viral driven and Simon diseases, such as the poverty complications of influenza and we type information and cytokine storm also play a key Roe.
So let me now turn to ATP 15, or three our product candidate in oncology.
Duncan McHale: So let me now turn to EDP1503, our product candidate in oncology. At the ESMO World Congress on Gravitational Cancer virtual meeting in July, we presented clinical data from our Phase I-II open-label study of EDP-1503 in combination with pembrolizumab in individuals with advanced metastatic microsatellite-stable colorectal carcinoma, triple negative breast cancer, and those with multiple tumor types who have relapsed on prior checkpoint inhibitor treatment.
At the ESMO World Congress, I'm confident I know cancer virtual meeting in July.
We presented clinical data from our phase one to open label study EVD P 50, Nancy in combination with Pembrolizumab.
In individuals with advanced metastatic microsatellite stable colorectal carcinoma.
Triple negative breast cancer, and those with multiple tumor types relapsed on prior checkpoint inhibitor treatment.
These data provide the first substantiation of our hypothesis, but our products could stimulate immune responses by syntax to combat tumor growth in humans inline with our preclinical data.
Duncan McHale: These data provide the first substantiation of our hypothesis that our products can stimulate immune responses via syntax to combat tumor growth in humans in line with our preclinical data. We were particularly encouraged by the results in patients with triple negative breast cancer. As you may know, metastatic triple negative breast cancer is an aggressive disease with very few treatment options.
We were particularly encouraged by the result in patients with triple negative breast cancer.
As you May know metastatic triple negative breast cancers, and aggressive disease with very few treatment option.
Duncan McHale: Historically, most patients receive cytotoxic chemotherapy in this relapse setting and with only a 10 to 20 percent clinical response rate. The poster presented at ESMO GI included preliminary data on 11 triple-negative breast cancer patients, including 8 treated with the high dose of EDP-1503 and 3 with the lower dose. An overall response rate of 25% and a disease control rate of 37.5% were observed across all triple negative breast cancer patients receiving the high dose. There were no drug-related grade 4 or grade 5 adverse events and only four grade 3 events, suggesting EDP-1503 could be an attractive candidate to combine with checkpoint inhibitors and other agents such as cytotoxic chemotherapy or antibody drug control. Although the number of treated patients is still small, these data compare favorably to historical studies of anti-PD-1 monotherapy in heavily pre-treated patients with triple negative breast cancer, which yielded an overall response rate of between 5 and 10%.
Historically, most patients we see cytotoxic chemotherapy induced relapse setting and with only a 10% to 20% clinical response rate.
The poster presented at ESMO Gi I included preliminary data on 11, triple negative breast cancer patients, including eight treated with the height as VP 15, or three and three was below it does.
And overall response rate of 25% and a disease control rate of 37.5% words that across all triple negative breast cancer patients receiving the high dose.
There were no drug grateful ore grade five adverse event and only fool grade three event.
Suggesting ATP 15, or three could be an attractive candidate to combined with checkpoint inhibitors and other agent such as cytotoxic chemotherapy or antibody drug conjugate.
Oh, no the number of treated patients still small these day to compare favorably to historical studies of anti PD, one monotherapy in heavily pretreated patients with triple negative breast cancer, which have yielded novo response rate of between five and 10%.
Duncan McHale: These efficacy data are in the range for clinical results observed in newly approved treatment for third-line or later metastatic triple negative breast cancer. If the current response rate is maintained, then the pleiotropic immunostimulatory actions of EDP-1503 will make it an ideal agent to combine with any therapy which increases neoantigen generation. Additionally, it has the potential to augment cell death by enhancing the initial inflammatory reaction in the tumor.
These efficacy data are in the range preclinical results observed in newly approved treatment for third line or later metastatic triple negative breast cancer.
If the current response rate is maintained then the patriotic Immunostimulatory axes V. P 59, three make it an ideal agent to combined with any therapy, which increases neoantigen generation.
It has the potential to augment cell death by enhancing the initial inflammatory reaction in the tumor.
They suggest that the combination of targeted agent to drive a look like and flunked you action Neoantigen the generation acumen site.
Simba Gill: This suggests that the combination of a targeted agent to drive a localized inflammatory reaction and neoantigen generation at tumor sites, with an amino stimulatory agent and a checkpoint inhibitor could be an ideal early treatment regimen. It would maximize the potential for durable clinical responses whilst minimizing the need for broad-acting, poorly-tolerated chemotherapeutic regimes. Based on these data, we are now focused on enrolling additional individuals with triple negative breast cancer in our ongoing Phase 1-2 trial and expect to report additional data from this cohort in the fourth quarter of 2020. I will now turn the call back over to Sim. Thank you, Jonker. I want to conclude with a reminder of the upcoming milestones across our portfolio. Beginning with the EDP 1815,
With the name you nailed it stimulates reagent under checkpoint inhibitor could be an ideal early treatment regimen.
It would maximize the potential for durable clinical responses, while minimizing the need for brought acting poorly tolerated chemotherapeutics regime.
Based on these data we're now focused on enrolling additional individuals with triple negative breast cancer and our ongoing phase one two trial and expect to report additional data from this cohort in the fourth quarter Twentytwenty.
Let me now turn the call back over December.
Thank you Duncan.
Simba Gill: We expect data from the Phase 2 trial with Rutgers in COVID-19 in the fourth quarter of this year, 2020, for the Phase 2-3 CACTUS-E trial. We also expect interim safety data and futility analysis in the fourth quarter of this year. We also expect to initiate a Phase 2 trial of EDP1815 in moderate psoriasis in the third quarter of this year, with data by mid-2021. But we didn't spend time discussing today the additional trials that we're looking to initiate... with EDP 1815 in atopic dermatitis, a phase 1b trial in the fourth quarter of this year, as well as our first non-live product candidate for inflammatory Data from these trials is expected in the first quarter and mid-2021, respectively.
I want to conclude with reminder of the upcoming milestones across our portfolio.
Beginning with the P. eighteenfifty.
We expect data from the phase two trial, which looked as encoded 19 in the fourth quarter of this year Twentytwenty.
For the phase two three tied to each trial.
We expect interim safety data and futility analysis in the fourth quarter this year.
We also expect to initiate a phase two trial of E. D. P 18, 15 in Multisite psoriasis in the third quarter of this year with data by mid 2021.
We didnt spend time discussing.
Today or the additional trials that were looking to initiate.
Would you repeat 18 15.
In a topic dermatitis, a phase one be trial in the fourth quarter this year.
As well as a first.
Non life product candidate for inflammatory diseases, EGP 18, 67 in a public dermatitis in the first quarter of 2021.
Data from these trials are expected in the first quarter and mid 2021, respectively.
Simba Gill: We plan to provide more detail on the unmet need for atopic dermatitis on our third quarter call in October. Finally, we expect to report additional data from our Phase 1-2 clinical trial of EDP-1503 in triple negative breast cancer in the fourth quarter of this year. Following a follow-on offering in June and the drawdown of an additional $10 million under our existing debt facility in July, we have sufficient capital to support our operations into the third quarter of 2021.
We plan to provide more detail on the unmet need and they taught dermatitis on our third quarter cool in October.
Finally, we expect to report additional data from a phase one two clinical trial of E. D. P 50, no three in triple negative breast cancer in the fourth quarter of this year.
[noise] wholesale follow on offering in June and the drawdown of an additional 10 million under our existing debt facility in July we have sufficient capital to support our operations into the third quarter of 2021.
Simba Gill: Beyond, All key clinical milestones for each of our ongoing programs, while enabling continued investment in our plan. Our lead programs, EDP-1815 for psoriasis, COVID-19, and EDP-1503 for triple negative breast cancer, have shown promising potential in key areas where there is a medical need, where the potentially unique activity of our product candidates may prove particularly beneficial. Over the next 6-12 months, we expect 6 clinical readouts, which could further validate our platform, reinforce the predictability of our preclinical models, highlight the potential breadth of syntax as a drug target across a broad array of programs, and enable the further expansion of our efforts into other indications, where we may be able to provide transformative results. Alongside the progress of our current pipeline, we've expanded discovery into other disease areas such as neuroinflammatory In closing, I'd like to thank the team at Evelo.
Beyond.
Operator: Because of their exceptional work, we've been able to continue to deliver on our commitments during the COVID-19 pandemic. We look forward to updating you again soon, and I'd like to now turn the call over to the operator for questions. Thank you. Ladies and gentlemen, if you have a question or comment at this time, please press star then one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key.
All key clinical milestones, but each of ongoing programs.
While enabling continued investment in our platform.
Our lead programs.
The 18 15 for psoriasis and cope with my team and E. B P 50, no tree.
A triple negative breast cancer have shown promising potential in key areas of unmet medical need.
Whether potential unique activity of our product candidates may prove particularly beneficial.
Over the next six to 12 months, we expect six clinical Readouts, which could further validate our platform reinforced the predictability of a preclinical models highlights the potential breadth of syntax.
As a drug target across a broad array of programs.
And is able to further expansion of our efforts into other indications, where we may be able to provide transformative results.
Alongside the progress of a current pipeline, we've expanded discovery into other disease areas, such as newer inflammatory disorders metabolic dysfunction viral related inflammatory synta syndromes and for vaccination.
In closing I'd like to thank the team to develop.
Because of their exceptional work, we've been able to continue to deliver on our commitments during the cold It 19 pandemic.
We look forward to update you again soon and I'd like to now turn the call it but to the operator for questions.
Thank you ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
Connor Meehan: Again, if you have a question or comment at this time, please press star then 1 on your telephone keypad. Our first question or comment comes from the line of Connor Meehan from Morgan Stanley. Your line is open. Hi y'all, this is Connor Meehan on behalf of Matthew.
If your question has been answered or you wish to remove yourself into Q simply press the pound cake.
Again, if you have your question or comment at this time. Please press Star then one on your telephone keypad.
Our first question or comment comes from a line of Conor mean from Morgan Stanley. Your line is open.
Hi, all a this is called me an entre Matthew Thanks for taking your question. So you touched basically are you took touch briefly on the response rates in a row alone, but can you just comment on the initial efficacy for 53 and I guess, how you intend to evaluate the supplementary affected at that has.
Simba Gill: Thanks for taking the question. You touched briefly on the response rates of Pembroke alone, but can you just comment on the initial efficacy of 1503 and, I guess, how you intend to evaluate the supplementary effect that 1503 has above or beyond Pembroke alone? And then, just quickly, what kind of commercial contribution do you see for the COVID program if it is successful? Thank you. I'll let Duncan answer the question on how we're looking at the combination study in terms of the readouts and how we're assessing that ongoing KNBC combination clinical study with Pembroke. Duncan, do you want to take that question?
Above or beyond Pembro alone and then just quickly what kind of contract commercial contribution do you see for the coated program. If if successful. Thank you.
Well that Duncan out so the.
Question on how we're looking at the at the combination study in Tennessee, the read outs and how assessing.
That ongoing can be C.
A combination clinical study with Pepper Duncan <unk> do I take my question and then how about you know a whole oh. So the question about kind of 90.
Duncan McHale: And then hand it back to me, and I'll answer the question about COVID-19. Yeah, sure. This is an open-label cohort of the combination, so really what we are comparing is the objective response rate, or overall response rate, we see within that cohort with the historical data. So we're looking really for what would be a significant increase over the historic rate of 5% to 10%.
Yeah I'm sure Sam this is [noise].
Right.
The combination and open label I kind of one of the combination. So really what we are comparing is the objective response rate or overall response rate you see we did not go with the historical data. So we're looking really for you know what would be a sort of a significant increase over there isn't a historically.
The 5% to 10% here as you sort of seen at the minute a response rate of 25% would suggest that we.
Duncan McHale: So here, as we've sort of seen at the minute, a response rate of 25% would suggest that EDP1503 is doing something more than Pembrolizumab, and the combination is therefore better than Pembrolizumab alone, with all the caveats of historical response. We're also looking at some of the biomarker data with some of the predictors of Pembrolizumab response, and that data will be released at a conference in the upcoming So Conor, hopefully that was helpful. Let me answer your other question on COVID-19. It's actually an incredibly straightforward question for us, which may or may not be true for other biotech companies. The reason it's a very straightforward question for us, Conor, as you know, from our outset, we had a very clear vision and purpose for the company, which we've been very public about since the day we founded the company.
We need to be did you know if he is doing something more than their pembrolizumab and and the combination is therefore, I didnt pembrolizumab alone with all the caveat of historical as funds and we're also looking at some of the biomarker data become the predicted the pembrolizumab respond and that data would be released today.
The conference in the upcoming time.
So can I hopefully that was helpful. Let me obviously your other question on covered my team. It's actually an incredibly straightforward question for us, which may or may not be truth. Other biotech companies. The reason, it's very straightforward question Ross corner as you know for my outset, we had a very clear vision and.
Purpose for the company with would be very public on this though we found that the company.
Duncan McHale: And that vision is to create a new profile of medicine which would be not only effective but also safe, convenient for oral delivery, and affordable. We've always been incredibly clear about that point. And our definition of affordable is something that is affordable for all populations globally and all patients at all stages of disease. That is enabled because of the power of syntax, which opens up the possibility to create that profile in a way that is not addressable with other things.
And that vision is to create a new profile of medicine.
Which would be not only affected but also safe convenient by oral delivery and affordable we've always been incredibly clear about that point and our definition of affordable is something that is affordable third populations globally and eight patients at all stages of disease that is enabled.
Because of the power syntax, which opens up the possibility to create that profile.
The weather, which is not addressable with other things. So does that some of the prepared comments we made.
Simba Gill: So going back to some of the prepared comments we made. The reason, for example, why antibodies aren't used in moderate or earlier stage patients with inflammatory disease is linked to cost, linked to the inconvenience of injections and infusions, as well as potential concerns, as we mentioned, on the part of clinicians and some patients around safety and tolerability. So for us, it's pretty straightforward; we're just going to execute on the vision and the plan we always had, which was to provide medicine for very large patients on an affordable basis. And that's what we're going to do in COVID-19, assuming we're successful. Understood, thank you. Thanks, Carl.
The reason.
For example.
For the reasons for example antibodies are used in Madrid earlier stage patients with inflammatory disease.
Just a cost linked to the inconvenience of injections infusions.
As well as potential concerns as we mentioned.
On the part clinicians and some places around safety and Tolerability.
So for us, it's pretty straightforward, but just going to execute on the vision and the plan. We always had which was to provide messes that very large patients on an affordable basis and that's what we're going to live in code at 90.
That's helpful.
Understood. Thank you.
Thanks.
Thank you. Our next question or comment comes from the line of Chris Shibutani from Cowen. Your line. Your line is open.
Good morning, Pam I used to Chris.
Pam: Thank you. Good morning, this is Pam on for the update. Can you comment on what you're seeing in the field as you try to get the phase two psoriasis study going in these unprecedented times? What is the status there, and what specific challenges are you encountering?
Let me update.
Today, and what you're seeing in the field as he tried to get that they teach right study going indeed unprecedented times, what do the said there and what specific challenges are you in catching.
Hi, Pam.
Simba Gill: Hi Pam, good to hear your voice. So just to clarify your question, linked to recruitment and that type of issue, is that what you were referring to with your question? Yeah. Yeah.
Good to hear voice, so I just to clarify your question like to Recruitments and and that type of issue is that when you were referring to of course sometime.
Yeah, Yeah, so having said that.
Simba Gill: Yes, so we, as we said, are looking to essentially initiate the formal phase 2 dose ranging study shortly. We haven't yet started dosing, but we have spent a lot of time together with our CRO working out sites and looking at dynamics linked to recruitment. What we've done, Pam, obviously, these are very uncertain times, and what we've done in the guidance we're giving, which is to get a result on the interim data by the middle of next year, is to provide conservative guidance, which assumes that it's going to be slower recruitment than we would otherwise normally see. Having said that, at the moment, the situation we anticipate is going to be okay, and certainly, as we look across all of the sites we're working through, which, to be clear, are global, as you know, so we've got multiple sites across different countries in Europe, multiple sites across different regions in the U.S., and if we look at those in total, we're confident we're going to be able to recruit PAM
Yeah, Yeah. So so we.
As we set up or looking to essentially initiate the thermal phase two dose ranging study.
Shortly we haven't yet started dosing, but we have spent a lot of time together with our COO.
Working up sites and look at dynamics linked to recruitment what we've done I'm, obviously very uncertain times and what we've done in the guidance, we're getting which is together as a result on the interim data by by the Middle of next year is to provide conservative guidance.
Which assumes that it's gonna be slow recruitment then we would otherwise normally see.
Having said that.
At the moment or the situation.
We anticipate is going to be okay.
And certainly.
As we look across all the sites, we're working through which to became a global as you know so we've got multiple sites across different countries in Europe.
Multiple sites across different regions in the U.S.
And if we look at those.
In total so we're confident looks to be able to recruit power. We have mitigated some of the risk, but it's obvious in the current environment by increasing the number of sites.
Simba Gill: We have mitigated some of the risk that is obvious in the current environment by increasing the number of sites, but we have done the fieldwork, and we and FDRO, as I said, believe that we're going to be able to continue to recruit, depending on the region. And so obviously, we're trying to open up sites; we're aiming to open up sites in multiple geographies to again mitigate against what might happen with a given spike at any given moment in time. I hope that it's helpful. It's very helpful. If I can ask a follow-up question on 1867, can you remind us of what properties you think make it likely that 1867 will be more successful in atopic dermatitis than 1815 or others like 1067? Yeah, I'll say a couple of things, and I'll let Mark get into the science. Just one clarification.
And you'll remember that we also actually increased the size of other studies to give us more flexibility from that perspective as well. So we've taken steps to have more sites, but help us recruitment, but being conservative in our guidance and.
As much as one can predict anything right now we're confident we're going to be able to get the guidance, we've given them and potentially could even be set.
Practically we're not able to comment panel on what do we living with in terms of Rick recruitment right now because we're not actively recruiting right now, but we have done the field work and we have CLL.
As I said believed that we're going to be able to 'cause it continued to recruit.
Depending on the region and so obviously, we're trying to open up site.
Oh, we're aiming broken up sites and and multiple geography to again today than what might happen with a given spike at any given moment in time.
Okay. That's helpful.
Okay very helpful. If I can ask a follow up on equaled 67 can you remind us of what property you think make it likely that equaled 67 will be more successful in atopic dermatitis than 18, 15 or others like 10.
66.
Yeah, I'll say, a couple of things and all that marked at into the science.
Just wanted to clarify Oh.
Simba Gill: The way we think about all our programs in inflammation is that they are working on multiple different cytokine pathways that are pleiotropic, and that leads to the inflammation resolution that Mark discussed and prepared Mark, and I suspect he'll expand on. And each microbe is different in terms of which pathways each microbe is impacting, but they're all leading to inflammation resolution. We look at atopic dermatitis as a model system for HPs, broadly, just to be clear. So it's atopic dermatitis as an attractive indication in terms of fundamental unmet need for moderate disease and beyond, but it's also a model for broader ATPs including asthma, food allergy, et cetera. I'll let Mark answer the question from a more fundamental scientific perspective.
The way we think about.
Four programs and inflammation is that they are working on multiple different lifetime parkways, the petrotec them at least the inflammation resolution.
The Mark discussed in his prepared remarks, and like I suspect bill ill expand on and each microbes different in terms of which.
Pathways each microbes impacting.
Several leading information, but we look at a topic during the crisis as a mobile system HP broadly just to be clear.
So so it's a topic dermatitis as an attractive.
Indication in terms of fundamental unmet need for.
I will moderate diseases and beyond but it's also a mobile abroad, right piece, including asthma food allergy etcetera.
Well, let mark answer the question from a more fundamental fines.
The.
Yes. So they are the fractions of eating 67, if not it took to the pharmacology and not specifically related to a topic to other type of so it is very effective reproducibly affected in preclinical models, but actually that's true for quite a variety of preclinical models and whats interesting.
Mark Bodmer: Yes, so the attractions of EDP1867 are not, in terms of the pharmacology, not specifically related to atopic dermatitis. So it is very effective, reproducibly effective, in preclinical models, but actually that's true for www.ncbi.nlm.nz. So they both have broad inflammation resolution, https://www.youtube.com or the link in the description below. So we're looking at optimized Translational Pharmacology, if you'd like, from all of us pre-clinically. The other aspect of this was actually thinking of these... a very different organism to EDP-KT15; it was isolated in a different part of the gut.
In the comparison.
The aging 15 is that.
They have a slightly different propensities facilities to.
Inhibit and in the different systems. So they both have the broad inflammation resolution asked so there's no. This is not like particularly is like antibodies seasonal policies specific pathways that are targeting overlapping park. So we're looking at optimizing the.
A translational oncology like from what we're seeing Preclinically.
It's what we'll see how quickly the other aspect of this is actually they could be specific you'll be seeing says as drugs in terms of pharmaceutical properties and I've been focused season of the west indicating 67 as it is a very different organism CDP.
The 15 it was isolated.
That's different Michael biological properties has different sensitivities to bile acid and I said. It was also selected for its particular ability to Lilly with sad, but actually to habits activity crude by gamma radiation as we said early on we talked about EPA.
He succeeds office deliberately normalized will not viable product, which we think is a big separately in the field and.
Mark Bodmer: Deliberately non-liable, non-buyable product, step into the field, and, as you're aware, Pam, you know, [inaudible] for more information. This is a new field. So... We are exploring the range of pharmacology and the range of microbiological and pharmaceutical properties and the distinctions which complement the overlaps between 1815 and 1867 do that, but to explore the range of different types of agents that can be used with different chemicals.
Where hum you know often.
What we're doing gets confused with microbiome activities and Ah. So it was a way of.
Formalizing the fact that there's no microbiome affect these are directly acting agents the skipping the whole microbiology component attracting directly on her cells and me.
As for testing so the strategy was to.
It was a new fields so.
So we are exploring the range of pharmacology in the range of microbiological policies.
Parties, and a six months or would compliment the overlaps between 18 being an 18 60, so Vicki give us the range we need to go for that you were going to continue.
To do that but it's for the range of different types of agents and these are different kaniskina types.
Mark Bodmer: Classical drugs, as well as using them to expand the range of disease-induced diseases. So, you know, the specific question of whether EDP1867 will be better or worse, but the broad question of having, really striking pharmacology and preclinical models, overlapping. Thank you. Thank you. Our next question or comment comes from the line of Matthew Licini from VMO. Your line is open. Hi, this is Jin, on behalf of Matthew.
Goldrock terms as well as using them to expand the range all disease indications we get.
Into capturing symbols comments about getting the broad potential of UBS attacks in different products around the different.
Occasions so.
Specific question of whether he to creating 67 holding back a little worse.
They told me items, that's a clinical question, we don't have the office.
But the growth question of having.
Oh really striking pharmacology in preclinical models, which is overlapping buttons, but divergence in some of the models to scale.
To to go after the.
Clinical range.
Thank you.
Thanks.
Thank you. Our next question or comment comes from the line of Matthew Ritchie from BMO. Your line is open.
Hi, This is Chen on for Matt you and thanks for taking my question Congrats on the progress.
Matthew Licini: And thanks for taking our questions and congrats on the progress. Two from me: so how are you guys thinking about the long-term commercial outlook?
To from me.
Could you how are you I think you might be along the trend commercial I love for a colder treatment could you Guy <unk> point to any benchmark that you think are appropriate including vendors in the air from pricing perspective, and how are you guys think Haas and I've a follow up after that.
Simba Gill: Could you guys... End [inaudible] Hey Jed, thanks for the questions and thanks for the comment on progress. Just actually to just comment on your thank you as well. Mark and I were actually just reviewing the formal press release a few days ago, and your comment is well made because the progress we've made over the last six to twelve months is pretty remarkable. Back to the fundamental point that we are now expecting six important clinical readouts over the next six to twelve months. So thank you for that on the COVID question. I partly answered it in my response to Connor's question.
Hey, guys. Thanks for the questions.
Thanks for calling on progress just actually to just calling on your thank you for a progress.
Mark and I were actually just reviewing the form a press release, a few days ago.
And your your comment as well made because the progress we've made over the last 612 months is pretty remarkable.
Back to the fundamental point that we now are expecting six important clinical readouts over the next six to 12 month. So thank you for that.
Simba Gill: So what we've always said, just to repeat on that one, is that we want to deliver medicines that help very large patient populations globally and at all stages of disease with effective, safe, convenient, and, very importantly, affordable medicines. So our goal has always been a price on an affordable basis that links to each market's ability to pay for the relevant drug. We're in a very fortunate position because of the nature of the product to essentially be able to, at scale, manufacture it much more cost-effectively than an antibody or, at the extreme, a cell therapy. And that gives us lots of pricing flexibility.
On the Koby question I, partly to onto that.
And my response to the corners question. So what we've always said just to repeat on that one is that we want to deliver match them, which help very large patient populations globally and that all stages of disease with effective they convenient and very importantly, affordable match. So goal has always been.
The price on an affordable basis that links to each markets ability to pay the relative drug where in a very fortunate position because of the nature Oh.
Oh, the product to essentially be able to at scale manufacture much more cost effectively than an anti body or extremists cell therapy and that gives us lots of pricing flexibility, we're not commenting a beyond that but you can be confident that will price on that.
Simba Gill: We're not commenting beyond that. But you can be confident that we will price on an affordable basis, which would allow the drug to be accessible for very large patient populations around the world, assuming that we drive efficacy. And we're not commenting beyond that at this point. Can this trial be a pivotal trial? Are there any gating factors for moving on to Phase 3?
As an affordable basis, which would allow the drug to be accessible for very large patient populations around the world assuming that we write up because the and we're not comedy beyond that at this stage.
Understood and Candi child, you have to put all trial. Its not is there any gating factors or moving on to phase three.
So for the code the trial.
Simba Gill: for the COVID trial? Yeah. So the UK trial, so we have two COVID trials, the UK PACTIC-E trial, it's called, which is a phase 2, 3 trial. And then in the US, we just got approval for a phase 2 trial. So, if I take them in that order...
Yeah.
So you can try to actually cover trials the the UK at the key trial, it's cool, which is a phase two three trial.
And then in the U.S.
We just got approval for a phase two trial.
So.
We'll take them in that order.
Simba Gill: The UK study is structured to reveal whether or not we are making a fundamental difference linked to progression of the disease and linked to mortality. And so... Obviously, we need to generate the data, but it is quite conceivable that if we were to generate positive data through that study, we'd be able to look for some form of an accelerated approval, in the best case, without having to do any additional studies. We obviously have to generate the data, we have to have discussions with regulatory agencies, but the trial, as I said, is set up very deliberately as a Phase II-III study. The U.S. study is a phase 2 study, so assuming that's positive, we'll go into an expanded phase 3, and they're both set up to allow rapid progression to either, in the UK situation, potential rapid approval. Obviously, again, we're in an uncertain world in terms of how regulatory agencies will look at data in an effort to try and accelerate approval, given the need that we all have. But that's basically a summary of the situation.
Do you pay study is structured to.
Reveal whether or not we are making fundamental difference I like to progression of the disease and linked to mortality.
And so.
Obviously, we need to generate the data, but it is quite conceivable, but if we were to generate positive data through that study.
We'd be able to look for.
Some form of an accelerated approval or in a best case without having to do any additional studies, we obviously have to generate the data we have to other discussions with regulatory agencies.
But the trial as I said is set up a very deliberately if they see three study.
The U.K.U.S. study.
As a as a phase two study so assuming that's positive will go into an expanded phase three.
And that both set up to allow rapid progression to either in the UK situation petrel rapid approval, obviously again, when an uncertain world and in terms of how regulatory agencies will look at data in an effort to try and accelerated approval given the needs that we all have but.
That's basically somebody the situation.
Got it that's helpful. Thank you.
Simba Gill: Got it. That's helpful. Thank you. Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star and then one on your telephone keypad. Our next question or comment comes from the line of Chris Howerton from Jeffries. Your line is open.
Okay.
Thank you again, ladies and gentlemen, if you ever question or comment at this time. Please press Star then one on your telephone keypad. Our next question or comment comes from a line of Chris Howerton from Jefferies. Your line is open.
Chris Howerton: Great. Thanks so much for taking the questions. I guess, you know, for me, Simba, just a couple questions.
Great. Thanks, so much for taking the questions.
I guess you know for me soon but just a couple of questions first of all with respect to the cash runway you know does that take any considerations for CMC scale up or any other activities that might be required in the back end to move quickly towards some of these near term commercial opportunities were describing.
Simba Gill: First of all, with respect to the cash runway, you know, does that take any considerations for CMC scale-up or any other activities that might be required in the back end to move quickly towards some of these near-term commercial opportunities we're describing? And then the second question I have would be thinking about the strategy within oncology more broadly. You know, we've obviously had some announcements this morning with respect to Keytruda, working in triple negative breast cancer, and then, of course, Medimatic's antibody drug conjugate. So maybe just help us understand your vision in terms of how your product might fit within that evolving landscape. Thanks for taking the questions. Hi Chris.
And then and the second question I have would be thinking about the strategy within oncology more broadly you know, we've obviously had some announcements. This morning with respect to Keytruda you know working in triple negative breast cancer, and then of course.
At a medix antibody drug conjugate so.
Maybe just help us understand your vision in terms of how your product might sit within that evolving landscape. Thanks for taking the questions.
Hi, Chris.
Simba Gill: Thanks for the questions, Chris. So on the first one, we've already implemented a number of measures to put us in a position to provide product for COVID-19 patients over the course of next year, sufficient for 10 to 15 million patients with what we have already essentially lined up. And the initial investments linked to that have already been made, to answer your question. Chris, obviously, until we have approval.
Thanks for the questions Chris So.
On the first one.
We've already.
It does that number of measures to put us in a position to provide.
Well, that's the cobot 19 patients.
Over the course of next year sufficient for 10 to 15 million patients with what we have already.
Essentially lined up and the initial investments linked to that have already been made to answer your question.
Yes, obviously until we.
Simba Gill: We're not going to pull the trigger on the spend, but we have everything ready to allow us to provide, as I said, products for 10 to 15 million patients. So that's already factored in. If we were to get an approval, which, to the previous question, could be on an accelerated basis and could be earlier next year, then that first wave of supply is lined up. Going beyond those 10 to 15 million patients, we've not yet made the relevant investments, but we are obviously ready to do that quickly if we were to get that positive result. So that's where we are in terms of scale-up preparedness, and we did that very quickly given that none of us knew that COVID was going to be what it is becoming until around March and April of this year.
Have approval when I'm going to pull the trigger on the spend but we have everything ready.
Files to provide as that product or 10 to 15 million patients.
So that's already factor then.
If we want to get.
And approval, which to the previous question could be on an accelerated basis and could be.
Early next year.
Then.
First wave of supply is lined up.
I'm going beyond that 10 to 15 million patients, we've not yet made a the relevant investments, but obviously ready to do that quickly. If we work to get that positive result, but that's where we are in terms of.
Scott preparedness.
And we get that very quickly given that if none of this new co because that would be what it's become a until around March April of this year.
Simba Gill: So on your question about recent data linked to Keytruda and TMBC, Immunomedics products for Delvey and TMBC, and how we see ourselves fitting in that space. We think there's very nice complementarity between the different approaches. So at the simplistic summary level, as you know Chris, checkpoint inhibitors, whether it's Keytruda or any of the others, are essentially removing the brake that is applied to the immune system by the tumor. One would anticipate that that is often going to be required.
So on your question on recent data.
Later could trigger and TMB see immunomedics caught up to 12 and can be seen how we see ourselves.
The change in that space, we think this very nice complement parity between the different approaches that a simplistic summary level.
As you know, Chris checkpoint inhibitors, whether its countries or any of the others are essentially removing the break that is applied to the immune system by the tumor.
One.
I would anticipate that that is often going to be required.
Simba Gill: The antibody drug conjugates, immunomedics products, various others, and other approaches are looking at essentially increasing neoantigen generation and or exposure. And we come in as a very nice third complement where we're activating and amplifying the relevant parts of the immune response which are actually needed to kill the tumor and needed to recognize the tumor antigen, basically. And that's what we have reported preclinically, as you know Chris, in terms of seeing increased infiltration and activation of the relevant T-cell populations and K-cell populations, and macrophage populations, as well as increased levels in the tumor microenvironment of relevant chemokines and upregulation of MHC class 1.
The antibody drug conjugates immunomedics products does others and other approaches are looking at essentially increasing neo Ashton.
Generation and or exposure.
And we come in as a very nice third complement well, what activating and amplifying the relevant parts of immune response, which were actually needed to kill.
The tumor and needed to recognize the tumor antigen basically and that's what we have reported on pretense that as you know Chris in terms of seeing increased infiltration activation at the relevant T cell populations and pay cell populations macrophage populations as well as.
Increased levels in the tumor micro environment, all relevant kina kind and up regulation that makes the cost one.
Simba Gill: So all of that is going to be very complementary with antibody drug conjugates which impact neoantigens and or checkpoint inhibitors which are removing the brakes, so hence... Duncan's comments that we can see are a very nice opportunity as we go forward to actually be the foundation to which other things can be added from first-line therapy to last-line because again we've got the fundamental benefits that all our products have of being oral, safe, So that means that we, given the properties I've just described, could establish ourselves as a foundation from early stage to late stage patients to which other things will be added. And that's a pretty unusual position, and I appreciate the question, Chris, because a lot of people don't actually fully appreciate that. That's always been a strategic attempt.
What was that it's going to be very complementary with.
Antibody drug conjugates, what's impacting Neoantigens and.
Ooh checkpoint inhibitors with the removing the break so hence bunkers comment that we can see a very nice opportunity as we go forward.
Well actually be the foundation to which other things can be added from first line therapy to law flying out because again, we got the fundamental benefit but it will probably have a thing or a safe well tolerated in oncology on a relative basis.
And also again, the affordability point I'll come back to the coated 19 question. So that means that we given the properties I've just described curved establish ourselves as a foundation.
From early stage, the late stage patients to which other things will be at it.
And that's a pretty unusual position and I. Appreciate the question, Chris because a lot of people don't actually fully appreciated, but that's always been a strategic hopefully that was helpful out because.
Simba Gill: Hopefully, that was a helpful answer. Yeah, perhaps I could just ask for some slight clarification. So I think, you know, in terms of the rationale and the overall mechanism, completely understand and in fact agree. But I guess, you know, maybe help us understand what that clinical development path looks like. What would be the initial setting in which you would anticipate a potential approval and, you know, how would the label expansion move to kind of meet this vision that you're describing right now? Sure. Duncan, do you want to... take that question?
Yeah, perhaps I could just ask a slight clarification. So I think you know the in terms of the rationale in the overall mechanism.
Completely understand in fact degree, but I guess, you know maybe help us understand what that clinical development path looks like what would be an initial.
Hey, you know setting in which you would anticipate a potential approval and you know how would the label expansion move to kind of meet this vision that you're describing right now.
[noise] Charles Duncan do you want to.
Picked that question yeah.
Yeah, I mean, I I think could you just sort of thing and the initial studies at the minute are demonstrating you did that we've we've got clear sort of anti tumor activity on this particular one is on in a single open label study, we did with Pembrolizumab its low.
Duncan McHale: Yeah, Yeah, I mean, I think, because you've sort of seen the initial studies at the minute are demonstrating that we've got clear sort of anti-tumor activity. This particular one is in a single open-label study with pembrolizumab. It's likely as we move forward that we would do a similar sort of study, but a blinded study just to prove that you have evidence of an anti-tumor effect in monotherapy. And I think once we've got that, then I think we will look at the actual sort of set of treatment and treatment options that patients have within triple negative breast cancer and start to work with partners about positioning EDP-1503 in combination with the rationale that Simba was talking about, sort of, you know, as an early type therapy in that sort of space would be what our strategy was. But the next steps would be to demonstrate, I think, clearly in a blinded study the sort of activity of the agent on its own before we then go into the combination.
Likely as we move forward that we would do.
Similar sort of study, but a blinded study just to prove that you have evidence of anti tumor effect in monotherapy and I think once we've got that then I think we will look at the actual sort of.
Active treatment and treatment options that patients have within triple negative breast cancer and.
Start to work with partners about positioning GDP 53 in combination with.
With the rationale that the to move talking about sort of.
As an early type therapy in that sort of space would be what our strategy was the the next steps would be to demonstrate.
I think clearly in a blinded study the sort of the activity of the agent on it. So before we then go into the combination setting.
Duncan McHale: Got it. Okay. Well, thank you so much for taking the questions, and I hope all of you are well. Thanks, Chris. Thank you. I'm showing no additional questions in the queue at this time.
Got it okay well. Thank you so much group for taking the questions in the Obama viewer well thanks.
Thanks, Chris.
Thank you I'm showing no additional questions in the queue at this time I'd like to turn the conference back over to Dr. go for any closing remarks.
Simba Gill: I'd like to turn the conference back over to Dr. Gill for any closing remarks. I just wanted to thank everybody for their continued commitment to Evelo and for following us. We appreciate it and look forward to staying in close contact with all of you and keeping you updated on our progress in what is going to be a very busy 6 to 12 months. Thank you very much.
So just wanted to thank everybody for their continued commitment to Hello, and following us appreciate it and look forward to staying.
In close contact with all the June keep you updated all progress in what is.
Going to be a very busy six to 12 months. Thank you very much.
Operator: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day!
Ladies and gentlemen, thank you for participating in todays conference. This concludes the program you may now disconnect everyone have a wonderful day space right.
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Operator: The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan and the National Science Foundation. The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan and the National Science Foundation. The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan and the National Science Foundation. The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan and the National Science Foundation. The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan and the National Science Foundation. The Biosciences Inc. is a non-profit organization founded in 1996 by the University of Michigan. A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
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