Q1 2021 PDS Biotechnology Corp Earnings Call
Yeah.
Hello, and welcome to the Pds Biotechnology first quarter 2021 earnings call and webcast at this time all participants are in a listen only mode.
And you want you require operator assistance. Please press star zero on your telephone keypad of question and answer session will follow the formal presentation. As a reminder of this conference is being recorded its now my pleasure to turn the call over to the and Randolph. Please go ahead.
Good morning, and welcome to Pds Biotechnologies first quarter 2021 earnings conference call and audio webcast.
With me today, and your Doctor and Frank Baidu Auto Chief Executive Officer, Dr. Lauren The blade, Chief Medical Officer, and Dr. Seth Van Voorhees, Chief Financial Officer.
Earlier this morning, Pds biotech issued a press release announcing financial results for the quarter ended March 31 2021.
We encourage everyone to read the press release as well as P. D. F. Biotech quarterly report on form 10-Q, which will be filed with the SEC later today.
The company's press release is available and PDF biotechs website at Pds biotech Dot com and the quarterly report will be posted later today.
And it has done this conference call is being webcast through the company's website and will be archived there for future reference.
Before we begin I would like to caution listeners that comments made by management. During the conference call will include forward looking statements within the meaning of federal securities laws, including the Safe Harbor provision of the private Securities Litigation Reform Act of 1995.
Forward looking statements involve material risks and uncertainties and the company's actual results may differ materially for a discussion of these risk factors, including among others. The risks related to COVID-19, the impact such pandemic may have on the company's business operations financial operations and results of operation and of the company's ability.
To respond to the related challenges, including those noted and this morning's press release, please refer to PDF biotechs and SEC filings.
Investors potential investors and other listeners are urged to consider these factors carefully in evaluating the forward looking statements and are cautioned not to place undue reliance and such forward looking statements. Please.
Please note that the contents of this conference call contains time sensitive information and accurate only as of the date of the live broadcast May 13 2021.
Except as required by law the company undertakes no obligation to revise or update any statement to reflect events or circumstances that take place. After the date of this call. Following todays prepared remarks, we will open the discussion for a question and answer session with that I would now like to turn the call over to Dr. Frank but I do I do.
Thanks.
Thank you, Dan and thanks to everyone on the call today.
2020, one has so far been unexciting your pds biotech the.
The company has continued to advance clinical development of various immune based immuno oncology pipeline from key initiative, and we are making significant progress with our clinical trials.
Since we last spoke to you on our fourth quarter call. We have made further progress with our ongoing phase II clinical trials as well as with our preclinical pipeline products.
Our lead oncology candidates Pds Oh, one O. One as you may recall is currently being studied and we phase II clinical trial and advanced HPV associated cancer.
The most advance of these trials is the National Cancer Institute led study evaluating and the whole triple immuno therapeutic combination of Pds Oh, one O. One with two of E. M. D surround the clinical stage of Immunotherapies renter been thrust of our Alpha and 70 824, we just said.
The functional checkpoints inhibitor.
And in the chest IL 12 for and 90 241, which is on the immune of cytokine.
The Triple combination is being evaluated and HPV 16 positive relapsed or refractory advanced HPV associated cancers, and these include anal cervical head and neck vaginal and volume of cancers.
This population is the well documented difficult to treat the patient population and which more effective therapies are desperately need it.
In January we announced that the National Cancer Institute led trial has achieved its preliminary efficacy benchmark with the we own more of the first eight patients, which approximates the at least 40% achieving tumor regression.
And this benchmark represents a doubling of the response rate seen in this population of refractory patients with standard of care of checkpoint inhibitors.
And at least a 30% increase over the results reported with the most promising experimental agents in this population to date, which is been for the offer.
As the result of the significant preliminary efficacy achievement. The second arm was opened up to study the combination and refractory HPV 16 positive patients who have in addition, also failed treatment with checkpoint inhibitors and.
And this population who are few auctions. The treatment response rate is only about 10% with the median survival time of about three two for months.
A few weeks ago, we announced that more mature interim data from the Triple combination trial has been accepted for oral presentation on June seven of the 2021 American society of clinical oncology also known as the hospital annual meeting.
As you May know it is quite uncommon for phase two trial interim data to be selected for oral presentation. We are hopeful that the promising data from the ongoing trial will demonstrate the potential of the platform and oncology and Pds Oh, one of one in particular in the treatment of advanced HPV related cancers.
We look forward to share on the data with the scientific and the investment community.
The most critical limitation to effective cancer immunotherapy has been the ability to induce in the body large numbers of potent.
Humor attack and kill of T cells that can infiltrate and kill tumor cells.
The recently published preclinical study of the novel Triple combination by the National Cancer Institute.
Demonstrated the ability of P. D. S. L. One O one to promote the induction of large numbers of tumor infiltrating killer T cells.
When administered in combination with either bench or for some awful for and.
17, and 90 241 for the Triple combination.
Most importantly, the study revealed the diverse immune had effectiveness recruited a large number of killer T cells and prime These T cells for specific to the record lines target and kill HPV 16 positive cancers, leading to superior regression of advanced tumors with the triple combination.
The ongoing National Cancer Institute study seeks to study of this triple combination in humans.
Successful for installation of the results from preclinical to human will be significant and could provide the demonstration of the potential of the birth of immune based immunotherapies to overcome one of the major limitation inhibiting broad efficacy of cancer immunotherapy.
And that's I already mentioned the interim data from this trial will be presented by the National Cancer Institute of the ESCO Conference next month and an oral presentation.
Our second trial, it's the Pds biotech initiated versatile and 002 trial.
As with the NCI led trial, we are seeking to confirm the strong synergy between PD. So one of one and checkpoint inhibitors demonstrated in preclinical studies.
The versatile 002, if the multicenter open label single arm non randomized trial of approximating the 96 patients evaluating the combination of Pds are one O one with the anti PD, one checkpoint inhibitor pember lose them up and also known as Keytruda.
This combination is being evaluated in the first line treatment of recurrent or metastatic head and neck cancer.
Our partner Merck is providing the drug and also sit on the joint steering committee for the trial, while Pds biotech has responsibility for the day to day of management and the financing of the study.
We believe that the combination of Pds, Oh, one O one and Keytruda, which is F. D. A approved standard of care in this indication has the potential to provide significantly improved clinical benefit compared to treatment with keytruda alone.
This means that patients whose cancer has returned all spread following initial treatment will be able to take of this chemotherapy sparing combination of two immuno oncology agents and.
And the approach and back may be very appealing to patients.
Patients are actively being screened and enrolled at multiple sites and the United States and we anticipate that preliminary data will potentially be available late in the fourth quarter of 2021 for during the first half of 2020 two.
Similarly to the Triple combination trial, the successful trial of Keytruda with Pds O. One O. One that confirms the published preclinical data could justify the evaluation of several of our pipeline products with checkpoint inhibitors.
Moving onto the third trial the immunotherapy trial.
The MD Anderson led immunotherapy trial, if the phase II trial of Pds or one of one in combination with standard of care chemo radiotherapy or CRT for the treatment of locally advanced cervical cancer.
The study will investigate the safety and preliminary efficacy outcomes of this combination.
We announced the initiation of the study in October.
The study is based on the observation by MD Anderson cancer Center, the cervical cancer patients with tumor infiltrating T cells may have and better clinical outcomes after CRT treatments.
The study is also actively recruiting and enrolling patients and we anticipate the preliminary data will be available during the fourth quarter of 2021 or during the first quarter of 2020 two.
Dr. Laurence <unk>, our Chief Medical Officer will provide additional details about our ongoing clinical trials shortly.
As I have mentioned before based on the potential for unique combination of potency and safety suggested by our phase one clinical trial two of our three phase two trials combined Pds of one O one with standard of care.
That has been FDA approved and shown to be effective and the specific indications.
Based on the observed efficacy of the Pds Oh, one O. One one of therapy with respect to see the H T cell induction and regression of.
See I and lesions observed from the phase one clinical trial, we believe that the ability to combine pds of one O. One with FDA approved standard of care mitigate development risk.
In addition, if the studies demonstrate significantly enhanced clinical benefits over the standard of care alone without compounding toxicity. We believe that this will present, a clear and more rapid path to commercialization of the combination.
After initial commercial approval our strategy of evaluating Pds, Oh, one O one and all HPV associated cancers, as well of combining Pds Oh, one O. One with standard of care. We believe also positions us for rapid market penetration and expansion.
I'll briefly discuss the target markets for Pdfs of one O one.
As some of you already may know the HPV cancer market is large and is expected to remain robust for the next several decades. Despite the use of preventive HPV vaccines first introduced in 2006.
There are currently about 43000, new incidences of these cancers every year in the United States alone.
H P. The associated cancer continues to present, the critical medical concern of some.
Of these cancers continue to be on the rise.
HPV associated head and neck cancer. For example has recently been described as the silent epidemic due to the rapidly increasing incidence of this counselor.
Anal cancer incidents has also been steadily increasing.
By far the vast majority of these cancers are caused by HPV 16, which is the most oncogenic type of HPV.
Next I'll provide an overview on the continued development of our oncology pipeline.
Pds or one or two combines diversity and platform technology with the proprietary tumor specific protein or antigen known as T cell receptor gamma alternate reading frame protein also known as the TARP for T. A R. P.
Talk was identified by the National Cancer Institute and is strongly associated with prostate and breast cancers, as well as acute myeloid leukemia leukemia or AML.
It is estimated the TARP if the associated with almost 400000, Kansas each year in the United States, including 90% of prostate cancers.
The percent of breast cancers, and the 100% of AML.
A MLS of particularly deadly disease with a five year survival rate of less than 30 per cent.
And the human clinical study in prostate cancer patients. The tariff of antigen was found to be highly immunogenic and the patients leading to a significant reduction in the tumor growth rates.
In preclinical studies conducted a pds biotech.
Pds of one or two demonstrated the ability to dramatically enhance the induction and of in vivo TARP specific C. D H killer T cells.
The majority of the preclinical work Lapidus Oh, one of two has been completed and our goal is to move pds or one or two into the clinic next year.
Yeah.
Also in late clinical development is Pds Oh, one of three.
In April of 'twenty, and 'twenty, we announced the expansion of our cooperative research and development agreement or creator with the National Cancer Institute to include studies of Pds Oh, one of the three.
Which combines diverse immune technology with novel peptides derived from the cancer associated protein known of Mark one.
These novel proprietary and highly immunogenic peptides were developed by the lab of tumor immunology and biology of the National Cancer Institute.
<unk> is expressed in a wide range of solid tumor types, including breast colorectal and ovarian and lung cancers.
In preclinical studies conducted at Pds biotech.
P. S O. One of three has demonstrated the ability to generate powerful in vivo Mark one specific.
See the eight killer T cells.
In humans.
Due to burst and means the ability to effectively promote important immunological processes and to activate the type one interferon signaling pathway, we anticipate strong in vivo tumor targeting CDA T cells that may present, the potential to more effectively treat Mach one express.
And tumors.
As part of our collaboration with the National Cancer Institute. The Institute is performing preclinical combination studies of the clinical formulation of P. B S. O. One of three with other immuno therapeutic agents ahead of the planned human clinical study next year.
Moving on now to our infectious disease pipeline.
This March we announced that the COVID-19 vaccine consortium, consisting of Pds biotech pharma quote biotechnology and belonged for received the commitment from the Ministry of Science technology, and innovation of Brazil. The M. C T I.
To fund up to our probes and meet me 60 million U S dollars to support the clinical development and commercialization of reverse immune based COVID-19 vaccine and Brazil.
Pds biotech will be providing burst and even for the program.
And our partner form of core is responsible for manufacturer of the antigen and also for performing the human clinical trial in Brazil.
From a core is in active discussions with and visa.
The progress of the clinical program in Brazil.
From a core have indicated to pds biotech that they plan to begin the combined phase one two trial before the end of the year.
I'll move on now to P. S O to O two.
Which combines and personnel with novel influenza vaccine antigens and the preclinical universal flu vaccine.
We announced last year, the tedious biotechs collaborator professor of Gerald Woodward and of the University of Kentucky School of Medicine was awarded a grant from the and I E. A D to support preclinical development of the program.
So if the Woodward initiated those studies earlier this year in partnership with the collaborative influenza vaccine innovation centers and network of the and I E. A D to develop and more durable.
Broadly protective and longer lasting vaccine effective against the multiple strains of influenza.
Pacific team, including pandemic strains.
We anticipate results from those studies and the clinical formulation will be available by the end of the calendar year.
Now I'd like to pass the call to Dr. Lauren Wood, who will provide more comprehensive clinical updates for both our oncology for all of our oncology programs Lauren.
Thank you Frank and.
And once again, thanks to all of you for joining us this morning.
As Frank just detailed we have made significant progress and our oncology pipeline since our fourth quarter call.
I'll begin with our ongoing oncology clinical trials.
And the investigator initiated study of Pds of 101 in combination with benchmark test of the.
Also known as <unk> and 70 820 for a first in class bifunctional checkpoint inhibitor, and and $92 41, and the antibody conjugated cytokines and designed to facilitate entry of the cytokine IL 12 into the tumor microenvironment and to enhance the local.
T cell response was initiated in June 'twenty, and 'twenty was encouraging and faster than projected initial accrual. Despite the COVID-19 and then.
This NCI and let study was the result of independent preclinical animal studies conducted by the NCI, which showed strong synergy between the three agents spin.
Specifically the triple combination resulted in enhanced anti tumor activity when compared to treatment with the individual agents or with dual combinations of these agents.
The details and findings of these preclinical studies were published last year and the June 2020 issue of the journal for immunotherapy of cancer also known as J I T C.
We previously announced that this investigator led study of cheap both of its initial safety benchmark.
Meaning that fewer than two dose limiting toxicities were observed and the first six patients who received the triple combination.
And its initial efficacy benchmark.
The initial observation of objective response, and three or more of the initial patients indicated that the triple combination was at least two times more of 100% more effective and reducing tumor burden compared to the standard of care.
Outcomes and this patient population to date.
As a reminder, this.
Patient population is very difficult to treat the best objective responses reported to date and advanced HPV cancer patients who have failed prior therapies is 12% to 24%.
Many of these patients had failed multiple treatments performed rolling and the NCI and led trial.
With the achievement of the initial efficacy threshold, the NCI and added a second arm to the trial to explore the effectiveness of the triple combination and patients who have failed checkpoint inhibitors raising the bar significantly.
Advanced HPV cancer patients, who have failed checkpoint inhibitor therapy has very few treatment options left the highest objective response rates reported to date and this population who in addition has failed checkpoint inhibitor therapy are generally 10% to 15%.
Dr. Julius Strauss the principal investigator of this trial will be presenting more mature data from the study at the upcoming 2021 annual meeting of the American Society of clinical oncology and early June.
<unk> is arguably the world's preeminent oncology meeting and we were thrilled to learn that those data have been accepted for oral presentation as part of the main program.
As you know there are tens of thousands of abstracts submitted to ask of each year and only a handful of those are selected for oral presentation.
And we believe that these data were selected because of the historical historic difficulty and treating this patient population and the compelling interim data from this trial.
Patients often come to the National Cancer Institute when they have exhausted all other treatment options.
Advanced HPV cancer patients enrolled and the study had failed multiple therapies and we believe that Pds of one on ones published preclinical efficacy when combined with these two immune modulating agents demonstrates the potential to significantly improve clinical outcomes for patients with advanced and currently.
The untreatable HPV associated cancers.
Now onto the Pds sponsored versatile 002 study as.
As Frank discussed during his remarks activation of sites and enrollment and Bruce.
<unk> continues to progress and we currently have 14 sites open to enrollment.
As a reminder, the primary endpoint diverse of titles around zero. Two is the objective response rate of our O. R. R. At nine months following initiation of treatment.
B of leading cohort of 12 patients to assess safety of the combination and of formal planned interim analysis evaluating response to treatment and the first 38 patients.
We estimate the data on the initial 12 subjects for safety will be available sometime between the fourth quarter of 2021 of the first half of 2020 two.
The study's lead principal investigator is Dr. True Jared Weis. The served as the section chief of thoracic and head and neck oncology at the University of North Carolina School of Medicine, Leinberger comprehensive cancer Center, and we're thrilled to have Dr. Weiss involved and the study.
Moving now to the MD Anderson led phase II clinical trial of Pds and 101 in combination with standard of care chemo radiation radiotherapy for treatment of locally advanced cervical cancer also known as the immuno search study.
The study will enroll approximately 35 patients and investigate the safety of the combination and preliminary oncologic outcomes.
In addition, it will explore immune timing by Pds of one O one as well as other biomarkers of the immune response, and both blood and tumor tissue.
We believe the PD L 101 has demonstrated the ability to activate the immune system and induce tumor targeting killer T cells may provide improved outcomes to patients for cervical cancer for.
Preliminary data from this trial, we anticipate will be available sometime between Q4, 2020, one and early 2020 two.
The study is being conducted by Doctor and clock M D ph D and.
And associate professor of radiation oncology at the M D Anderson cancer Center.
Moving now to our infectious disease program and the planned clinical trial of our COVID-19 vaccine T. S O two of three.
If approved by N V. So the randomized placebo controlled phase one two study will evaluate safety immunogenicity and preliminary efficacy of Pds and <unk> three and approximately 360 healthy adult.
Patients in the study will receive two doses of Pds O two and three and administered three weeks apart.
Study participants will be divided based on age within 18 to 50 by the age group and of greater than 56 years of age group.
The low dose and hydro's vaccine or placebo will be tested in each of these age groups and.
The initial evaluations of efficacy will be conducted starting 2014 days following receipt of the second dose of vaccine.
Specifically, we're seeking to characterize safety reactor Genesee and validate the induction of Sars COVID-19 two specific neutralizing antibodies as well as C. D. A killer and C. D for helper T cells directed against Sars COVID-19 two.
Our co development partner farm of core will be meeting on a regular basis with regulatory officials from N visa to review ongoing data from the phase <unk> trial, and an effort to react as quickly as possible to results.
Contingent upon release of funds by the Brazilian M. C. T. I if the phase one two studies successfully establishing both safety and efficacy we are prepared to scale up into a phase III trial to confirm Pds Oh, two of three effectiveness and preventing COVID-19.
And infection.
One of the planned analyses in the phase III design is the assessment of efficacy against variance of the virus the.
And robust T cell induction by Bruce you mean may potentially provide protection against currently circulating variants of concern.
P. S O two of three is being designed to induce an immune response against conserved regions.
Residents and Cyrus Kobe true and two specific laws and generate long term T cell memory conserved regions of the virus or those debt remained stable despite ongoing viral mutations.
I would now like to turn the call over to our CFO and Dr. Seth Van Voorhees to review, our first quarter 2021 financials.
Net.
Thank you Lorne and good morning, everyone.
I'd like to turn our discussion for a review of our financial results for the quarter ending March 31, 2020 one for the first quarter of fiscal 'twenty. One our loss from operations was approximately $3 million versus the loss of approximately $4 million during the same period in 2020.
For a net loss of <unk> 14 cents per basic and diluted share compared to a net loss of 39 cents per basic and diluted share for the first quarter of 2020.
Research and development of expenses total approximately $1 4 million in the first quarter of 2021 as compared to $2 million for the first quarter in 2020 a decrease of approximately 0.6 million for 28 per cent.
For the first quarter of 2021 general and administrative expenses were approximately $1.6 million compared to approximately $2 1 million for the same period in 2020.
A decrease of approximately zero point of 4 million for 19%.
From a cash flow perspective, we started 2021 with approximately $28 $8 million of cash and used approximately $3 8 million.
Operations and the first quarter of 2021.
Leaving us with the cash balance at the end of the period of approximately $25 million.
Our business strategy allows us to keep our cash burn at relatively low levels as demonstrated by our first quarter results. The.
The strategy use utilize the cash we raised from the capital markets on our oncology development programs while Kim.
While continuing to develop our infectious disease products through non dilutive financing sources or out licensing agreements.
In addition to the three oncology clinical trials currently underway or investigator sponsored studies, which involve low levels of financial commitment from Pds, while at the same time, maintaining 100% ownership of the commercial rights of diversity and products being investigated.
As a consequence, we were able to utilize our cash resources in the most efficient manner to create value for our shareholders.
Thank you for your time today and I'd like now to turn the call back to Frank for final remarks.
Thank you very much Seth and Lauren.
Before we begin our question and answer session I would like to thank our stellar team members here of Pds biotech and all of our clinical partners for their entire and work.
It is an exciting time of Pds biotech with the potential of having some solid initial proof of concept data for our <unk> platform and oncology next month.
It is through their dedication and the expertise of our team that we have been successful and significantly the progressing the reactive Pds Oh, one O one phase II clinical trials and oncology.
We'll also continuing to develop our preclinical pipeline.
The data and now being generated from our ongoing clinical trial programs will serve as the foundation to allow us to build a reverse immune based pipeline into the next generation of cancer Immunotherapies as well as novel vaccines that may induce a broader range of protection against the infectious diseases.
That concludes our prepared remarks, operator, please begin our question and answer session.
Thank you and I'll be conducting a question and answer session, if you'd like to be placed and the question queue. Please press star one of the telephone keypad.
A confirmation tone will indicate your line is and the question queue. You May press star two if he'd like true great question from the queue for.
And for participants using speaker equipment and may be necessary to pick up your handset before pressing star one one moment. Please while we poll for questions.
Our first question.
And today is coming from Joe page of this from H C. Wainwright Your line is alive.
Good morning, everyone. Thanks for taking the question and glad you're all doing well.
Of two sets of questions and I'd like to start with the COVID-19 platform first obviously you have a very defined.
Graham in Brazil, and the funding to go along with it and I guess I wanted to approach of my question. This way how can we view as the importance of T cells continues to increase and visibility.
Further potential reach I'm, sorry geographical reach of the program and I'm thinking specifically of all of the volatile environments and the significant problems that India is having and discussions about freeing up of intellectual property for other vaccines and just very dynamic environments.
I just wanted to get a sense of you know potential geographical reach that you might be working on.
And thank you very much for your question and this is Frank and I think.
One of the one of the out.
I wouldn't call it the challenge, but one of the facts of the matter is that this program. We anticipate asset continues to build up that it will become more and more visible one of the key thing because you did mention that's becoming very prevalent today is the key role of importance of T cells and robust immunity against <unk>.
And 19, one of the things that we have mentioned price of quite often is the fact that we believe very strongly that the next generation of COVID-19 vaccines.
<unk> be able to demonstrate.
The rate robust T cell responses.
Importantly against Kwanza of regions of the virus, because we know today that this virus lots of very high propensity for mutation.
And therefore being able to generate or develop the vaccine that can provide a broader range of.
Of protection becomes very important.
Now we continue to focus on our oncology pipeline, we are providing support to from a core in terms of diverse immune expertise, but they they have of the responsibility for developing this vaccine and performing the human clinical trials and Brazil, specifically, so intense of the regional components.
The trial now is really going to be performed in Brazil by pharma call. However, I think once the data does become available the initial data does become available.
<unk> retains the right to be able to develop the vaccine as we see fit right. So we will continue to evaluate the situation as it progresses and as data becomes available hopefully we will be making the appropriate decisions and determine where to go from there, but one of the things that we've also mentioned right from the start.
Our goal isn't really to rush to be one of the first to market right. We've called the second generation COVID-19 vaccine, what we would like to do here is to develop a vaccine the past the attributes that are critical for a successful global COVID-19 vaccine.
And that means it must must achieve will have certain critical characteristics. It should have induced the broad range of immune responses. So not only neutralizing antibodies, but very importantly, C. D eight and CD four T cells as well as memory T cells that the recognized conserved regions of the virus.
Secondly, it should be stable should have long term stability overcoming the cold chain situation that we see with the number of the vaccines today and very importantly, it should be safe and.
And very well tolerated and.
And we believe the diverse mean based COVID-19 vaccine checks each of these boxes and so the goal is really to develop this and really make sure that we have something that is highly competitive and the global markets today.
That's actually a.
Really helpful and and thanks for re emphasizing having.
Having the second generation and not necessarily rushing so thanks for restating that again Mike.
The second question has to do with all one O. One it's really two parts. The first part is the logistical question, saying you know obviously, we'd love to know the data but.
Can't wait to Alaska, but I guess, you know can you share with us sort of the general range of number of patients that we can expect data on and any sort of translational data that might be presented as well just the types of and scope of data.
Sure so we.
The the abstract will be made available by US go on May the 19, so you'll you'll you'll you won't have to wait too long to get an insight into what the data looks like.
And but I think it's going to be it's going to be and the range of I would say probably around 20 to 25 patients.
So it will it will be at least I would say approximately and midway through the for the.
Full trial, so I think it would if it will be of robust enough.
And there are a robust enough of data package that would give us some very good insight into what's actually going on with the triple combination and these patients got it and got it and then the second part is and this goes to some of your prepared comments and also something that we've discussed before with you and that.
Is one of the key challenges and I O studies of our I O combination studies is how to tease out the impact of a particular asset in this case versus immune so with all 101 as part of your prepared comments you know.
You certainly talked about the preclinical data and study the that the NCI has done with regard to the significant increases in the CDA T cells now I guess how does.
You guys have given some of your views and I'd like for you to repeat it but also how does the M. C. I view. This like you said these are patients that no longer have any.
Options and the insight and sea ice view of the true importance of the significant boost and CDA T cells that can infiltrate the tumor and any perceived risks around.
Again, the concept by started with about teasing out the individual contribution.
Right and that's that's a really good question and very important and something that we have spent a lot of time discussing and so without without really going into the specifics of the data.
The way the trial was run and the patient population addressed this some of these questions and hopefully hopefully and in the next couple of weeks, we will be able to Dell much deeper into the data and really answer some of those questions. But we are quite confident that a lot of these questions are addressed and the data package that will be really.
And and the next few weeks.
And.
Please hi Lawrence.
Hi, Hi, Joe Good morning, so the other thing that I'd like to add is that.
Your your question is very timely and and we believe one of the strength of the NCI trial is is that this same group was responsible for conducting the phase one two study of the interest the alpha.
And 70 820 for monotherapy and the H P. D advanced cancer population and there. They saw objective response rate of approximately 30% importantly, the same group also conducted the phase one trial of the immune targeting cytokines and $92 40.
One and H F. IL 12, there and they saw zero objective response rates and that human clinical trial, although they did see five or six patients that had stable disease. So I think the MTI group is uniquely positioned to be to be able to evaluate.
And the activity and the efficacy preliminarily of this triple combination because they did the monotherapy studies of the individual investigational and need to go.
The therapeutic agents apart from Tds of one O one and so again as the highlighted earlier during our comments it was quite impressive in terms of the preclinical data clearly dual combination therapy with superior to mono therapy, and the preclinical studies and clear.
On the Triple combination therapy with superior to the dual combination therapy. So in the context of that preclinical translational and background, we anticipate that we will see.
More potent outcomes with the triple combination of humans, and then have to evaluate those outcomes and the context of what's already been documented with treatment with the monotherapy agents and the NCI group is well placed to be able to comment on that.
Got it. Thank you very much for that color and what I think is a real important benchmarking and looking forward to the data. Thanks, a lot guys.
I think the laws.
Thank you as a reminder of that star one to be placed and the question queue. Our next question is coming from Leland <unk> from Oppenheimer. Your line is not of life.
Hey, good morning, Frank and team Thanks for taking the questions and congrats on all of the all the great progress.
Wanted to ask on the versatile study once we begin to see data from that and as you contemplate.
Further development sort of the regulatory question, how you would see a registration study design I mean would that be kind of keytruda plus minus one of them.
And one would we need to have survival data for approval could you file off of response rate, maybe just give us some color on your thoughts there for what that would look like and and also a question on the COVID-19 side just.
And just kind of the maybe keying off of Joe's question, just more and are focused way of are there any gating factors that we're waiting for from and visa or is it just the process you know Ajay.
Review and kind of complete the assessment for the true.
At the beginning and thank you.
Thanks, Lauren do you want to take the first couple of question and then after you're done and now I'll address the COVID-19 question.
Right, yes so.
Thanks for your question, we do anticipate that the FDA would want to see a randomized phase II trial.
And that.
And that was blinded for Registrational trial, and they've made it pretty clear and the statement.
And July of 2018 debt, they really wanted to see randomized trials.
That definitively established activity of the agents and so as you mentioned it would likely be keytruda with and without Pds, Oh 101 in a randomized trial.
We clearly would be going for primary endpoint of objective response rate.
First and foremost our target objective response rate for.
For a diversity of two study is 33% so as people may be aware with pember illusion of App mono therapy, and the keynote Oh.
Oh for eight study of the objective response rate is approximately 20% and those who have adequate tumor marker expression of PDL, 120% is one and five patients and the goal of the versatile <unk>. Two study is to see objective response rates of 33% or more which moves the needle from.
One and five patients responding to one and three patients responding. So objective response rates would be the primary outcome, probably also accompanied by duration of response.
As the key secondary endpoints and then subsequently overall survival.
We believe those would be.
The three major endpoints in a randomized trial that the FDA would.
The considering of course the <unk>.
Design of any trial is going to be driven by the objective data that's observed in.
And our versatile Oh, two study and so there may be flexibility for adaptive trial designs, depending upon what the data.
Yes would be the most efficient regulatory pathway to proceed with.
But we believe Lauren thank you very much yeah. Thank you.
Okay great.
And if that's the address your question before I move on to the COVID-19.
And that's that's helpful clients, Yes, and please be please go ahead.
Okay. Thanks.
And regarding any gating items that.
The unnecessary to get the trial go and so as I mentioned in my my remarks that.
From a core is responsible for the manufacturing of the antigen and that's going to be used and the trial Pds, we'll be providing verse of immune diversity of me. It's ready to go and Pulmicort is in discussions with and visa, which is their regulatory agency regarding and providing a final package per hour too.
Entering into human clinical trial completion of their manufacturing process is going to be important and the final documents that the I'll provide the swan and visa so as we and the products we understand it today that would be of key gating item.
And their discussions with them visa given them the green light to initiate human clinical trials and getting the manufacturing done and providing the fact the.
What we would call in the in the with.
And with the M D of our CMC package or the <unk>.
The I M P M.
I and PD package to allow them to initiate the clinical trials.
Got you. Okay. That's helpful. And then and then one last question if I may I mean, given the.
There's the potential for the burst of immune platform and a lot of a lot more of that could be done versus the bandwidth just kind of curious you know.
You may see kind of partnerships or sort of the deals with.
Third Party company materialize down the road and as others become more and more aware of the potential of the platform and where they may be able to bring to bear with regard to incorporating that with their own.
Strategies as obviously you can move forward with your core programs.
For you.
Yes no.
And that's very important so as you may notice our our primary focus it's the immuno oncology right and that's really one reason why our infectious the two infectious disease programs that had been run pretty much of 100% by the partners. We will probably never have the resources, we need to really develop all of the all of the products we could put.
Actually developed with burst of immune and immuno oncology.
Now our our current phase II clinical trial provides the very important proof of concept and immuno oncology and we believe that this is going to be very critical for our rapid expansion and growth and 10th of developing the immuno oncology product. The proof of concept. The first real proof of concept of data.
<unk> is what's going to be presented at the Opco next next month.
And so we anticipate that that would provide a strength springboard to really.
Stop the second portion of our business plan, which is to partner with other companies developing immunotherapies of other companies who have suitable antigens.
We could combine with burst of immune to devote some of these more effective T cell activating immunotherapies, but.
What's the what you said is absolutely correct of the proof of concept of data that we are currently generating with these multiple phase II clinical trials is really what the industry needs to see to confirm of validate the potency and the potential of this technology to be utilized in and multiple immunotherapies and also very importantly, and.
Hips with other companies to build all of these programs.
Terrific alright, great well, thank you and very much look forward to fiasco updated data.
Thanks, a lot.
The U we reshape of our question and answer session I would like to turn the floor back over to management for any further of closing comments.
Thank you very much and thank you very much to all for your continued interest in PDF by a day.
We believe the 2021 will continue to be unexciting year for the company.
We have multiple ongoing clinical trials of pdfs of one O. One in various advanced HPV associated cancers, and as I mentioned interim data from our most advanced proof of concept phase II trial will be presented on June seven of the ethical conference in an oral presentation the per.
Presentation abstract will be made publicly available by osco unmade the 19.
We anticipate that the interim data will provide validation of Bruce noon and PTO Pds <unk> hundred one's potential to overcome the critical limitation of immune of immunotherapy by activating large numbers of potent tumor targeting killer T cells in vivo and therefore facilitate.
And more effective therapy.
We anticipate that this will also provide the springboard to focus primarily on building out our oncology pipeline and also to partner with other companies to accomplish the goal.
We appreciate your ongoing support and this pursuit.
For more information about the company and our ongoing clinical trial. Please visit our website of PDF biotech dot com.
And you bear market again.
Thank you that does conclude today's teleconference of the webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.