Q2 2022 PDS Biotechnology Corp Earnings Call
[music].
Greetings welcome to P to P. T S biotech second quarter 2022 earnings call and webcast.
At this time, all participants are in listen only mode.
And answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad. Please.
Please note this conference is being recorded.
At this time I'll turn the conference over to Kathy de Christina <unk> Investor Relations Gabby you may now begin.
Good morning, and welcome to P. S. Biotechnologies second quarter 2022 earnings conference call and webcast with me today from the company are Doctor, Frank, but I do I know Chief Executive Officer, Dr. Laurent If he would chief Medical Officer, and Matt Hill, Chief Financial Officer.
Earlier this morning, Pdfs biotech issued a press release announcing financial results for the quarter ended June 30th 2022.
Encourage everyone to read the press release as well as P. D. S. Biotechs report on Form 10-Q, which will be filed with the FCC. Shortly the company's press release is available on the P. P. S web site at P. D S biotech dotcom and.
In addition, this conference call is being webcast and will be archived on the company's website for future reference.
Before we begin we need to remind everyone that on today's call. The company will be making forward looking statements regarding regulatory and product candidate development plans as well as research activities.
Information in this presentation may include forward looking statements.
Including within the meaning of section 21 E of the United States Securities Exchange Act of 1934 as amended and section 27, a of the United States Securities a banking 33, as I mentioned concerning PDF Biotechnology Corporation and other matters. These statements may discuss goal intention and.
I have to teach your plans trends events results of operations or financial condition or otherwise based on current beliefs of the company's management as well as the functions made by and information currently available to management.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted a description of these can be found in P. D. S. Biotechs. Most recent filings with the SEC you are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call.
But to the extent, which required by applicable law or regulation PSB undertakes no obligation to update the forward looking statements included today to reflect subsequent events or circumstances.
As you can see we're utilizing slides to help summarize our programs and milestones and any to streamline the presentation of background information and updates. We know your time is a precious commodity and we want to leave as much time as possible for Q&A. Your feedback on this structure would be welcome but that I would now like to turn the call over to Dr. Frank but I do I do.
Frank.
Thank you Debbie and thanks to all of you for joining us this morning.
This past quarter. The P. D. S. Biotech team has worked diligently to advance the development of our oncology and infectious disease pipelines and we have made tremendous progress on these fronts.
Here you can see the broad overview of our lead versus immune based candidates P. D. S O one O one.
An investigational immunotherapy designed to treat human papilloma virus or HPV 16.
Cancers.
As a reminder.
Ill reverse immune technology platform promotes the delivery of tumor associated proteins.
Cold antigen to the immune system and simultaneously activates the immune system to induce antigen specific killer T cells.
P. S O one O one combines burst immune with HPV 16 antigen and therefore promotes the induction of CDA positive killer T cells that target and kill tumors that are HPV 16 positive.
Our second proprietary oncology platform combines bursting you with cytokines such as IL 12.
This combination of verse view with cytokines leads to the reduction in the population of immune suppressive cells, such as myeloid derived suppressor cells also called M. D S.
Preclinical data with this platform.
Yes that this technology may allow us to treat a broader population of advanced cancer patients beyond those who respond to checkpoint inhibitors.
Yeah.
We are evaluating P. D S O one O one across four ongoing phase II clinical trials.
In the three most progressed studies.
We are evaluating P. D. S O one O one as a combination treatment with various anti cancer agent in advanced and refractory cancers.
We are studying these combinations in multiple HPV associated diseases.
And at different stages of the disease.
From locally advanced cancer.
To terminally ill patients with recurrent metastatic checkpoint inhibitor refractory disease.
We are performing these studies in collaboration with some of the most respected cancer centers in the world.
In the fourth trial investigators at Mayo clinic are leading a study to evaluate PD is a one O one.
In monotherapy or in combination with Keytruda in early stage oral cancer.
It is important to note that our approach of performing this broad range of studies is to enable us to understand and which indications the various combinations may work better.
And to allow us to select the most promising combinations and indications to rapidly progress into pivotal trials.
This broad approach allows us to mitigate the risk of product development as we know that not every combination it's likely to be a promising every disease indication.
As we look ahead.
Our key priority is to advance P. D. S O one O one as rapidly as possible to commercialization.
To date, we have reported efficacy and safety data from 80 patients in two trials and we are highly encouraged by the fact that the results continue to demonstrate the promising efficacy and safety of P. D. S O one O one.
These results have also been accurately predicted by our preclinical studies, which is highly encouraging.
The clinical data generated to date is beginning to elucidate, which indications and combinations could potentially be selected for pivotal studies.
Yeah.
Importantly, we presented very encouraging data in June at <unk> Com.
From two of our ongoing phase II clinical trials.
Diversity towels zero zero to study.
It's evaluating pdfs of 101 in combination with Merck's anti PD, one checkpoint inhibitor therapy Keytruda off Prem believes them up in patients with HPV 16 positive recurrent.
And or metastatic head and neck cancer.
The National Cancer Institute, let Triple combination study is evaluating P. D. S. O 101 in combination with a checkpoint inhibitor.
And NHS IL 12.
In both checkpoint inhibitor naive.
And refractory patients in a range of advanced HPV positive cancer patients who have failed prior therapy.
As I mentioned earlier.
This combination of person home.
A checkpoint inhibitor and.
And I hope well may enable us to treat a broader population of refractory and very difficult to treat patients.
Dr alone wood will be covering highlights from the ESCO data presentations shortly.
Yeah.
In addition to the data presentations.
We also have some exciting news announcements related to the versatile trial during the quarter.
As we announced in May we received notification of the acceptance of the clinical trial application or Cta to allow expansion of diverse hotel study into the U K.
Our strategy is to expand the trial into various sites outside of the United States.
Due to the time taken to prepare at international sites where trial.
We believe that this approach of getting the various regulatory agencies familiar with our products.
Facilitate rapid transition to an efficiently enrolling pivotal trial to accelerate development.
This goal of expanding diversity policy reserve two trial into the European Union based on recent data is accounted for in our financial projections.
We will provide updates as enrollment in Europe begins.
Also during the quarter based on the results so far from the rest of the towels. There was there were two trial, we were granted fast track designation by the FDA for P. D. S. O 101 in combination with Pembina lithium op for the treatment of HPV 16 positive head and neck cancers.
As you know the Fda's fast track designation program is designed to aid in the development.
And to expedite the review of drug candidates that could potentially treat serious or life threatening conditions.
And that has demonstrated the potential to address an unmet medical need.
Lastly on versus the towels there was there were two.
Our independent safety data monitoring committee or DMC metaphor. It's scheduled review of the administration of <unk> hundred one in combination with Keytruda.
The Committee Safety review included data from 43 patients in both the checkpoint inhibitor naive.
And the checkpoint inhibitor refractory groups.
This more than doubles, the 19 patients whose data was presented IOSCO in June .
<unk> hundred one in combination with Keytruda continues to appear safe and well tolerated.
Specifically as of the DMC review, there were no drug discontinuation related to toxicity.
And no grade three or higher treatment related adverse events attribute it to the combination.
The DMC recommended continuing the trial with no modifications.
The safety profile of P. D. S. A one O one plus keytruda continues to hold up and we continue to believe that diverse mean based immunotherapies may enable not only more effective cancer therapies, but also safer and better tolerated therapies.
Yeah.
Our third P. D. S O. One O. One trial is the ongoing M. D. Anderson led phase two immunotherapy study.
Which is evaluating <unk> hundred one in combination with standard of care chemo radiotherapy or C. R T.
In patients with locally advanced cervical cancer, who have either.
Lymph node metastasis.
Or tumors a size greater than five centimeters.
This study is evaluating clinical responses as well immunological biomarkers.
Both in the tumor environment and in the blood circulation to better understand how P. D. S. O. One O. One made me working immunological and how it may improve standard of care.
In this trial, so far promising clinical results as well as immunological data have been generated.
And we have been informed by the M. D. Anderson team that an abstract has been submitted for presentation at the society for immunotherapy of cancer or S. I T C meeting in November .
Okay.
To avoid jeopardizing acceptance of their abstract we will wait until then bargo has been lifted to present the data.
We continue to believe that it is in the best interest of all shareholders, who are with data to be scrutinized.
Peer reviewed and presented to a larger audience of investors.
Potential partners and key experts in the field.
Yeah.
As we've discussed previously we are thrilled to have established a relationship with the Mayo clinic.
This relationship has progressed from simply being a site for diverse hotels. There was there were two study to now include the ongoing investigator initiated trial, where P. D. S. O. One O. One is being evaluated both as a monotherapy and in combination with Keytruda.
This study is being conducted in newly diagnosed patients with HPV 16 associated Ara for NGL cancer.
Enrollment is ongoing and we will provide updates as they become available.
Finally, a quick regulatory note here.
We plan on meeting with the FDA this quarter to discuss the Registrational path forward for P. D. S. O 101 in combination with Keytruda and.
And there are also expecting to meet with the FDA later in the year to discuss the NCI led triple combination study.
We are hopeful that these meetings could greenlight progression into pivotal trials for both programs.
We project based on current results that the dual combination will focus on checkpoint inhibitor naive patients.
And the Triple combination will address checkpoint inhibitor refractory indications.
Due to a greater breadth of anti immune suppressive activity.
Our goal is to prioritize commercialization of PD is a one O one.
And this could therefore caused us to adjust the timeline for initiation of the <unk>, Oh, one or two and P. D. S O one O three clinical studies.
P D S O one or two and PD is a one O three are progressing according to schedule and are currently in clinical stage manufacturing.
Similar to our first immune oncology pipeline.
We continue to leverage strategic collaborations to advance our infect immune infectious disease programs with minimal capital outlay.
Last month.
Our collaborator Dr. Ted Ross and his team presented preclinical data on the universal flu vaccine at <unk>.
41st American Society of Virology meeting.
Based on these promising results we continue to work with the National Institute of allergy and infectious diseases also known as N I E I D to.
Kate who advancing P. D S O to O two into the clinic.
Discussions with N I AIB continue to progress.
As part of this process last month, Dr. Ted Ross and Professor Jeremy Woodward P. D. S. Biotechs collaborator of the University of Kentucky School of Medicine presented the preclinical universal flu efficacy data to the larger and I E. I D group.
Last week <unk> presented the effecting your clinical manufacturing and human safety data too and I AIB program stuff.
I'll turn the call over to Laura who will discuss these data in detail.
Lauren.
Thank you Frank and thanks to all of you for joining us on the call today.
As Frank just mentioned, we recently presented encouraging preclinical data from our influenza vaccine program in a poster at the American Society of Nephrology meeting.
In this study it was found overall that P. D. S O to O two neutralized multiple strains of influenza and provided full protection against lethal infection in animals.
The P S O to O two universal flu vaccine contains the intact immune nanoparticle formulated with computationally optimized broadly reactive antigens or Cobra.
Influenza antigens developed by the laboratory of renowned influenza expert Dr. Ted Ross.
The vaccine was evaluated for its potential ability to induce broadly neutralizing and diverse types of influenza antibodies.
These antibodies were demonstrated to be effective against multiple influenza strains and also provided full protection against lethal doses of the flu virus.
Highlights of the poster included.
Animals vaccinated with P. D S O to O two demonstrated significantly higher antibody levels against multiple influenza strains compared to animals vaccinated without in fact mean.
100% of animals vaccinated with P. D S O to O. Two survived obesity dose of the flu virus without sickness.
All animals in the Cobra antigen only group got sick and showed significant body weight loss and only 40% survived.
None of the untreated animals survived the lethal challenge.
P D S O to O. Two was equally effective using 25 fold lower doses of the copper antigens.
Importantly, no detectable virus was found in lungs from animals vaccinated with P. D S O to O two.
Another advantage of P. D. S O to O. Two is the induction of T cells. In addition to antibodies to provide robust protection against diseases.
Currently there is no universal flu vaccine that provides broad protection against multiple strains of influenza ACOG.
According to the World Health organization. The flu is estimated to result in about three to 5 million cases of severe illness and up to 650000 deaths each year.
We are pleased by these data, which suggests that P. D. S O to O. Two has the potential to achieve the goal of providing the broad protection thought and a universal influenza vaccine.
Let's turn now to our 2022 Astro data.
Here, we summarize the data presented from our versatile 002 phase II clinical trial, providing an update on the first arm of the trial, which is being conducted in checkpoint inhibitor naive patients.
The goals of the diversity of Chile, 002 study is to double the objective response rate or a R. R over vaccine with Keytruda monotherapy reported to be about 17% and the key note 048 study.
The O R. R refers to tumor size reduction.
30% or more.
Keeping that in mind, let's get into the data presented at Astro.
And objective responses seen in seven of 17 patients or 41, 2%.
Additionally, two of the seven patients had no evidence of disease or complete response.
Please note that these data include both confirmed and unconfirmed responses.
89% of patients treated were alive at a median of nine months, suggesting a survival benefit with P. D. S. O. One O one is administered with Keytruda.
Clinical benefit which is the percentage of patients who have stable disease, plus those who have experienced objective responses with 76, 5%.
At the time of the data cut off patients had received a median of four out of five doses of PD, one and nine out of 35 doses of Keytruda.
On the safety side, there were no treatment related adverse events greater than or equal to grade three and the 19 patients and no patients discontinued treatment as a result of toxicity the <unk>.
Same was observed in the 43 patients included in the recent data monitoring Committee review.
This compares favorably to Keytruda monotherapy were grade three or greater treatment related adverse events were reported and 17% of patients.
The interim data from this study appears to demonstrate the clinical efficacy of P. D. S. O. One O one and confirms the synergy with checkpoint inhibitors documented in preclinical studies.
Frank mentioned, we will be discussing these data further with the FDA soon to determine a path forward to potentially begin a registrational phase of development.
Turning now to the 2022 triple combination trial data.
As a reminder, this is the N C. ILEC Triple combination study evaluating P. D. S O. One O one in combination with two investigational immune modulating agents.
Owned by Merck K G a a.
Venture fees Alpha and N 90, 241, which is also known as NHS IL 12 the.
The Triple combination is being studied in patients with extremely difficult to treat HPV positive advanced relapsed and refractory cancers.
Historically objective response rates in checkpoint inhibitor refractory patients have generally been less than 10%.
Ultimately most patients treated with checkpoint inhibitor therapy will continue to progress and become checkpoint inhibitor refractory.
Median survival for these patients usually is in the range of only three to four months.
As Frank mentioned, the proprietary combination of bursting unit NHS IL 12 is expected to expose a greater population of tumors to the immune system and can be achieved with checkpoint inhibitors alone.
This may allow P. D S. A one O one induced killer T cells to kill a greater number of HPV 16 positive cancer cells, resulting in better clinical outcomes.
Understanding the historical survival data in this difficult to treat population helps put our findings into context.
Now moving into the data.
It was observed that 88%.
Checkpoint inhibitor naive patients had evidence of an objective response.
This is the highest response, we are aware of to date any recurrent or refractory HPV related cancer.
77% of checkpoint inhibitor refractory patients were alive at a median follow up of 12 months.
As I mentioned these terminally ill patients historically would have been expected to list generally for a median of only three to four months.
75% of checkpoint inhibitor naive patients were alive at a median follow up of 17 months again, suggesting promising durability of the immune response.
There were no great five treatment related adverse events.
43% of patients experienced grade three treatment related adverse events with 7% experiencing grade four events.
This safety profile compares very favorably with Tempur loosen up plus chemotherapy were grade three and higher treatment related adverse events were reported and 72% of patients in the keynote <unk> four eight study.
Importantly, similar responses occurred across the entire range of HPV 16 positive cancers, including anal cervical head and neck vaginal and Bolivar cancers.
The results presented at <unk> suggest that the proprietary burst immune IL 12 combination may have the ability to overcome additional tumor immune suppression that is not addressed by checkpoint inhibitors alone.
These results combined with the previously reported data from this trial showing the tumor shrinkage only occurred in HPV 16 positive subjects suggest the potency of P. D. S O one O one across both trials.
The data also suggests that this novel combination adverse immune and IL 12 has the potential to provide improved clinical outcomes and overall survival for patients with refractory H P D associated cancers.
With that I'll now turn it over to Matt for you of our financial results.
Matt.
Thank you Lauren.
And thanks to all of you on the call today.
We continue to manage our cash carefully and have been fiscally prudent with our clinical strategy leveraging partners to allocate costs to cover the investigation of a wide range of HPV 16 associated cancers.
We wish to warmly. Thank all of those partners for their interest and confidence in P. S O water, one and diversified platform.
Moving into our summary financials for the second quarter ended June 32022.
Research and development expenses increased to $3 8 million for the three months ended June 32022, and $2 $8 million for the three months ended June 32021, the increase of $1 million was primarily attributable to an increase of $4 million in critical study and research.
Development costs.
$7 million in personnel costs $1 million in facilities.
This was partially offset by a decrease of $42 million in.
Factoring services.
General and administrative expenses increased to $3 $3 million for the three months ended June 32022 up from $2 $3 million for the three months ended June 32021.
The increase of $1 million is primarily attributable to an increase of <unk> $8 million in personnel costs and $2 million in legal fees.
We finished the quarter with nearly $53 million in cash and a strong position as a result of our partner model and continuous financial discipline, which we expect.
We will fund our operations into 2024.
P. D. S has brought in key resources to set ourselves up for the next stage of growth. We've also expanded our team with the addition of experienced biotech and pharma veterans to lead our business development and legal functions.
In May we welcomed centuries of Ari as senior Vice President business development to lead our business strategy and manage the company's potential licensing and partnering opportunities in support of our pipeline.
And in June we welcomed Spencer Brown, senior Vice President and General Counsel.
With that let's open it up to questions operator.
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One of them. Please pull for questions, what's gonna have starwood. Thank you.
Thank you.
Our first question is from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your questions.
Hi, congratulations on all the progress this quarter and thanks for taking my questions.
So I had a few here for you first question I wanted to ask you as you talked about the EU opportunity. So curious if.
If you could size that are you know help us think about that opportunity for you and then the next steps for your flu vaccine. What are you thinking about hearing could you compare and contrast, your platform with the mrna platforms. We've seen some data from <unk> and the last question I had for you is what was the physician feedback on your pipeline. It asking when you presented your data. Thank you.
Well, thank you very much for the question.
I will start answering and I'll also hand over to Loren to add any additional comments.
The EU opportunity I think.
As you know.
Head and neck cancer is widely spread and we one of the key key.
Key components of unofficial clinical trial is recruitment, we believe that expanding the trial in teu is going to significantly enhance and hence our ability to enroll patients and to run the trial efficiently.
Now we are we are looking for to potentially moving into a pivotal trial pending the feedback from the FDA.
And we anticipate that getting the EU sites getting those regulators familiar with our product and our data to date.
Even if we have to transition into a pivotal trial will be very beneficial in getting those trials running outside the United States unless you may be aware, sometimes it takes several months and even sometimes close to a year to get some of those ex U S sites up and running and so getting those activities going sooner than later, we believe.
Could potentially be very important in allowing us to efficiently enroll in the trial and get the trial executed efficiently and so that's one of our key our key goals and getting the EU sites up and going and that is as I mentioned this already.
Taken account.
Taken account in our financial projections.
It's not a new activity that we're undertaking currently.
Moving on to the flu vaccine.
Mrna platforms have been extremely.
Impressive and the ability to rapidly generate vaccines against multiple agents into viral agents. For example won I think there has been some data announced recently showing that the seasonal flu vaccine result is comparable to what's seen with the current flu vaccines Fluzone for example.
Now what we are doing is very different what we are developing is a vaccine will be broadly active against multiple strains of the flu.
And so.
The way, we see it is that with a successful universal flu vaccine.
Current approach of trying to understand what strain of flu is going to be prevalent in a particular year and rapidly trying to generate their vaccine for that particular screen of the flu more or less becomes obsolete.
Because you'll have a universal flu vaccine that is effective against multiple strains of the flu right and that's the that's the ultimate goal of unaffected Universal flu vaccine a vaccine that is going to be effective.
Against several strengths and that's the approach the computational approaches that professor pegged Ross has taken has been to evaluate multiple strains of the flu over the last couple of decades and to try to incorporate the immunogenic regions of those particular proof flu strains into these cobra proteins like in what we now show us that by.
And those Cobra proteins with versus affecting you were able to induce potent and broadening of reactive neutralizing antibodies right and so that would be the goal. The goal would be that with the universal flu vaccine would make the current approach yourself, having to rapidly develop a new vaccine every year more or less obsolete.
And I think that with the physician feedback I will hand over to Laura and Loren can give us some update on what the physician feedback has been today.
Okay.
Oh, yes, thanks, Frank and thanks for the question Louise.
The feedback I ask or twenty-two regarding the versatile oh, two poster as well as the NCI Triple combination poster was significant.
The feedback from physicians on versatile Oh, two was not only the objective response rate of 41%, which is historically greater than.
A doubling of the 17% objective response rates seen with keynote <unk> four right. So they were impressed by that there was a lot of commentary regarding that the second focus of the comments that we got was the tolerability of the regimen and specifically that there were no greater than or equal to grade three treatment.
<unk> related adverse events and there were no discontinuation of drug therapy associated with the combination regimen. This contrast to greater than grade three events of 17% reported with keynote <unk> four eight so physicians were very impressed by.
That differentiated tolerability of the combination regarding the triple combination everyone was very very impressive and there was a lot of commentary on the survival data not only in the CPI naive patients where the follow up was more extended 17 months of follow up but the.
Back that even N C. P. I refractory subjects that had received the triple combination whether it was low dose or high dose that the survival was approximately 77%.
It was really about survival associated with the triple combination.
As well as the differentiator and Tolerability of the dual combination profile in diversity Oh two study.
Thank you.
The next question comes from the line of Jim Molloy with Alliance Global Partners. Please proceed with your questions.
Yes.
Hi, Good morning. Thank you for taking my questions I had a quick question I was wonder if you could talk a little bit of a characterization of potential partnership markets markets I know obviously.
Contributed and Merck.
Obvious elephant in the room, but how would you characterize that.
<unk> for potential partnerships given some of the data you've seen strong have you seen so far.
Yeah. Thanks, a lot for the question.
I think.
The more the more data, we continue to generate the stronger and stronger the Pds story becomes and the more compelling data also becomes and I think also I mean with the.
The large pharma companies as you know partnering is one of our strategies, but I think they will make they will make that internal decisions as to what is critical and important for them and theyre and theyre partnering strategy, but I think our Pds, we continue to progress our data generation and we believe that the more data we continue to Jen.
Right.
Longer. This started becomes then also creates strong opportunities for partnering with Merck and beyond beyond Merck right. So I think we are looking at the broad business development strategy and also very importantly.
If we get the green light from the FDA to move into pivotal trials. That's also making it puts us in a different category right that it makes us even more attractive but for potential partnering and we have brought on as senior Vice President of business development, whose key focus is really to start understanding and generating those business development.
Opportunities that we are certainly we are certainly looking broadly and we believe the data that has been generated to date as I mentioned, we haven't data already from 80 patients across both trials.
Data from both trials are.
Hum.
Provide strong indications that P. S O one O one of its working across both indications of both trials and across the entire spectrum of HBV, Kansas right. So that's a very compelling package of data because there is cigna 80 patients. That's a very significant number of people patients and so we believe we have very strong.
And that's what allowed that's what has caused us to activate this approach of beginning those business development discussions. So yes, Jimmy it is unimportant piece of our business strategy and that's something that we are focused on and we're looking very broadly just beyond our current partners.
Okay, maybe a quick follow up if I could could you talk a little bit on timing of an end of phase two potentially starting a pivotal phase III.
Tell program that combo with the <unk> and then.
It's just the timing for starting the phase one.
For the Universal flu.
Jim could you please repeat the first part of the.
Question, the first box to I'm, sorry, the timing.
Current expectations and timing for an undisclosed too with the FDA and starting to potentially a pivotal phase III.
Through the combo.
Okay.
We anticipating talking to the FDA regarding that trial and our proposal for a pivotal trial this quarter.
By the end of this quarter, we should have strong feedback from the FDA in terms of whether or not we can move that trial forward into a pivotal if the if we do get the green light to do so we anticipate that the trial could be started sometime during the first half of next year, but again that is contingent on the response that we.
Get from the F D. A that would be our hope and that's what we are preparing to do and hopefully we will be able to move that into pivotal. So early next year.
With the with the Universal flu vaccine I think as I mentioned doing.
During the earlier part of the call we are working with the NIH we are.
Hopeful that we will be able to get attract some non dilutive funding to move that into human clinical trials is very difficult to project, what the exact timing would be and Dr. Ted Ross is really a strong advocate for the program and he is working with the NIH to.
Two to also presented to them the data of the opportunity and so forth and as I mentioned they are.
Ted roster himself and the NII.
I'd have met the P. D. S. T must also met with the ni AIB to provide them with information that they need.
Hopefully need need to make that decision. So we are hopeful but that decision has not been finalized at the end I E I D. Yet.
And so my anticipation is that I would say the earliest it could potentially go into human clinical trials would be sometime next year. If everything works out in this program has green lighted and funded by the NIH.
But we will we will keep you updated on that progress.
Thanks for taking the questions.
No problem. Thanks, a lot.
Yeah.
Our next question comes from the line of Leland <unk> with Oppenheimer. Please proceed with your questions.
Hey, good morning, and congratulations on the progress a couple of questions for me just one kind of a sort of a science question Frank in the versatile O Tuesday that you've put some say that's true.
There's an analysis based on complete.
What's it seems the G P S.
The complete pausing score I'm wondering you know it didn't show sort of any clear correlation between those levels and response with the regimen and I'm just wondering if there's been any further analysis you've done.
Two.
To look at that thank you.
Lauren do you want to take that.
Yes, I can thanks, so much leland well for everyone on the call just to reinforce.
The entry criteria for all study subjects on birth of child, Oh too is that the composite score. The C. P. S score measuring PD L. One in the patients tumor tissue. They must have a C. P S score greater than or equal to one that is the cause of that is the current standard of care.
Higher meant to receive Keytruda monotherapy.
And doing the PDL one characterization, we also look to see whether or not individuals have composite scores that are greater than one specifically greater than 20% at this preliminary stage Leland we have not seen any correlation at all between C. P F score.
Sure and greater than 20, but this is a small number of subjects that we presented at Astro and we're going to continue to characterize and look at whether or not the C. P. S score has any impact on correlation with the clinical outcomes.
We have additional studies that are planned regarding characterizing immunogenicity and HPV 16 specific responses to see whether or not that correlates with clinical outcomes as well, but that's what we have today.
Okay. Thanks, and then.
A question on the surgical side obviously.
Looking forward to the phase III data that will be will be coming up claims just wanted to ask how that may change or add to your plans in in 'twenty, three and beyond with respect to.
Continued development of of the candid in saying.
And cancer I mean, obviously, a huge need in cervical cancer as well. So just wanted to ask how you may look to deploy resources alongside the.
True to combo and head and neck is pending the internet's forgive us.
Right.
Yeah. That's that's that's unimportant question I think one of the things to bear in mind is the.
The strategy that we've currently taken off looking at multiple combinations in multiple indications is very important in our strategy of really rapidly understanding which combinations provide the most benefit and which indications right and so I think one of the things that we would have to do is also to look at the standard of care and how.
We can improve or what the potential is to improve the standard of care. So I think the data that's been generated with versatile and the triple combination of very compelling today right those but those are more or less in later stage patients. The early data that's been generated by MD. Anderson is also very compelling and but it's still it's still early.
So I think we would like to see what the data looks like the full data package. When it's available and I think at that point, we will have to make a decision. If we see some compelling improvements over the standard of care and as we see with them. Their styles. There was there was to know compounding of the toxicity.
That would be again very compelling and we will have to determine how we prioritize the trials and which ones we want to move into pivotal. So how should we do we are planning to do it now with the triple and the dual but that that's a little bit behind those studies and very interesting data to date, but I think once the whole package is available we will sit down and determine what the real.
Our opportunity is in terms of that specific indication.
Great. Thank you thanks for taking the question.
No problem you're welcome.
Our next question comes from the line of Joe <unk> with H C. Wainwright. Please proceed with your question.
Hey, everybody. Good morning, Thanks for taking the question so Frank more on the flu program and I'm Gonna balance my question by saying, obviously the field over the years has been constantly teased with a universal flu vaccine and the data that you've presented seem to differentiate and position you well. So I guess I wanted to take the question.
Further beyond the details you provided today and say you know at least what's your broad view of how you can get this to market quickly because I know you said youre looking at potential.
Non dilutive capital or potential grant money from the NIH.
How competitive do you think that process is.
You know what would.
Tds look to potentially do on its own to rapidly advance this asset.
Yeah.
Thanks, a lot.
Okay. Good question has a lot of the things that we have been discussing internally.
I think with the Universal flu vaccine one of things we want to do currently looking at the infectious diseases versus oncology is to really focus our resources on the oncology and move those programs to what's commercially commercialization as rapidly as possible and to be overall financially efficient and that's why we've taken the approach.
Or at least hope it trying to get the early data for about the Universal flu program.
We are some non dilutive funding approaches that's really been our our key desires to accomplish today.
In term in terms of the differences I think what's unique here is the antigens that are being utilized youre right I mean, universal flu vaccines have been discussed for over a decade and the approach that has typically been taken has been to put together probably viruses two or three different strains of the flu.
Together into a single vaccine right and with the hopes of generating antibodies against those specific strengths of the flu that have been incorporated into that particular vaccine.
What's being done differently here.
Is the antigen approach right in terms of the computational design, where a much broader.
Number of strengths have been taken into consideration over the last several decades in terms of okay. What strains of flu have we seen over the last decade, how how have they changed over the years, what's out what are the consistent regions of those strains that can be muddled into a specific antigen now when that is done.
When you give that vaccine even without affecting me and you can see that you get you get some immune responses, but they are not as broadly protective.
When you combine those novel Cobra antigens with infecting the beauty from affecting me if its ability to do what is necessary to generate a powerful immune response rate, which is presentation of the antigens into the rice processing presentation pathways as well as activating the critical immunological Sigma.
<unk> pathway when you put those two together we've seen for the first time broadly neutralizing highly potent.
On site.
Flu antibody antibodies as well as very importantly, T cells right and we see in the animal studies complete protection right and nobody no viral presence in the lungs. After after vaccination with with that with that vaccines. I think there is a very significant opportunity I think one of the things that.
We would do is our business upper teens business development activities.
Well not to just focus on oncology only will very much look at opportunities to infectious diseases to however, we believe that having some early human clinical data confirming the breadth of immune response in humans as well as confirming the safety will be very significant in allowing us to bring on additional partners.
In the infectious disease space too just like we've done with oncology generated about early human data, we've generated significant data today really showing and demonstrating very compelling results right. Our goal is we believe that that could potentially be important and.
Attracting similar partnerships in the infectious disease space, but those are key goals for PDF and that those are key things that we're working on to hopefully get it to the clinic generate that data, while also potentially talking to prospective and potential partners.
Got it thanks very helpful. Frank.
Youre welcome.
We have time for one more question.
Our next question is coming from the line of Robert Leboyer with noble capital markets.
Good morning, I'll keep my question short and just ask.
About the trial the pivotal trial.
Potentially start next year in terms of what you're seeing do you have any projections as to the number of patients or length of trial.
And secondly in terms of the out licensing and business opportunities do you have any milestones or any parameters as to whether these things are going to be entirely license early stage collaborations.
To a certain development point or any specific strategy related to those products.
Hey, Robert Thanks, a lot I'll take the first stop and hand, it over to Loren to also give you. Some additional information on the on the trial strategy, but in terms of the trials I think that one of the key things. We want to do is to have that discussion with the FDA just understand have them understand what we are thinking and also get to.
Some feedback on what they would like to see in that trial in terms of how how we move forward.
We have all options on the table, where we are preparing that we would at least the goal would be that we would put that we could potentially partner one or both of them.
Oh, we also preparing just in case, we would want to move them forward on our own independent right. So currently what we would want to do would be to we have between now and when we get those trials going to really understand what the partnering opportunities are and will be.
And also look at look at what those opportunities are and hopefully make the best decision as we would typically with stripe to do for the company and the company's shareholders. But currently we are evaluating all options and all potential options available to the company.
Lauren would you want to add anything on the clinical trial the pivotal trials. Yes. Thanks. Thanks, so much for that question, Robert we estimate that a pivotal trial looking at the a versatile zero-zero two combination which would involve P.
D S O one O one plus keytruda versus Keytruda monotherapy in the exact same population that we are currently studying versatile oh two would require approximately.
250 to 270 subjects. This is dependent on screen fail rates that can vary globally as well as regionally as well as the incidence of HPV 16, as Frank had mentioned the concurrence with the FDA and advice from the FDA regarding the strategy.
The pivotal trial design is going to be critical and we will hear about that before the end of this quarter with the hopes that we would start the study in the first half of 2023. The other issue is that as Frank also mentioned during the call our expansion into Europe . We believe is laying the groundwork.
<unk> to not only introduce first Utah or two ex U S. But also set up that infrastructure for a global study.
The projected enrollment would be approximately.
A window is anywhere from 18 months following initiation of the study depending on enrollment rates.
Okay, great. Thank you very much.
Thank you we've reached end of our question answer session I'll hand, the floor back to management for closing remarks.
Thank you very much.
Again, thank you for joining us on today's call as you can see we've made significant progress during the first half of the year to.
To date P. D. S. O 101 has been administered to over 100 patients in the ongoing phase two trials and we have provided data from 80 patients in both the Keytruda combination and the National Cancer Institute lead Triple combination.
The fact that recruitment is progressing well and that both the safety and efficacy continue to appear to be strong is extremely encouraging and we believe provides validation and proof of concept.
We look forward to continued progress and success during the next six months ahead. We appreciate your continued support and we will update you as we progress our clinical and preclinical programs.
We wish you all the best for the remainder of the summer. Thank you very much.
This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.