PDS Biotech at A.G.P. Showcase: Versamune’s Promising Potential

On Wednesday, 21 May 2025, PDS Biotech (NASDAQ:PDSB) showcased its strategic advancements at the A.G.P. Virtual Annual Healthcare Company Showcase. The company’s CEO, Frank Bedoatu, highlighted both promising developments and challenges in the fight against HPV16-positive head and neck cancer. While the potential of PDS Biotech’s Versamune technology was emphasized, the path forward includes navigating clinical trials and regulatory hurdles.

Key Takeaways

• PDS Biotech’s Versamune technology shows promise in treating HPV16-positive cancers, with a significant market opportunity.
• Phase 2 trial data indicates improved survival rates with Versamune HPV combined with Keytruda.
• The ongoing Phase 3 VERSATILE 003 trial aims to confirm these results, with interim data readouts planned.
• Collaboration with the National Cancer Institute on the MAC one program shows early positive results.
• Presentations at ASCO will provide further insights into current trials and future strategies.

Financial Results

• The market opportunity for advanced HPV16-positive head and neck cancers is valued at $4 to $5 billion in the US and Europe.
• Versamune HPV’s potential expansion into other HPV16-positive cancers could reach over $10 billion in these regions.

Operational Updates

• The VERSATILE 003 trial focuses on recurrent or metastatic HPV16-positive head and neck cancer.

- It features a 2:1 randomization in favor of the treatment arm.

- Median overall survival is the primary endpoint, with FDA discussions anticipated.

• Three abstracts have been accepted for ASCO presentations, including updates on the VERSATILE 002 and 003 trials.
• The MAC one program, in collaboration with the National Cancer Institute, has shown that the combination of Versamune and PDS01 ADC enhances MUC one-specific killer T cells.

Future Outlook

• PDS Biotech aims to execute the VERSATILE 003 program and achieve key milestones.
• The company aspires to have the first FDA-approved therapy for HPV16-positive head and neck cancer.
• Expansion into other HPV16-positive cancers remains a strategic focus.

Q&A Highlights

• Versamune HPV targets the underlying cause of cancer by training the immune system, potentially offering stronger efficacy than current treatments.
• In the VERSATILE 002 trial, median overall survival reached 30 months, a significant improvement over the historical standard of care.
• Over 20% of trial participants experienced complete or near-complete tumor shrinkage.

For more detailed insights, readers are encouraged to refer to the full transcript.

Full transcript - A.G.P. Virtual Annual Healthcare Company Showcase:

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: And everyone, and welcome to our next fireside chat. Again, my name is James Malloy, biotech and specialty pharmaceutical analyst here at AGP. In this chat, we’re talking with another of our coverage companies, PDS Biotech, which we have as bio rated with a $4.50 price target. PDSB is developing Versamune, their lead T cell activating technology. It’s currently being studied in a phase three versatile o three trial in h p v sixteen positive head and neck cancers.

With us today from PDSB is CEO Frank Bedoatu. Thank you for joining us here today, Frank.

Frank Bedoatu, CEO, PDS Biotech: Well, thank you very much for the introduction and for having participated in AGP’s health care company showcase.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Well, I was hoping maybe we could start with a maybe a brief overview of PDSP for our listeners.

Frank Bedoatu, CEO, PDS Biotech: Joe, I’ll be happy to do that. So PDSP Biotechnology is a New Jersey based late clinical stage biotech company developing targeted immunotherapies for cancer. Our lead investigational product, VersiMune HPV, is currently in a Phase III clinical trial for recurrent or metastatic HPV16 positive head and neck cancer and is being developed to treat various HPV sixteen positive cancers. Now Jim, something that many of our listeners may not know is that because of the rapidly increasing incidence of head and neck cancer, head and neck cancer has been described as a silent epidemic. Now some publications even project that by 02/1930, the incidences will be increasing at a rate of about thirty percent per year.

Now what’s interesting is that it’s also reported that these increases in incidence are driven almost exclusively by one specific type of aggressive head and neck cancer, HPV sixteen positive head and neck cancer, right? So these are cancers of the head and neck area caused by infection with the most carcinogenic type of HPV, which is called HPV sixteen. Right? So head and neck cancers, as you know, have been traditionally related to alcohol and tobacco consumption. Today, the experts project that by the 2030s, the majority of head and neck cancers in The United States and Europe will be HPV HPV sixteen positive.

So today, this market represents about a 4 to $5,000,000,000 opportunity in The United States and Europe for PDS Biotech. And it has also been published that these patients with advanced HPV sixteen positive head and neck cancers may have the worst survival prognosis compared to the HPV negative head and neck cancers as well as other head and neck cancers caused by other types of HPV. So this registrational trial is the first ever registrational trial to be performed in HPV sixteen positive head and neck cancer. And Versmune HPV has been granted fast track designation by the FDA based on our phase two VERSAL zero zero two data.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Now I’m sure a lot of us have heard about the immunotherapies, the p d ones, p d l ones, and all these things, and obviously everyone knows chemo. How does the immunotherapy like Versamune, does that have the advantage in targeting cancer, obviously, p v h p v 16 focus, and how does that play a role within the h the treatment paradigm? Should it be approved?

Frank Bedoatu, CEO, PDS Biotech: So, Jim, that’s an interesting question. So to be able to put my response in context, I’ll first of all provide some of the limitations of the current approaches to cancer treatment, such as chemotherapy, cytotoxic drugs and even the EGFR inhibitors. So these approaches have been effective in rapidly shrinking tumors. However, they are not as effective in treating the underlying cause of many cancers nor do they appear to be effective in promoting the long term and sustained clinical benefit. Therefore, with advanced cancers, the survival times are still short on the current therapeutic approaches.

Now in recurrent metastatic head and neck cancer for specifically, even with a combination of chemotherapy and the EGFR inhibitor cetuximab or also known as Erbitux, the median overall survival is only about ten months. Right? Meaning that you have a fifty percent chance of living for about ten months on this therapy. Now, how does an immunotherapy such as Version HPV differ? So I would say first, let’s consider the fact that what typically kills the cancer patient is not the primary tumor, but rather the micro metastatic cancer cells that spread and grow very aggressively.

So now let’s assume that we can develop a therapy that trains the immune system to target a specific marker that’s present in all these cancer cells and that we can activate and deploy the immune system to invade the body, seek out, infiltrate, and kill these cancer cells, including the micro metastatic tumors. What I just described is Versamune HPV and the target markers are called the e six and e seven proteins of HPV sixteen. Right? So Jim, to to provide a little bit more color to this question and the answer, so in in the February issue of the clinical of clinical cancer research, doctor Ann Clark and her team at MD Anderson Cancer Center published a study of Versamune HPV in locally advanced cervical cancer patients. Now in this study, they measured the quantity of cancer cells including the micro metastatic tumors using a technique that measured what is called the circulating tumor DNA.

So in one arm of the study, they had patients who received Versamune HPV with the standard of care chemotherapy and radiation. In another arm of the study, they had patients who received only the standard of care chemotherapy and radiation. So among the HPV sixteen positive patients who were evaluated, in the worsening HPV arm, there was a one hundred percent elimination of the circulating tumor HPV 16 DNA at three to four months after start of treatment. In the patients who only received the chemotherapy and radiation, there was only a 50% reduction in the circulating tumor DNA. And so what they also reported was that in the patients who had no detectable circulating tumor DNA, their two year recurrence free survival was ninety two percent.

However, if there was any detectable circulating tumor DNA, their two year recurrence free survival rate dropped drastically to only thirty percent. Right? And so what I just described is the advantage of an effective t cell immunotherapy such as Versamine HPV in promoting patient survival. Now if you look at the EGFR inhibitors, for example, there are several publications reporting much weaker efficacy in HPV positive head and neck cancer versus HPV negative head and neck cancer. And the key reason for this is because they do not target the underlying HPV integration into the host genome.

Right? And so that’s where an effective t cell targeted immunotherapy differs from your standard approach to treating cancer and the potential advantages.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: And and you’ve got some numbers to back it up. The the phase two VERSATILE o o two trial that read out end of middle last year. It had some excellent median overall survival, what, thirty months versus twelve to eighteen months for historical controls. Could you walk, sort of listeners through the o o two, data and how that informs, the ongoing o o three trial?

Frank Bedoatu, CEO, PDS Biotech: Yes. So that that’s a very good question, Jim. So with the VERSTILE two trial, as you mentioned, we’ve had some very encouraging survival data. To date, with the with the historical published results, if you look at the standard of care, which is Keytruda or Keytruda plus chemotherapy, typically the standard, the median overall survival ranges between about twelve to thirteen months, which means that if you go on those therapies today, you have approximately a fifty percent chance of living twelve to thirteen months on average. However, if you went on to the VERSAL two trial with the median overall survival being thirty months, you had about a fifty percent chance of living thirty months or more, a significant improvement over what this standard of care is.

Today, that’s actually the 13 median overall survival to the best of our knowledge is by far the most extensive survival reported in recurrent or metastatic head and neck cancer to date. And so as we’ve also discussed in the past, our the primary endpoint for our phase three VERSAL zero zero three trial is median overall survival. And so with the maturity of our phase two data to date, it gives us significant encouragement and confidence going into this phase three clinical trial based upon the really durable responses that we have seen in the VERSAL two trial. And also very important, not even just the survival, which is important here, but also the tolerability of the combination of Versamune HPV with Keytruda or pembrolizumab and also the tumor shrinkage levels that we have seen. We were we also reported that ninety two that over twenty percent of the patients in the trial had complete or almost complete ninety to 100% tumor shrinkage.

So again, demonstrating that Versamines HPV appears to be highly effective in generating the right type of killer T cells in the right quantity to promote a pretty potent antitumor immune response. So very encouraging data moving into our phase three clinical trial.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: And walk through the the o three trial, PDS one zero one with Keytruda, first line, very similar to the the phase two trial that had good results. Sort of walk through the the key differences and similarities between the two trials, if you would, please. And then what, what sort of the next interim look or next catalyst we should be looking for,

Frank Bedoatu, CEO, PDS Biotech: please? Yes. So, Jim, so those two trials, our VERSATILE two phase two trial and our VERSATILE three phase three trial are practically identical except for the fact that in the phase three trial, we are including a control arm, which in this case would be Keytruda. This trial is designed to have a two to one randomization, meaning that for every two patients who enroll and get onto the treatment arm, one patient will be enrolled onto the control arm. In this trial, also slightly different from the initial, the initial objective response rate was the primary endpoint whereas survival was a secondary endpoint.

In this case, based upon discussions with the FDA, the FDA highly encouraged that we utilize median overall survival as the primary endpoint for the VERSAL three phase three trial. What we have also done with the phase three trial is to build into that trial design two interim data readouts. And so this would give us the opportunity to have early discussions with the FDA pending what the results turn out to be. But as as you mentioned, this trial has actually started. We anticipate that there will be some key enrollment and site activation milestones as we as we go along.

And also for our Versatile zero zero two phase two trial, we’ll continue to we will continue to give other milestones as the trial gets to completion. Right? So we have we we should hope hopefully have quite a bit of updates on these two trials in the next few months.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: And in just a couple weeks, you’ll have some you have three abstracts at ASCO. Care to tease a little bit what what we’re seeing there at ASCO?

Frank Bedoatu, CEO, PDS Biotech: Yes. So I think for ASCO, we we are very pleased to have three abstracts accepted. So for the fur the first abstract will deal with our VERSAL zero zero two phase two trial as we’ve said. This trial is a mature trial at this stage and we’ll be providing an update on the survival data for this trial. For the VERSATILE three trial, as you mentioned, this is where we will be presenting a trial in progress.

And as I mentioned, this is the first ever registrational trial to be performed in recurrent metastatic first line HPV sixteen positive head and neck cancer. So we will be happy to provide more details on the trial design. And for the third poster, doctor Routman of Mayo Clinic will be presenting some exciting data on the neoadjuvant treatment of HPV positive locally advanced oropharyngeal cancer with Versamune HPV and Versamune HPV plus Keytruda. So some interesting data from Jim, are you talking are you talking about the the MAC one program? Yeah.

MAC one. Yeah. The MAC one program. Okay. Yes.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Combination with the the antibody drug conjugate.

Frank Bedoatu, CEO, PDS Biotech: Yes. I’ll be I’ll be happy to do that. So a lot of the early preclinical work on this program was actually done by and at the National Cancer Institute. So the National Cancer Institute developed and patented the novel modified or what we call the agonist peptide sequences of MAC one that we are using with our Versamune platform. So the initial work that was done focused on confirming that these novel MUC one sequences were highly immunogenic in in these cancer patients and that the derived t cells would recognize, target, and kill human cancer cells in vitro, right, including colon cancer, breast cancer, ovarian cancer, and pancreatic cancer.

Right? So this work this work was done with those those types of cancer cells in an in vitro fashion. This work is published, by the way. And so then these novel sequences were then formulated with our Versamune and demonstrated to promote enhanced MUC one specific c d eight killer t cells that targeted and killed MUC one targets in vivo. This enhanced potency was also demonstrated with the combination of Versamune MUC one and PDS o one ADC.

Now this trial is a typical phase one two a trial design. The details of the trial are not yet public as we are waiting the timelines from the National Cancer Institute who will be running this trial under our collaborative research and development agreement with the National Cancer Institute. And we anticipate that the trial will be made public on clinicaltrials.gov in due course.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: And the IND was just recently approved, right?

Frank Bedoatu, CEO, PDS Biotech: That is

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Is the timing any word on the timing on the start or anything like that, or is it still to be determined?

Frank Bedoatu, CEO, PDS Biotech: It’s still to be determined. As you know, there’s a lot going on within the government agencies at the moment, So all those things are currently being worked out for to get some clarity on the timing.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Dan, anything else on the pipeline you want to touch on as we’re getting towards about three minutes to go?

Frank Bedoatu, CEO, PDS Biotech: So I think I’ll say we have made some really significant progress over the last twelve months with our Versamune HPV program. We’re extremely excited about the potential to have the first FDA approved therapy for HPV sixteen positive head and neck cancer. We are also extremely encouraged with the market potential of Versamune HPV, not only in the first target indication which is recurrent metastatic HPV sixteen positive head and neck cancer, a huge potential market opportunity. But for the same product in other in HPV sixteen positive locally advanced head and neck cancer as well as other indications like cervical cancer, anal cancer, penile vaginal and vulva cancers which could eventually lead over a 10 to over a $10,000,000,000 opportunity in The United States and Europe for this product. As we discussed, we look forward to providing an overview of the accepted ASCO abstracts and also to update the markets on our continued progress as we continue to focus our efforts and resources on execution of the Versatile three program.

And with that, I would like to thank you again for the opportunity to discuss the potential impact and market market and clinical impacts of our program. Thank you very much again.

James Malloy, Biotech and Specialty Pharmaceutical Analyst, AGP: Our pleasure. Thank you, Frank, very much for taking the time out and walking our listeners through this afternoon and for all of you listening as well. Well, this ends our PDSB chat. Please stay tuned for the next fireside chat coming up right after this.

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