Latest news with #FrankBedu-Addo
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15-05-2025
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- Yahoo
PDS Biotechnology Corp (PDSB) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Net Loss: Approximately $8.5 million or $0.21 per basic and diluted share for Q1 2025, compared to $10.6 million or $0.30 per share for Q1 2024. Research and Development Expenses: $5.8 million for Q1 2025, down from $6.7 million in Q1 2024. General Administrative Expenses: $3.3 million for Q1 2025, compared to $3.4 million in Q1 2024. Total Operating Expenses: $9.1 million for Q1 2025, compared to $10.1 million for Q1 2024. Net Interest Expenses: $0.6 million for Q1 2025, compared to $0.5 million for Q1 2024. Cash Balance: $40 million as of March 31, 2025, compared to $41.7 million as of December 31, 2024. Capital Raise: Raised approximately $11 million from a securities purchase agreement, with potential for an additional $11 million from warrant exercises. Debt Refinancing: Completed refinancing with new lenders, extending the term to 36 months with the first four months interest only. Warning! GuruFocus has detected 1 Warning Sign with PDSB. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PDS Biotechnology Corp (NASDAQ:PDSB) initiated the versatile 003 phase 3 clinical trial for Versamune HPV plus pembrolizumab, targeting HPV 16 positive head and neck cancer. The trial design, approved by the FDA, includes approximately 350 patients and aims to improve outcomes for a growing population with HPV 16 positive head and neck cancer. PDSB announced the addition of new clinical sites, including Mayo Clinic, to the versatile 003 trial, indicating strong institutional support. The company reported a decrease in net loss from $10.6 million in Q1 2024 to $8.5 million in Q1 2025, attributed to increased tax benefits and lower operating expenses. PDSB secured $11 million in funding through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months. The company reported a net loss of $8.5 million for Q1 2025, indicating ongoing financial challenges. Research and development expenses, although reduced, still amounted to $5.8 million for the quarter. The cash balance decreased from $41.7 million at the end of 2024 to $40 million as of March 31, 2025. Enrollment and activation of clinical sites for the versatile 003 trial are still in progress, with no public update on patient enrollment numbers. The company does not currently provide financial guidance, creating uncertainty about future financial performance. Q: How does the KEYNOTE-689 trial impact the enrollment expectations for the versatile 003 phase 3 trial? A: Dr. Kirk Shepard, Chief Medical Officer, explained that the KEYNOTE-689 trial primarily involved HPV negative patients, with only 3% to 4% being HPV positive. Therefore, it should not affect the versatile 003 trial, which focuses on HPV 16 positive patients. Dr. Frank Bedu-Addo, CEO, added that the new treatment might accelerate the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. Q: What should we expect from the upcoming ASCO poster presentation regarding the durability of the treatment? A: Dr. Frank Bedu-Addo highlighted that the treatment's durability is a key characteristic, with patients maintaining clinical responses long-term, translating to improved survival rates. The versatile 002 trial showed a 30-month median overall survival compared to the standard 12 months, indicating significant durability and survival benefits for HPV 16 positive patients. Q: How does the KEYNOTE-689 trial affect physician interest in participating in the versatile 003 trial? A: Dr. Kirk Shepard stated that there is strong enthusiasm from investigators and key opinion leaders to participate in the versatile 003 trial. The KEYNOTE-689 trial does not apply to HPV positive patients, and the steering committee and investigators are excited about the trial's prospects. Q: What differentiates PDS Biotech's MUC1 program from previous high-profile failures targeting the same antigen? A: Dr. Frank Bedu-Addo explained that the differentiation lies in the technology's ability to effectively present antigens and activate the right immunological pathways. The MUC1 program uses novel, more potent antigens designed by the National Cancer Institute, combined with PDS Biotech's technology, to enhance immune response and target MUC1 positive cancers. Q: Has the first patient been enrolled in the versatile 003 trial, and how is enrollment progressing? A: Dr. Frank Bedu-Addo mentioned that enrollment is ongoing, with sites undergoing internal processes and patient screening. The company aims to provide updates once they have a clearer picture of enrollment rates and can estimate when interim data readouts will occur. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
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Q1 2025 PDS Biotechnology Corp Earnings Call
Mike Moyer; Managing Director; LifeSci Advisors, LLC Frank Bedu-Addo; President, Chief Executive Officer, Director; PDS Biotechnology Corp Lars Boesgaard; Chief Financial Officer, Principal Accounting Officer and Principal Financial Officer; PDS Biotechnology Corp Kirk Shepard; Chief Medical Officer; PDS Biotechnology Corp Mayank Mamtani; Analyst; B. Riley Securities Joe Pantginis; Analyst; H. C. Wainwright & Co James Molloy; Analyst; Alliance Global Partners Operator Greetings and welcome to the PDS Biotech first quarter in 2025 earnings conference call. (operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, lifestyle you, sir. You may begin. Mike Moyer Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first quarter 2025 results and clinical programs update call. I'm joined on the call today by the following members of the company's management team. Dr. Frank Bedu-Addo, Chief Executive Officer, Dr. Kirk Shepard, Chief Medical Officer, and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company's recent progress in its clinical development program. Mr. Boesgaard will review the financial results for the quarter ended March 31, 2025, and Dr. Shepard will then join the call to help address questions from our covering analysts. As a reminder, during this call, we will be making forward-looking. Statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10 and annual report on Form 10k, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now I'd like to turn the call over to Dr. Bedu-Addo. Frank Bedu-Addo Thank you, Mike, and good morning, our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical first quarter of 2025 in recent weeks have been a productive period for PDS Biotech, led by the initiation of our versatile 003 phase 3 clinical trial of Versamune HPV plus HPV plus pembrolizumab is a potential treatment for first line recurrence and or metastatic HPV 16 positive head and neck squamous cell carcinoma or head and neck with recurrent or metastatic HPV 16 passive head and neck cancer are difficult to treat and represent a large fast-growing population in need of targeted therapies to treat the underlying cause of the is projected that by the mid-2030s, HPV 16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the United States and Europe. Considering the strength and durability of the clinical responses observed in our versatile 002 phase 2 are excited to get the versatile 003 registrational trial underway and are confident in the potential of the combination of Versamune HPV and pembrolizumab to significantly improve outcomes for patients with recurrent and or metastatic HPV 16 positive head and neck are pleased to announce that new sites, including Mayo Clinic sites were recently added to the trial, and we continue the process of activating additional clinical sites. We look forward to the continued progression of this we announced previously, the versatile 003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go-ahead by the US Food and Drug Administration or two arms of the trial include a treatment arm of the Versamune HPV and pembrolizumab combination versus the control arm of pembrolizumab are enrolled in a two to one randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our versatile 002 clinical trial seen over the last year and a half with the most recent data presented at the European Society for Medical Oncology. ASCO Congress in encouraging patient survival and clinical responses coupled with promising tolerability as seen in the versatile 002 clinical trial will be the subject of a poster presentation of the 2025 American Society of Clinical Oncology annual Meeting, or data underscore our belief in the potential of the combination to be the first HPV-16 targeted therapy for head and neck cancer and a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck versatile 003 trial in progress is the first phase 003 trial in the high-risk HPV 16 population and has also been accepted for presentation at the 2025 ASCO annual Mayo Clinic will present the results of the MC20-O-seven 10 study investigating Versamune HPV alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV 16 positive oropharyngeal three presentations will be held on Monday, June 2, 2025, from 9 A.M. to 12 P.M. Central Daylight Time during the head and neck cancer poster in our pipeline last week we announced that at the American Association of Immunologists Immunology 2025 annual meeting, pre-clinical efficacy and immune response data in mice and ferrets with a novel infect immune-based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral studies were funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases NIA Center for Influenza Vaccine Research for high-risk collaborative approach between NIA and PDS Biotech allows PDS Biotech to focus our resources on our versatile 003 clinical March, we were pleased to announce FDA clearance of our investigational new drug IND application for the combination of Versamune M1 and our IL-12 fused antibody drug conjugate PDS01ADC to treat metastatic colorectal cancer. Several highly prevalent solid tumors are Mach one positive, including non-small cell lung cancer, ovarian cancer, breast cancer, liver cancer, and are pleased to continue our strong relationship with the National Cancer Institute; MCI and this phase 1 and phase 2 clinical trial is scheduled to be run under our collaborative research and development agreement with the MCI. PDS Biotech will continue to focus our efforts on progressing the versatile 003 phase 3 clinical I will turn it over to Lars for a review of our results for [2025], Lars. Lars Boesgaard Thanks, Frank. And good morning, for the first quarter of 2025, we reported a net loss of approximately $8.5 million or about $0.21 per basic and diluted share for the three months ended March 31. That compares to $10.6 million or $0.30 per basic and diluted share for the three months ended March 31, 2024. This decrease is due to increased benefit from income taxes as well as lower operating and development expenses were $5.8 million for the first quarter compared to $6.7 million for the prior year quarter. This decrease was primarily due to lower clinical trial expenses. General administrative expenses were $3.3 million for the first quarter compared to $3.4 million for the prior year total operating expenses were $9.1 million for the first quarter compared to approximately $10.1 million for the prior year quarter. Net interest expenses were $0.6 million for the first quarter, which compared to approximately $0.5 million for the prior year cash balance as of March 31, 2025, was $40 million compared to $41.7 million as of December 31, 2024. You'll recall that on February 27 this year, we announced that we had entered into a securities purchase agreement with new and existing healthcare focused institutional investors, as well as participation for certain directors of the company. And under that arrangement, we raised approximately $11 million upon the closing. And with an additional $11 million that may be funded upon full cash exercise of the warrants that were included in the more recently, at the end of April, we completed a refinancing of our debt with new lenders, resulting in the extension of the term to 36 months, with the first four months being interest that operator we can open the call to questions. Operator (Operator Instructions)Mayank Mamtani, B. Riley Securities. Mayank Mamtani Yes. Good morning team. Thanks for taking your questions and Congrats on getting the versatile 003 phase 3 lamping up. So, first on, the Keytruda head and neck, new achievement data we saw at ACR, could you comment on how such a standard of care, changing data set impacts enrollment expectations of your phase 3, and did we sort of learn anything. If anything, on the HPV positive, tumor set and how maybe checkpoint inhibitors, monotherapy responses, response rate looks like in SPV 16 positive, and then I have a follow up. Frank Bedu-Addo Mike you're referring to the KEYNOTE-689 trial. Mayank Mamtani That's right. Frank Bedu-Addo Okay. Kirk, I'll hand over to you to start if you have any comments on that. Kirk Shepard Sure, can you hear me okay. Frank Bedu-Addo Yes, we can hear you. Kirk Shepard Great. The KEYNOTE-689 trial, should not affect our versatile 003. The reason is 689 was a study of mainly HPV negative patients. That's because the eligibility criteria of the to be that the patients were eligible for surgery and most patients who are HPV positive at this stage are not eligible for surgery. So that resulted in only 3% to 4% of the patients of this study being HPV positive. So, the study was focused mainly on HPV negative patients and not positive. Frank Bedu-Addo Kirk, thanks a lot. So, that's very important because even if this does become standard of care, there is going to be very little impact on the HPV positive it may actually speed up the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. And this is something that we actually had our steering committee evaluate and give us advice on. And their feedback to PDS was Even if this new adjapan treatment is approved, since very few HPV positive patients are actually eligible for surgery at this stage, there should be negligible impact on the HPV 16 recurrent metastatic head and neck cancer population. And that's exactly what we saw as Kirk mentioned, only about 3% of the patients were actually HPV positive. Mayank that answered your question. Mayank Mamtani Yes, it you, both. And then, second on this, ask poster presentation coming up, could you talk to what we should be looking to learn on durability, incremental from what you've shown before, and maybe if you could comment on, just your durability, how might that be tracking relative to, also the emerging data from the next generation EGFR targeted therapies. Thanks again for taking your questions. Frank Bedu-Addo Thanks, my I'm not going to speak much about the EGFR inhibitors. I think they will make their presentations at ASCO. We will learn more. At this point, we can't say any more than they have currently presented to the markets. We have no additional information on how their programs are performing. But with regards to PDS Biotech, and our versatile 002 trial, as one of the key characteristics of this technology and the product is the On our corporate deck, one of the slides that shows how these patients react long term. I think one of the key things with oncology today with the current cytotoxic drugs, including cetuximab, is you get pretty good responses upfront, a good objective response rates. But what we have not seen to date in head and neck cancer, and many other cancers is once you are able to achieve these clinical you maintain these responses long term. That is the challenge, and that is exactly what we see with our adverse immune HPV plus KEYTRUDA formulation, where the patients who have clinical responses, including stable disease, partial responses, and complete responses, the majority of these patients appear to be maintaining those clinical responses long term and that has translated also to survival, which is very important. And so, as our last presentation at ASCO, as you recall, we presented a 30-month median overall survival, right. The standard today is approximately 12 months. So, really just putting that into perspective, right. Today, with the standard of care, if a patient had gone on to the standard of care, which have been KEYTRUDA or KEYTRUDA chemo. The probability of living 12 months was about 50%. You had a 50% probability of living for 12 months. However, if that patient had gone on to our versatile 002 trial, They had a 50% probability of living for 30 months or more. Right, that's the kind of durability we've seen in this HPV 16 population, which by the way, in some studies that have been public, have shown that in head and neck cancer, they found that in HPV 16 patients had the worst prognosis for survival once the disease becomes an advanced recurrent metastatic disease, to HPV negative and other types of HPV, the HPV 16 positive patients had by far the worst survival prognosis. So this is for us is an extremely encouraging result. And what we tend to do is to give an additional update on a more recent data cut on that durability and survival of these patients in the versatile 002 trial. Mayank Mamtani Thank you, Frank. Frank Bedu-Addo You're welcome. Operator Joe Pantginis, H. C. Wainwright & Co. Joe Pantginis Hi guys, good morning. Thanks for taking the question. So, I want to ask two nuanced questions regarding your two lead programs, and part of it you've already started to discuss. So first with KEYNOTE-689, when you're comparing it again, it's apples and oranges, even though I think from a perception standpoint. There are some, I guess, investor, comparing apples to oranges here, at least from a perception standpoint, so I'm just curious, how do you view the learning curve here and does it apply at all and I don't think it does, to physicians, impact and being able to want to participate in versatile 003 and then I have a follow up. Frank Bedu-Addo So, no to date and I'll ask Kirk to give his opinions on that. But to date, we have seen very strong enthusiasm from the investigators and the key opinion leaders in actually participating in the versatile 002 trial. I'll actually hand over to Kirk to give any comments before I get back to continuing my answer. Kirk, any comments on interest in the trial based on KEYNOTE-689. Kirk Shepard Yes, no, the response was very brisk and all the same from our steering committee, which are the experts in head and neck cancer, that 689 does not apply to HPV positive patients. And this is even before they saw the data broken down, which we saw at the AACR. And sure enough, when we saw the data, as Frank had mentioned, I mentioned earlier too, only 3% of the patients were HPV positive because it's not appropriate to treat these patients with surgery upfront. So, it's been discussed a lot with our investigators and especially our steering committee that this should not affect our patient accrual at all. And we're very fortunate that we have a number of versatile 002 investigators with us now who have experience with this drug and are very excited for versatile 003 to get started. Frank Bedu-Addo Thanks a lot, Joe, so along those lines, I think very importantly, I think that the oncologist and the key opinion leaders in the space really understand that this there are very few people who are going to be HPV positive who will be eligible for that new Apan treatment. And one of the things you can see in relation to that is that even at Mayo Clinic, one of the studies that we will be presenting at ASCO has to do with utilizing our Versamune HPV plus KEYTRUDA in that new adjuvan setting for HPV 16 positive patients. And one of the key things that the KOLs mentioned on our last AOL call was that their very strong recommendation for this combination based upon the tolerability that we've seen in the patients today would be to rapidly move it into that earlier stage setting, which would be locally advanced head and neck cancer. we have, we've already seen the experts in the field, based upon the promising results that we've seen in versatile 002, take that. Combination to start evaluating it in this patient population who will not be really impacted, who may not get any benefit from the KEYNOTE-689 since the HPV positive, can we take our combination and apply it now to those patients who may not be eligible for surgery, but can go on this new adjuvant/adjuvant treatment with our we see a significant opportunity for this combination there too. Joe Pantginis Great, I appreciate that added color, Frank and Kirk. So, my second nuanced question is your newly or IND approved, MUC1 program, so I wanted to do a little bit of historical perspective to where we are today and especially your program. I want to focus on the antigen itself; this has been a key target. I mean, MUC1 for immunotherapy and or cancer vaccines for more than two decades now, and there have been some, pretty high-profile failures with this target. So, I wanted to just get a little more sense again from you guys, why are you differentiated here, and I guess can you describe interest, from sites to participate knowing this history. Thanks a lot. Frank Bedu-Addo Really great question, Joe. Well, I'll start by saying that very similarly in HPV 16 positive head and neck cancer, cervical cancer over the last 20 years, there have also been some very high-profile failures. Right. However, with our technology, we now see that for the first time, we have a technology and product that has now has really strong data, very durable responses in moving into a pivotal registrational trial for the first time, right. There have been many failures in HPV 16, positive cancer over the last 20 years. the reason I'm giving you this analogy is it's important to recognize two things, not only the antigen. But the technology that is able to now perform the immunological function that the previous technologies have not been able to perform. That's very important in being able to activate the right immunological signaling pathways and also more effectively present those antigens into the right presentation pathways. So having a strong antigen doesn't get you very far. If it can't be effectively presented. And the right immunological pathways also activated both have to go hand in hand, now, moving from where we've demonstrated that this technology can do this effectively in head and neck cancer with the HPV antigens, we're now moving on to the Mach one after this proof of con solid proof of concept that we've generated the Mach one, these are novel antigens, agonist, what we call agonist epitopes that have been designed by the National Cancer Institute. And what they have, what they, these antigens have been designed to do is to be much more immunologically potent than the native MUC1 antigens. Therefore, having a much stronger ability to activate the immune system to recognize MUC1 as a foreign agent. And what we have now done is now taken our verse immune it with those novel or more potent antigens to facilitate their presentation to the immune system and to facilitate the training of the immune system to recognize them as foreign agents and then also activate those trained T cells to now be a lot more potent in attacking and killing the MUC1 positive And so, really, we have to look at it in the entirety of what's really happening here. The antigen alone does not do much to guarantee you or to generate an effective anti-tumor response. And what we're also doing in the study is combining it with our IL-12 anti-used antibody drug conjugate, right. And so, with the IL-12, we have demonstrated also with our HPV programs that by targeting the tumors and really driving the IL-12 away from the circulating blood, but into the tumors, which is the tumors are the required site of T cell activation, right. So, by being able to get both our T cells. And the IL-12 into the patient's tumors. We've also demonstrated significantly enhanced survival and anti-tumor responses. So, the goal is to apply this combination again to this program is being performed as part of our collaboration, collaborative research involvement agreement with the National Cancer Institute. So, this is a program where the first trial is going to be a single-site study and that's going to be done by the NCI. And this collaboration also allows us to focus our resources and efforts on running our versatile 003 program. Joe Pantginis Frank, really appreciate that detailed explanation and looking forward to see initial data thanks a lot. Frank Bedu-Addo You're welcome. Operator James Molloy, Alliance Global Partners. James Molloy Hi Frank, good you for taking my question. Just a quick, follow up on, 003. Has the first patient, have you guys announced the enrollment of the first patient yet. I, did I miss that, or what's the expectation on that. And then any anecdotal comments, from the docs on how they on enrollment and how sort of that's proceeding or how the conversations are going with the potential enrollees. Frank Bedu-Addo No, we have not made it public in how enrollment is going. So, as James, once the sites are activated, we act the sites actually have a number of internal processes they will undergo followed by screening of patients. So, the patients have to be screened that's part of the process of getting all these patients into the trial. This process is occurring as we continue to activate more sites, and the goal is to hopefully eventually get to a steady recruitment as the larger sites such as Mayo Clinic take longer to activate and get going. So our goal here is to update the markets when we have a much better idea of how enrollment is going and when we are able to approximately estimate when we're going to get to that interim data readout point. So, we will provide more updates when we have much better insight into when we, how the, what the recruitment rates should be and when we'll get to those data readout points. James Molloy That makes sense. Just starting the trial literally to try to guess that yet, I guess, and then maybe, on a mechanistic looking at the print for the OpEx for the quarter. Is this sort of the level we should anticipate going forward or expect that to kind of ramp up going through '25 or '26. Frank Bedu-Addo Lars, I'll hand over to you for that. Lars Boesgaard Yes, hi Jim. This is Las here. Yes, so we don't currently provide financial guidance, but I think it's fair to say that that we're happy the trial is, has been started well, the way it has, and as you probably are aware, right, we do tend to see a bit of a higher spend in the first couple of quarters, like we get the year up and running. So, I think without giving you any specific numbers, I think we see a relatively stable in terms of the trial spends going forward. James Molloy Okay great thank you very much for taking the questions. Operator There are no further questions at this time. I would now like to turn the floor back over to Dr. Frank do for closing comments. Frank Bedu-Addo Thank you, closing, we are very pleased to have initiated the versatile 002 registration trial this quarter. This study is the first phase 3 clinical trial specifically in the growing population of HPV 16 positive head and neck are excited based on the strong Versatile 002 results and our fast-track designation about the potential for Versamune HPV in head and neck cancer. We expect to provide updated results from our ongoing phase 2 versatile 002 study at ASCO in a couple of weeks. Our engagement with investors and clinical investigators has validated our approach and the long-term opportunity that we believe the H targeted immunotherapy presents in the HPV 16 positive head and neck cancer look forward to keeping you updated on our progress. And thank you very much again for your time and support. Thanks a lot. Operator This includes today's teleconference. You may disconnect your lines at this you for your participation. Sign in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
PDS Biotechnology commences trial for head and neck squamous cell carcinoma
PDS Biotechnology has commenced the randomised, multi-centre Phase III clinical trial, VERSATILE-003, to assess the efficacy and safety of Versamune HPV plus pembrolizumab for head and neck squamous cell carcinoma (HNSCC). The combination therapy is intended for use as a first-line treatment of individuals with recurrent or metastatic HPV16-positive HNSCC. According to the company, the open-label, global and controlled trial is structured for enrolling nearly 350 subjects. They will be assigned to either the investigational arm or to a control arm, receiving only pembrolizumab at a 2:1 ratio. Overall survival is the primary endpoint, with secondary endpoints being progression-free survival, objective response rate, duration of response, and disease control rate. Mayo Clinic Comprehensive Cancer Center Oncology, Head and Neck Disease Group associate professor Katharine Price is set to oversee the trial as principal investigator. PDS Biotechnology CEO and president Frank Bedu-Addo said: 'We are thrilled to share that the first trial site has been initiated, and activation of additional clinical sites continues. 'Considering the strength and durability of the clinical responses in our VERSATILE-002 study, we are pleased to get this registrational trial underway. We are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care.' Versamune HPV is a subcutaneous immunotherapy that has demonstrated 'potential' in stimulating high levels of HPV16-specific cluster of differentiation 8 +(CD8+) and CD4+ T cells, activating several immune pathways. It received fast track designation from the US Food and Drug Administration (FDA). This status could result in a priority review for the biologics license application (BLA) when submitted. This decision by the US regulator is supported by data from the multicentre VERSATILE-002 Phase II trial. The company is advancing its lead programme in advanced HPV16-positive head and neck squamous cell cancers with the pivotal trial. PDS stated that Versamune HPV is being developed not only in conjunction with a standard-of-care immune checkpoint inhibitor, but also in a triple combo therapy that includes the Interleukin-12 (IL-12) IL-12 fused antibody-drug conjugate (ADC), PDS01ADC, and a standard-of-care immune checkpoint inhibitor. "PDS Biotechnology commences trial for head and neck squamous cell carcinoma" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
