PDS Biotech Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer
PDS Biotech (PDSB) has initiated VERSATILE-003, a groundbreaking Phase 3 clinical trial evaluating Versamune® HPV in combination with pembrolizumab for HPV16-positive head and neck cancer treatment. This global, multi-center study represents the first-ever Phase 3 trial for this specific cancer type.
The trial will enroll approximately 350 patients in a 2:1 ratio, comparing the combination therapy against pembrolizumab alone as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The study's primary endpoint is overall survival, with secondary endpoints including objective response rate and progression-free survival.
Following promising results from the VERSATILE-002 Phase 2 trial, Versamune® HPV received Fast Track designation from the FDA, making it eligible for Priority Review upon Biologics License Application submission. Dr. Katharine Price from Mayo Clinic Comprehensive Cancer Center will serve as the Principal Investigator.
PDS Biotech (PDSB) ha avviato VERSATILE-003, un innovativo studio clinico di fase 3 che valuta Versamune® HPV in combinazione con pembrolizumab per il trattamento del cancro testa-collo positivo per HPV16. Questo studio globale e multicentrico rappresenta il primo trial di fase 3 mai condotto per questo specifico tipo di cancro.
Lo studio prevede l'arruolamento di circa 350 pazienti in un rapporto di 2:1, confrontando la terapia combinata con pembrolizumab da solo come trattamento di prima linea per il carcinoma squamoso della testa e del collo (HNSCC) recidivante/metastatico positivo per HPV16. L'endpoint primario dello studio è la sopravvivenza complessiva, con endpoint secondari che includono il tasso di risposta obiettiva e la sopravvivenza libera da progressione.
Dopo risultati promettenti dal trial di fase 2 VERSATILE-002, Versamune® HPV ha ricevuto la designazione Fast Track dalla FDA, rendendolo idoneo per una Revisione Prioritaria al momento della presentazione della domanda di licenza biologica. La Dr.ssa Katharine Price del Mayo Clinic Comprehensive Cancer Center sarà il Ricercatore Principale.
PDS Biotech (PDSB) ha iniciado VERSATILE-003, un innovador ensayo clínico de fase 3 que evalúa Versamune® HPV en combinación con pembrolizumab para el tratamiento del cáncer de cabeza y cuello positivo para HPV16. Este estudio global y multicéntrico representa el primer ensayo de fase 3 jamás realizado para este tipo específico de cáncer.
El ensayo inscribirá aproximadamente 350 pacientes en una proporción de 2:1, comparando la terapia combinada con pembrolizumab solo como tratamiento de primera línea para el carcinoma de células escamosas de cabeza y cuello (HNSCC) recurrente/metastásico positivo para HPV16. El objetivo primario del estudio es la supervivencia general, con objetivos secundarios que incluyen la tasa de respuesta objetiva y la supervivencia libre de progresión.
Tras resultados prometedores del ensayo de fase 2 VERSATILE-002, Versamune® HPV recibió la designación de Vía Rápida de la FDA, lo que lo hace elegible para una Revisión Prioritaria al momento de presentar la solicitud de licencia biológica. La Dra. Katharine Price del Mayo Clinic Comprehensive Cancer Center será la Investigadora Principal.
PDS Biotech (PDSB)는 HPV16 양성 두경부암 치료를 위해 pembrolizumab과 함께 Versamune® HPV를 평가하는 혁신적인 3상 임상 시험 VERSATILE-003을 시작했습니다. 이 글로벌 다기관 연구는 특정 암 유형에 대한 최초의 3상 시험을 의미합니다.
이 시험은 약 350명의 환자를 2:1 비율로 등록하여, 재발/전이성 HPV16 양성 두경부 편평세포암(HNSCC)에 대한 1차 치료로 pembrolizumab 단독과 비교합니다. 연구의 주요 목표는 전체 생존율이며, 2차 목표로는 객관적 반응률과 무진행 생존이 포함됩니다.
VERSATILE-002 2상 시험에서 유망한 결과를 바탕으로, Versamune® HPV는 FDA로부터 신속 심사 지정을 받았으며, 생물학적 제품 면허 신청 시 우선 심사 대상이 됩니다. Mayo Clinic Comprehensive Cancer Center의 Katharine Price 박사가 주요 연구원으로 활동할 예정입니다.
PDS Biotech (PDSB) a lancé VERSATILE-003, un essai clinique de phase 3 révolutionnaire évaluant Versamune® HPV en combinaison avec pembrolizumab pour le traitement du cancer de la tête et du cou positif pour HPV16. Cette étude mondiale et multicentrique représente le tout premier essai de phase 3 pour ce type de cancer spécifique.
L'essai recrutera environ 350 patients dans un ratio de 2:1, comparant la thérapie combinée à pembrolizumab seul comme traitement de première ligne pour le carcinome épidermoïde récurrent/métastatique de la tête et du cou (HNSCC) positif pour HPV16. L'objectif principal de l'étude est la survie globale, avec des objectifs secondaires incluant le taux de réponse objective et la survie sans progression.
Suite à des résultats prometteurs de l'essai de phase 2 VERSATILE-002, Versamune® HPV a reçu la désignation Fast Track de la FDA, le rendant éligible à un examen prioritaire lors de la soumission de la demande de licence biologique. Dr. Katharine Price du Mayo Clinic Comprehensive Cancer Center sera l'investigateur principal.
PDS Biotech (PDSB) hat VERSATILE-003 initiiert, eine bahnbrechende Phase-3-Studie zur Bewertung von Versamune® HPV in Kombination mit Pembrolizumab zur Behandlung von HPV16-positivem Kopf-Hals-Krebs. Diese globale, multizentrische Studie stellt die erste Phase-3-Studie für diesen spezifischen Krebs dar.
Die Studie wird etwa 350 Patienten in einem Verhältnis von 2:1 einschließen, wobei die Kombinationstherapie mit Pembrolizumab allein als Erstlinientherapie für rezidivierende/metastatische HPV16-positive Plattenepithelkarzinome des Kopfes und Halses (HNSCC) verglichen wird. Der primäre Endpunkt der Studie ist das Gesamtüberleben, während sekundäre Endpunkte die objektive Ansprechrate und das progressionsfreie Überleben umfassen.
Nach vielversprechenden Ergebnissen aus der Phase-2-Studie VERSATILE-002 erhielt Versamune® HPV die Fast Track-Einstufung von der FDA, wodurch es für eine Prioritätsprüfung bei Einreichung des Antrags auf biologische Lizenz in Frage kommt. Dr. Katharine Price vom Mayo Clinic Comprehensive Cancer Center wird als Hauptprüfer fungieren.
- First-ever Phase 3 trial for HPV16-positive head and neck cancer
- FDA Fast Track designation received
- Promising results from Phase 2 VERSATILE-002 study
- Large-scale trial with 350 patients
- Potential for Priority Review upon BLA submission
- Results and efficacy yet to be proven in Phase 3
- Extended timeline required for patient enrollment and trial completion
- Competition from existing pembrolizumab treatment
Insights
PDS Biotech's initiation of the VERSATILE-003 Phase 3 clinical trial represents a significant milestone in their development pipeline. This pivotal trial evaluating Versamune® HPV in combination with pembrolizumab for HPV16-positive head and neck cancer carries several important implications:
The trial design demonstrates scientific rigor with 350 patients randomized 2:1 to receive either the combination therapy or pembrolizumab monotherapy. The primary endpoint of overall survival, coupled with comprehensive secondary endpoints, provides a robust framework for efficacy assessment.
Particularly noteworthy is the FDA Fast Track designation granted based on Phase 2 VERSATILE-002 results, which makes the therapy eligible for Priority Review upon BLA submission. This regulatory advantage could potentially accelerate approval timelines if trial results prove positive.
The combination approach with pembrolizumab (an established checkpoint inhibitor) suggests a mechanistically sound strategy. Versamune® HPV's ability to stimulate HPV16-specific T cells complements pembrolizumab's mechanism of releasing the brake on existing immune responses.
For a company with
The initiation of VERSATILE-003 addresses an important unmet need in HPV16-positive head and neck squamous cell carcinoma treatment landscape. As the first-ever Phase 3 trial specifically targeting this population, this represents a potential paradigm shift in how we approach these cancers.
Clinically, the combination approach is particularly promising. While pembrolizumab monotherapy has shown efficacy in HNSCC, many patients still don't respond optimally. The Versamune® technology potentially enhances immune response by activating multiple immune pathways and stimulating both CD8+ and CD4+ T cells specific to HPV16.
The trial's global, multi-center design under the leadership of Dr. Katharine Price from Mayo Clinic ensures robust patient recruitment and protocol execution. The 2:1 randomization favoring the investigational arm appropriately prioritizes gathering data on the novel combination while maintaining statistical power.
If successful, this approach could offer substantial clinical benefits compared to current standards. Immune-based therapies that specifically target the underlying viral etiology (HPV16) represent a mechanistically rational approach. The subcutaneous delivery also offers practical advantages for administration compared to some alternative treatment modalities.
The "strength and durability of clinical responses" mentioned from the Phase 2 study suggests promising preliminary efficacy, though the definitive assessment will come from this larger, randomized trial.
First-ever HPV16-positive head and neck cancer Phase 3 clinical trial
PRINCETON, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment.
“We are thrilled to share that the first trial site has been initiated and activation of additional clinical sites continues,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “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.”
VERSATILE-003 is a global, multi-center, randomized, controlled and open-label Phase 3 pivotal trial designed to evaluate the safety and efficacy of Versamune® HPV in combination with pembrolizumab as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The trial is designed to enroll approximately 350 patients into either the investigational arm or into a control arm receiving pembrolizumab alone at a 2:1 ratio. The primary endpoint is overall survival, and secondary endpoints include objective response rate, progression free survival, disease control rate and duration of response. Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center will serve as the trial’s Principal Investigator.
“Advancing into Phase 3 is a significant milestone in our mission to improve treatment options for patients with HPV16-positive recurrent/metastatic HNSCC,” noted Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “We are optimistic about the potential of Versamune® HPV in combination with pembrolizumab to enhance immune response and deliver meaningful clinical benefits.”
Versamune® HPV is an HPV-specific T cell stimulating immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. Based on data from the VERSATILE-002 Phase 2, open-label, multicenter trial, the U.S. Food and Drug Administration granted Versamune® HPV Fast Track designation, making it eligible for Priority Review at the time of Biologics License Application (BLA) submission. For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
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FAQ
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