PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line Recurrent or Metastatic Head and Neck Cancer
PDS Biotechnology (Nasdaq: PDSB) has aligned with the FDA on the Phase 3 VERSATILE-003 trial for its Versamune® HPV immunotherapy in HPV16-positive first-line recurrent or metastatic head and neck cancer. The trial, set to begin in Q4 2024, will focus on the combination of Versamune® HPV and pembrolizumab, which has received Fast Track designation. The company presented data from VERSATILE-002 and proposed a triple combination therapy, which the FDA supported. However, to avoid delays, the FDA agreed to proceed with the 2-arm double combination trial. The updated VERSATILE-003 study will have overall survival as the primary endpoint, with revised statistical endpoints based on mature survival data.
PDS Biotechnology (Nasdaq: PDSB) ha raggiunto un accordo con la FDA per il trial di Fase 3 VERSATILE-003 per la sua immunoterapia Versamune® HPV nel trattamento del cancro testa-collo ricorrente o metastatico di primo piano positivo per HPV16. Il trial, che inizierà nel quarto trimestre del 2024, si concentrerà sulla combinazione di Versamune® HPV e pembrolizumab, quest'ultimo ha ricevuto la designazione Fast Track. L'azienda ha presentato i dati del VERSATILE-002 e ha proposto una terapia di combinazione tripla, che è stata supportata dalla FDA. Tuttavia, per evitare ritardi, la FDA ha concordato di procedere con il trial a doppia combinazione a 2 bracci. Lo studio aggiornato VERSATILE-003 avrà come obiettivo primario la sopravvivenza globale, con endpoint statistici rivisti basati su dati di sopravvivenza maturi.
PDS Biotechnology (Nasdaq: PDSB) se ha alineado con la FDA en el ensayo de Fase 3 VERSATILE-003 para su inmunoterapia Versamune® HPV en cáncer de cabeza y cuello recurrente o metastásico positivo para HPV16 de primera línea. El ensayo, que comenzará en el cuarto trimestre de 2024, se centrará en la combinación de Versamune® HPV y pembrolizumab, el cual ha recibido la designación de Vía Rápida. La compañía presentó datos del VERSATILE-002 y propuso una terapia de combinación triple, que fue respaldada por la FDA. Sin embargo, para evitar retrasos, la FDA acordó proceder con el ensayo de combinación doble de 2 brazos. El estudio actualizado VERSATILE-003 tendrá la supervivencia global como punto final primario, con puntos finales estadísticos revisados basados en datos de supervivencia maduros.
PDS 바이오테크놀로지(Nasdaq: PDSB)는 HPV16 양성 재발성 또는 전이성 두경부암의 перш 번째 라인에서 Versamune® HPV 면역요법에 대한 Phase 3 VERSATILE-003 시험에 대해서 FDA와 협의하였습니다. 2024년 4분기에 시작될 이 시험은 Versamune® HPV와 빠른 경로 지정을 받은 pembrolizumab의 조합에 초점을 맞출 것입니다. 회사는 VERSATILE-002의 데이터를 발표하고 FDA의 지원을 받은 삼중 조합 요법을 제안했습니다. 그러나 지연을 피하기 위해 FDA는 2암중 조합 시험을 진행하기로 합의했습니다. 업데이트된 VERSATILE-003 연구는 전체 생존률을 주요 목적으로 하며, 성숙한 생존 데이터에 근거한 수정된 통계적 목표를 갖습니다.
PDS Biotechnology (Nasdaq: PDSB) a conclu un accord avec la FDA concernant l'essai de phase 3 VERSATILE-003 pour sa thérapie immunitaire Versamune® HPV dans le cancer de la tête et du cou récidivant ou métastatique de première intention positif pour HPV16. L'essai, qui devrait débuter au quatrième trimestre de 2024, se concentrera sur la combinaison de Versamune® HPV et de pembrolizumab, qui a obtenu la désignation Vitesse de traitement. L'entreprise a présenté les données de VERSATILE-002 et a proposé une thérapie de combinaison triple, qui a été soutenue par la FDA. Cependant, pour éviter des retards, la FDA a accepté de procéder à l'essai de combinaison double à 2 bras. L'étude mise à jour VERSATILE-003 aura la survie globale comme objectif principal, avec des points d'évaluation statistiques révisés basés sur des données de survie matures.
PDS Biotechnology (Nasdaq: PDSB) hat sich mit der FDA über die Phase 3 Studie VERSATILE-003 für ihre Versamune® HPV Immuntherapie bei HPV16-positivem, wiederkehrendem oder metastasiertem Kopf- und Halskrebs geeinigt. Die Studie, die im vierten Quartal 2024 beginnen soll, wird sich auf die Kombination von Versamune® HPV und Pembrolizumab konzentrieren, das die Fast-Track-Status erhalten hat. Das Unternehmen stellte Daten aus VERSATILE-002 vor und schlug eine dreifache Kombinationstherapie vor, die von der FDA unterstützt wurde. Um jedoch Verzögerungen zu vermeiden, stimmte die FDA zu, mit der 2-armigen Kombinationsstudie fortzufahren. Die aktualisierte VERSATILE-003-Studie wird das Überleben insgesamt als primären Endpunkt haben, mit überarbeiteten statistischen Endpunkten basierend auf ausgereiften Überlebensdaten.
- FDA alignment on Phase 3 VERSATILE-003 trial design
- Fast Track designation for Versamune® HPV + pembrolizumab combination
- Positive maturation of VERSATILE-002 results over the past year
- Strong key opinion leader and investigator support for VERSATILE-003 trial
- Delay in exploring triple combination therapy (Versamune® HPV + PDS01ADC + pembrolizumab)
- Additional safety analysis required for PDS01ADC dose optimization
Insights
PDS Biotech's alignment with the FDA on the Phase 3 VERSATILE-003 trial design for Versamune® HPV in HPV16-positive head and neck cancer is a significant development. The trial's focus on overall survival as the primary endpoint, coupled with the Fast Track designation, underscores the potential impact of this immunotherapy.
Key points to consider:
- The decision to proceed with a 2-arm double combination trial of Versamune® HPV + pembrolizumab, rather than including a third arm with PDS01ADC, demonstrates a strategic approach to expedite the trial initiation.
- The maturation of VERSATILE-002 results has allowed for revised statistical endpoints, potentially strengthening the study design.
- The FDA's support for both double and triple combinations suggests confidence in the Versamune® platform's potential.
However, investors should note that the separate dose optimization study for PDS01ADC could lead to future pipeline expansion, but may also require additional resources and time. The Q4 2024 initiation timeline gives PDS Biotech ample preparation time, which could be important for a well-executed Phase 3 trial.
The advancement of Versamune® HPV to Phase 3 in first-line recurrent or metastatic HPV16-positive HNSCC is noteworthy. This patient population has targeted treatment options, making this trial potentially groundbreaking.
Critical aspects to consider:
- The combination of Versamune® HPV with pembrolizumab could enhance the efficacy of immunotherapy in this specific cancer type.
- The focus on HPV16-positive HNSCC represents a precision medicine approach, which aligns with current trends in oncology.
- The reported encouraging survival and disease control response rates from VERSATILE-002 suggest promising efficacy, though full data will be important for a comprehensive evaluation.
It's important to note that while the Fast Track designation may expedite the regulatory process, the ultimate success will depend on the Phase 3 results. The planned future addition of PDS01ADC to the regimen indicates a multi-pronged strategy to potentially improve outcomes further, which could be a differentiator in the competitive oncology landscape.
PDS Biotech's progress with the FDA for its Phase 3 VERSATILE-003 trial presents a significant milestone for the company's pipeline and potential market position. Key financial implications include:
- Accelerated development timeline: The Q4 2024 initiation could mean faster time-to-market if the trial is successful, potentially leading to earlier revenue streams.
- Resource allocation: The decision to separate the PDS01ADC dose optimization study may require additional capital but allows for focused resource deployment on the main Phase 3 trial.
- Market opportunity: Targeting HPV16-positive HNSCC as a first-line treatment in recurrent or metastatic settings addresses a specific market need, which could translate to strong pricing power if approved.
Investors should monitor cash burn rates as the company prepares for this pivotal trial. The Fast Track designation may provide opportunities for more frequent FDA interactions and potential for priority review, which could enhance the company's value proposition. However, it's important to remember that Phase 3 trials are costly and success is not guaranteed, making this a high-risk, high-reward scenario for PDS Biotech's financial future.
Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024
Conference Call Today at 8:00 a.m. Eastern Time
PRINCETON, N.J., Aug. 01, 2024 (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 and the development of infectious disease vaccines, today announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding next steps in its planned Phase 3 clinical trial of its Versamune® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune® HPV (formerly PDS0101) in this indication.
PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune® HPV + pembrolizumab, and the triple combination of Versamune® HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune® HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune® HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.
The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune® HPV + pembrolizumab combination has received Fast Track designation.
“We appreciate the FDA’s support in the development of both the double and triple Versamune® HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune® HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy.”
Kirk Shepard, MD, Chief Medical Officer, continued, “We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial.”
Conference Call Details
Date: August 1, 2024
Time: 8:00 a.m. ET
Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 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 PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® 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 PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® 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® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
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6 Degrees
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Email: gmangiaracina@6degreespr.com
FAQ
When will PDS Biotech initiate the Phase 3 VERSATILE-003 trial for HPV16-positive head and neck cancer?
What is the primary endpoint of the VERSATILE-003 Phase 3 trial for PDSB's Versamune® HPV therapy?
Has the FDA granted any special designation to PDS Biotech's Versamune® HPV + pembrolizumab combination?
What recent data did PDS Biotech present to the FDA regarding its Versamune® HPV therapy?
