PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer
PDS Biotechnology (PDSB) has received FDA clearance for its IND application to evaluate the combination of Versamune® MUC1 and PDS01ADC in treating metastatic colorectal cancer (mCRC). The Phase 1/2 trial will be conducted under a Cooperative Research and Development Agreement with the National Cancer Institute.
The treatment targets MUC1-positive tumors in Proficient Mismatch Repair/Microsatellite Stable mCRC, which represents 95% of mCRC patients. These tumors typically show resistance to current immunotherapies and second-line chemotherapy. The company recently received U.S. Patent #12,201,685 for methods using combinations of the Versamune® platform and various immunocytokines.
While this marks progress for the Versamune® platform's expansion beyond HPV-related cancers, PDS Biotech maintains its primary focus on the ongoing VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma.
PDS Biotechnology (PDSB) ha ricevuto l'approvazione dalla FDA per la sua domanda IND per valutare la combinazione di Versamune® MUC1 e PDS01ADC nel trattamento del cancro colorettale metastatico (mCRC). La sperimentazione di Fase 1/2 sarà condotta sotto un Accordo di Ricerca e Sviluppo Cooperativo con il National Cancer Institute.
Il trattamento mira ai tumori positivi per MUC1 in pazienti con mCRC a Riparazione Errata Proficiente/Stabilità dei Microsatelliti, che rappresentano il 95% dei pazienti con mCRC. Questi tumori mostrano tipicamente resistenza alle attuali immunoterapie e alla chemioterapia di seconda linea. L'azienda ha recentemente ricevuto il brevetto statunitense #12,201,685 per metodi che utilizzano combinazioni della piattaforma Versamune® e vari immunocitochine.
Questo segna un progresso per l'espansione della piattaforma Versamune® oltre i tumori correlati all'HPV, ma PDS Biotech mantiene il suo focus principale sulla sperimentazione clinica di Fase 3 VERSATILE-003 nel carcinoma a cellule squamose della testa e del collo positivo per HPV16.
PDS Biotechnology (PDSB) ha recibido la aprobación de la FDA para su solicitud IND para evaluar la combinación de Versamune® MUC1 y PDS01ADC en el tratamiento del cáncer colorrectal metastásico (mCRC). El ensayo de Fase 1/2 se llevará a cabo bajo un Acuerdo de Investigación y Desarrollo Cooperativo con el Instituto Nacional del Cáncer.
El tratamiento se dirige a tumores positivos para MUC1 en pacientes con mCRC con Reparación de Errores Proficiente/Estabilidad de Microsatélites, que representan el 95% de los pacientes con mCRC. Estos tumores suelen mostrar resistencia a las inmunoterapias actuales y a la quimioterapia de segunda línea. La empresa recibió recientemente la Patente de EE. UU. #12,201,685 para métodos que utilizan combinaciones de la plataforma Versamune® y varias inmunocitoquinas.
Si bien esto marca un progreso para la expansión de la plataforma Versamune® más allá de los cánceres relacionados con el HPV, PDS Biotech mantiene su enfoque principal en el ensayo clínico de Fase 3 VERSATILE-003 en carcinoma de células escamosas de cabeza y cuello positivo para HPV16.
PDS Biotechnology (PDSB)는 전이성 대장암(mCRC) 치료를 위한 Versamune® MUC1와 PDS01ADC의 조합을 평가하기 위해 FDA의 IND 신청 승인을 받았습니다. 1/2상 시험은 국립암연구소와의 협력 연구 개발 협약에 따라 진행됩니다.
이 치료법은 MUC1 양성 종양을 목표로 하며, 이는 mCRC 환자의 95%를 차지하는 유전자 수선이 능숙한/마이크로위성 안정성 환자에서 발생합니다. 이러한 종양은 현재의 면역 요법 및 2차 화학 요법에 대한 저항성을 보이는 경향이 있습니다. 회사는 Versamune® 플랫폼과 다양한 면역 사이토카인을 사용하는 방법에 대해 미국 특허 #12,201,685를 최근에 받았습니다.
이것은 HPV 관련 암을 넘어 Versamune® 플랫폼의 확장을 위한 진전을 나타내지만, PDS Biotech은 HPV16 양성 두경부 편평 세포 암종에 대한 진행 중인 VERSATILE-003 3상 임상 시험에 주력하고 있습니다.
PDS Biotechnology (PDSB) a reçu l'approbation de la FDA pour sa demande IND visant à évaluer la combinaison de Versamune® MUC1 et PDS01ADC dans le traitement du cancer colorectal métastatique (mCRC). L'essai de Phase 1/2 sera mené dans le cadre d'un Accord de Recherche et Développement Coopératif avec le National Cancer Institute.
Le traitement cible les tumeurs positives pour MUC1 chez les patients atteints de mCRC à Réparation des Erreurs Proficiente/Stabilité des Microsatellites, représentant 95% des patients atteints de mCRC. Ces tumeurs montrent généralement une résistance aux immunothérapies actuelles et à la chimiothérapie de deuxième ligne. L'entreprise a récemment obtenu le brevet américain #12,201,685 pour des méthodes utilisant des combinaisons de la plateforme Versamune® et de diverses immunocytokines.
Bien que cela marque un progrès pour l'expansion de la plateforme Versamune® au-delà des cancers liés au HPV, PDS Biotech maintient son attention principale sur l'essai clinique de Phase 3 VERSATILE-003 dans le carcinome épidermoïde de la tête et du cou positif pour HPV16.
PDS Biotechnology (PDSB) hat die Genehmigung der FDA für seinen IND-Antrag erhalten, um die Kombination von Versamune® MUC1 und PDS01ADC zur Behandlung von metastasiertem kolorektalem Krebs (mCRC) zu evaluieren. Die Phase 1/2-Studie wird unter einem Kooperativen Forschungs- und Entwicklungsvereinbarung mit dem National Cancer Institute durchgeführt.
Die Behandlung zielt auf MUC1-positive Tumoren bei Patienten mit kompetenter Fehlerreparatur/mikrosatellitenstabilen mCRC ab, die 95% der mCRC-Patienten ausmachen. Diese Tumoren zeigen typischerweise eine Resistenz gegenüber aktuellen Immuntherapien und einer Chemotherapie der zweiten Linie. Das Unternehmen hat kürzlich das US-Patent #12,201,685 für Methoden erhalten, die Kombinationen der Versamune®-Plattform und verschiedener Immunzytokine verwenden.
Obwohl dies einen Fortschritt für die Erweiterung der Versamune®-Plattform über HPV-bezogene Krebserkrankungen hinaus darstellt, bleibt PDS Biotech weiterhin auf die laufende Phase-3-Studie VERSATILE-003 bei HPV16-positivem Kopf- und Halsplattenepithelkarzinom fokussiert.
- FDA clearance received for IND application to begin Phase 1/2 trials
- Treatment targets 95% of mCRC patient population
- New U.S. Patent granted for Versamune® platform combinations
- Partnership with National Cancer Institute through CRADA agreement
- Treatment still in early clinical development phase
- Company resources divided between multiple clinical programs
- Targets tumors historically resistant to immunotherapy
Insights
PDS Biotech's FDA clearance for their Versamune® MUC1 + PDS01ADC combination IND represents a significant pipeline expansion beyond their lead HPV-focused programs. This regulatory milestone enables progression to Phase 1/2 trials for metastatic colorectal cancer (mCRC) through a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute—a partnership structure that typically reduces development costs and leverages federal expertise.
The strategic value extends beyond this single indication. MUC1 is overexpressed in multiple large-market cancer types including colon, pancreatic, ovarian, breast, and non-small cell lung cancers, potentially creating a platform opportunity with broad applications. For context, colorectal cancer alone has a market size approaching
The recently issued U.S. Patent #12,201,685 strengthens their intellectual property position, covering methods of using Versamune® combinations with immunocytokines. This patent protection is particularly valuable for a small-cap biotech (
Most importantly, this candidate targets Proficient Mismatch Repair/Microsatellite Stable mCRC—representing
The Versamune® MUC1 + PDS01ADC combination represents a mechanistically sound approach to a challenging cancer subset. Microsatellite Stable colorectal cancers have historically shown response to immunotherapies due to their non-inflamed tumor microenvironment and low mutational burden.
What differentiates this approach is the combination of targeted MUC1 immunotherapy with an antibody-drug conjugate (ADC). Versamune® technology helps activate dendritic cells and generate tumor-specific CD8+ T cells, while the ADC component can deliver cytotoxic payloads directly to cancer cells. The synergistic potential could help overcome the immunotherapy resistance typically seen in MSS colorectal cancers.
MUC1 represents a compelling target as it's not just overexpressed in
The NCI's involvement through the CRADA arrangement adds scientific credibility. The institute typically selects promising novel agents for such collaborations and contributes significant resources toward clinical development.
While patient outcomes in refractory mCRC remain poor with current standard treatments, this dual-mechanism approach targeting a well-validated tumor-associated antigen could potentially drive more durable responses than single-agent approaches—though efficacy still needs to be demonstrated in clinical trials.
Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer Institute
Second Versamune® platform candidate targets MUC1-positive solid tumors
U.S. Patent #12,201,685 covering methods of using combinations of the Versamune® platform and various immunocytokines, including PDS01ADC recently issued
PRINCETON, N.J., March 13, 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 that the U.S. Food and Drug Administration has cleared its Investigational New Drug (“IND”) application filed in January 2025 to evaluate a combination of Versamune® MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma (“mCRC”) in patients who failed previous treatment.
“MUC1 is over-expressed in multiple solid tumors including colon, pancreatic, ovarian, breast, and NSCLC, and is associated with drug resistance and poor patient outcomes. This results in an unmet need for more effective, safer, better-tolerated targeted treatment options. Versamune® MUC1 targets mCRC tumors that are MUC1-positive and will be studied in Proficient Mismatch Repair/Microsatellite Stable mCRC, which accounts for
The National Cancer Institute (“NCI”), under its Cooperative Research and Development Agreement (“CRADA”) with PDS Biotech, will lead the Phase 1/2 clinical trial evaluating the combination of Versamune® MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.
“The IND clearance of Versamune® MUC1 marks progress for our Versamune® platform and its potential to expand beyond HPV-related cancers,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Though our focus remains on our recently initiated VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma, we are pleased to support the NCI investigation of a therapy that shows promise in driving strong, durable anti-tumor immune responses.”
U.S. Patent #12,201,685 covers the methods of using the proprietary combination of Versamune® and cytokines to overcome immune suppression in the tumor and improve the anti-tumor immune response.
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 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 conduct planned clinical trials for Versamune® HPV, PDS01ADC, Versamune® MUC1 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, Versamune® MUC1 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
What is the significance of FDA's IND clearance for PDSB's Versamune® MUC1 combination therapy?
What percentage of metastatic colorectal cancer patients could potentially benefit from PDSB's new treatment?
What types of cancers express MUC1 that could be targeted by PDSB's Versamune® MUC1?
What patent protection has PDSB secured for its Versamune® platform combination therapy?
