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PDS Biotech Announces New Composition of Matter Patent for PDS0101 in Japan

1. PDSB receives broad patent for PDS0101 in Japan, enhancing IP portfolio. 2. Market exclusivity for PDS0101 extends into the 2040s in the U.S. 3. PDS0101 is in Phase 3 trials for HPV16-related cancer treatment. 4. Growing incidence of HPV16-related cancers increases market demand for PDS0101. 5. Company plans to strengthen its IP protections for PDS0101 and other agents.

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Why Bullish?

The patent enhances PDSB's competitive advantage, historically linked to rising stock value post-ip announcement.

How important is it?

The patent secures PDSB's market position and future revenue streams, making it highly impactful.

Why Long Term?

Strong patent protection will support sustained revenue growth over the decade.

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PDS Biotech Secures Patent for PDS0101 in Japan: Key Developments

December 09, 2025 | Source: PDS Biotechnology Corporation

New Patent Enhances Intellectual Property Protections for PDS0101

PDS Biotechnology Corporation (Nasdaq: PDSB), a leader in late-stage immunotherapy, has announced a significant milestone with the issuance of Patent No. 7783866 by the Japan Patent Office. This patent grants comprehensive composition of matter and methods of use claims for PDS0101, further strengthening the company's robust intellectual property portfolio.

The new patent complements existing protections for PDS0101 in the United States, China, Australia, and Hong Kong, extending the company’s market exclusivity into the 2040s. Anticipated biologics exclusivity in the United States enhances these protections, vital for the commercialization processes of PDS0101.

Context: Rising Incidence of HPV16-Related Cancers

The incidence of HPV16-related cancers continues to rise sharply, particularly in the U.S. and Europe. PDS0101 is currently undergoing a Phase 3 clinical trial in combination with pembrolizumab, targeting HPV16-positive recurrent/metastatic head and neck cancer.

Dr. Frank Bedu-Addo, President and CEO of PDS Biotechnology, emphasized the importance of this patent: “The issuance of an additional patent for PDS0101 in Japan... marks an important step in protecting the value of our innovative immunotherapies as we advance our pipeline worldwide.”

Future Strategies and Research Directions

PDS Biotech plans to continue expanding its intellectual property protections not only for PDS0101 but also for other investigational agents in development. The company's commitment to safeguarding its innovations underscores the strategic importance of strong patent rights in the competitive biopharmaceutical landscape.

  • Recent patent granted for PDS0101 in Japan enhances global IP portfolio.
  • Continuous efforts to expand patent protections across various regions.
  • Focus on advancing clinical trials and research in immunotherapy.

About PDS Biotechnology Corporation

PDS Biotechnology is at the forefront of immunotherapy innovation, aiming to transform how the immune system interacts with cancer cells. The company has launched pivotal trials for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers. Its investigational therapy, PDS0101 (Versamune® HPV), is in development alongside standard immune checkpoint inhibitors.

For additional details, visit www.pdsbiotech.com.

Forward-Looking Statements

This article contains forward-looking statements regarding PDS Biotechnology Corporation’s operations and future goals. These predictions are subject to risks and uncertainties and involve assumptions regarding anticipated performance. Actual results may differ materially from those projected, influenced by a variety of factors.

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