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Zetagen Therapeutics Secures Composition-of-Matter Patents from USPTO for Novel Breast Cancer Platform

via Business Wire

(Composition-of-matter and compound patents are valuable forms of intellectual property within the pharmaceutical industry)

  • Zetagen Therapeutics receives allowances and issuances for first-of-its-kind breast cancer drug candidates: ZetaMet™, ZetaMast™, and ZetaPrime™
  • Enhanced Intellectual Property Portfolio – These allowances and newly granted patent reinforce Zetagen’ s expansive IP estate, now surpassing 70 assets worldwide
  • Expanded Protection & Strategic Value – These patents underscore the company's defensible innovation, strengthening its appeal to investors, partners, and future acquirers

Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via intratumorally administration, for primary and metastatic breast cancers, announced today they have successfully secured the foundational Composition-of-Matter patents and claims from the USPTO for their proprietary breast cancer platform.

“Securing these allowances and composition-of-matter patents for our intratumorally administered breast cancer therapeutics represents a strategic leap forward in our mission to redefine oncologic care,” said Joe C. Loy, CEO of Zetagen Therapeutics. “This latest patent protects the molecular uniqueness of our drug ZetaPrime™ and affirms the disruptive potential in our pursuit to minimize off target side effects of conventional chemotherapeutics. We are proud to advance precision therapies designed to target tumors directly and deliver meaningful hope to patients with limited options.”

Zetagen Therapeutics has built a robust intellectual property portfolio anchored in its groundbreaking discoveries in intratumorally drug administration for both primary and metastatic breast cancer. The company’s IP estate—which now includes multiple composition-of-matter patents—focuses on proprietary and established molecules designed to be delivered directly into tumors, reducing systemic toxicity and off-target side effects. This precision method not only protects healthy tissue but also holds the potential to significantly improve survival outcomes by enhancing therapeutic efficacy at the site of disease. Zetagen’ s growing suite of patents underscores its commitment to redefining standards of care and advancing targeted oncology innovation.

“Receiving multiple composition-of-matter patents for our breast oncology candidates is a transformative milestone for our scientific and clinical mission,” said Bryan S. Margulies, Ph.D., CSO of Zetagen Therapeutics. "By securing these patents, we validate the unique molecular design of our compounds and strengthen our pursuit of transformative therapies for underserved patient populations."

Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

About ZetaMet™ (Zeta-BC-003) – Lead Drug Candidate:

ZetaMet™ is a groundbreaking molecular pathway drug, targets metastatic breast cancer in bone, ceasing lytic activity, inhibits pain, and regenerates new bone all via locoregional administration, 30-minute outpatient procedure, without systemic limitation, minimizing skeletal related events (SRE) while increasing survival rates.

ZetaMet™ has been awarded 2x FDA Breakthrough Designations and has been approved in the treatment of 8x Compassionate Use stage 4 cancer patients in the US and Canada. ZetaMet™ has demonstrated cross-species efficacy at consistent concentrations, with findings published in several peer-reviewed journals—underscoring its translational promise from lab to clinic. Notably, these individuals had previously failed to respond to standard treatments such as chemotherapy, surgery, and radiation.

Zetagen has successfully completed enrollment of phase 2a clinical trial for the treatment of metastatic breast cancer to the spine, University of British Columbia, preliminary results available upon request and full study results anticipated November 2025.

About ZetaMast™ (Zeta-MBC-005)

ZetaMast™ is a proprietary drug-eluting hydrogel carrier designed for locoregional administration, controlled release of small molecules in treatment of multifocal, unresectable, liver metastases from breast cancer with potential to increase survival rates.

Zetagen has completed preclinical studies, drug elution refinement, toxicity testing and a dose optimization study, results published in peer-review journal PLOS-One.

Zetagen plans to file an IND with the FDA this fall and upon approval conduct a Phase 1b dose escalation study early 2026.

About ZetaPrime™ (Zeta-PBC-007)

ZetaPrime™ is a neo-adjuvant treatment for primary HR+ breast cancer, engineered for a locoregional administration following diagnosis. Utilizing a proprietary hydrogel-like lipid carrier, formulation enables controlled release of two small molecules— one being our novel molecular entity, and the ability to deliver other companies CDK4 or CDK4/6 protein inhibitor and any anticancer therapeutic. Designed for solubility within adipose tissue, approach targets primary breast cancer, aiming to mitigate off-target effects, reduce necessity for lumpectomies and mastectomies, postpone radiation exposure, and enhance patient survival.

About Zetagen Therapeutics

Founded in 2015, Zetagen Therapeutics is a private, clinical-stage, biopharmaceutical company, dedicated to developing proprietary carriers delivering tumoricidal therapies intratumorally via a singular injection for primary and metastatic breast cancer, minimizing patient side effects and postponing palliative radiation with the potential to increase survival rates.

The company's ‘Zeta” platform encompasses the following breast cancer drug candidates ZetaMet™ (Zeta-BC-003), ZetaMast™ (Zeta-MBC-005) and (NEW) ZetaPrime™ (Zeta-PBC-007). To learn more, visit www.zetagen.com.

Zetagen Upcoming Events

Zetagen will attend the San Antonio Breast Cancer Symposium (SABCS) in December.

Forward-Looking Statements

This press release contains certain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

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