Latest news with #ZetagenTherapeutics
National Post
28-07-2025
- Business
- National Post
Zetagen Therapeutics Secures Composition-of-Matter Patents from USPTO for Novel Breast Cancer Platform
Article content (Composition-of-matter and compound patents are valuable forms of intellectual property within the pharmaceutical industry) Article content Article content Expanded Protection & Strategic Value – These patents underscore the company's defensible innovation, strengthening its appeal to investors, partners, and future acquirers Article content SYRACUSE, N.Y. — 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. Article content '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,' Article content said Joe C. Loy, CEO of Zetagen Therapeutics Article content . '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.' Article content 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. Article content said Bryan S. Margulies, Ph.D., CSO of Zetagen Therapeutics. Article content 'By securing these patents, we validate the unique molecular design of our compounds and strengthen our pursuit of transformative therapies for underserved patient populations.' Article content 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. Article content About ZetaMet™ (Zeta-BC-003) – Lead Drug Candidate: Article content 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. Article content 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. Article content 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. Article content 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. Article content 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. Article content 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. Article content About ZetaPrime™ (Zeta-PBC-007) Article content 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. Article content About Zetagen Therapeutics Article content 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. Article content 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 Article content Zetagen will attend the San Antonio Breast Cancer Symposium (SABCS) in December. Article content Forward-Looking Statements Article content 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. Article content Article content Article content Article content Article content Article content
Business Wire
17-06-2025
- Health
- Business Wire
Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases
SYRACUSE, N.Y.--(BUSINESS WIRE)--Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing first-of-its-kind targeted therapies for primary and metastatic breast cancer, announced today the peer-reviewed publication in PLOS-One of their dose optimization in-vivo study results of ZetaMast™ (Zeta-MBC-005). Zetagen identified two concentrations of ZetaMast™ (Zeta-MBC-005) which demonstrated superior effectiveness, reduction in tumor burden, and increased survival rate over control Doxorubicin. ' Patients with disseminated metastatic breast cancer involving the liver, face a poor prognosis and new approaches are urgently needed, ' stated Debasish Tripathy, MD, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. ' Although some therapies have been designed for direct administration for liver metastases, they have not demonstrated efficacy in significantly improving survival. ZetaMast™ is an innovative therapeutic approach that has demonstrated systemic biological effects potentially extending beyond liver metastases in preclinical models, offering promising potential to enhance outcomes in this setting.' ZetaMast™ (Zeta-MBC-005) Increased Survival in a Mouse Xenograft Liver Metastases Model. The 4T1, TNBC cell line, tagged with luc2 luciferase (4T1-luc2), was implanted directly into the liver of BALB/c mice. Seven days after tumor inoculation, mice were treated with various concentrations via a single administration of ZetaMast™ (Zeta-MBC-005) (30-, 60-, 120-, 180-, 240-, or 480-μg) in combination with 5-mg/kg doxorubicin. Mice in the Control group received 5 mg/kg of doxorubicin and the ZetaMast™ (Zeta-MBC-005) carrier without Zetagen's small molecule, administered every 72-hours. ZetaMast™ (Zeta-MBC-005) has the ability to deliver Zetagen's small molecules intratumorally as well as other therapies, avoiding off-target side effects. 'Effective locoregional therapies are likely the key to reducing breast cancer mortality for patients with disseminated metastatic disease and increasing 5-year survival above 31%. If treatments like ZetaMast™ (Zeta-MBC-005) can be given when and where needed, increasing the duration of overall tumor control, which may be enough to tip the balance towards a favorable impact on survival,' stated Bryan S. Margulies, MS, Ph.D., CSO of Zetagen. To view the ZetaMAST™ (Zeta-MBC-005) dose optimization study results go to About ZetaMAST™ (Zeta-MBC-005) ZetaMast™ (Zeta-MBC-005) is a proprietary drug eluting carrier designed for locoregional administration, controlled release of two small molecules in the treatment of multifocal, unresectable, liver metastases from breast cancer with the potential to increase survival rates. The USPTO has granted Zetagen a 'Composition of Matter' patent for ZetaMast™ (Zeta-MBC-005), and Zetagen has also submitted a filing to the FDA for Orphan Drug Designation. Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase 1b clinical trial set to commence early 2026. About Zetagen Therapeutics Zetagen has three novel drugs in development, ZetaMet™ (Zeta-BC-003), for the treatment of metastatic breast cancer to bone, ZetaMast™ (Zeta-MBC-005) for breast cancer liver metastases (BCLM), and (NEW) ZetaPrime™ (Zeta-PBC-007) for the treatment of primary HR+ breast cancer, all with inspiring results. To learn more, visit The FDA has acknowledged Zetagen's innovative research with multiple Breakthrough Designations, notably ZetaMet™ (Zeta-BC-003). Under FDA and Health Canada (HC) approval through the Expanded Access (Compassionate Use) programs, Zetagen has treated eight patients with ZetaMet™ (Zeta-BC-003), with results featured in several peer-reviewed journals. Furthermore, Zetagen has completed enrollment for its Phase 2a open-label clinical trial focused on treating metastatic breast cancer in the spine. Zetagen Upcoming Events Zetagen will attend the 2025 San Antonio Breast Cancer Symposium (SABCS). 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. Source: Zetagen Therapeutics, Inc.
Yahoo
17-06-2025
- Health
- Yahoo
Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases
(Patients with disseminated metastatic disease from breast cancer are likely to have liver involvement in >50% of cases at some point during disease progression. These patients have poor prognosis; and, when treated with the standard of care systemic therapy they have a median survival of <9-months.) Zetagen identifies two concentrations of ZetaMast™ (Zeta-MBC-005) which were most effective in treating metastatic triple negative breast cancer (TNBC) in the liver ZetaMast™ (Zeta-MBC-005) exhibits significant decrease in tumor volume (4-fold) vs. control Doxorubicin ZetaMast™ (Zeta-MBC-005) demonstrates a 3.9-fold increase in survival rate over control Doxorubicin with no lung or brain metastases. SYRACUSE, N.Y., June 17, 2025--(BUSINESS WIRE)--Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing first-of-its-kind targeted therapies for primary and metastatic breast cancer, announced today the peer-reviewed publication in PLOS-One of their dose optimization in-vivo study results of ZetaMast™ (Zeta-MBC-005). Zetagen identified two concentrations of ZetaMast™ (Zeta-MBC-005) which demonstrated superior effectiveness, reduction in tumor burden, and increased survival rate over control Doxorubicin. "Patients with disseminated metastatic breast cancer involving the liver, face a poor prognosis and new approaches are urgently needed," stated Debasish Tripathy, MD, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. "Although some therapies have been designed for direct administration for liver metastases, they have not demonstrated efficacy in significantly improving survival. ZetaMast™ is an innovative therapeutic approach that has demonstrated systemic biological effects potentially extending beyond liver metastases in preclinical models, offering promising potential to enhance outcomes in this setting." ZetaMast™ (Zeta-MBC-005) Increased Survival in a Mouse Xenograft Liver Metastases Model. The 4T1, TNBC cell line, tagged with luc2 luciferase (4T1-luc2), was implanted directly into the liver of BALB/c mice. Seven days after tumor inoculation, mice were treated with various concentrations via a single administration of ZetaMast™ (Zeta-MBC-005) (30-, 60-, 120-, 180-, 240-, or 480-μg) in combination with 5-mg/kg doxorubicin. Mice in the Control group received 5 mg/kg of doxorubicin and the ZetaMast™ (Zeta-MBC-005) carrier without Zetagen's small molecule, administered every 72-hours. ZetaMast™ (Zeta-MBC-005) has the ability to deliver Zetagen's small molecules intratumorally as well as other therapies, avoiding off-target side effects. "Effective locoregional therapies are likely the key to reducing breast cancer mortality for patients with disseminated metastatic disease and increasing 5-year survival above 31%. If treatments like ZetaMast™ (Zeta-MBC-005) can be given when and where needed, increasing the duration of overall tumor control, which may be enough to tip the balance towards a favorable impact on survival," stated Bryan S. Margulies, MS, Ph.D., CSO of Zetagen. To view the ZetaMAST™ (Zeta-MBC-005) dose optimization study results go to About ZetaMAST™ (Zeta-MBC-005)ZetaMast™ (Zeta-MBC-005) is a proprietary drug eluting carrier designed for locoregional administration, controlled release of two small molecules in the treatment of multifocal, unresectable, liver metastases from breast cancer with the potential to increase survival rates. The USPTO has granted Zetagen a "Composition of Matter" patent for ZetaMast™ (Zeta-MBC-005), and Zetagen has also submitted a filing to the FDA for Orphan Drug Designation. Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase 1b clinical trial set to commence early 2026. About Zetagen TherapeuticsZetagen has three novel drugs in development, ZetaMet™ (Zeta-BC-003), for the treatment of metastatic breast cancer to bone, ZetaMast™ (Zeta-MBC-005) for breast cancer liver metastases (BCLM), and (NEW) ZetaPrime™ (Zeta-PBC-007) for the treatment of primary HR+ breast cancer, all with inspiring results. To learn more, visit The FDA has acknowledged Zetagen's innovative research with multiple Breakthrough Designations, notably ZetaMet™ (Zeta-BC-003). Under FDA and Health Canada (HC) approval through the Expanded Access (Compassionate Use) programs, Zetagen has treated eight patients with ZetaMet™ (Zeta-BC-003), with results featured in several peer-reviewed journals. Furthermore, Zetagen has completed enrollment for its Phase 2a open-label clinical trial focused on treating metastatic breast cancer in the spine. Zetagen Upcoming EventsZetagen will attend the 2025 San Antonio Breast Cancer Symposium (SABCS). Forward-Looking StatementsThis 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. Source: Zetagen Therapeutics, Inc. 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National Post
06-05-2025
- Business
- National Post
Zetagen Therapeutics Announces Successful Completion of Enrollment in Phase 2a Clinical Study of ZetaMet™ (Zeta-BC-003) Metastatic Breast Cancer
Article content (690,000 patients annually are diagnosed with metastatic lytic bone lesions with only non-curative, palliative therapies available) Article content Article content ZetaMet™ (Zeta-BC-003) is a first-of-its kind molecular pathway designed to resolve metastatic cancer lesions, inhibit pain, and regenerate bone Phase 2a study examines the safety and efficacy of ZetaMet™ (Zeta-BC-003) for the treatment of metastatic bone lesions to the spine in Stage 4 breast cancer patients ZetaMet™ (Zeta-BC-003) has the potential to be a curative treatment, without systemic limitations, for metastatic lytic breast cancer lesions to bone Article content SYRACUSE, N.Y. — Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic and primary breast cancers, announced today they have successfully completed enrollment in their phase 2a study, which will evaluate ZetaMet™ (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions ( #NCT05280067). Article content 'We are excited to reach another critical milestone in the development of ZetaMet™ (Zeta-BC-003),' said Joe C. Loy, Zetagen's Chief Executive Officer. 'We launched this study with stage IV breast cancer patients suffering from spinal metastases, because we recognize their severe pain and how debilitating it is, and that current treatments remain largely palliative. Our objective with ZetaMet™ is to eliminate cancer cells responsible for bone destruction, alleviate pain, stimulate the regeneration of bone lost to lytic lesions, enhance overall quality of life, while improving survival rates.' Article content The 26-week study, conducted at the University of British Columbia, (UBC) Vancouver, BC, Canada, will evaluate the safety and efficacy of ZetaMet™ (Zeta-BC-003) in treating vertebral bone defects created by lytic metastatic breast cancer. The study will measure the reduction of skeletal related events (SRE), pain, change in vertebral body defect size, and postoperative prescribed opioid use. The Company anticipates reporting top-line results early fourth quarter of 2025. Article content Zetagen expects to submit an Investigation New Drug (IND) application to the U.S. Food and Drug Administration ('FDA'), leveraging its FDA's Breakthrough designations. Article content ZetaMet™ (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, administered locoregionally, to inhibit pain while regenerating new bone, with the potential to increase survival rates. Article content ZetaMet's (Zeta-BC-003) small molecule mechanism of action (MOA) via a novel molecular pathway initiates a circuit which results in tumor cell death. Article content The US Food & Drug Administration (FDA) has recognized Zetagen's discoveries with multiple Breakthrough Designations including ZetaMet™ (Zeta-BC-003). Article content Zetagen with FDA and Health Canada (HC) approval via their Expanded Access (Compassionate Use) programs has treated several patients with ZetaMet™ (Zeta-BC-003) with results published in multiple peer-reviewed journals. Article content Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet™ (Zeta-BC-003) demonstrated resolution of 7 lytic lesions (radiated and non-radiated), reduction in pain, significant reduction in opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer. To view this publication via open access, go to: Article content Founded in 2015, Zetagen Therapeutics is a private, clinical-stage, biopharmaceutical company dedicated to developing breakthrough therapies via local administration for metastatic and primary breast cancers. Article content The company's 'Zeta' platform encompasses the following breast oncological drug candidates ZetaMet™ (Zeta-BC-003), ZetaMAST™ (Zeta-MBC-005) and (NEW) ZetaPrime™ (Zeta-PBC-007). To learn more, visit Article content Zetagen will attend the upcoming San Antonio Breast Cancer Symposium (SABCS) this December. Article content 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. Source: Zetagen Therapeutics, Inc. Article content Article content Article content Article content Article content Article content
