Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases
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(Patients with disseminated metastatic disease from breast cancer are likely to have liver involvement in >50% of cases at some point during disease progression.
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These patients have poor prognosis; and, when treated with the standard of care systemic therapy they have a median survival of <9-months.)
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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.
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SYRACUSE, N.Y. — 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.
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About ZetaMAST™ (Zeta-MBC-005)
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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.
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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.
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Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase 1b clinical trial set to commence early 2026.
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About Zetagen Therapeutics
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Zetagen has three novel drugs in development,
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ZetaMet™ (Zeta-BC-003)
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, for the treatment of metastatic breast cancer to bone,
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ZetaMast™ (Zeta-MBC-005)
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for breast cancer liver metastases (BCLM), and
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(NEW) ZetaPrime™ (Zeta-PBC-007)
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for the treatment of primary HR+ breast cancer, all with inspiring results. To learn more, visit
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.
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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.
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Zetagen Upcoming Events
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Zetagen will attend the 2025 San Antonio Breast Cancer Symposium (SABCS).
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Forward-Looking Statements
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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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CTV News
2 hours ago
- CTV News
A long-standing puzzle of ‘missing' ordinary matter in the universe may be solved, astronomers say
An artist's illustration depicts ordinary matter as pops of color in the spaces between galaxies. Jack Madden/IllustrisTNG/Ralf Konietzka/Liam Connor/CfA via CNN Newsource Astronomers have used mysterious fast radio bursts, or millisecond-long bright flashes of radio waves from space, to help them track down some of the missing matter in the universe. Dark matter and dark energy make up most of the universe. Dark matter is an enigmatic substance that shapes the cosmos, while dark energy is a force that accelerates the expansion rate of the universe, according to NASA. Both are impossible to directly observe but can be detected due to their gravitational effects. But the rest of the universe is made of cosmic baryons, or ordinary matter, which can be found in tiny particles called protons and neutrons. 'If you add up all the stars and planets and cold gas that you see with your telescopes, it only amounts to less than 10% of ordinary matter in the universe,' said Liam Connor, assistant professor of astronomy at Harvard University. While astronomers thought most of the universe's ordinary matter was floating in the spaces between galaxies, called the intergalactic medium, or within the extended halos of galaxies — vast, spherical regions including stars and hot gas — they couldn't measure this foglike matter. That's because ordinary matter emits light at different wavelengths, but much of it is so diffuse that it's like trying to spot fog, astronomers say. The inability to detect roughly half of the cosmos' ordinary matter led to a decades-long cosmology struggle called the missing baryon problem. Now, Connor and his colleagues have directly observed the missing matter by using the flashing of fast radio bursts to essentially map out what couldn't be seen before. They reported their findings in a new study published Monday in the journal Nature Astronomy. 'The FRBs shine through the fog of the intergalactic medium, and by precisely measuring how the light slows down, we can weigh that fog, even when it's too faint to see,' Connor, the paper's lead author, said. Much of the work for the study took place while Connor was a research assistant at the California Institute of Technology. Down the road, astronomers believe they can use fast radio bursts to help illuminate the otherwise invisible structure of the universe. Flashing lights lead the way More than a thousand fast radio bursts, or FRBs, have been detected since their discovery in 2007. Only about 100 have been traced back to galaxies, according to the study authors. Astronomers are still unsure of the exact causes behind the bursts, but finding more of them could reveal their murky origins. universe matter An artist's depiction shows how brief, bright bursts of radio waves travel through the fog between galaxies, known as the intergalactic medium. Each wavelength allows astronomers to 'weigh' the otherwise invisible ordinary matter. Melissa Weiss/CfA via CNN Newsource To illuminate the missing matter, the new analysis relied on a mixture of previously observed fast radio bursts, as well as bright flashes that had never been observed until the research was underway. The 69 fast radio bursts examined in the study exist at distances ranging from 11.74 million to nearly 9.1 billion light-years from Earth. The farthest, named FRB 20230521B, was discovered during the research and is the current record holder for the most distant fast radio burst ever observed. The study team used the Deep Synoptic Array, a network of 110 radio telescopes, to find and identify 39 of the fast radio bursts in the study. The telescope array, designed to trace fast radio bursts back to their origin points, is located near Bishop, California, at Caltech's Owens Valley Radio Observatory. The W. M. Keck Observatory in Hawaii and Palomar Observatory near San Diego helped measure the distances between the fast radio bursts and Earth. And the other 30 fast radio bursts were found by the Australian Square Kilometre Array Pathfinder and other telescopes around the world. When radio waves travel as fast radio bursts toward Earth, their light can be measured in different wavelengths that spread out. How much the light spreads out is dependent on how much matter is in its path. The team was able to measure how much each fast radio burst signal slowed down as it passed through space before reaching Earth, illuminating the gas it encountered along the way. The speed of fast radio bursts can be affected by what they travel through, meaning different wavelengths of light arrive at different times. While long, red wavelengths travel more slowly to reach Earth, shorter, bluer wavelengths arrive more quickly. Each wavelength allowed astronomers to measure the invisible matter. The short pulses of fast radio bursts are crucial for this measurement because they act like flashing cosmic beacons, Connor said. 'We can measure very precisely how much the radio pulse is slowed down at different wavelengths (it's called plasma dispersion), and this effectively counts up all the baryons,' Connor said. 'For a star that shines continuously or a source that is not in the radio, we can not measure this 'dispersion' effect. It must be impulsive, short, and at radio wavelengths.' The team was able to use the dispersion of light to map and measure matter along the pathway of the fast radio bursts. 'It's like we're seeing the shadow of all the baryons, with FRBs as the backlight,' said study coauthor Vikram Ravi, an assistant professor of astronomy at Caltech, in a statement. 'If you see a person in front of you, you can find out a lot about them. But if you just see their shadow, you still know that they're there and roughly how big they are.' universe matter The Deep Synoptic Array helped astronomers find previously unknown fast radio bursts. Vikram Ravi/Caltech/OVRO via CNN Newsource After mapping out all the fast radio bursts and the matter they passed through and illuminated, the team determined that 76% of cosmic matter exists as hot, low-density gas in the space between galaxies. Another 15% can be found in galactic halos, while the remainder is located within galaxies themselves as stars, planets or cold gas. A crucial cosmological tool The observation-based findings align with prior predictions made using simulations, according to the study authors. William H. Kinney, professor of physics at the University at Buffalo's College of Arts and Sciences, agreed. 'So the upshot is that they came up with a new way of finding the baryons we knew had to be there, but whether they were really in the (intergalactic medium) instead of in halos was still something of an open question,' said Kinney, who was not involved in the research. 'The decades-old 'missing baryon problem' was never about whether the matter existed,' Connor said. 'It was always: Where is it? Now, thanks to FRBs, we know: Three-quarters of it is floating between galaxies in the cosmic web.' Understanding the distribution of ordinary matter can help researchers understand how galaxies grow and evolve. 'Baryons are pulled into galaxies by gravity, but supermassive black holes and exploding stars can blow them back out — like a cosmic thermostat cooling things down if the temperature gets too high,' Connor said. 'Our results show this feedback must be efficient, blasting gas out of galaxies and into the (intergalactic medium).' Fast radio bursts also may be able to help map the cosmic web in detail, Ravi said. This structure, largely made of dark matter, serves as the backbone of the universe, according to NASA. Caltech is currently planning to build another radio telescope in the Nevada desert, which could build upon the findings from the new study by finding and tracing up to 10,000 fast radio bursts per year, Connor said. 'It's a triumph of modern astronomy,' Ravi said. 'We're beginning to see the Universe's structure and composition in a whole new light, thanks to FRBs. These brief flashes allow us to trace the otherwise invisible matter that fills the vast spaces between galaxies.'


Globe and Mail
8 hours ago
- Globe and Mail
Diabetes Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight
Diabetes Companies are vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. (Albany, USA) DelveInsight's, ' Diabetes Pipeline Insight 2025 ' report provides comprehensive insights about 200+ companies and 200+ pipeline drugs in the Diabetes pipeline landscape. It covers the Diabetes pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetes therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Diabetes Pipeline. Dive into DelveInsight's comprehensive report today! @ Diabetes Pipeline Outlook Key Takeaways from the Diabetes Pipeline Report In April 2025, Gan & LEE Pharmaceuticals announced a study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin. In March 2025, Dong-AST Co. Ltd announced a study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control. In March 2025, Novo Nordisk A/S announced a study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. DelveInsight's Diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for Diabetes treatment. The leading Diabetes Companies such as vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Promising Diabetes Therapies such as Aspirin, DA-2811, Forxiga, TG103, and others. Stay ahead with the most recent pipeline outlook for Diabetes. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Diabetes Treatment Drugs Emerging Diabetes Drugs Profile Cadisegliatin: vTv Therapeutics Cadisegliatin, also known as TTP399, is an innovative oral medication developed by vTv Therapeutics, designed as a liver-selective glucokinase activator. It aims to serve as an adjunctive therapy to insulin for individuals with type 1 diabetes (T1D). This drug has been recognized for its potential to improve glycemic control by enhancing hepatic glucose uptake and glycogen storage independently of insulin, addressing a critical need in diabetes management. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. LY-3209590: Eli Lilly and Company Insulin efsitora alfa (LY3209590) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase III development for adults with type 1 and 2 diabetes. THDB0206: Tonghua Dongbao Pharmaceutical BC Lispro (THDB0206) is an ultra-rapid-acting insulin analog developed by Tonghua Dongbao Pharmaceutical Co., Ltd. for the treatment of Diabetes. BC Lispro is designed to restore early-phase insulin secretion, which is often impaired in diabetic patients. This insulin analog utilizes a new formulation technology that allows for rapid absorption and action, mimicking the physiological pattern of insulin secretion after meals. Such characteristics are expected to reduce the risk of late postprandial hypoglycemia, providing patients with greater flexibility in managing their insulin injections. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. CPL207280: Celon Pharma CPL207280 is a novel G-protein-coupled receptor 40 (GPR40) agonist under development for the treatment of Diabetes. CPL207280 acts as an agonist for GPR40, a receptor that plays a crucial role in enhancing glucose-stimulated insulin secretion from pancreatic beta cells. This mechanism is particularly beneficial for T2D patients, as it can improve glycemic control without the risk of hypoglycemia, a common side effect associated with other diabetes medications. Currently, the drug is in the Phase II stage of development to treat Diabetes. XW014: Sciwind Biosciences XW014 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sciwind Biosciences for the treatment of obesity and Diabetes (T2D). XW014 functions as a GLP-1 receptor agonist, which means it mimics the action of the GLP-1 hormone that is released after meals. This hormone plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. As an oral small molecule, XW014 offers advantages over traditional peptide-based GLP-1 therapies, such as ease of administration and the potential for combination therapies with other oral medications. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diabetes. KN056: Suzhou Alphamab Co., Ltd. KN-056 is a glucagon-like peptide-1 receptor (GLP-1R) modulator developed by Suzhou Alphamab Co., Ltd. for the treatment of Diabetes. KN-056 functions as a GLP-1R modulator, which means it targets the glucagon-like peptide-1 receptor. GLP-1 is a hormone that plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. By modulating the GLP-1 receptor, KN-056 aims to improve glycemic control in patients with Diabetes. Currently, the drug is in the Phase I stage of its clinical trial for the treatment of Diabetes. The Diabetes Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Diabetes with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetes Treatment. Diabetes Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Diabetes Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetes market Explore groundbreaking therapies and clinical trials in the Diabetes Pipeline. Access DelveInsight's detailed report now! @ New Diabetes Drugs and Medication Diabetes Companies vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. The Diabetes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Diabetes Products have been categorized under various Molecule types such as, Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of Diabetes Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Diabetes Market Drivers and Barriers Scope of the Diabetes Pipeline Report Coverage- Global Diabetes Companies- vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Diabetes Therapies- Aspirin, DA-2811, Forxiga, TG103, and others. Diabetes Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Diabetes Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Diabetes Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Diabetes Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Diabetes: Overview Pipeline Therapeutics Therapeutic Assessment Diabetes– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Cadisegliatin: vTv Therapeutics Drug profiles in the detailed report….. Mid-Stage Products (Phase II) CPL207280: Celon Pharma Drug profiles in the detailed report….. Early Stage Products (Phase I) KN056: Suzhou Alphamab Co., Ltd. Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Diabetes Key Companies Diabetes Key Products Diabetes- Unmet Needs Diabetes- Market Drivers and Barriers Diabetes- Future Perspectives and Conclusion Diabetes Analyst Views Diabetes Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +19193216187 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:

National Post
8 hours ago
- National Post
Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases
Article content (Patients with disseminated metastatic disease from breast cancer are likely to have liver involvement in >50% of cases at some point during disease progression. Article content These patients have poor prognosis; and, when treated with the standard of care systemic therapy they have a median survival of <9-months.) Article content 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. Article content SYRACUSE, N.Y. — 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. Article content About ZetaMAST™ (Zeta-MBC-005) Article content 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. Article content 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. Article content Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase 1b clinical trial set to commence early 2026. Article content About Zetagen Therapeutics Article content Zetagen has three novel drugs in development, Article content ZetaMet™ (Zeta-BC-003) Article content , for the treatment of metastatic breast cancer to bone, Article content ZetaMast™ (Zeta-MBC-005) Article content for breast cancer liver metastases (BCLM), and Article content (NEW) ZetaPrime™ (Zeta-PBC-007) Article content for the treatment of primary HR+ breast cancer, all with inspiring results. To learn more, visit Article content . Article content 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. Article content Zetagen Upcoming Events Article content Zetagen will attend the 2025 San Antonio Breast Cancer Symposium (SABCS). 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 Contacts Article content Investor Inquiries: Article content Article content Article content