ZetaMet (Zeta-BC-003) / Zetagen Therap - LARVOL DELTA

Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions: Results from a Phase 2a Trial (SABCS 2025) - P2 | "There were no SREs and Zeta-BC-003 provided a CR (no active tumor) in all 6 pts for all 9 lesions, decreased MBC bone defect volume, increased stability (SINS), decreased pain (NRS & MED), and increased patient QoL. Zeta-BC-003 prevented SREs while 53% of MBC pts with bone mets reported an SRE (Parkes et al. Oncologist 2018)."

Clinical • Metastases • P2a data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Zetagen Therapeutics to Present Preliminary Results from Phase 2 Clinical Trial Targeting Metastatic Breast Cancer to Bone at the 2025 San Antonio Breast Cancer Symposium (Businesswire) - "The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067)....Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs).....A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions."

P2a data • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

ZGMBC: ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Zetagen Therapeutics, Inc | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

ZGMBC: ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Zetagen Therapeutics, Inc | Trial primary completion date: May 2025 ➔ Sep 2025

Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

ZGMBC: Evaluating ZetaMet Via Outpatient Local Intratumoral Injection Procedure to Treat Breast Cancer Bone Metastases in the Spine to Control Pain and Prevent Complications Such as Fracture (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Zetagen Therapeutics, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Musculoskeletal Diseases • Oncology • Pain • Solid Tumor

Zetagen Therapeutics Announces Successful Completion of Enrollment in Phase 2a Clinical Study of ZetaMet (Zeta-BC-003) Metastatic Breast Cancer (Businesswire) - "Zetagen Therapeutics, Inc...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 (ClinicalTrials.gov #NCT05280067)....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."

Enrollment closed • P2a data • Breast Cancer

ZGMBC: Evaluating ZetaMet Via Outpatient Local Intratumoral Injection Procedure to Treat Breast Cancer Bone Metastases in the Spine to Control Pain and Prevent Complications Such as Fracture (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Zetagen Therapeutics, Inc | Phase classification: P=N/A ➔ P2 | Trial completion date: Sep 2024 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ May 2025

Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Musculoskeletal Diseases • Oncology • Pain • Solid Tumor

Developing Topics. (PubMed, Alzheimers Dement) - "This study allowed us to rationally select different types of nanoparticles over others which will be further optimized using industrial methods. A validation of the active transport triggering will be made on a BBB-on-a-chip model. After validation, the NP effect on CC rhythmicity will be evaluated on organotypic brain culture and be formulated in dissolving microneedles."

Journal • Alzheimer's Disease • CNS Disorders • Sleep Disorder

Zetagen Therapeutics Expands IP Portfolio, Achieving a Milestone of 64 Worldwide Patents in 2024 (Businesswire) - "Zetagen Therapeutics, Inc...announced today in 2024 they nearly doubled their worldwide IP portfolio to 64 patents, spanning across 36 countries including the United States, Europe, Canada, Australia, Japan, United Kingdom, India, Sweden and Switzerland....'Our ambition is to continue growing our intellectual property portfolio with discoveries around the development of Zeta-BC-003 and Zeta-BC-005 for the treatments of metastatic breast cancer, but also for future discoveries towards primary breast cancer treatments'....Additional 34 patents under review including 10 with the USPTO; Including multiple submissions of Composition of Matter for new molecular entities."

Patent • Breast Cancer

Zetagen Therapeutics Announces First Patients Enrolled in Phase 2a Clinical Study of ZetaMet (Zeta-BC-003) Metastatic Breast Cancer (Businesswire) - "Zetagen Therapeutics, Inc...announced today that the first two patients have enrolled in the phase 2a study, which will evaluate ZetaMet (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions."

Trial status • Breast Cancer