Zetagen Therapeutics Announces Successful Completion of Enrollment in Phase 2a Clinical Study of ZetaMet™ (Zeta-BC-003) Metastatic Breast Cancer

(690,000 patients annually are diagnosed with metastatic lytic bone lesions with only non-curative, palliative therapies available)

• 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

SYRACUSE, N.Y.--(BUSINESS WIRE)--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 (ClinicalTrials.gov #NCT05280067).

"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."

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.

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.

About ZetaMet™ (Zeta-BC-003)

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.

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.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet™ (Zeta-BC-003).

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.

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: https://www.tandfonline.com/doi/full/10.2217/pmt-2023-0069

About Zetagen Therapeutics

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.

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 www.zetagen.com

Zetagen will attend the upcoming San Antonio Breast Cancer Symposium (SABCS) this 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. Source: Zetagen Therapeutics, Inc.