ZetaMet™ Receives Breakthrough Device Designation from U.S. Food and Drug Administration (FDA) for Treatment of Metastatic Bone Cancers

• The technology is a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone

• Zetagen Therapeutics is developing the therapy for patients living with metastatic bone lesions and other osteologic conditions

• The Company is targeting its first human clinical trial for metastatic bone lesions to begin in early 2022

SYRACUSE, N.Y.--(BUSINESS WIRE)--Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, today announced it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet™ technology. Previously known as ZetaFuse™, ZetaMet™ is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

“We are pleased to receive this important designation from the Agency and look forward to partnering with them,” said Joe C. Loy, CEO of Zetagen Therapeutics. “Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions.”

ZetaMet™ works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as “osteoblasts”, and inhibits cells associated with bone degradation called “osteoclasts”. The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called “lytic lesions.” Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.¹

ZetaMet™ has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

About Zetagen Therapeutics

Founded in 2015, Zetagen is a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions. Our multi-patented, ZetaMet™ technology is a first-of-its kind molecular pathway designed to suspend cancer, inhibit pain, and regenerate bone. Zetagen exclusively-licensed the platform technology from the State University of New York in 2016. This novel therapy, a drug-eluting implant technology, has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022. In addition to ZetaMet™, the Company’s pipeline includes other oncologic treatments for Skeletal Related Events (SREs), i.e., ZetaMet™ Flowable™ and ancillary osteologic treatments including, ZetaFuse™, ZetaSet™, ZetaDent™ and ZetaBase™. To learn more, visit www.zetagen.com

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 statement 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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^1	Li S, Peng Y, Weinhandl ED, et al. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93. doi:10.2147/CLEP.S28339