Zetagen Therapeutics announced the publication of clinical data in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) highlighting the successful use of ZetaFuse (Zeta-ZF-002) in a patient with Stage 4 non-small cell lung cancer (NSCLC) and multi-level cervical degenerative disc disease (DDD). The study demonstrated radiographic fusion at all three cervical levels within eight months, despite the patient's compromised health and ongoing chemotherapy.
Breakthrough Therapy for Complex Cases
The report details the case of a 64-year-old patient with NSCLC, obesity, a history of smoking, and cervical DDD at three levels. Following a work-related accident, the patient underwent a three-level anterior cervical discectomy and fusion (ACDF) procedure utilizing ZetaFuse under an FDA Expanded Access protocol (Compassionate Use). ZetaFuse, a novel anti-tumorigenic and osteoinductive biomaterial, is designed to promote bone growth.
Overcoming Challenges to Bone Healing
According to Dr. Pedro Sanz-Altamira, a hematologist and oncology specialist at Dana Farber Cancer Institute, the patient had been treated with cytotoxic therapy and immunotherapy, both known to negatively impact bone healing. Despite this, the patient exhibited an "excellent bone healing response" to ZetaFuse.
Addressing Unmet Needs in Spine Surgery
Dr. Nikhil Thakur, Chief Medical Officer of Zetagen and an orthopaedic spine surgeon, emphasized the lack of approved resources for spine surgeons treating cancer patients with orthopedic fusion needs. The successful outcome in this case suggests the potential of ZetaFuse to fill this gap.
Zeta Platform and Metastatic Cancer Treatment
ZetaFuse shares the same mechanism of action as Zetagen’s lead oncology drug candidate, ZetaMet (Zeta-BC-003), which is currently in Phase 2a clinical trials for metastatic breast cancer to bone. Both ZetaFuse and ZetaMet have received FDA Breakthrough Designations. ZetaMet aims to resolve metastatic breast cancer bone lesions, inhibit pain, and regenerate bone, potentially increasing survival rates.
Prior Data on ZetaMet
Two-year follow-up data on ZetaMet, published in 2023, demonstrated resolution of lytic lesions, significant pain reduction, prevention of vertebral fracture, and increased survival in a patient with Stage 4 breast cancer. The patient experienced complete resolution of lesions and an increased survival rate of 36 months following treatment with ZetaMet.
Future Directions
Zetagen is currently enrolling patients in clinical trials for ZetaFuse in cervical fusion for DDD and ZetaMet for metastatic breast cancer lesions to the spine. The company's "Zeta" platform is based on a novel opioid growth factor receptor (OGFR) antagonist pathway targeting the management of the p21 transcript.
